Control Problems of the National Nutrition Program E. M. NELSON, U. S. Food and Drug Administration, Washington, D. C. The following is an illustration of the practical importance of food standards in law enforcement: An act of Congress defines butter and requires that butter contain not less than 80 per cent milk fat. If a firm should manufacture butter containing 75 per cent butter fat, i t is necessary only to determine by proper analysis that the butter contains less than 80 per cent fat in order to prove that the product is in violation of the law. However, if there were no standard for the fat content of butter, it would be encumbent upon an enforcement agency to prove by appropriate chemical analysis not only the actual composition of the product but also that the fat content was too low to entitle the product to be sold as butter. The prevailing practices in the manufacture of butter and the composition of the resultant product would have to be considered if a legal contest developed.
The program that has recently been launched of enriching flour and bread with vitamins and minerals has imposed certain problems on those agencies which have a legal obligation to see that standards of quality are maintained. There are at present no definition and standard for flour or for bread under the Federal Food, Drug, and Cosmetic Act, but it is anticipated that those for flour will become effective within six months and those for bread will follow. Chemical methods for the rapid determination of vitamin B1, riboflavin, and nicotinic acid would aid immeasurably in the manufacture of flour which contains these vitamins in substantial quantities and in the production of flour and bread to which they are added. There is an opportunity now for biochemists to render useful service to the industry and to enforcement agencies by developing chemical methods for the determination of several of the vitamins. The value of “enriched” flour and bread in a national nutrition program will depend in considerable measure on the facilities for their proper production and the assurance the public will have of their composition.
Legal Status The act also prescribes the procedure that shall be used in the promulgation of such definitions and standards. Some of the requirements are that the Administrator of the Federal Security Agency must give proper notice of a public hearing and set forth the proposed standard in general terms. He must specify the time and place for the hearing not less than 30 days after the date of the notice. Any interested party may be heard a t such a hearing. The Administrator must base his order in which definition and standard is set forth only on substantial evidence of record at the hearing. I n the proposed definitions and standards for flour which formed the basis for the public hearing held last September, vitamins or minerals were not included as optional ingredients. There was no uniform practice in the industry which could serve as a basis for proposing such a standard. The fact that the addition of vitamins and minerals was not recognized in the proposal was not intended to imply that the Food and Drug Administration was opposed to the use of such ingredients. I n fact, manufacturers were advised of their privilege of offering proposals and evidence in support of them at the hearing. Such proposals were made and considerable testimony in support of them was offered by representatives of the Subcommittee on Medical Nutrition which is advisory to the Surgeons General of the War and Navy Departments. Obviously it would be inconsistent for the Food and Drug Administration t o promote the manufacture or sale of any product that is subject to the jurisdiction of the Food, Drug, and Cosmetic Act. The act does not prohibit the addition of vitamins to foods, provided the products are properly labeled and such addition does not result in adulteration. This statement does not apply to foods for which standards have been promulgated and which specify whether or not vitamins may be added. The law does, however, impose on the Food and Drug Administration a definite obligation in connection with the promulgation of definitions and standards to see that they will “promote honesty and fair dealing
OR the past several months many statements intended
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to promote the use of flour and bread with added vitamins and minerals have appeared. There was considerable activity in connection with this program several months earlier. The Food and Drug Administration was injected into the picture in connection with definitions and standards for flour which were considered a t public hearings beginning September 9, 1940. Extensive manufacture of flour and bread with added vitamins creates problems of control for the industry and for state and federal agencies. Some matters will be discussed here, pertaining to standards for foods and to the need of rapid methods for the determination of vitamins as they relate to these developments. The Food, Drug, and Cosmetic Act provides for the promulgation of definitions and standards for foods as follows: “Whenever in the judgment of the Administrator such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity.” 721
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in the interest of consumers”. If proposals are made to fortify foods to improve their nutritional value, such proposals should be considered from that viewpoint. While the Food and Drug Administration is concerned with developing standards for foods, equally important is its regulatory obligation to enforce all provisions of the act, including those which prohibit misbranding and adulteration, and condemn the labeling of a product that is false and misleading in any particular. For example, there is a duty of checking the vitamin content of preparations of all descriptions. At present there are no legal standards for the composition of enriched flour or for bread made from it. On April 1 a proposed definition for enriched flour, based on the hearings, was published in the Federal Register. If this standard is adopted, it will probably not become effective before August, 1941. There have been no hearings to consider definitions and standards for bread. Until there are legal standards these products will have to meet such standards as may be required in the light of representations made for them.
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of the vitamin. Agents used for adsorption should be further studied so as to permit their standardization.
Opportunity for Public Service One of the present chemical methods for the determination, of riboflavin depends primarily on measuring the intensity of fluorescence of a solution when exposed to a source of ultraviolet rays. Such fluorescence is not specific for the compound, and it is therefore necessary t o prepare test solutions by procedures designed to eliminate interfering substances. Here again we have in riboflavin a characteristic compound whose properties need further study to find reactions which are a specific for the molecule. No one will question the statement that our knowledge concerning pellagra would be greatly advanced within a year if we had a rapid and dependable method for the determination of nicotinic acid. Such a method is needed in studying not only the treatment of the disease but also the distribution of nicotinic acid in foods that may be available to people in those regions where pellagra is present. Not only is there an opportunity for the chemist to distinguish himself, but he has a definite obligation to society. One of the questions I am asked most frequently is, “What methods must I use in the determination Gf vitamins to comply with the requirements of the Federal Food, Drug, and Cosmetic Act?” The act imposes no requirements on the use of any specific method in the manufacture of a product that comes within its purview. The Food and Drug Administration is given no authority to approve or accept methods which a manufacturer may wish t o use. The manufacturer should assure himself that any method he uses will yield accurate results. In the enforcement of the act the Food and Drug Administration is required to use the U. S. Pharmacopoeial methods for products prescribed in the Pharmacopoeia. If a method of assay for a vitamin is prescribed in a definition and standard for a food, as is the case in the standard for evaporated milk with vitamin D, that method must be used by the Food and Drug Administration in establishing a violation. The law provides adequate safeguards to permit the manufacturer t o use official methods for the examination of shipments of his own products that may be charged to be in violation of the act. Let us assume that a shipment of goods has been seized because it has been charged that the goods are deficient in vitamins. Section 304, paragraph (c), of the act reads in part as follows: “The court a t any time after seizure up t o a reasonable time before trial shall by order allow any party to a condemnation proceeding, his attorney or agent, to obtain a representative sample of the article seized”. The claimant is therefore given an opportunity to obtain a sample of the goods in question and to make such further examination as he desires. If’ there are official methods that are applicable he can apply them and determine whether or not he wishes to contest the seizure. The chemist who develops a practical method for the determination of a vitamin may have every assurance, therefore, that his method will have wide application. It may be used in the manufacture of products for plant control, in clinical studies for improving the treatment of disease; it may be used by enforcement agencies to assure the consumer of products of satisfactory quality; and it will of course be an important tool in the hands of the biological chemist in furthering our knowledge of nutritional essentials and their distribution in nature. Development of new quantitative methods are seldom spectacular enough to receive recognition in the form of awards, but the investigator in this field should obtain just as much satislaction in his contribution to society as one who is fortunate enough t o make a unique discovery that lends itself better to a popular dissertation.
Need for Rapid Quantitative Methods The addition of vitamins t o such widely used foods as flour and bread brings to our attention forcefully the need for more rapid methods for the determination of vitamins. The proposed federal standard for enriched flour requires that such flour contain certain specific quantities of at least three vitamins-thiamin, riboflavin, and nicotinic acid. While real progress has been made in recent years in developing chemical and biological methods for the quantitative determination of these vitamins, there is vast rocm for improvement. Several goups are actively engaged in studying the available methods with a view to making them adaptable to flour and bread, and these efforts will undoubtedly be helpful; but it should be emphasized that there is need for some fundamental research directed toward developing new methods. The research worker who has dealt with vitamins has had a fascinating field to study during the past twenty-five years. There has been a continuous chain of important discoveries. Most investigators who have given consideration to methods for determining vitamins have concerned themselves only to the extent that such methods be adapted to further research. The industry has found it profitable t o promote the sale of many products on the basis of their vitamin content, necessitating methods for plant control, but available methods leave much to be desired. While we have not yet emerged from the era in which there is necessity for studies on biological methods for the determination of vitamins involving the use of such animals as the rat and the chick, we have entered an era in which the best efforts of the organic chemist and the physical chemist are in demand, and here is an opportunity to render a most useful service. The vitamins for which methods are most urgently needed are now available in pure form and in sufficient quantity t o permit systematic studies of their properties and specific reactions. These problems are well deserving of the attention of our most capable chemists, and there are many methods of approach that should be investigated. The thiazole group has not been found in nature other than as a constituent of the vitamin B1molecule or as a product of vitamin B1degradation. This is also true of the pyrimidine nucleus which forms tho other half of the vitamin B1 molecule. The vitamin B1 molecule can readily be split into these two groups. I t would be surprising if a systematic study of the reactions of either one of these groups did not suggest compounds m-hich could serve in the quantitative determination of the vitamin. Present methods for the chemical determination of vitamin B, involve a process of adsorption and elution. Further study of these processes is necessary t o ensure quantitative recovery End of Symposium
