RESEARCH ANIMAL METHODS
VSC/443/543 -  Class notes for 9/26/11

Mrs. Brown’s Sad Story: A History of the Food, Drug, and Cosmetic Act

Wanting nothing but to have beautiful, dark eyelashes,

Mrs. Brown went blind in the spring of 1933.

She suffered tremendous pain during the three months

it took for her corneas to slough off--all because she used an eyelash dye.

Susan E. Wilson-Sanders, D.V.M., M.S.
The University of Arizona - Tucson, AZ

Each year during the Congressional sessions in Washington, DC a bill is introduced entitled the “Consumer Products Safe Testing Act”. The purpose of the bill is to establish non-animal acute toxicity testing as the standard for federal regulations requiring product safety evaluation. This legislation, if passed, would change the way in which safety evaluations are performed for all new drugs, medical devices, household products, food additives, cosmetic, pesticides, industrial chemicals, and other consumer goods. The bill makes the false assumption that valid “alternative” methods are already available to replace the long-recognized and accepted whole animal models for toxicity and safety testing.

Many Americans support the passage of such an act because they strongly support the use of “cruelty-free” products. In today’s market, many companies advertise that “no animal testing was performed” in the approval of their shampoo, eyeliner, mascara, perfume, or other product. While most of us in the animal research community recognize this as deceptive advertising, the public has been taken-in by the tricks of the trade. In my contact with students at the University of Arizona, I routinely find that most oppose cosmetic testing on animals. The same students, mostly female, are not opposed to wearing cosmetics; in fact, most are heavily supporting the cosmetic industry through liberal application of eye shadow, liner, mascara, and all the arts which make them lovelier to behold. Today, we women have no fear to try all the latest in shades and hues, creams and lotions, softeners and toners--all hoping to look in the mirror and see ageless beauty. There is no concern that these very beautifiers could cause us irreparable damage. That instead of looking in the mirror and saying “Mirror, mirror, on the wall, who’s the fairest one of all”, we might never be able to see our image in the mirror again because we were blinded by “Lash-Lure”, like some of our grandmothers and great-grandmothers were in the 1920's and 30's.

The history of why the Food, Drug, and Cosmetic Act was needed has been lost to “baby-boomers” and later generations of Americans. It would seem that our Congress men and women would not forget, as it was in their own hallowed halls that the Act was debated during the early 1930's. It was during those years that physicians, consumer’s advocacy groups, and citizens told their pitiful stories of the horrors of burns, blindings, and death; and when the drug, food, and cosmetic lobbyists so successfully argued against passage of the Act that it took nearly 10 years to pass both houses of Congress. This same Act, together with its many amendments, today still protects the unsuspecting and unknowing public. The very animal tests, so many now oppose, were set up by Congress to ensure that when we purchase a non-prescription medication, a new “blusher”, or a scented soap, that we have little to fear. The modern-day Act requires that the ingredients of products be clearly listed on the label. Labels must prescribe the safe use of the product and the steps to be taken if the product is inadvertently or purposely misused and there is potential for toxicity and injury to the user or abuser. Animal testing provides the vital information needed on toxicity and treatment or prevention of toxicity that is found on every product label; but here we are, nearly 70 years from the days of “Lash-Lure”, “Koremlu”, and “Dinitrophenol”, and our Congress, with the support of many Americans, is proposing to ban the testing procedures that have proven so effective in protecting us from our own vanity.

For the moment, I ask you to take a step back in time, to review the history of the Food, Drug, and Cosmetic Act. Let us make the quantum leap into the past, into the America of the 1930's, into the households of our grandmothers, to hear the stories of Mrs. Brown, and the countless others, who suffered and died, and to live the accounts documented in the Congressional Record of 1933-1935 as Congress debated the passage of the Food, Drug, and Cosmetic Act.

The use of cosmetics is not a new fad brought on by the Twentieth Century; their use can be traced back to the time of the early Egyptians, whose queens applied kohl, which was made from malachite and galena (a lead ore) to darken their lids, eyebrows and lashes. Red iron oxide and red lead were also used by ancient Egyptian women to redden their cheeks and lips. In 400 BC, the ladies of ancient Greece used cubes of lead carbonate as a face powder. Later, in 54 AD, Poppaea, wife of Nero, used kohl, barley flour and butter to treat her pimples, rouge, lead and chalk powders to whiten her face, and a pumice stone as a tooth brush. In the Roman era, kohl was made from antimony, as well as copper and lead. Oriental women used a complexion powder called batikha made of powdered marble, rice and borax. In early America, talcum powder was used as the foundation of women’s fair complexions, with coloring agents added to give the women a gentle blush to their cheeks.

In the late 1800's and early 1900's the cosmetic drawer of the average American woman consisted of a can of talcum powder, a chamois skin, and a bottle of hand softener usually made of glycerin, tragacanth (a gum-like material from Astragalus, a thorny shrub) , and rose water. For the wealthier ladies, a box of pink or white face powder, a powder puff, and a bottle of perfume might also be found in the drawer. Rouge, lipstick, nail polish, and the eye enhancing agents were not commonly used and when observed, usually classed a woman as “fast”, if not worse. Because women during that era used little “make-up”, there were few cases of injury occurring from use of cosmetics. The focus of the public, at the turn of this Century, instead, was on the injuries occurring due to contaminated food products being distributed to consumers and the false advertising and sale of brews, potions, and concoctions which were being represented as wonder cures for everything from the common cold, to obesity and tumors. Dr. Harvey W. Wiley, and other physicians of the day, led a nation-wide campaign to inform the public and apply pressure on Congress to pass legislation which would protect the public from impure food and drugs.

Despite the concerns of their constituencies regarding impure food and drug products, special interest groups stalled the passage of protective legislation. Two events stirred public interest to the boiling point. First was the discovery that American soldiers fighting the Spanish-American War were being served rotten canned meat. A few years later, the public and Congress were enraged by Upton Sinclair's book, "The Jungle", which exposed the unsanitary practices of the U.S. meat industry. As a result of these two events, Teddy Roosevelt pushed Congress into formulating legislation which resulted in the passage of the Pure Food and Drug Act of 1906. The Pure Food and Drug Act prohibited the interstate commerce of foodstuffs and drugs which gave false claims of purity and quality. The purpose was to control fraudulent claims, but there was no requirement for safety testing prior to shipping food through interstate commerce.

During the period between the Pure Food and Drug Act's passage and the 1930's little was done to curb the marketing of unsafe cosmetic products, foods, or drugs. During this period American consumers were at the mercy of companies who portrayed their products as safe and effective, when many products were poisons which could maim or kill.

Some products were innocuous, but simply were not what they were represented to be. For example, apple cider could be marketed as “pure” but was, in truth, two parts water and one part cider with some sodium benzoate added to dice up the flavor. Today, of course, this same product could be marketed as “Ciderade”, but at least we can read the label and see what we’re getting. Even ice cream was not what it seemed. Creameries commonly used vanillin, the flavor factor in the vanilla bean, as an additive to their product without using the real bean. Instead, they used vanillin synthesized from cloves which also contains vanillin. The ice cream packaging companies did not want to inform the public what they were getting because they feared American housewives would not buy their product if they knew they were getting oil of cloves extract and not vanilla bean extract as the flavoring agent in their families’ desserts.

In contrast to cider and ice cream chicanery, there were many serious discrepancies in advertising encouraging people to buy products that would be harmful to them. Smooth-talking men and women on the radio waves would sing the praises of a product, and Americans would flock to the nearest drug store to buy these “patent medicines” without consulting their physician. Fat-reducing agents were receiving great attention in those days (We haven’t changed a bit, have we? Still battling the bulge). One such agent, which was highly touted as being exceptionally effective, was Dinitrophenol, a compound that was used in the manufacture of explosives. (In more modern times, this compound has been used as an herbicide and insecticide and is known to be extremely toxic to humans and animals.) Physicians were seeing numerous cases of injury and death from consumption of this agent. The unsuspecting users, mostly women, could go blind. The Washington D.C. News, July 16, 1935 described the use of Dinitrophenol this way:

“It’s just like jiggering the stove damper and pouring gasoline over the fire...It causes the body to consume, at a terrific rate, energy builders. The pulse rate goes faster and the temperature rises, and instead of storing up the food as fat, it burns it off and actually cooks the victim.”

One young woman, aged 25, died within 5 days of beginning on her Dinitrophenol-induced diet. Another diet fraud of the day was companies selling packaged, “ordinary, wholesome food in attractive packages” (we still fall for this trick today!!). The directions were to use the pre-packaged product exclusively and eat one of these containers of food a day; simply “a starvation process” was the words used by physicians who testified to Congress. Other diet products were laxative based which were so severe that the food “rushed through the body before it can be assimilated.”

By the 1930's injurious cosmetics were also of concern to the American public, for the industry had grown from a fledgling state into a multi-million dollar business venture for a number of enterprising companies. Women were attracted by the Tennysonian advertising for “eternal beautification” and were spending a substantial portion of their budgets on new beauty products. Women’s magazines, such as Harper’s Bazaar, were filled with ads for lipsticks, toners, perfumes, color enhancers and more. Not only could a woman stir her husband's emotions, the ads would say, but she would need a policeman at her door to fight away the admirers. One cosmetic manufacturer was quoted as saying “We sell a service to a woman, we sell a belief in the efficacy of mysterious liquids and grains” An Elizabeth Arden ad read:” And like a garden is the beauty of woman. Tended, it sings with glory....neglected, weeds creep in....the garden is no longer a romance and delight, but one grieves over it--that lovely eyes should be marred by lines, a charming mouth by a double chin or a ‘scraggly’ throat beneath.”

Many cosmetics produced in the early part of this century were harmless and could provide some measure of enhancement for a woman’s looks, but there were others that caused temporary or permanent injury and even death. The lovely Mrs. Brown, a young woman of high society, found out the hard way. She used Lash-Lure, a product which was heavily advertised and marketed across the United States. Thousands of reports of injury following use of this compound were reported in the medical literature and in the newspapers. In the fall of 1933, The Journal of the American Medical Association gave accounts of several women who experienced symptoms and signs from minor eye irritation, to ulceration, and death. The dye contained an aniline compound related to p-phenylenediamine. In the 1920-30's, aniline dyes were commonly used in hair coloring agents, but most manufacturers marketed these products with warnings of the possible ill effects of getting the dye into the eyes. Most hair dyes were used in beauticians’ facilities, and it was standard practice to perform a skin sensitivity test prior to applying the hair dye. Even knowing that small amounts of alanine were irritants, the company who produced Lash-Lure marketed their product which contained 25-30 times more aniline than hair dye as being safe to use. The use of paraphenylenediamine in cosmetics had been banned in Europe since the 1880's because of the many cases of toxicity observed there; the United States had not restricted use of the compound.

Numerous physicians, cosmetologists, and concerned citizens testified before Congress during the early 1930's providing horror stories of the use of Lash-Lure. One young woman, Miss E.N., was seen by her physician in 1929 after having had her lashes dyed at her local beauty parlor. Her eyelids were swollen so that she could barely open her eyes. The lids were covered with many small watery blisters and there was marked chemosis of the conjunctiva. She exhibited marked photophobia. She was treated and slowly improved. Ten days from the onset of her illness, abscesses developed on the lids. In 1933, this same patient was seen again, after using the same product at her beauty shop. This time, the irritation was markedly worse and she required hospitalization. Her eyebrows had also been dyed, and the skin around the brows showed a vesicular eruption and tremendous edema. It took six weeks of nursing care before she returned to a semblance of normalcy. Her vision was permanently affected by the injury.

Drs. Forbes and Blake from Tampa Florida brought to Congress the case of a fatality resulting from use of Lash-Lure. The patient, aged 52, had her right eyebrow “plucked” and the dye applied to the right brow and lashes. This was performed by her daughter, a beautician. Within 30 seconds of application, her eyes, brows, and adjacent tissues began to burn and swell. The pain was so severe, that her daughter would not proceed with the left eyebrow/lash treatment. An hour later she was unable to open her eye. She went to her physician the next day and her temperature was 104^oF. Eight days after the onset of the illness, the woman was referred to Forbes and Blake. The skin over the right side of her forehead and cheek was covered with deep sloughing ulcers which were covered with purulent exudate. The conjunctiva also showed deep ulceration and the conjunctival sac was filled with tenacious yellow exudate. The lymph nodes on the right side of the neck were considerably enlarged. The heart sounds were abnormal. Three hours later the woman was dead. Although an autopsy was not obtained, a conjunctival culture showed pure Staphylococcus aureus. The physicians’ conclusion was that septicemia had resulted from the infection superimposed upon the severe necrotizing response caused by Lash-Lure.

As a result of the number of cases of injury related to Lash-Lure, and other aniline based lash/brow dyes, many states began to ban the use of aniline dyes. The Food and Drug Administration supported the ban but could not prevent the manufacture, false advertising, and sale of this hideous product, because the Pure Food and Drug Act did not cover cosmetics. Lash-Lure was not alone in causing suffering to scores of American women. There were many, many products on the market that were causing injury: Anti-Mole, a remedy, contained 50% nitric acid and 25% glacial acetic acid. It took off the moles along with the side of the victim’s face! Berry’s Freckle Ointment contained 12% mercury and produced mercury toxicity. Some unsuspecting people purchased Bleachodent to whiten their teeth and burned their gums and tongues because of the high content of hydrochloric and sulphuric acid. Carbon tetrachloride, which we know today is carcinogenic and produces hepatic toxicity, was a common ingredient of “dry” shampoos. Is your scalp itching? Use Dr. Dennis’s Compound which “prevents and stops the itch in one minute” because of its concentration of chloral hydrate, or Dewsberry Hair Tonic which stops an itching scalp with copper chloride and pyrogallic acid.

Women were not the only casualties of cosmetic fraud. A “whisker” dye was found to be as dangerous as the dyes offered to women because it contained excessive amounts of silver. Men also used “whisker” removers which contained lead acetate, which could cause permanent baldness. Thallium acetate was also found to be a potent depilatory. Thallium, which is used as a rat poison, was found by a Dr. Sabouraud to remove hair (probably when someone spilled rat poison on their arm). The primary product culprit was Koremlu cream, which was advertised as a “permanent and safe” depilatory. The marketing company even went on to say that Koremlu would have a beneficial effect on the skin itself. The cream had to be used “regularly” to obtain optimum results. Late in 1930, the American Medical Association began to receive inquires from their members regarding Koremlu. Patients were experiencing various ailments including losing all scalp hair, neuritis, myalgia, and arthralgia. Many of the nation’s leading department stores sold the product, and Vogue and Cosmopolitan carried its advertising. The product was eventually banned in some states, but continued on the shelves in others. Eventually the company went bankrupt due to the mounting insurance claims for damages resulting from use of Koremlu. The former vice president of Koremlu, Inc. went on to become the president of Croxon, Inc., which promoted a depilatory called Croxon cream. False advertising was once again utilized. Advertising claimed the product would permanently remove hair, preventing regrowth by permanently destroying the hair and root. The claims even went on to indicate that extensive research by doctors had resulted in this miracle hair remover. In actuality, it was simply a hair bleach and did not remove hair at all. The ingredients cost 5 cents per jar; the jars were sold for $5 each in 1930! The Pure Food and Drug Act could not prevent continuation of this fraud.

The Pure Food and Drug Act did not require any form of testing to ensure that a product was safe or effective. Anyone could concoct a brew and market it with claims that it was a wonder cure. For example, a shirt salesman made a small fortune selling Banbar to diabetes patients. The elixir was made from horse-tail weeds and was absolutely worthless, but many patients used Banbar in lieu of insulin and died as a result. In another instance, a liniment made of ammonia, eggs, and turpentine was widely advertised as a cure for tuberculosis. A physician acted as spokesperson for the liniment and eventually lost his license and was expelled from the AMA for supporting fraud. A mother and son made ads saying how wonderful the liniment was, and even after the son died of tuberculosis, the woman continued her testimonials praising the effects of the useless liniment. The whole case went to court, and an investigation showed that the woman was being paid by the liniment manufacturer for her testimonials. The jury found the woman guilty of fraud and blocked future sale of the product.

The debate in Congress continued for nearly 10 years, with revisions of the Pure Food and Drug Act being tabled on many occasions. Special interest groups played an important role in the lengthy debate. Soap manufacturers wanted to be excluded from the definition of “cosmetic”, ice cream companies wanted to be excluded from labeling requirements, tuna packers wanted the right to seize bad cans of tuna, “recondition” it, re-can it, and sell it again. Drug companies did not openly oppose the Bill for fear of destroying public confidence but worked behind the scenes to “water” it down. In the midst of all this debate, the issue of “socialized medicine” made its debut and government agencies pitted themselves against each other.

A tragic incident occurred in 1937 which increased the public outcry to a frenzy, and Congress finally took decisive action. The incident involved "Elixir of Sulfanilamide". Sulfa derivatives were among the first antibacterials discovered, but Sulfas were so bad-tasting that physicians had trouble influencing children to take the life-saving drugs. Pleasant tasting elixirs were needed to disguise the bitter flavor. S.E. Massengill, Inc. dissolved sulfanilamide into sweet-tasting diethylene glycol (modern-day anti-freeze) and marketed Elixir of Sulfanilamide. One hundred people, mostly children, died from renal failure following use of the antibiotic elixir. The company denied any wrong doing, but the firm's chief chemist committed suicide following public exposure. The toxicity of this solvent had not been tested in animals prior to marketing because animal testing was not required under the 1906 law. Even simple animal tests would have proved the extreme toxicity of this compound.

Injury to citizens was not the only factor that led to the final debate and passage of the Act. Advertising had become one of the most hotly contested parts of the Bill. Newspapers and magazines, as well as product manufacturers, were strongly opposed to control of advertising. To assuage the special interests, Congress deleted control of advertising from the Bill, and regulation of advertising was left in the hands of the newly formed Federal Trade Commission. With the removal of the contested issue of advertising, enough votes were finally available for passage of the Bill, and the Food, Drug, and Cosmetic Act of 1938 became law. The Act remains today, though it has been amended many times.

Control of labeling was assigned to the FDA and labeling standards were established. The initial Act required pre-distribution clearance of any new drug. No provision for approval for food additives was made at that time. Animal studies were required by the law, but no guidelines were given. Studies in rats of up to one month were considered sufficient. Within 10 years, studies of up to 3 months were required; by 1957, 6-month studies in the rat and dog were considered to be an adequate assessment of the chronic toxicity of a drug. The 1957 standards are still the norm in many parts of the world. In 1949 the FDA published its first animal safety testing guidelines. In 1982, the FDA standards were altered to require a one year study in a non-rodent, and an 18 month study (or longer) in a rodent for chronic toxicity studies.

Pre-marketing clearance for food additives which were not generally recognized as "safe" was added in 1958. The "Delaney Clause", found in the 1958 amendment, stated that "...no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal". Following the thalidomide disaster in 1962, Congress passed the Kefauver-Harris Amendment, requiring drug manufacturers to prove efficacy as well as safety of a drug prior to its approval for marketing. New guidelines for animal studies were discussed, announced in Congressional subcommittee in 1966, and published in 1968. It was at this time that guidelines for effects of drugs on reproduction and teratogenicity were established.

Many of our grandmothers have lived to see the changes that were brought about as a result of the sad stories of Mrs. Brown and the countless other men, women, and children who suffered because there were no safety standards for drugs, cosmetics and products. They would say to us “We’ve come a long way baby”. Today’s consumers have a host of prescription and non-prescription drugs, cosmetics, and household products to choose from. Their safety and efficacy has been tested extensively in animals, and for the most part consumers can feel safe in using the product within the boundaries set forth in the prescription or labeling of the compound. We can reduce our weight safely through diet pills or such packaged foods as Weight Watchers, and can change our hair to red, blue, or green on a whim without worry. We don’t need to be concerned when our daughters rummage in our cosmetic drawers when they play “dress-up”, choosing eyeliner, mascara, blusher and lipstick. We can smile at our grown up little girls dressed in spike-heels too big for them and faces painted like china dolls, because we know that more than 60 years of animal tests have ensured that our cosmetics are safe. Even the animal activist who buys the shampoo with its big bold letters No animal testing has been protected because animal testing was done.

Now, let us come back to the future, leaving the stories of the past. We are the grandmothers and grandfathers of our future generation and must not forget the lessons that were learned by our ancestors. Progress continues. New pharmaceuticals are being developed to fight cancer, arthritis, heart disease, and the many other maladies which still plague man and animals alike. Our vanity has not changed through the many centuries since kohl darkened Cleopatra’s eyelids--we still look for eternal beauty. Cosmetic companies will continue to develop new products for us to use in our quest to stop the progress of time, and it is our responsibility to ensure that these products are safe for ourselves, our children, and our children’s children. While biomedical science has made great strides in finding alternative testing techniques, such as in vitro screening procedures, computer simulations, and other methodologies, there is still a need for the use of live animals in the final stages of testing of many drugs and other products.

The “Consumer Products Safe Testing Act” now has over 40 sponsors. The bill ignores the currently existing Congressional mandate (The NIH Revitalization Act of 1993, Public Law 103-43) for establishing and validating new alternative test methodologies, which once validated would be acceptable for regulatory use. Requirements of this law recognize that, as they become available, non-animal tests must be validated as adequate to protect human and animal health and the environment. To complete the task assigned by PL 103-43, fifteen government agencies and organizations, working as the Interagency Coordinating Committee on the Validation of Alternative Methods have been working on this task. A final report from the committee is now in review. The Consumer Products Safe Testing Act would throw out all the work that has been accomplished by PL 103-43.

The Congress of the United States responded to the needs of its citizens in the early years of this century and passed the Pure Food and Drug Act and the Food, Drug, and Cosmetic Act to protect us. The Congress of our day needs to be reminded of the past, or the young people of the Twenty-first Century may relive the horrors of Lash-Lure, Koremlu, and Dinitrophenol. Americans must not forget Mrs. Brown’s sad story.

References

Burns, J. “Overview of Safety Regulations Governing Food, Drugs, and Cosmetics in the United States” in Safety Evaluation and Regulation of Chemicals, First International Conference on Safety Evaluation and Regulation of Chemicals, Boston, Mass, 1982. Editor F. Omburger, Karger Publishing Company, New York, 1983, pp 9-16.

Phillips, M.C. Skin Deep, Vanguard Press, New York, 1934.

A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments, Vol. 1 and 4, U.S. Department of Health, Education , and Welfare, Public Health Service, Food and Drug Administration, U.S. Government Printing Office, 1979.

Temen, P Taking Your Medicine, Harvard University Press, Cambridge, Mass, 1980.

Bollier, D., Claybrook, J. Freedom from Harm, Public Citizen and Democracy Project, pp13-47, 1986.

Brookes, V.J., Poisons, Robert E. Krieger Publishing Company, New York, 1975, pp 77-78

“Consumer Products Safe Testing Act Returns” NABR Alert, Vol. XVIII, No.a, April 23, 1996

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