PACIFIC SOUTHWEST ASSOCIATION OF CHEMISTRY TEACHERS MISREPRESENTATION AND FALSE CLAIMS' F. LESLIE HART Los Angeles District, Food and Drug Administration
ADVERTISING may he
traced hack to prehistoric times. The pictures of now-extinct animals, pierced with spears, still visible in a Cantahrian cave, advertised the artist's skill as a huntsman. It has been said that the caravan which the Queen of Sheba led to Israel was really a campaign put on by the Ethiopian Chamber of Commerce to advertise the precious metals and spices of her native land. Effective advertising needs a medium of dissemination. This had to await the invention of the printing press and the newspaper, which gave the purveyor of foods and drugs a method of acquainting the public with the merits of his wares. A note in the "Tatler," in the year 1110 says, "If a man has Pains in his Head, Cholic in his Bowels or Spots in his Cloathes, he may here meet with proper Cures and Remedies." Wehster defines "advertising" as "any form of public announcement intended to aid, directly or indirectly, in the sale of a commodity." This definition includes, in addition to the usual newspaper, magazine, radio, or television announcements, such th'mgs as labels, circulars either enclosed within the package or handed out with it, and booklets sent through the mail or otherwise distributed with the purpose of encouraging the sale of a product. In 1937-38, while Congress had under consideration new legislation to replace the obsolescent Food and Drugs Act of 1906, there was much controversy over vesting of jurisdiction over advertising, whether in the Federal Trade Commission or in the Food and Drug Administration. Congress finally passed the Wheeler-Lea Act, which provided that dissemination of false advertising with respect to foods, dmgs, or cosmetics constituted an unfair or deceptive act under the basic Federal Trade Commission Act. But jurisdiction over 'labeling" was given to the Food and Drug Administration under the Food, Drug, and Cosmetic Act of 1938. That act defined "labeling" as "all labels and other written, printed, or graphic matter (1)upon any article or any of its containers or wrappers
' Paper given at the Pacific Southwest Association of Chemistry Teachers' session in the joint meeting with the Southern California Sections of the American Chemical Society st Pomona College, Claremont, April 29, 1950.
or (2) accompanying such articles." It will he seen that circulars and other material accompanying a package of a food, drug, or cosmetic come within the purview of the Food and Drug Administration. It is the purpose of this paper to consider this latter type of advertising and the efforts of the Administration to protect all consumers against deception through its false use.= Methods of distribution of promotional literature used by manufacturers of proprietary medicines change as the scope of the law changes through judicial interpretations. The original 1906 Act classified articles as misbranded if false or misleading statements occurred on the package or label. In 1911 a court held that "an advertising circular inclosed with an article inside the carton in which it is offered for sale does not induce the sale or deceive the intending purchaser, and is not within the purview of the Act." An attempt to correct this narrow construction was made in 1912 through the passage by Congress of the Sherley Amendment to the Act. This used the phraseology, "if its package or label shall bear or contain any statement. . .which is false and fraudulent." Under this clause the Supreme Court ruled that false and fraudulent statements on a circular within a package now constituted misbranding, hut a patent medicine manufacturer needed only to ship his medicine and circular separately to avoid the law. The present Act expanded still further the concept of misbranding. That law declares a food, drug, or cosmetic misbranded "if its labeling is false or misleading in any particular." Since that time there has been a continuous legal battle to deline the term 'Laccompanying." One phase of this battle was fought in the Federal District Court of Southern California. Here a promoter of a crude petroleum oil first sold the oil as a labeled treatment for a long list of ailments; then he transferred the curative claims to a circular packed inside the cartons used to ship the medicine to the druggist. Later he shipped the circulars and the medicine separately. His latest stunt was to supply matrices of advertisements to newspapers The scientific methods used by the Food and Drug Administration to test the claims for patent medicines are shown in the recent, intere~tingfilm, "Fraud Fighters."
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directing them to print additional copies of the advertisement and deliver them to druggists for circulation to their customers. Each change of distribution was the result of some legal action instituted by the Food and Drug Administration. This manufacturer was lined $1500 in 1942, sufferedover 125 seizures of his oil from 1944 to 1946, was enjoined in 1947 and again in 1949 to stop shipping misbranded drugs, and in between these years he was 6ned $9000. He also was sentenced to two years in jail, this sentence being suspended during a probation period. Courts now hold that physical accompaniment of advertising circulars with the product is not essential. In one case which went to the Supreme Court, the misleading statements of which the Government complained had been distributed apart from the drugs. Some circulars had been given away with the sale of the drug, some had been displayed in stores for free pickup, some had reached customers hy mail, and some had been sold independently. The Supreme Court said this all constituted "accompaniment " and therefore labeling amenable to the Act. To quote a pertinent part of Justice Douglas' decision: "The drugs and the literature had a common origin and a common destination. The literature was used in the sale of these drugs. It explained their uses. Nowhere else was the purchaser advised how to use them. It constituted an essential supplement to the label attached to the package.. . . It would take an extremely narrow reading of the Act to hold that these drugs were not misbranded.. . . It would indeed create an obviously wide loophole to hold that these drugs would be misbranded if the literature had been shipped in the same container, but not misbranded if the literature left in the same or the preceding mail. The high purpose of the Act, to protect customers who under present conditions are largely unable to protect themselves in this field, would then be easily defeated. . . . One article or thing is accompanied by another when it supplements it or explains it. . .. No physical attachment one to the other is necessary. It is the textual relationship that is significant." Last year's Annual Report from the Food and Drug Administration said that 150,000,000 people in this country use foods, drugs, or cosmetics prepared by others. These products were made, shipped, or stored by more than 77,000 firms doing interstate business. The Administration's responsibility is to enforce the rules laid down by Congress to ensure these commodities are safe, pure, and truthfully labeled. For this job the Administration was allotted 31/3cents per consumer for the year 1949. Early laws, against misrepresentation followed the Gilbert and Sullivan theory of making the punishment fit the crime. In one of the early Teutonic states a wine-maker who had adulterated his wine was sentenced to drink 6 quarts of his wine. From this he died. Early English bakers, l i e present-day ones, sold shortweight bread. Those caught were sentenced to sit in the pillory with bread dough draped around their necks. Present-day laws are more humane. The Food, Drug,
JOURNAL OF CHEMICAL EDUCATION
and Cosmetic Act punishes violators with line or imprisonment, or both, a t the discretion of the Court. First offenders are subject to a h e of $1000, imprisonment for one year, or both, for each count. Subsequent offences may be subject on each count to $10,000 line or three-year imprisonment, or both. The law also provides for injunction proceedings. This procedure has been found quite useful in many cases. Civil action against the misbranded goods through seizure proceedings may also be taken through libels filed in Federal Courts. This method of action, which is entirely independent of criminal action, quickly removes the misbranded goods from the market. The most flagrant examples of misrepresentation are found in the fields of the so-called patent medicines and in medical devices. It is a sad commentary on the greed of purveyors of these nostrums and gadgets, and on the credulity of people suffering from diseases, that organized campaigns for funds to combat such diseases as cancer, heart disease, or tuberculosis, or publicity on epidemics of influenza and polio also bring forth advertisements of nostrums for the home treatment of these diseases. You will not usually 6nd such rank frauds on the shelves of your local drug store. They are advertised through the smaller radio stations and in the pulp magazines. The 1949 Annual Report mentioned previously observed that "such opportunistic attempts to capitalize on human misery have received little sympathy from the courts." That year, in just one of the Admmistration's sixteen field districts, cases were brought against three cancer remedies. One was stopped by injunction; two were prosecuted, found guilty, and ordered by the Court to discontinue interstate business. A description of some of these devices may be of interest. Here are some of the contraptions that have come under the scrutiny of the courts in recent years, and have been condemned. A vapor-bath system, consisting of certain drugs and plumbing connections between a generator and bath cabinets, which could be purchased for $2,200, was represented as effective for diabetes, abscess of the lungs, decay of the jawbones, and blood poisoning, among a long list of other ailments. An apparatus for administering electric shock, selling for $1,200, was represented as a cure for abscess of the liver, internal growths, heart disease, paralysis, cancer, tuberculosis, infantile paralysis, and other disease conditions. A device for administering an enema, priced at $1,190, was offered for the treatment of arthritis, rheumatism, neuritis, high and low blood pressure, toxic heart conditions, ulcers of the stomach and bowels, colitis, chronic appendicitis, gall bladder and liver troubles, kidney and bladder troubles, asthma, migraine, toxic skm troubles, lumbago, and for good measure, "a host of ills that have heretofore been obscure." Another device called Spectro-Chrome was a 1000watt lamp in a cabinet supplied with different-colored
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glasses to fit an aperture through which the light bathes the patient. W ~ t hhead pointing toward the north, the patient received "tonatious" a t favorable times of the day, with a "Favorscope" supplied to correct for "solar, lunar, terrestrial radiant and gravitational iufluences" based on "vibrant breath phenomena." By using appropriate glasses to color the light as required for the particular disease to be treated, the device was claimed to be effective for diabetes, cancer, tuberculosis, syphilis, and a long list of other ailments. Said Dinshah P. Ghadiali, who manufactured the apparatus and who scorned the use of drugs, "Give me a case of appendicitis, and I will send the man back in one night, having his appendix inside of h i instead of in a glass bottle." This lamp, more marvellous than Aladdin's, was not for sale. To get it, one had to join an "institution" a t a fee of $90. The lamp was then furnished free. The Administration found that at least 5000 had been distributed, and Ghadiali himself claimed the figure was 9000. With them, for a price, was distributed sc-called "encyclopedias" and other "literature" which gave voluminous information about the use of the lamp and sought to cloak the scheme in oriental mysticism and sanctity. The first action against the lamp deception was seizure and injunctions against further distribution. Ghadiali nevertheless continued to distribute the lamps; then criminal prosecution was filed. During the trial, which lasted 42 days, the Government presented an array of relatives and physicians of victims who had used the device and had died from the diseases it was represented to cure. The jury brought in a verdict of guilty and the court imposed against Ghadiali and his corporation a h e of $20,000, and a three-year prison sentence against Ghadiali, but imprisonment was suspended on the condition that the business be stopped. The Atomic Age has also brought a host of promoters in its wake, offering weird devices, or fantastic nostrums based on atomic disintegration, for the cure or prevention of even the most serious diseases. Many
of these are dangerous; all are worthless. The publicity on atomic energy in our magazines, newspapers, and d i o adds an aura of science to these worthless products. Many have had their day in court and have been found wanting. One was called the U-235 Drinking Water, a product consisting of brown-colored lumps of very low-grade carnotite ore which the user was directed to drop into his drinking water. It was offered as a cure for polio, prostate trouble, gout, cancer, and 41 other diseases. This same faker offered an "atomic ray" salve that would build tiasues, relax nerves, clear up skm infections, and correct chronic a p pendicitis, and also sold a "radioactive" bath powder for treatment of diabetes, neuritis, and low vitality. Another entrepreneur offered an "atomic film" salve to relieve corns, ease stomach distress, and promote healing of gums after tooth extraction. The "Master Cell" was offered for sale in New England by an ex-pharmacist, now a farmer. This was a little, perforated, concrete "patty-cake" that embodied a mysterious cell said to ije "a breeding place for new life." The inventor claimed the use of it would improve the human race and induce reluctant hens to lay more eggs. These frauds would seem to make healing claims so far beyond the bounds of human credulity that no sales could be made. Unfortunately such is not the case. Men afEicted with cancer, diabetes, and other now-incurable diseases, like drowning men, grasp at straws. To paraphrase Saint Paul's description of the Athenians who "spend their time in nothing else but either to tell, or to hear, some new thing" these sufferers, when told their case is hopeless, feeling they have nothing t o lose, try out any remedy or device they may see advertised for their aaction. A federal judge had just these people in mind when he said, "The purpose of this statute is to protect the public, the vast multitude which includes the ignorant, the unthinking, and the credulous, who, when making a purchase, do not stop to analyze."
ERRATUM In the mnouncement of proposed reviews of audio-visual aids, on page 488 of our September issue, the address of Dr. R. T. Sanderson was incorrectly given. It should have been: Department of Chemistw, University of Iowa, Iowa City, Iowa.
