Animals in Product Testing

The Food, Drug and Cosmetics Act

The Food, Drug and Cosmetics Act is a revision and expansion of the Food and Drug Act of 1906, which was passed on the same day as the Meat Inspection Act. Both of these Acts came about as a result of public outrage over the filthy conditions of a Chicago meatpacking plant.

The original act was replaced with the Food, Drug and Cosmetic Act in 1938 on the heels of an incident involving a drug called Sulfanilamide, which was commonly used to treat streptococcal infections (strep throat). In 1937, the S.E. Massengill Company decided to create a liquid form of the drug, and the company's chief chemist developed a formulation, which used diethlyene glycol as a medium for the liquid Sulfanilamide. No one knew at the time, however, that diethylene glycol, is a deadly poison. Since no testing of pharmaceutical drugs were required at the time, the liquid Sulfanilamide was released to the public, and 107 people-mostly children-died.

The uproar that arose from this tragedy spurred Congress to pass the Food, Drug and Cosmetic Act in 1938. Provisions of the act are enforced by the U.S. Food and Drug Administration (FDA). Among other regulations, the Food, Drug and Cosmetics Act requires proof of the scientific safety of new pharmaceutical drugs and a number of chemical compounds that change the chemistry of the body before they can be marketed. At this time, the FDA requires some of that testing to be carried out on animals.

Animal testing on cosmetics and household products, such as window cleaners and laundry detergents is not required by the Food, Drug and Cosmetics Act. However, the FDA urges companies to conduct whatever toxicological tests are appropriate to substantiate the safety of their products. Traditionally, manufacturers have used animal tests to provide the substantiation they need to meet regulatory requirements-and to obtain documentation of safety that can help them in court in the event of a lawsuit.

The Act defines cosmetics as "articles other than soap which are applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance." The FDA has classified cosmetics into 13 categories:

• Skin care (creams, lotions, powders and sprays)
• Fragrances
• Eye makeup
• Manicure products
• Makeup other than eye (lipstick, foundation and blush)
• Hair coloring preparations
• Shampoos, permanent waves and other hair care products
• Deodorants
• Shaving products
• Baby products (shampoos, lotions and powders)
• Bath oils and bubble baths
• Mouthwashes
• Tanning products

Go to the FDA homepage.