Foods and Cosmetics Safety

Food and Color Additives
by Food and Drug Administration (FDA)

(Page 2 of 5)

The Food, Drug, and Cosmetic Act of 1938

In 1930, the Bureau of Chemistry became the Food and Drug Administration. In 1933, the new FDA recommended a complete revision of the obsolete 1906 act. A five-year legislative battle ensued.

To show the need for a new law, the FDA put together an exhibit for Congress featuring problem products that the agency was unable to act against under the 1906 act. The collection of products included deceptive foods, dangerous cosmetic ingredients, and worthless devices and medicines.

Some of the deceptive foods in the exhibit were egg noodles that were really "plain noodles packed in yellow cellophane so that they looked like egg noodles," Junod says. "There was also chicken packed in a jar. You could see white meat on the outside, but it contained dark meat on the inside."

But it wasn't until a drug-related tragedy occurred that a new food and drug law was passed. After 107 people died from a poisonous ingredient in a product called Elixir Sulfanilamide, Congress passed the Food, Drug, and Cosmetic Act with new provisions in 1938.

The FD&C Act also extended regulatory control to cosmetics for the first time, in response to concerns about cosmetic safety. For example, a coal tar-based eyelash dye called Lash Lure had caused serious eye injuries, including blindness, and possibly one death.

The FD&C Act required that colors had to be listed (approved) before they could be used in foods, drugs, and cosmetics, and in addition, those made from coal tar sources had to be batch certified. The Color Certification Program, supported by user fees, continues today, with nearly 18,000,000 pounds certified for composition and purity in the FDA's laboratories in fiscal year 2005.

"More consumer-oriented than its 1906 predecessor, the 1938 Federal Food, Drug, and Cosmetic Act represents a true watershed in U.S. food policy," Junod says. "The 1938 Act eliminated the 'distinctive name proviso' and required instead that the label of a food 'bear its common or usual name.' The food would be illegal or misbranded if it represented itself as a standardized food unless it conformed to that standard."

The FD&C Act authorized three kinds of food standards - identity, quality, and fill of container. In 1939, the first food standards were issued for canned tomatoes, tomato purée, and tomato paste. The standards looked like a recipe of listed ingredients. The next standards were for jams and jellies. Junod says, "By 1957, standards had been set for many varieties of foods such as chocolate, flour, cereals, bakery products, milk, cheese, juices, and eggs."

Amendments for Food and Color Additives

In 1950, the Delaney Committee started a congressional investigation of the safety of additives that laid the foundation for the Food Additives Amendment and the Color Additive Amendments. Rep. James Delaney, D-N.Y., later submitted a change to the bill proposing the Food Additives Amendment by inserting the Delaney Clause, which prohibited the approval of any food additive shown to induce cancer in humans or animals in studies with a relevant route of exposure. Variations of the Delaney Clause were also included in the Color Additive Amendments and animal drug provisions.

Enacted in 1958, the Food Additives Amendment required manufacturers of new food additives to establish their safety to FDA's satisfaction before marketing. Food additives are substances that have no proven track record of safety and that must be approved by the FDA before they can be used. A food substance generally recognized by qualified experts as safe for its intended use, based on publicly available information, is excluded from the definition of food additive. Also in 1958, the FDA published the first list of GRAS substances, which contained nearly 200 substances including ascorbic acid, papain, and propylene glycol.

The Color Additive Amendments, enacted in 1960, defined "color additive" and required manufacturers to establish the safety of color additives prior to their use in coloring foods, drugs, cosmetics, and medical devices. At the time, about 200 color additives were in commercial use.

Under the 1960 Amendments, all the color additives were put on a provisional list for use on an interim basis pending evaluation by the FDA. The agency subsequently began permanently listing in the Code of Federal Regulations those color additives for which scientific data established their safety. Today, about half of the original 200 color additives are permanently listed for use in foods, drugs, cosmetics, and medical devices. Recent additions include D&C Black No. 2, approved for use in certain cosmetics, and mica-based pearlescent pigments, approved for use in contact lenses.

In 1966, the Fair Packaging and Labeling Act required products marketed on a retail basis to consumers in interstate commerce to be honestly and informatively labeled, with the FDA enforcing provisions on foods, drugs, cosmetics, and medical devices.

In 1969, President Richard Nixon convened a White House Conference on Food, Nutrition, and Health. "This important conference reinvigorated the agency's food program," Junod says. "The conference set the agency on a new path with regard to nutrition and food labeling."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.