C&EN
Makers of food additives are keeping their eyes on the spectacular growth of new foods and the shifting moods of regulation-minded Washington
Feature
Food
Additives Howard J . Sanders, Associate Editor, Chemical and Engineering News, Washington, D.C.
A
trip to the neighborhood supermarket and a scanning of its enticing array of food packages can be a revelation. What is immediately apparent is the almost staggering variety of foods available. They include everything from spinach soufflé, shrimp scampi, and blue-cheese dip to frozen daiquiri mix, frozen beef stroganoif, and canned lobster thermidor. Also, of course, bread, milk, eggs, meat, and other staples. Today, on its crammed, resplendently colorful shelves, the typical large supermarket carries some 8000 different food items. Twenty years ago, it might have carried only about 1500. A large supermarket nowadays may stock not only plain rice (both regular and precooked) but also wild rice, curry rice, herb rice, saffron rice, créole rice, chicken-flavored rice, and beefflavored rice. All that it probably offered 20 years ago was plain rice. The U.S. food industry is headed for an even greater diversity of products in the future. One food industry executive predicts, "Ten years from now, the big supermarkets will carry 12,000 items. Half of these will be different from those sold today." A host of factors is bringing about this revolution in the food industry. One of the most important is the growing use of food additives. These include flavors, flavor enhancers, preservatives, emulsifiers, artificial sweeteners, vitamins, colors, anticaking compounds, antifoaming agents, and many 100 C&EN OCT. 10, 1966
others. Without such additives, most of the new food products available today would be impossible—or at least grossly inferior by present standards. Take some random examples. General Mills' Rice Provence contains, among its many ingredients, monoand diglycerides (emulsifiers), monosodium glutamate (flavor enhancer), butylated hydroxyanisole, butylated hydroxytoluene, propyl gallate (antioxidants), propylene glycol (carrier), and citric acid (sequestering agent). General Foods' Whip 'n Chill dessert mix contains adipic acid (acidulant), propylene glycol monostearate (emulsifier), and sodium carboxymethylcellulose ( stabilizer ). Sara Lee's frozen cherry cream cheesecake contains sorbic acid (preservative) and ascorbic acid (antioxidant). General Foods' Awake, a frozen concentrate for imitation orange juice, contains citric acid (acidulant), gum arabic (thickener), carrageenan (stabilizer), vitamins A, Bl9 and C (nutrient supplements), and calcium phosphate (anticaking compound), in addition to flavors and artificial color. Without additives, Rice Provence, Whip 'n Chill, and Awake would be utterly impossible. Without additives, Sara Lee's cherry cream cheesecake, because of limited shelf life, might be commercially infeasible. In recent years, the demand for food additives has been steadily climbing. According to estimates by Arthur D. Little, Inc., the use of additives in
Part 1
foods made in the U.S. has risen from 419 million pounds in 1955 to 661 million pounds in 1965—a gain of 58% in 10 years. Looking to the future, ADL estimates that the use of food additives will climb to 852 million pounds in 1970 and to 1.03 billion pounds in 1975. These figures do not cover such widely used food ingredients as sugar, salt, and starch, which usually are not regarded as additives. On a dollar basis, the value at the manufacturers' level of additives used in foods made in the U.S. has increased from $172 million in 1955 to $285 million in 1 9 6 5 - a gain of 66%. By 1970, these 'sales are expected to reach about $400 million and by 1975 are likely to exceed $500 million. Companies with a special mission Although the rise in consumption of food additives has not been meteoric, it has been impressive. Also impressive has been the expanding number of chemical companies that in recent years have been placing special stress on developing new and better food
This is Part 1 of a two-part series. Part 2, which will appear next week, will be a detailed survey of individual food additives. It will also discuss new developments in the food industry that will affect the future demand for additives.
C&EN
Makers of food additives are keeping their eyes on the spectacular growth of new foods and the shifting moods of regulation-minded Washington
Feature
Food
Additives Howard J . Sanders, Associate Editor, Chemical and Engineering News, Washington, D.C.
A
trip to the neighborhood supermarket and a scanning of its enticing array of food packages can be a revelation. What is immediately apparent is the almost staggering variety of foods available. They include everything from spinach soufflé, shrimp scampi, and blue-cheese dip to frozen daiquiri mix, frozen beef stroganoif, and canned lobster thermidor. Also, of course, bread, milk, eggs, meat, and other staples. Today, on its crammed, resplendently colorful shelves, the typical large supermarket carries some 8000 different food items. Twenty years ago, it might have carried only about 1500. A large supermarket nowadays may stock not only plain rice (both regular and precooked) but also wild rice, curry rice, herb rice, saffron rice, créole rice, chicken-flavored rice, and beefflavored rice. All that it probably offered 20 years ago was plain rice. The U.S. food industry is headed for an even greater diversity of products in the future. One food industry executive predicts, "Ten years from now, the big supermarkets will carry 12,000 items. Half of these will be different from those sold today." A host of factors is bringing about this revolution in the food industry. One of the most important is the growing use of food additives. These include flavors, flavor enhancers, preservatives, emulsifiers, artificial sweeteners, vitamins, colors, anticaking compounds, antifoaming agents, and many 100 C&EN OCT. 10, 1966
others. Without such additives, most of the new food products available today would be impossible—or at least grossly inferior by present standards. Take some random examples. General Mills' Rice Provence contains, among its many ingredients, monoand diglycerides (emulsifiers), monosodium glutamate (flavor enhancer), butylated hydroxyanisole, butylated hydroxytoluene, propyl gallate (antioxidants), propylene glycol (carrier), and citric acid (sequestering agent). General Foods' Whip 'n Chill dessert mix contains adipic acid (acidulant), propylene glycol monostearate (emulsifier), and sodium carboxymethylcellulose ( stabilizer ). Sara Lee's frozen cherry cream cheesecake contains sorbic acid (preservative) and ascorbic acid (antioxidant). General Foods' Awake, a frozen concentrate for imitation orange juice, contains citric acid (acidulant), gum arabic (thickener), carrageenan (stabilizer), vitamins A, Bl9 and C (nutrient supplements), and calcium phosphate (anticaking compound), in addition to flavors and artificial color. Without additives, Rice Provence, Whip 'n Chill, and Awake would be utterly impossible. Without additives, Sara Lee's cherry cream cheesecake, because of limited shelf life, might be commercially infeasible. In recent years, the demand for food additives has been steadily climbing. According to estimates by Arthur D. Little, Inc., the use of additives in
Part 1
foods made in the U.S. has risen from 419 million pounds in 1955 to 661 million pounds in 1965—a gain of 58% in 10 years. Looking to the future, ADL estimates that the use of food additives will climb to 852 million pounds in 1970 and to 1.03 billion pounds in 1975. These figures do not cover such widely used food ingredients as sugar, salt, and starch, which usually are not regarded as additives. On a dollar basis, the value at the manufacturers' level of additives used in foods made in the U.S. has increased from $172 million in 1955 to $285 million in 1 9 6 5 - a gain of 66%. By 1970, these 'sales are expected to reach about $400 million and by 1975 are likely to exceed $500 million. Companies with a special mission Although the rise in consumption of food additives has not been meteoric, it has been impressive. Also impressive has been the expanding number of chemical companies that in recent years have been placing special stress on developing new and better food
This is Part 1 of a two-part series. Part 2, which will appear next week, will be a detailed survey of individual food additives. It will also discuss new developments in the food industry that will affect the future demand for additives.
additives and on providing better technical service to the food industry. Outstanding -among these companies is Monsanto, which, of course, is no newcomer to the additives field. In fact, the company's first three products were saccharin, caffeine, and vanillinall used in foods. In 1961, Monsanto executives, after carefully re-examining the question of where the company could make most effective use of its special scientific skills, agreed that one of the most promising areas was chemicals for foods. As a result, Monsanto that year set up a separate food ingredients section in its development department. The following year, it organized a separate food ingredients section in its research department. Today, Monsanto has four times as many people working on research, development, and marketing of food additives as it did in 1962. "Our food ingredients program," Monsanto president Charles H. Sommer told the company's annual shareholders' meeting in March, "is rapidly fulfilling its early promise. We expect its growth and profitability to accelerate as we become a closer working partner in the food-processing industry's efforts to improve the flavor and convenience of its products." Another extremely active company in the food additives field is Pfizer. Ever since the company launched its production of tartaric acid and cream of tartar in 1862, it has had an intense interest in the food industry. About five years ago, Pfizer set up a food and beverage department in its Chemical Division, with a sales force specifically assigned to the food industry. "Today," says Ira J. Friedman, director of chemical research and development at Pfizer, "more than half of the money we invest in chemical research (which does not include our research on drugs, minerals, pigments, metals, consumer products, and agricultural products) is spent on developing new products specifically for the food industry." In 1963, Union Carbide set up special research and development, technical service, and marketing groups to handle its products for the food, drug, and cosmetic industries. "We are definitely placing greater stress on marketing and research on food additives," says Dr. Charles E. Colwell, a research and development manager in Union Carbide's Chemicals Division. As one evidence of this intensified interest, Carbide in 1962 introduced a special trademark, Sentry, to designate 102 C&EN OCT. 10, 1966
PRODUCTION. Use of additives in foods made in the U.S. last year reached 661 million pounds. Among the many chemical plants turning out additives for the food industry is this Pfizer facility for making fumaric acid. Fumaric acid finds widespread use in gelatin desserts, puddings, and other foods
some of its major food-grade additives. This trademark now appears on its highest quality propylene glycol, sorbic acid, potassium sorbate, and sodium carboxymethylcellulose. "Very obviously," Dr. Colwell points out, "we are anxious to grow in the food area." Other chemical companies are likewise stepping up their emphasis on food additives. Among these are Allied Chemical, Mallinckrodt, Atlas Chemical Industries, Hercules, Abbott, Miles, and others. Admittedly, however, there has been no stupendous tidal wave of interest among chemical companies in general to develop new additives for the food industry. Some major chemical firms such as Du Pont say that their interest in food chemicals is no greater now than it was several years ago. Other companies, however, are clearly accelerating their research .and sales efforts in the food area. Fifteen or 20 years ago, they point out, many chemical companies supplying the food industry were content merely to fill orders, with no overwhelming enthusiasm, for chemicals that the food companies happened to need and had been using for years—acids, alkalies, gums, bleaching agents, colors, and so on. Often these were chemicals used in much larger quantities by other industries. The food industry, therefore, was "just another incidental customer." Now, more and more chemical companies are eagerly going out of their way to develop chemicals specifically designed to meet the specialized needs of the food industry. More and more chemical firms are working closely with
food companies to help solve the intricate scientific and technical problems involved in developing new foods. Reasons for interest Chemical companies have many compelling reasons for assiduously courting the food industry: • The food industry is the largest industry in the U.S. The typical American family spends more money on food than on any other single item in its budget. • Sales of the food industry are growing. Retail food sales have climbed from about $40 billion in 1950 to an anticipated $80 billion in 1966. This has come about partly because of the nation's expanding population and rising standard of living. It has also come about through the food industry's development of more highly formulated products that command premium prices. • The food industry is continually introducing new products—products that generally place a high demand on food additives. As one evidence of this growth of new food products, General Foods says that 28% of its total net sales in fiscal 1966 was accounted for by products it was not making 10 years ago. • Sales of convenience foods, which use especially large amounts of additives, have been sharply increasing. According to one estimate, the dollar sales of convenience foods in the U.S. have risen at an average rate of 1 1 % a year since 1958. On the other hand, in the same period, the dollar sales of all food products (including conveni-
ence foods) have grown at an average annual rate of only 4%. • In the past few years, a sharp increase has occurred in the sales of lowcalorie foods. This increase has resulted in a rapid growth in the d e m a n d for the non caloric sweeteners. This has also resulted in a rising d e m a n d for other additives used in low-calorie foods—flavorings, vitamins, thickening agents, and others. • T h e public is becoming increasingly interested in more sophisticated foods, more flavorful foods, more exotic foods. Partly, this trend is a result of greater world travel, higher standards of living, higher cultural levels. People who a few years ago would not b e caught dead eating anything b u t meat and potatoes are now avidly buying frozen pizzas, frozen Chinese dinners, frozen shish kebab, frozen enchiladas—not to mention such other frozen foods as flounder almondine, breast of chicken à la Kiev, broccoli au gratin, and asparagus hollandaisestyle. T h e public's growing preference for ethnic foods and for less bland and more highly formulated foods is increasing the d e m a n d for flavors, colors, and other food additives. • Foods are being shipped greater distances and are being stored for greater lengths of time. Consequently, there is a growing need for additives to prevent or retard food deterioration. These additives include mold inhibitors, yeast inhibitors, bac-
teria inhibitors, antioxidants, anticaking compounds, and others. • T h e food industry is becoming more technically knowledgeable. More food companies are willing to experiment with radically n e w food formulations. More are willing to try out not only n e w uses for traditional food additives b u t also compounds that are totally new. • People generally have more leisure time than ever and have developed a marked preference for informal dining. T h e y are spending more time in the family room around the television set or in the back yard around the charcoal grill. In the past few years, these trends have rapidly increased the d e m a n d for snack foods (pretzels, onion-flavored crackers, bacon-flavored potato chips, cheese d i p s ) . They have also increased the d e m a n d for convenience foods and outdoor cooking items (frozen entrees, soft-drink mixes, barbecue sauce, instant marin a d e m i x ) . Many of these products d e p e n d heavily on the use of additives. Says a spokesman for Fritzsche Brothers, a leading flavor manufacturer, "In the past few years, our sales of flavors to snack producers have undergone fantastic growth. Our sales of concentrated garlic flavor and onion flavor have absolutely skyrocketed." • Industry experts agree that the years ahead will see rapidly expanding use of food substitutes—simulated meats, simulated orange juice, simu-
lated coffee, and many others. Such products will provide a powerful stimulus to the use of a diversified array of food additives. Convenience
foods
Of all the factors promoting the sales of food additives, probably the most important has been the mounting d e m a n d for convenience foods—cake mixes, frozen pies, T V dinners, dehydrated potatoes, dry soups, frozen fish
FLAVORS. The public is becoming increasingly interested in more sophisticated, more flavorful foods. James T. Ryan, Jr., of International Minerals & Chemical inspects a sample from the company's large collection of flavorings. IMC is the nation's leading producer of the flavor enhancer, monosodium glutamate
SOFT DRINKS. A major market for food additives is in soft drinks. The rising demand for low-calorie beverages is rapidly pushing up the sales of artificial nonnutritive sweeteners OCT. 10, 1966 C&EN
103
GEL RESEARCH. Major food companies are continually carrying out research on new products. A scientist at General Foods' Technical Research Center uses an automatic titrator in studying the transformations of gels
sticks, brown-and-serve rolls. The housewife of today, who may very likely have an outside job or be deeply involved in community activities, is no longer willing to spend three hours in the kitchen preparing dinner. She wants to get it on the table, piping hot, in a half hour or less. Partly because of her greater buying power, she is quite willing to pay the extra price for what food companies elegantly call "foods with built-in maid service." The increasing demand for convenience foods is reflected in the phenomenal rise in the sales of frozen foods. According to Quick Frozen Foods magazine, U.S. sales of commercial prepared frozen foods (excluding potatoes and seafoods, which it classifies elsewhere) rose from 0.28 billion pounds in 1954 to 1.95 billion pounds in 1964—a sevenfold increase in a mere 10 years. Expressing the views of many leaders in the food additives field, Joseph G. Jarrell, industry manager of the cellulose and protein products department of Hercules, says, "Our optimism 104
C&EN OCT. 10, 1966
about the use of chemical additives in the food industry is based largely on the sensational growth of convenience foods." Such foods usually require more additives than conventionally cooked foods because in many cases they are prepared under more severe conditions of temperature, pressure, or agitation. Therefore, they may require special flavorings, flavor enhancers, colors, and other additives to make up for the partial loss of flavor, color, texture, and other properties caused by processing. Also, convenience foods, unlike conventional home-cooked foods, are often not eaten immediately after they are prepared. Therefore, they may need special preservatives, antioxidants, and other additives to maintain their freshness and desired physical properties over long periods of time. Pointing to the huge benefits made possible by convenience foods, Dr. Emil M. Mrak, chancellor of the University of California, Davis, says, "Convenience foods have literally disenslaved the housewife. They have permitted her to serve with ease a diversity of nutritious foods of consistent high quality. . . . These great advances have been brought about through the work of chemists, their development of new processes, and the safe use of chemicals." Value of additives In today's foods, additives serve an enormous range of functions. They make foods more nutritious, more colorful, more flavorful. They inhibit the staling, molding, or bacterial decomposition of foods, the browning of fruit, and in other ways prevent or retard the deterioration of foods. They stabilize foods by inhibiting the separation of salad oils or the collapse of whipped toppings. Some food additives speed up the manufacture of foods. One compound, for example, makes it possible to cure sausages in 20 to 30 minutes, compared to the 90 minutes or more required previously. Other additives accelerate the aging of flour or the clarification of wines. Some additives improve the texture of foods, prevent the caking of particles, increase the viscosity of foods, adjust the alkalinity or acidity of foods, or aid in the leavening of baked products. Others keep foods moist, tie up unwanted metals, or act as dispersing agents for flavors, colors, antioxidants.
Intentional and
nonintentional
All of these compounds are intentional food additives. That is, they are materials deliberately added to foods in relatively low concentration to serve some specific desirable purpose. Food additives, however, can also be nonintentional. The nonintentional additives get into food not because they are expected to serve some useful function in the final product but because they are more or less unavoidable. In this category are such things as a plasticizer in a packaging film that migrates into a food, or a pesticide that remains as a tiny residue on an agricultural crop, or an equipment lubricant that manages to adhere to a food. None of these serve a useful function in the food but, where they are present in permitted low concentration, are considered harmless. Recognizing the broad scope of the term "food additive," the Food Protection Committee of the National Academy of Sciences-National Research Council several years ago came up with an all-encompassing definition. "A food additive," the committee said, "is a substance or a mixture of substances, other than a basic foodstuff, which is present in food as a result of any aspect of production, processing, storage, or packaging." Clearly, this definition, which will serve as our definition of "food additive" in this report, includes both intentional and nonintentional additives. In this report, however, the emphasis will be primarily on intentional food additives. These deliberate additives, in fact, are what most people think of when they speak of food additives. Additives
amendment
By far the most significant development in the food additives field in the past decade was the enactment on Sept. 6, 1958, of the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act of 1938. This amendment, which took effect on March 6, 1960, completely altered the Government's method of regulating the use of additives in foods. The law has had a profound impact on the food additives field and on the food industry in general. Its repercussions are still being deeply felt and will continue to be felt for many years to come. Enactment of the Food Additives
LEAVENING. Large quantities of chemicals are used as leavening agents in baked goods. A home economist (left) and a cereal technician at Stauffer investigate the use of a new leavening formulation for a biscuit dough
KITCHEN. Many food companies have for testing food products under homelike prepared in this way are often tested evaluate the public acceptance of a new
their own kitchens conditions. Foods by taste panels to product
VITAMINS. One of the most important food additives is vitamins. Pfizer makes vitamin C (ascorbic acid) in this plant at Groton, Conn. Vitamin C is added to many frozen or canned fruits, fruit juices, and fruit drinks
NONINTENTIONAL. Food companies are concerned about both intentional additives and the nonintentional ones, such as pesticides. K. E. Dugganf a chemist at General Foods, uses a gas chromatograph to measure pesticide residues
THEIR TOTAL SALES INCREASING, FOOD ADDITIVES INCLUDE STAR Millions of dollars at the manufacturers' level of additives" used in foods made in the U.S. 1955
Emulsifiers Acidulants Stabilizers and thickeners Flavoring agents and flavor enhancers Leavening agents Preservatives (including antioxidants) Artificial sweeteners Colors (FD&C certified) Miscellaneous 6 Totals
I960
1963
1962
1961
1964
1965
$18.76 17.45 44.59 61.63
$27.28 20.97 54.58 60.25
$29.41 22.20 56.98 66.84
$33.30 22.90 61.25 71.16
$35.18 24.76 63.50 61.78
$38.10 24.55 76.16 60.11
$40.0 24.6 80.0 62.5
3.52 8.20
4.02 16.20
4.00 18.40
3.96 21.40
4.08 24.24
4.27 26.05
27.5
0.50 6.39 10.68
6.61 9.48 14.14
7.99 8.46 15.52
9.40 9.45 17.72
9.77 10.25 20.20
7.89 10.40 25.77
10.5 27.0
$171.72
$213.53
$229.80
$250.54
$253.76
$273.30
$285.3
4.2
9.0
a
Does not include such widely used ingredients as sugar, salt, and starch. Source: Arthur D. Little, Inc., estimates
Amendment, which was passed by the House and Senate in the closing days of the 85th Congress, received, in general, only modest coverage in the daily press. The brief news item on page one of The New York Times of Sunday, Sept. 7, 1958, which reported the signing of the measure by President Eisenhower, was severely overshadowed by news stories bearing such attention-getting headlines as SHELLING OF QUEMOY Is HALTED . . . MUSKIE'S CHANCES ON RISE IN MAINE . . . B U L GANIN OUSTED FROM PRESIDIUM . . . MEXICAN CAPITAL SWEPT BY RIOTING.
Although the Food Additives Amendment lacked somewhat the dramatic quality of temporarily halted bombings in Asia and of flaring riots in Mexico City, it was not lacking in significance to the average American consumer. The law provided, for the first time, that no additive could be used in foods unless the Food and Drug Administration, after a careful review of the test data, agreed that the compound was safe at the intended levels of use. An exception was made for all additives that, because of years of widespread use in foods, were "generally recognized as safe" (GRAS) by experts in the field. These GRAS (pronounced "grass") substances, which include pepper, cinnamon, baking powder, citric acid, monosodium glutamate, mono- and diglycerides, and about 575 other materials, did not have to undergo extensive or renewed animal testing to be approved as safe in foods. On the basis of somewhat tortured reasoning, these GRAS substances are not even considered food additives under the terms of the Food Additives Amendment. In the case of most GRAS substances, the Food and Drug Administration has not established tolerance levels. In other words, it has not spec106 C&EN OCT. 10, 1966
The Food Additives Amendment not only requires that an intentional additive be safe in its intended use but implies that it must also perform its intended function. The manufacturer must submit to FDA the data indicating the minimum amount of an antioxidant, for example, actually needed to retard oxidation, so that the tolerance, if any, may be set no higher than necessary. Under the law, FDA is not required to pass judgment on whether the function served by the additive is, in fact, desirable. This judgment is left to the market place. The Food Additives Amendment applies both to intentional and nonin-
ified the maximum allowable concentration of the additive in each type of food. F D A merely requires that the additive be of appropriate food grade, that the user follow good manufacturing practice, and that he use the least amount needed to accomplish the intended result. In the case of approved non-GRAS substances, FDA sets necessary specifications for the product and, in most cases, establishes specific tolerances. For example, the tolerance for the séquestrant, calcium disodium EDTA, is 25 p.p.m. in beer, 100 p.p.m. in pecan-pie filling, 275 p.p.m. in cooked canned crabmeat.
J
Use of food additives rises more than 50% in decade Total pounds of additives8 used in foods made in the U.S. Millions of pounds
rotal value at manufacturers' level
1
()f additives8 used in foods made in the U.S.
I 300
125° Ι 200
Millions of dollars
1 j 1
1 720
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'55 '60 '61 '62 '63 '64 '65 '55 '60 '61 '62 '63 '64 '65 1 a Does not include such widely used ingredients as sugar, salt, and starch. 1 Source: Arthur D. Littje, Inc„ estimates 1
PERFORMERS, ALSO-RANS, A N D SOME JUST WAITING TO BE ASKED Millions of pounds of additives a used in foods made in the U.S. Emulsifiers Acidulants Stabilizers and thickeners Flavoring agents and flavor enhancers Leavening agents Preservatives (including antioxidants) Artificial sweeteners Colors (FD&C certified) Miscellaneous 6 Totals
,
1964
1965
1955
I960
1961
1962
1963
75.70 92.50 63.80 38.10
106.00 103.40 79.80 49.40
113.10 109.40 85.40 56.90
128.40 113.50 92.30 65.90
132.70 118.30 96.70 64.70
141.20 120.20 100.80 70.60
150.0 120.5 105.0 73.0
64.50 21.85
67.10 31.06
66.00 32.35
65.30 39.15
64.30 44.35
64.90 47.96
64.0 50.0
0.25 1.69 60.60
3.54 2.34 68.90
4.25 2.02 73.30
5.00 2.35 75.70
6.30 2.55 77.90
8.00 2.60 84.90
10.0 86.0
418.99
511.54
542.72
587.60
607.80
641.16
661.1
2.6
b
Includes nutritional supplements, enzymes, dough conditioners, anticaking compounds, moisture-retaining agents, yeast foods, clouding agents, séquestrants, and others.
tentional additives. However, it does not apply to pesticides on raw agricultural crops, which are covered by the 1954 Miller Pesticide Amendment. It also does not apply to food colors, which are covered by the 1960 Color Additive Amendments. It does, however, apply to foods preserved by ionizing radiation-on the grounds that this treatment, if excessive, might bring about chemical changes in foods that might be hazardous. As of June 30, 1966, about 2430 food additives (not including GRAS substances) were subject to FDA regulations under the Food Additives Amendment. This figure compares to about 2400 additives subject to regulations as of June 30, 1965, and 1540 additives as of June 30, 1964. The sizable increase of about 860 between fiscal 1964 and 1965 was caused mainly by the large number of synthetic and natural flavors that were finally granted official clearance. Prior to the amendment Before the Food Additives Amendment came into being, FDA could take no action whatever against a possibly harmful additive until it was already being used in foods involved in interstate commerce. FDA itself had to perform the necessary lengthy testing to prove the potential harmfulness of the additive and then carry its case to the courts in the hope of banning the offending chemical. Because of the often glacial slowness of this procedure, a food additive might have been in commercial use for months or even years before it could be removed from the food supply. Actually, the vast majority of food additive producers and food companies in those pre-amendment days took positive steps to ensure the safety of
their products before they were placed on the market. These steps were usually not as numerous or as thorough as they are today, but certainly most companies were vitally concerned about maintaining their reputations as responsible manufacturers, conscious of the public welfare. The chief problem was with the occasional irresponsible company that placed additives on the market with almost no safety testing or used additives wholly indiscriminately. As an executive of one major company points out, with obvious feeling, "The albatross around our necks in those days was the fly-by-night outfits, the gypsies. For example, there was that unscrupulous character who loaded his Halloween candy with so much orange dye that dozens of kids got sick." In April 1958, Elliot L. Richardson, then Assistant Secretary of the Department of Health, Education, and Welfare, told the Congressional subcommittee investigating the proposed Food Additives Amendment, "The bulk of the food and chemical industries is to be commended for voluntarily adopting precautions to forestall detriment to the public health. The commendable actions of the great majority, however, cannot provide protection against the minority. ,, Evolution of the amendment The Food Additives Amendment was an outgrowth of deliberations and hearings extending as far back as 1950. The proposed law aroused a torrent of controversy. Although many companies in the food and chemical industries actively supported the measure, others were vehemently opposed. In some quarters, the concept that food additives must be approved as safe by the Government before they
can be used in foods was met with fierce hostility. Some of the prime objections : • Government approval of food additives would be hopelessly bogged down in government paper work and red tape. The law would be grossly mishandled by "government zealots" or by "capricious, power-hungry Washington bureaucrats." • A n inordinate amount of testing would be required to obtain FDA approval of new additives. The cost of developing new additives and of establishing their safety would be prohibitive. The length of time involved in getting FDA approval would seriously delay the introduction of valuable new compounds. These factors, imposing an intolerable burden, would sharply reduce the incentive to develop new food additives. • Because it is much easier and safer to reject an additive rather than approve one, which, to the horror of all concerned, might later turn out to be harmful, FDA would be strongly persuaded to ban the use of many new additives. Much-needed additives would thus be kept off the market by the arbitrary, unreasonable decisions of "vulnerable civil servants." • Companies would be forced to reveal the composition of additive formulations that they had long held secret. • Since the reliable firms were already doing extensive testing to prove the safety of new food additives and since the Federal Food, Drug, and Cosmetic Act already provided means for controlling the use of additives, the new law was unnecessary. • The position of the small manufacturer of food additives would be gravely jeopardized. As the general counsel to the National Small Business Men's Association wrote somewhat disOCT. 10, 1966 C&EN
107
SOME ADDITIVES HAVE BEEN BANNED BECAUSE OF QUESTIONABLE SAFETY OR UNETHICAL USE The unfolding story of the use of chemicals in foods has obviously not been an endless procession of dazzling achievements, unmarred by occasional setbacks. Over the years, a number of food chemicals, sometimes after many years of use, have been banned by the Food and Drug Administration as hazardous. Various other chemicals have been prohibited because they could deceive the customer into thinking that a food was better than it really was or because they could camouflage poor manufacturing practices. FDA's action in prohibiting the use of various food additives has come about through expanding knowledge of the chemistry and toxicology of these compounds. "Our knowledge," declares one FDA official, "is not static. We must continually make changes, where necessary, on the basis of reliable new information—information that in many cases may result from new or improved experimental methods." In recent years, a number of additives have been banned because of the increased ability of scientists to determine subtle toxicological changes in test animals and to measure extremely minute quantities of chemicals in foods. Other additives have been banned because of a growing body of experience in the large-scale use of these compounds and because of the gradual, long-term evolution of scientific knowledge. Years back, some companies used monochloroacetic acid to preserve wines, carbonated beverages, salad dressings, and pickles. In one notorious instance, large numbers of people became ill from drinking an orange-flavored soft drink preserved with monochloroacetic acid. In the early 1940's, FDA barred the further use of this compound in foods. In the past, some companies used chemicals to upgrade deceptively the quality of foods. Sulfites, for example, were used to redden stale meat. Copper was used to brighten the green color of canned peas and thus make them appear less mature. Such doctoring of foods has been strictly forbidden ever since the Federal Food, Drug, and Cosmetic Act was passed in 1938. For about 25 years, nitrogen trichloride (Agene) was used to bleach and promote the aging of flour. In 1946, a British physician, Sir Edward Mellanby, found that dogs fed large quantities of flour treated with nitrogen trichloride developed running fits or canine hysteria. This material can also produce convulsions in cats, rabbits, and mink. The toxic compound was later found to be methionine sulfoxamine, formed in the flour by the action of nitrogen trichloride on methionine. In 1949, FDA prohibited the use of nitrogen trichloride to bleach and accelerate the aging of flour. Actually, no evidence was ever obtained that flour treated in this way was harmful to humans. Moreover, the milling industry had already stopped using the compound. For years, dulcin (4-ethoxyphenylurea) was used as an artificial sweetener. First synthesized in 1883, this compound is about 2 5 0 times sweeter than sucrose. In 1950, FDA prohibited its further sale after it was shown to produce cancer in rat livers. 108 C&EN OCT. 10, 1966
For almost 75 years, coumarin was a widely used ingredient in synthetic vanilla flavors and in chocolate and other confections. After coumarin was found to cause liver damage in rats and dogs, FDA in 1954 banned the use of the compound and its natural source, the tonka bean, as a food additive. Over the years, FDA has banned a number of synthetic food colors. In 1956, it withdrew its approval of FD&C Orange No. 1, FD&C Orange No. 2, and FD&C Red No. 3 2 . In 1960, it banned FD&C Yellows No. 1 , 2, 3, and 4 and FD&C Red No. 1 . In 1965, it prohibited the unrestricted food use of FD&C Red No. 4. All of these actions were taken as a result of FDA research showing the harmful effects of these compounds when ingested at high levels by laboratory animals. For about 10 years, diethylstilbestrol, a synthetic female sex hormone known to be a weak carcinogen, was permitted to be used in young male chickens if no residue remained in the edible portions of the animals at the time of slaughter. Diethylstilbestrol produced artificial caponization of the birds and thus made them fatten up faster. FDA later found that very small amounts of this compound, under actual conditions of use, were present in the livers and skin fat of the treated chickens. In 1959, FDA forbade further use of the compound in poultry, although it does permit its use in beef cattle because no residues are found at the time of slaughter. Perhaps the most widely known food additive banned under the 1958 Food Additives Amendment is safrole, a flavoring material extracted mainly from sassafras bark. For many years, safrole was the chief flavoring ingredient in root beer. If your root beer no longer has quite the kick it used to, it is probably because FDA in 1960, after carrying out long-term animal feeding studies in cooperation with industry, banned safrole as a food additive. Although sassafras leaves and the extract of sassafras bark can still be used in foods, they must be safrole-free. FDA clamped down on safrole because it can produce cancer in the livers of rats. Actually, an additive approved by FDA under the 1958 Food Additives Amendment can have its approval revoked. In June, for example, FDA officially proposed to withdraw its approval of cobaltous salts (the acetate, chloride, and sulfate) for use in beer. These additives have been used in Europe since 1956 and in the U.S. since 1963 to improve the stability of the beer foam. Recently, questions have been raised as to whether the cobaltous salts are really safe. Early this year, these compounds were vaguely implicated in the unexplained deaths of 2 0 people in Quebec City and 18 in Omaha, all of whom were heavy beer drinkers. Last March, Dow Brewery in Quebec City dumped more than $600,0 0 0 worth of beer because it contained these compounds. U.S. breweries voluntarily stopped using cobaltous salts in beer in mid-June. In midAugust, the Food and Drug Administration officially banned these compounds for use as beer additives.
jointedly in January 1958, "Since safety and adequate testing are matters of opinion, bureaucratic control of the research required will add a tremendous cost to the national food bill and will present an impossible barrier to small business." Much of the early apprehension and criticism of the Food Additives Amendment has long since vanished. The most frequently heard comment today about FDA's handling of the law is that it has been "entirely reasonable." Many companies praise FDA for its "able handling of a difficult set of regulations." "The provisions," says one industry man, "could have been hideously misapplied. They have not been. Much of the original anxiety was simply fear of the unknown." Although plenty of paper work is involved in getting FDA approval of new compounds and although long, frustrating delays sometimes occur, applications for new additives normally do not get "hopelessly bogged down." FDA does not have any deliberate inclination to ban the use of new additives because this is the "easier and safer" alternative. The compositions of secret formulations do not have to be revealed. Because the cost of food additives generally represents only a tiny fraction of the total cost of food products, the increase in food cost brought about by greater testing of these additives has been almost negligible. In favor of the amendment Many industry men today fully endorse the objectives of the Food Additives Amendment. Says Dr. Walter H. C. Rueggeberg, vice president and director of research and development at Atlas Chemical Industries, "Even if the law did not exist, I would not operate in any other way." Says Dr. Samuel M. Tuthill, director of quality control at Mallinckrodt, "No one can question the need for regulations that protect the public." Says H. E. O. Heineman, recently retired vice president of research and development at Pet Milk Co. and now senior technical consultant, "The food industry, although fearful at first, has come to respect the Food Additives Amendment. In the long run, it is helping not only the public but the food industry as well." Another industry spokesman declares, "We cannot go back to the old ways. The public demands—and has
every right to expect—that additives will be established as safe before they enter the food supply." Dr. Lloyd A. Hall, a consultant and former technical director of Griffith Laboratories, says, "The food industry has generally profited from the tightening up of standards and safety provisions. Most important, public confidence has been restored after years of apprehension aroused by horror articles and books on 'poisons in our foods.' " Poison per se For many producers and users of additives, one of the most significant features of the Food Additives Amendment is that it finally put to rest the much-criticized poison per se doctrine ( sometimes referred to conversely as the harmless per se doctrine). As Dr. Richard L. Hall, director of research and development at McCormick & Co., points out, "Although the additives industry had serious misgivings about how FDA would use its new powers under the Food Additives Amendment, it welcomed the amendment as a way out of the widely discredited per se principle." Under the poison per se doctrine, the property of being a poison is a characteristic inherent in certain substances. Some materials are poisons; others are not. The doctrine completely ignores the fact that every substance known is a poison to the human body if taken in large enough amounts. Drinking too much water or eating too much salt can kill you. The caffeine in coffee, the theobromine in cocoa, the oxalic acid in rhubarb—if taken in high enough doses—can be harmful, if not lethal. On the other hand, small amounts of arsenic (present in many natural foods) can be perfectly safe. Summing up the views of most scientists, Dr. Henry F. Smyth, Jr., an administrative fellow at Mellon Institute, says, "There is no such thing as a class of substances that are poisons . . . . A poison is simply too much." The original Federal Food, Drug, and Cosmetic Act of 1938 naively supported the poison per se concept. It stated that no food would be allowed to contain an added substance if it was poisonous or deleterious (unless the substance was required to produce the food or if it could not be avoided in good manufacturing practice). But what was a poisonous substance? Food manufacturers shuddered to think of which one of their
EVALUATION. Under the terms of the Food Additives Amendment, the Food and Drug Administration must give its approval to the use of a new compound before it can be added to foods. Discussing the safety of a proposed new additive are (left to right) Dr. Virdell E. Munsey, chief of FDA's Food Additives Branch, and Albert Holtz and Millo Prochazka, petition reviewers
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PANEL Companies are not only concerned about the safety of food additives but also, of course, about their public acceptance in foods. A taste panel at Pfizer studies the effects of the flavor enhancer, maltol, in a gelatin dessert
TISSUES. Because of the Food Additives Amendment, the amount of safety testing done on food additives has increased considerably. A scientist at Hazleton Laboratories prepares animal tissues for pathological examination. Hazleton Laboratories prepares and examines about 50,000 such tissues a year
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products might be seized by the Government because FDA decided that an additive it contained was poisonous or not harmless. This was no idle worry, no fancied fear. In 1956, three synthetic food colors were banned from sale after they were found to produce damage in experimental animals when fed in massive doses. They were prohibited because they violated the provision of the 1938 Federal Food, Drug, and Cosmetic Act that required that all synthetic coal tar colors be harmless. At the time, FDA defined "harmless" to mean that a material was incapable of producing harm in any quantity and under any conditions of use. The Food Additives Amendment kicked the fuzzy, unscientific, and largely unworkable poison per se doctrine out the window. By setting up a system of additive tolerances, the amendment gave formal recognition to the fact that a potentially hazardous substance can be used safely if the level of intake is low enough. This level, of course, depends both on the concentration of the substance in a food and the amount of the food consumed. With the principle of additive tolerances spelled out unmistakably in the new law, food companies and food additive producers breathed a collective sigh of relief. The concept that, under specified conditions, potentially hazardous substances can be used safely was also fully recognized in the Color Additive Amendments of 1960. These amendments established a system of tolerances not only for synthetic colors (as in the previous law) but for natural
colors as well. No longer could a food color be banned because, when consumed by laboratory animals in inordinately high doses, it was not harmless. A system of tolerances was likewise established under the 1954 Miller Pesticide Amendment, which covers pesticide residues on fresh fruit, vegetables, and other raw agricultural crops. A major virtue of the 1954, 1958, and 1960 amendments was that they provided necessary operating guidelines. For the first time, producers and users of food additives had formal procedures for determining in advance what was acceptable to the Government and what was not. Previously, companies were often caught in an engulfing fog of uncertainty—forced to rely chiefly on their own judgment to decide what was safe or unsafe, what was legally acceptable or what was not. In some cases, companies received guidance from the Food and Drug Administration on the safety of proposed new additives, although this guidance was strictly informal. Effects of the amendment The Food Additives Amendment has had far-reaching effects on chemical companies serving the food industry, as well as on the food industry itself. Compared to the situation before the amendment, the law has: • Lengthened the time required to develop new food additives. • Increased the cost of developing new additives. • Reduced the number of available food additives.
• Tended in many cases to change the types of compounds that companies are investigating as possible new food additives. • Tended virtually to eliminate some companies as developers of new food additives. • Forced some companies to abandon their research on various additives—not because the compounds were ineffective or were known to be unsafe but because the cost involved in obtaining FDA approval would have been prohibitive. Lengthy
testing
Although the amendment has unquestionably increased the time necessary to develop a new food additive, it is difficult, if not impossible, to make reliable estimates of exactly how much. One reason is the enormous variation in the amount of safety testing done by additive manufacturers before the amendment. In those days, some companies might have done only a 30-day or a 90-day feeding test in rats to check the safety of a new additive. On the other hand, some companies might have carried out two- or threeyear feeding tests in two or more species of animals. Now, FDA usually requires that a new additive undergo at least a twoyear feeding test in two species of animals (one a rodent and one a nonrodent) . Actually, the amount of testing demanded by FDA is highly vari-
able and depends on the additive and its proposed use. In the case of some compounds, FDA has asked for feeding studies of as long as seven years or in as many as four different species of animals. The trend in recent years has been for FDA to require longer testing in more species of animals before it is convinced of the safety of a new additive. And in some cases, it also requires testing in humans. The quoted figures are to some extent deceptive. As Dr. Bernard L. Oser, president of Food and Drug Research Laboratories, Inc., points out, "It's a rule of thumb that a two-year feeding study really takes three years. By the time you run the animal autopsies and perform the tissue examinations at the end of the study, correlate the data, write the reports, submit the evidence to FDA, have conferences with FDA, and work out the myriad other details, the two years have easily stretched into three." Dr. Oser adds, "Because of the Food Additives Amendment, it may now take as much as two to five years longer to get a new additive on the market than it did before the amendment." The problem of long test periods in determining the safety of food additives may not be insurmountable, however. Scientists at FDA, Albany Medical Center, MIT, Woodard Research Corp., Food and Drug Research Laboratories, and elsewhere are working on methods to reduce markedly the time it takes to determine the
LONGER TESTING. Getting a new food additive on the market may now take as much as two to five years longer than it did before the amendment, says Dr. Bernard L. Oser, president of Food and Drug Research Laboratories, Inc. In this room, his company breeds thousands of rats for short· and long-term feeding studies
safety of food chemicals with laboratory animals. Hopefully, in the future, it may be possible to find out in six months what may now take two years or more. Also, the results might be obtained with fewer animals and at lower cost. In conventional animal studies with rats, for example, about 150 rats (not including 50 controls) are fed an experimental additive for two years ( two years being the average life span of normal rats). At the end of this period, the animals are sacrificed and their organs are carefully examined for possible damage caused by the additive. In some of the new intensive methods, tissue specimens from various organs are periodically removed by biopsy from the liver, kidney, muscle, or other organs of live, intact animals. These tissues are then studied to determine whether the additive is producing any adverse effects. In this way, any undesirable changes can be discovered much more quickly. Some companies are now submitting to FDA the data from such intensified studies in their petitions for approval of new food additives. However, these data are still not being accepted by FDA in place of information from conventional long-term animal tests. The reason, FDA explains, is that the reliability and predictive value of such intensified, short-term studies have not yet been adequately determined. However, as scientists develop reliable methods for obtaining animal test data more rapidly and accurately, the use of these techniques should grow considerably. Cost of research For the same reasons that the amendment-caused increase in research time required to develop a new food additive is so difficult to measure, it is also difficult or impossible to determine accurately the increase in research cost. Needless to say, the cost has gone up. Today, a two-year feeding study in rats and dogs (including metabolism, reproduction, and other studies) may cost $100,000 or more. When cancer studies in two or more species of animals are also required, the total cost may exceed $300,000. In the days before the amendment, relatively few food or chemical companies carried out such extensive tests. In many instances, a company may have performed only a relatively simple 90OCT. 10, 1966 C&EN 111
day feeding study on rats, which might have cost only about $6000. Actually, the cost of safety testing is only one part of the total cost of developing a new additive. There is, of course, the cost of working out methods for synthesizing the compound in the laboratory and in the plant. There are the costs of proving the commercial usefulness of the additive and of developing precise methods for analyzing for the additive and its degradation products in foods. The cost of developing suitable analytical methods—methods that are often nowhere to be found in the scientific literature—may actually be as great as that of determining the safety of the compound. In addition, there is the cost of legal work involved in getting FDA approval, the cost of additional testing often required by FDA, and other expenses, sometimes wholly unanticipated, that never existed prior to the amendment. In some cases, says Dr. Oser, the total cost of introducing a new food additive may run as high as $2.5 million. This, of course, is not typical. Says an executive of a major chemical firm, "We estimate that, in general, the cost of developing a new food additive might range anywhere from $250,000 to $500,000 or more, and the time from five to 10 years. In the past 10 years, this cost has probably doubled—partly because of the greater amount of safety testing required and partly because of the increased costs of equipment and labor." A Merck spokesman says, "Food additives today are actually not an especially attractive field for research because of the high cost of getting FDA approval of new compounds." On the other hand, many observers say that, if a company has a genuinely promising new additive (preferably a world-beater) and is reasonably sound financially, the cost of safety testing is usually no great deterrent. "A company with a hot product," declares one industry man, "will gladly do the testing. It's just part of the cost of doing business." Reduced number of additives Because of the Food Additives Amendment, the number of available intentional food additives has decreased by about 15% since 1960. In general, the additives no longer on the market are those that previously found only limited use or were inferior to available compounds. Thus, 112 C&EN OCT. 10, 1966
the effort to get them approved would scarcely have been justified. The manufacturers simply let these compounds fall by the wayside. Most of these rejected additives were easily replaced, and today they are hardly missed. "Because of the removal of these marginal additives," says Dr. Orville E. Paynter, director of toxicology at Hazleton Laboratories, "mankind, it can safely be said, has not taken an irrevocable step backwards." The amendment has had a particular effect in reducing the number of additives that may enter foods inadvertently. This is especially true of chemicals used in packaging materials—chemicals that, before the amendment, had in many cases undergone relatively little testing and were largely unregulated by the Government. Although the Food Additives Amendment was designed primarily to control intentional additives, it has probably had an even greater impact on the nonintentional compounds. Suddenly, companies selling paper, plastics, or other packaging materials to the food industry had to be sure that the waxes, resins, colors, sizing agents, slimicides, defoamers, and other chemicals they used would be safe if any of these materials migrated into foods. Because of the Food Additives Amendment, organomercurial compounds designed to control slime in paper mills can no longer be used in making paper that comes in contact with foods. Organic tin compounds, unless permitted under the Meat and Poultry Inspection Acts, cannot be used to stabilize polyvinyl chloride films used to package foods, although some compounds of this type may be approved in the future. New emphasis in research In many chemical companies, the Food Additives Amendment has tended to shift the emphasis in food additive research. A marked trend has developed to investigate compounds that are already present naturally in foods or are chemically related to such compounds. The reason is that it is much easier and less costly to get FDA approval of a food additive if it can be shown that it is present naturally in, let's say, cheese that people have been eating for centuries. Understandably, FDA is much more stringent in its safety-testing requirements in the case of synthetic compounds that are totally new.
This trend toward research on naturally occurring material's is particularly evident in the flavoring field. It is hopelessly uneconomic for a flavoring manufacturer to spend hundreds of thousands of dollars to get FDA approval of a unique synthetic flavoring material if he is only going to sell 100 pounds of it a year—which is not at all uncommon in this field where a little goes a long way. Companies, therefore, have developed renewed interest in flavor components present naturally in foods. This interest is clearly reflected in the growing amount of gas chromatographic research being done on the numerous flavor and odor ingredients in fruits, beverages, meats, and other foods. This research has shown, for example, that, of the more than 100 compounds present in the volatile fraction of strawberries, about 50 are involved in the fruit's flavor and odor. Another major impact of the Food Additives Amendment is that it has tended to discourage research on additives that are not significantly better than compounds already on the market. There is not much point in spending vast sums of money in safety testing an additive if it is just a me-too item that, at best, may capture only a small percentage of the total market. The cold, harsh reality of the situation is forcing many chemical companies to examine much more thoroughly than ever the sales potential of new additives before they take the plunge in a costly safety-testing program. "With food additives," says a Merck scientist, "you have to pick your spots with extreme caution. Of course, there are always opportunities for new additives. But the companies that develop them must be surefooted and courageous. It also helps to be a compulsive optimist." Because of the many problems involved in developing new additives, food companies are doing more research than ever on solving food problems through use of additives that are already available and approved. Many seemingly insurmountable problems in formulating new foods could be solved through proper use of one or more existing additives. A brandnew compound, glittering with promise, is not always necessary. Because of the increased cost of getting new additives on the market, the small company with limited financial resources is largely ruled out today as a developer of new food chemicals. The cost is just too mas-
CHEMICAL RESEARCH. Dr. Robert P. Allingham (right) and Dr. Bryce Tate at Pfizer's Chemical Research Laboratories in Groton, Conn., prepare compounds chemically related to maltol, a flavor enhancer for carbohydrate foods
RESIDUES. The Food and Drug Administration does a considerable amount of testing of food additives. In this FDA laboratory, a chemist uses gas chromatography to determine various chemical residues on vegetables
sive a financial burden. Some small companies are hoping to solve this problem, however, by pooling their resources and developing new compounds jointly. In the food color field, for example, the six companies participating in the Certified Color Industry Committee are planning to finance jointly the costly animal-testing programs required for FDA approval of new compounds. An inevitable question: Has the Food Additives Amendment tended, in general, to discourage research on new food additives? The inescapable answer: Yes, it has—to an extent. Certainly, the amendment has not dangerously stifled research. Today, experimentation on new food additives
PACKAGING. The Food Additives Amendment has focused attention on the safety of additives used in films for packaging foods. Additives, which are also used in paper and other packaging materials, may possibly migrate into foods
is moving ahead at a reasonably rapid pace. Admittedly, this research is more selective—with the result that when a new compound does come on the market it is more likely to be a significant advance. Cancer clause Ever since the Food Additives Amendment came into existence in 1958, a swirling controversy has centered on its so-called cancer clause. This clause states that no chemical can be added to foods if in any amount it produces cancer when ingested by man or animals. This proviso was tacked onto the amendment through the determined efforts of Rep. James
J. Delaney (D.-N.Y.) in the final hours of debate on the measure. Many people feel that the cancer provision was jammed into the amendment without any chance of adequate, well-reasoned discussion. This clause, often called the Delaney clause, is probably the most hotly controversial section of the entire Food Additives Amendment. Supporters of this provision argue that, since we know so little about cancer and how it is produced by chemicals, we cannot take the risk of adding any amount of a known carcinogen to the food supply. They also point out that cancer is no threat to be brushed off lightly. Cancer accounts for about 16% of all deaths in OCT, 10. 1966 C&EN
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the U.S. and is second only to cardiovascular disease as the major cause of death in this country. Supporters of the cancer clause also emphasize that, although some people claim that certain specified low levels of carcinogens are harmless, this has never been proved. "We just don't know how to establish safe tolerances for carcinogens," one scientist argues forcefully. "A compound may have . no effect after continuous use for 20 years. But will it produce cancer after continuous use for 30 years?" Opponents of the cancer clause are convinced that threshold levels of carcinogenic activity do exist and that safe levels can be determined. "It is more likely than not," says Dr. John A. Zapp, Jr., director of the Du Pont toxicological laboratory, "that there are no-effect levels of carcinogens in man. If this were not the case, we could all expect to get cancer eventually because we are all exposed daily to small doses of environmental carcinogens—background radiation, natural estrogens, sunlight, and others." Many scientists are sharply critical of the idea that a chemical can be banned if it produces cancer when given in any amount. Even table salt and glucose, they assert, can induce cancer in animals if injected in huge doses. The law, they believe, should be changed to read that a compound cannot be approved "if found to induce cancer when ingested by man or animal in amounts and under conditions reasonably related to its intended use." The present cancer provision, many scientists bitterly complain, prohibits "the proper exercise of scientific judgment." Some scientists also contend: Why single out cancer? Why not ban the use of any amount of an additive that in any high dosage in man or animals may induce heart damage, kidney damage, liver damage, or what not? Is there some sort of special mystique to cancer? Further, they argue, the general requirement of the Food Additives Amendment that any additive, to be approved, must be safe at the levels used fully takes care of the situation. As the Council on Foods and Nutrition of the American Medical Association has stated, "Technically, this special [cancer] provision contributes nothing to the safe use of food additives since any hazardous use of an additive is already prohibited in the general provisions of the Food Additives Amendment." 114 C&EN OCT. 10, 196F
MORE SENSITIVE. The problem of zero tolerances has been accentuated by the development of more sensitive methods of analysis, such as atomic absorption spectrophotometry. This method is used here by Joseph L. Wallner of International Minerals & Chemical Corp. to determine trace elements in foods
Meanwhile, the debate rages on. While some people at FDA may grumble privately about the "scientific irrationality" of the cancer clause, they can do nothing about it. Their hands are tied by the law. The likelihood that the law will be changed in the foreseeable future to allow the setting of tolerances for carcinogens in foods is virtually nonexistent. As of now, no Congressman in his right mind is likely to endorse the removal or modification of the cancer clause and thus face the accusations of wildly indignant voters that "he came out in favor of cancer." However, some observers say that, in time, as more becomes known about the causes of cancer, this controversial provision will be eliminated—just as the poison per se doctrine was abandoned in 1958. Zero tolerances Also intensely controversial has been the concept of zero tolerance. In the past, the Government has said that, in the case of some compounds, no amount may be present in foods. This requirement has been of serious concern to chemical producers who make those nonintentional food additivespesticides. Under the provisions of the 1954 Pesticide Amendment, certain pesticides can only be used on certain crops if they leave absolutely no residue. As scientists patiently attempt to explain, no analytical method can prove that zero amount of a material is present. All that a method can show is that, in certain cases, nothing is detectable. And even though nothing is detectable, some very low con-
centration of the material may, of course, still be present. The problem of zero tolerances has become especially acute as scientists develop more sensitive methods of analysis. With the advent of gas chromatography, thin-layer chromatography, atomic absorption spectrophotometry, and other refined techniques, scientists can now measure materials in extremely low concentrations. It is now possible, for example, to detect a few parts per billion of the insecticides dieldrin and parathion. Formerly, the lowest concentration that could be measured was 0.1 p.p.m. Hence, what yesterday might have been a nondetectable, perfectly acceptable level may today be readily measurable and a clear-cut violation of the law. This problem flared into headlines in 1964 when the D.C. Department of Health prohibited the sale in the District of Columbia of hundreds of thousands of dollars worth of milk from Maryland, Pennsylvania, and Virginia. All of this milk had to be dumped because it was found to contain trace amounts of heptachlor, heptachlor epoxide, and dieldrin, which had been used to kill weevils in the soil on which the alfalfa later fed to the cows had been grown. These insecticides were detected only because scientists had switched to more sensitive analytical methods using gas chromatography, which picked up trace amounts that were previously unmeasurable. Because no official tolerances for commonly occurring pesticides have been established in milk, the allowable level under the law is regarded as zero. Surveying the problem, a special
PIONEER. The Government's interest in food safety goes back many years. A pioneer in this field was Dr. Harvey W. Wiley, seen here working at his laboratory bench. Chief of the Department of Agriculture's Bureau of Chemistry, he was the leading force behind the enactment of the Pure Food and Drug Law in 1906
ad hoc committee of the National Academy of Sciences-National Research Council in 1965 concluded that zero tolerances (established by the Food and Drug Administration) and no-residue registrations ( established by the Department of Agriculture) were "scientifically and administratively untenable and should be abandoned." The Government now, in part, agrees. In April, the Government announced that, in place of zero tolerances, the Food and Drug Administration, wherever possible, will set finite, negligible-residue tolerances for pesticides—chemical by chemical, use by use. In addition, all no-residue registrations will be cancelled on Dec. 31, 1967, unless extensions are granted because studies are still in progress to determine safe tolerances. What this means is that the Department of Agriculture will no longer accept applications for the registering of pesticides on the old no-residue basis. Moreover, all pesticides used on food crops will be subject to finite tolerances authorized by FDA. At last, the control of pesticides on foods will be placed on a sounder scientific footing. Attitudes of the public Food additive producers have their problems not only in dealing with the Government but also in coping with that illusory, though very real, factorpublic opinion. The public image of food additives has long been a source of intense concern to the makers of these chemicals, as well as to the food companies that use them. Companies are haunted by such
questions as: How many people really think that food additives are poisons or adulterants? How widespread is the belief that our foods are unwholesome because food companies have been "dumping noxious chemicals" into them? Is the use of additives, as some hot-eyed crusaders have suggested, part of a vast conspiracy to sap our national vitality through the sale of dangerous, chemically adulterated foods—not unlike what some zealots regard as the insidious plot to poison us all with fluoridated drinking water? Obviously, a segment of the population does consider food additives hazardous, if not in some cases lethal. They are all for eliminating additives from foods entirely. These are the people whom industry men frequently classify as crackpots, faddists, food quacks, or well-meaning but pitifully misinformed people. "As far as knowledge of foods is concerned/' one company official bemoans, "they are functional illiterates/' These are the people who automatically assume that natural foods are inherently good, but chemicals in foods are contaminants, adulterants, or poisons. They fail to realize, of course, that all food components are, in fact, chemicals. These are the people who, lacking knowledge, are driven by their wild, unreasoning fears. Often, these are fears aroused by books, magazines, or newspapers. Influence of books Some books, such as Upton Sinclair's "The Jungle," which became an overnight sensation when published
in 1906, have brought about muchneeded reform in the food industry. This book (the author called it a "cry for social justice") exposed conditions in the Chicago meat-packing industry and was a powerful spur to the enactment that same year of the first Pure Food and Drug Law. Other books, sometimes classed as scare books, have had the principal effect of alarming their readers with a barrage of startling revelations, replete with quotes from a multitude of alleged experts. In this general category are such books as "Our Daily Poison" by Leonard Wickenden (author of "Gardening with Nature"), published in 1955, and "The Poisons in Your Food" by William Longgood, published in 1960. The most recent entry is "The Hidden Assassins" by Booth Mooney, which was published in May. The author of "The Poisons in Your Food" ominously points out, for example, that 8-hydroxyquinoline (a preservative no longer used in foods) is present in contraceptives and rectal suppositories. He also points out that polyoxyethylene monostearate, an emulsifier and defoamer, is made by a chemical company that also manufactures—of all things!—explosives. The author of "The Hidden Assassins" is an equally implacable critic of food additives. In a chapter titled "Just a Little Bit of Poison," he writes, "Most of the food Americans consume is doctored, dosed, colored, and convenienced nearly to the point of nonrecognition." Later, he asserts that some industry people believe that food additives are necessary if they help sales and "do not make consumers noticeably ill." He further asserts that "chemicals added to food are 'unnatural' substances, and if the human body has never before been challenged by them, it may have no defense against them." Especially during the hearings on the Food Additives Amendment in 1957 and 1958, magazines and newspapers erupted with stories bearing such provocative titles &s "Poisons in the Pantry" and "Peril on Your Food Shelf." As one observer notes caustically, "The trouble with the authors of so many of these horror articles is that they seem to find a carcinogen under every bed." Nevertheless, these articles, despite a general lack of scientific evidence to support their scathing charges, tended in many cases to undermine the public's confidence in the food supply. OCT. 10, 1966 C&EN
115
ANIMAL STUDIES. Testing the safety of food additives in animals is a costiy procedure. A two-year feeding study in rats and dogs (including metabolism, reproduction, and other studies) may cost $100,000 or more. Here, workers at Food and Drug Research Laboratories, Inc., examine a dog used in such a study
CODEX. The Food Chemicals Codex has established quality standards for food-grade chemicals. A laboratory worker at Mallinckrodt analyzes one of the company's additives to make sure it meets Codex standards
Public confidence in foods was also shaken by the notorious cranberry scare of late 1959. In that year and the year previous, cranberry growers in the states of Washington and Oregon, contrary to regulations, used aminotriazole to kill weeds in cranberry bogs before, rather than after, harvest. As a result, shipments of the fruit were found to be contaminated with small amounts of this compound, which in rats can produce thyroid cancer. Alarm swept through the nation. Despite a temporary embargo on the cranberry crop and the banning of specific lots found to be contaminated and despite reassuring statements from industry and government officials, millions of people on Thanksgiving 1959 flatly refused to have anything to do with cranberries. Public confidence in foods was further shaken by Rachel Carson's widely read "Silent Spring," published in 1962. Although this book focused primarily on the dangers of pesticides, it tended to raise grave doubts about the safety of foods in general. Many industry people say that the phenomenal success of "Silent Spring" (for many weeks a best seller) was less a tribute to the cogency of Miss Carson's arguments than to her widespread reputation as a gifted and perceptive writer. Worried about
additives
How many people in the U.S. actually believe that chemicals in foods are a severe threat to their health is difficult to determine. No large-scale polls have ever been taken. One government official, as a rough guess, estimates that the group seriously worried about food additives and militantly opposed to their use constitutes 116 C&EN OCT. 10, 1966
no more than 5% of the total adultpopulation. "It includes," he says, "not only the victims of absurd rumors and hearsay but also members of the inevitable lunatic fringe." In any poll of public opinion on the matter, a great deal would depend, of course, on how the question was worded. If you went around asking people, "Do you think we would all be better off if foods did not contain all those dreadful chemicals?," vastly more than 5% would doubtless reply with a resounding yes. Obviously, fears that never existed before can be incited by a loaded question. Many observers in the food additives field and the food industry hasten to point out that the number of people gravely concerned about "poisons in our foods" is on the decline. Confidence in the food supply is growing, they say, because of increasing public recognition that the Government, through FDA and the Department of Agriculture, is making a concerted effort to guard the safety of American foods. Admittedly, relatively few. people outside the Government and the chemical and food industries are even vaguely aware of the Food Additives Amendment. However, most people recognize that the Government's regulatory agencies are intent on protecting their welfare. As evidence of this, various major food companies report that the number of crank letters they receive from people alarmed by "poisonous food additives," "the shoveling of noxious chemicals into our foods," and the "criminal adulteration of foods" has fallen off considerably in the past few years. Seldom now do companies get letters from people wanting to know whether a particular food additive with a menacingly polysyllabic name
on the label really causes cancer, or whether ice cream today, unlike the cherished kind that mother used to make, "actually contains 90% cellulose." The public, by and large, not only has confidence in the Government's supervision of the food supply but in the vigorous supervision exercised by food companies themselves. "The housewife," says one industry spokesman, "has confidence in such brand names as General Foods, General Mills, Campbell, Swift, Armour, Pillsbury. She knows that these and other food companies are not engaged in some nefarious scheme to poison the American public but are determined to produce the best, safest, most wholesome foods possible. She doesn't fall for all that poppycock in the scare books and the Police Gazette" Nevertheless, chemical and food companies are acutely sensitive to criticism from any quarter—even from readers of the Police Gazette. For this reason, the term "food chemical," once widely used, is now deliberately shunned by many companies. Some industry men may piously tell you that the term "is not adequately descriptive in view of the well-recognized fact that all food components are chemicals." The real reason is the stigma attached by some people to the word "chemical." Even the term "food additive" is anathema in some circles. Monsanto, for example, studiously adheres to the term "food ingredient." This term is innocuous enough but obviously is much too all-encompassing. Some companies have been deeply concerned—if not inordinately sensitive—about the public's possibly negative reaction to various chemical names on food labels. For years, some food manufacturers hesitated to use fumaric acid in their products on the grounds that the name would conjure up images of fuming sulfuric acid and other hideously corrosive materials. Nevertheless, a number of firms in recent years have added fumaric acid to their gelatin desserts and other products, with clear identification on the label—and with scarcely a ripple from the public. Informing the people Part of the credit for the growing public awareness of the value of food additives goes to a variety of companies, government agencies, and private
organizations. In recent years, these groups have been making special efforts to inform the public about the importance of additives. Monsanto, Pfizer, Dow, Du Pont, Union Carbide, and other chemical firms have used their company magazines and other publications to tell the factual story of food additives. In March, Monsanto Magazine carried an article titled "How Industry Works with the Food and Drug Administration to Keep the Nation Healthy," a report dealing with both intentional and nonintentional food additives. Last year, Union Carbide issued a booklet called "The Continued Safety of Our Food Supply," based on a talk given by Dr. Henry F. Smyth, Jr., of Mellon Institute at the 1965 Newspaper Food Editors Conference. In 1960 and again in 1964, the Department of Health, Education, and Welfare published a brochure called "Facts for Consumers: Food Additives" and in 1961 a leaflet called "What Consumers Should Know About Food Additives." Probably the most ambitious effort in this area was the publication in 1961 of a 64-page booklet called "Food Additives: What They Are/ How They Are Used," issued by the Manufacturing Chemists' Association. To date, MCA has distributed free some 230,000 copies of this booklet. Copies have gone to physicians, science teachers, home economics teachers, public health officials, newspaper and magazine editors, nutritionists, and many others. Following publication of this booklet, MCA put out several newsletters on food additives, as well as two filmstrips. MCA is convinced that its program has had a pronounced effect in improving public understanding of food additives. "We have replaced misinformation with documentable facts," says MCA's Allan E. Settle. "We have helped to substitute confidence for fear." Food Chemicals Codex Although as yet few members of the general public are even remotely aware of its existence, the Food Chemicals Codex should also help to increase public confidence in food additives. The Codex, which first began appearing in loose-leaf installments in December 1963, is a compilation of quality standards for approved food additives. It sets standards of purity for food chemicals and specifies-meth-
ods for identifying and determining the purity of these compounds. It also gives information on the physical properties of these compounds, methods of packaging and storing them, and other details. The Food Protection Committee of NAS-NRC has been working on the Codex since 1961. The first bound edition, covering about 500 food additives, was issued last month. Similar in many respects to the U.S. Pharmacopeia and the National Formulary for drugs, the book provides the first national standards for food additives. The status of the Food Chemicals Codex received a major boost on July 1, when Dr. James L. Goddard, Commissioner of the Food and Drug Administration, wrote the director of the Codex, "I am pleased to endorse the specifications in this Food Chemicals Codex prescribing minimum requirements of purity for an appropriate grade of food chemicals for intentional and purposeful use in food for man. The FDA will regard the specifications in the Food Chemicals Codex as defining an 'appropriate food grade' within the meaning . . . of the food additive regulations . . ." The published standards are sure to increase the purity of many commercial food-grade chemicals. These standards should also have other important effects. Says Dr. Tuthill of Mallinckrodt, "A public relations program emphasizing the publication and function of the Codex should help materially to improve the public's opinion of food chemicals." Dealing with the food industry Many producers of food additives say that one of their biggest problems, not too surprisingly, is the food industry itself. They find that getting a new additive accepted by the food industry is sometimes a strenuous, uphill battle. Food companies, in general, are extremely loath to modify an existing food product if it is already a commercial success. As one food industry man points out, "If an established product is grinding out millions of dollars a year for a company, you know darn well the company is not going to mess around with it by sticking in some new additive." Says another industry man, "Only an idiot would tinker with success." Chemical companies find that the food industry's deep reluctance to alter accepted products is a sizable OCT. 10, 1966 C&EN
117
bring about improvements in food taste or cause other quality changes that may be irresistibly appealing to some people but almost undetectable or even abhorrent to others. Technical level in the food industry
TESTS. Because many food companies do very little of their own testing of new food additives, the job has fallen largely to the chemical firms that make these compounds. Here, home economists in Pfizer's Technical Service and Product Development Laboratories prepare a new formulation for testing in foods
damper to progress in the food additives field. However, as Dr. Lee A. Miller, development manager for food ingredients at Monsanto, candidly admits, "Let's face it. No customer ever moves as fast as you would like him to. On the other hand, additive producers generally find that food companies are quite willing, if not eager, to use new additives in totally new food products. With these products, the consumer has no rigid, preconceived notions about what the food should look like, taste like, feel like. Such products give the food manufacturer wide latitude in the imaginative use of new additives. The most promising market for new additives, then, is in totally new types of foods. Since the food industry introduces some 5000 new or modified products a year (only a fraction of which, of course, are successful), the possibilities for using new additives are extraordinarily broad. These possibilities are expected to become even broader in the future as the pace of innovation in the food industry accelerates. One food company official emphasizes, "The food industry is not nearly so conservative as some of its vociferous critics make out. Remember, to the housewife reading the ads, just about the most exciting word in the world is NEW!" Another food company spokesman points out, "The marketing of many standard food items— the bread-and-butter items that have been around for years—has by now degenerated into a profitless price squeeze. Therefore, food companies simply must make innovations to maintain sales growth." Needless to say, food companies developing new products are not going overboard with the ecstatic heralding 118 C&EN OCT. 10, 1966
of each new food additive. Food companies must be convinced that the additive offers measurable advantages and will bring about wider public acceptance of a product. Says Mr. Heineman of Pet Milk, "The chemical companies are continually promoting new additives that supposedly would bring about significant improvements in food products. However, conservatism on the part of the food manufacturer is essential. . . . After all, if a new or modified product bombs, it is our skins, not theirs, that will be nailed to the wall." Taste
preferences
Says another food industry representative, "We are dealing here with such subtle and ephemeral things as taste preferences—things that are often incredibly difficult to predict. Therefore, in making changes in foods with new additives, we must move with extreme caution. Certainly, food preferences—next to sex—are just about the most personal and individual matters in the world." A Merck scientist points out, "When you are developing, for example, a new drug to fight hypertension, you have a fairly well-defined target. With food additives, however, you are often dealing with a target that is fantastically vague. The taste, texture, and aroma of foods are very nebulous, ill-defined things that can produce very differing responses in different people. Who can say with precision, for example, what constitutes a good piece of bacon?" Food additive companies find that it is easiest to sell a new additive to the food industry if it reduces significantly the cost of making the food or decreases the production time. Much more difficult to sell are additives that
A source of keen frustration to food additive producers is what they regard as the relatively low level of scientific skill in many food companies—particularly the smaller ones. "The trouble with too many people working in food laboratories," one industry man declares, "is that they aren't really scientists; they're just a bunch of fingerdippers, puttering around with their mystical formulations." As a result, he says, many food additives do not get properly tested. Another common lament is that many food producers cannot express their technical problems in precise scientific terms so that chemical companies can attempt to solve them. "The trouble with the food industry," says one Merck scientist, "is that it hasn't busted its problems apart yet—in clearcut scientific terms." Says another chemical spokesman, "Food industry people just don't tell us what they want in terms of specific chemical or physical properties. We can't hope to solve their problems if we don't know what they are." Complicating this problem is the food industry's great penchant for research secrecy. Says Dr. Tuthill, "The major difficulty lies in getting food companies even to whisper about their unmet needs for food additives." Also a matter of continuing concern is the level of research activity in the food industry. Admittedly, research on foods has been growing. According to the National Science Foundation, spending for research and development in the food and kindred products industry climbed from $64 million in 1956 to $135 million in 1964 (the latest available figure). This increase has very closely paralleled the industry's growth in net sales. However, the food industry's spending on R&D is far below that of the chemical industry. Compared to the $135 million spent on R&D by the food and kindred products industry in 1964, the chemical and allied products industry spent $1.28 billion. These figures represent only 0.4% of net sales in the food and kindred products industry in 1964, compared to 4.2% of net sales in the chemical and allied products industry. Because of the relatively low R&D expenditures in the food field, chemical firms serving the food industry are obliged to do a major share of the research and development on food additives. To a large extent, this is en-
tirely understandable. Food compa nies generally operate on low profit margins and usually can ill afford to spend massive sums on research to create new additives and find ways to use them. Quite obviously, chemical compa nies would be eager to see the food in dustry take more research initiative. In particular, they would like to see food manufacturers doing more re search on new uses for additives. This applies both to additives that have been approved by FDA and to those that are as yet unapproved but are un dergoing advanced testing. Chemical firms complain that, all too often, food companies will not even give a cursory look at a new additive unless it has already received FDA clearance. On the other hand, a chem ical company does not really know for sure whether its product has an ade quate market and is worth spending vast sums of money on to get FDA ap proval unless food companies express sufficient interest in it. Trapped in this dilemma, chemical producers are forced to do a great deal of use test ing and market research on their own. Nonfood
HODAGt HELP YOU? Many Industries depend on our knowledge of their problems to supply products in many categories suited to their specific ap plications. Perhaps this experience can help you, too. Use the convenient list of Hodag product and major industry experi ence, below, to let us know how Hodag may help you. Now might be an opportune time. Simply check the areas of interest, fill in your address, and mail us the entire ad.
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In many cases, a chemical company developing a new food additive must also develop sizable nonfood markets for the same product. Otherwise, the company might find it impossible to build a large-scale, efficient plant that would permit the additive to be sold at a competitive price. For example, one reason why the food antioxidant, butylated hydroxytoluene, is relatively inexpensive is because it is made in large volume to meet the demands also of the petroleum, rubber, and plastics industries. The compound sold to the food industry is, of course, of definitely higher purity than mate rial designed for industrial use. Today, many chemicals used in foods find large, if not predominant, use outside the food industry. Some 40% of the citric acid consumed in the U.S. goes into such nonfood items as drugs, cosmetics, and metal-clean ing solutions. About 9 5 % of the adipic acid ends up in nonfood prod ucts (88% alone goes into making nylon 66). However, the development of a suc cessful food chemical does not always depend on its also finding a ready mar ket outside the food industry. A shin ing example is monosodium glutamate, which is used exclusively in foods. Changing Washington
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Today, the producers of food addi tives, vitally affected by changing gov ernment regulations, are watching in-
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tently the shifting climate of opinion in Washington. No one really knows what further changes may be brought about by new government policies, the revised interpretation of existing laws, or the spelling out of specific rules in areas that formerly were matters of broad discretion. Many key questions are still suscep tible to widely varying opinion and in terpretation. How much evidence is needed to establish the safety of a new food additive? Will a new additive confuse the public into thinking that a food is better than it really is? How It's so easy! Just go to the right place - much of an additive will a person con CHEMICAL MATERIALS CATALOG. All the sume in the course of a day or a year or facts you need are tucked away in its pages a lifetime—a factor that will directly - and neatly ticketed in the 5-way index, affect the allowable level of that addi tive in foods? Or, as one observer ready to pop up foryour immediate use. Facts asks, "Should we base the allowable about chemicals. Facts about raw materials. level of a beer additive, for example, All up-dated, and carefully organized for on the typical adult consumption of process men by process men. Your copy of beer or on reports that some brewery CMC is a one-volume library of basic infor truck drivers drink 20 cans of beer a mation, ready to hand. Keep it on your desk. day?" Let it work for you and with you. It's a tire Says one food additives spokesman, less helper, a proven time-saver. And If $ "These are the quagmires, the discre tionary matters that may take months right as rain! of extra work to satisfy FDA. If gov REINHOLD CHEMICAL MATERIALS PUBLISHING ernment regulations are stiffened, CORPORATION problems such as these could become even more difficult in the future." Washington observers are particu larly concerned these days about the 430 PARK AVENUE, NEW YORK, Ν. Υ. 10022· major new policies that may be wrought by the aggressive new FDA Commissioner, Dr. James L. Goddard. Initially, Dr. Goddard focused his at tention almost exclusively on drugs. His vigorous attacks against a number of questionable drugs and his sweep The definitive directory to re ing charges against the drug industry search instruments, chemicals, in general swiftly demolished any services, books, equipment and complacency that may have existed tradenames. about the Government's role in the drug field. Issued annually in July, used In recent months, Dr. Goddard has daily to . . . been turning more of his attention to FIND WHO SELLS WHAT food additives. In mid-June, he pro posed a marked tightening of controls INQUIRE ABOUT PRODUCTS on nutrient supplements and nonnuLOCATE SALES OFFICES tritive sweeteners. "The American CREATE BIDDER'S LISTS consumer," he told a senior citizens' CONTACT VENDORS group shortly before making his official announcement, "has an excellent PLACE ORDERS chance of taking in the recommended daily requirement of vitamins and minerals through the [ordinary] foods he eats, without resorting to any of the dietary, multivitamin, or mineral supplements." FDA is now attempt ing to establish new regulations to limit the use of vitamins and minerals in fortifying foods. Unless industry and nutritionists are able to force an extended delay (re cent protests have already forced a delay), the new regulations, probably in modified form, will become effective sometime next year. The new con trols may limit significantly the use of
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supplementary vitamins and minerals in foods and are expected to forbid the extravagant promotion of these ad ditives to the general public. Among the products under attack are various breakfast cereals, fruit drinks, infant formulas, and dietary supplements that, FDA believes, contain unneces sarily large amounts of added vitamins and minerals or contain added nu trients in nutritionally insignificant amounts. Announcing the proposed new reg ulations on artificial sweeteners, Dr. Goddard stated that the presence of these sweeteners in foods must be con spicuously noted on the label. The label must also indicate how the cal orie content of the food compares with that of the same food sweetened to the same degree with sugar. This cal orie reduction must be at least 50% if the food is to be promoted for calorierestricted diets. Because of these proposed regula tions and others that may be antici pated in the future, key people in the food and food additives fields are read ing with special intensity these days each new pronouncement from Wash ington's regulatory agencies. Like the vast majority of companies in the food and food additives industries, these agencies are deeply resolved to pre serve the safety, wholesomeness, and economy of the American food supply.
Laboratory Guide
120 C&EN OCT. 10, 1966
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U. S. STONEWARE AKRON 9. OHIO
1829 S. State St., Chicago, III. 60616 Dept. CEN
USED EQUIPMENT AMMONIA & UREA PLANTS FOR SALE at Hamilton, Ontario, Canada. Late model units (1959) with design capacity 165 TPD ammonia and 200 TPD urea (max. 187 TPD am monia and 285 TPD urea). Plant uses steel-mill by-product as feed stock (coke oven & blast furnace gases). For sale in entirety, as indiv. operating units, or piece meal . . . equipment includes com pressors up to 4600 H P . . . T316 SS tanks, vessels, columns, evapora tors, pumps, pipe & valves, etc... high pressure steel autoclaves, tow ers, vessels, spheres. . . 180' high rect. prilling tower. . . process in strumentation, etc. 80% of plant U.S. made. SEND FOR BROCHURE. Perry Equipment Corp. 1415 N. 6th St., Phila., Pa. 19122 phone (215) 763-3505 OCT. 10, 1966 C&EN 121
