Cosmetics Under the Law: The Act of 1938

For thirty-two years the main federal food and drug law of the United States said nothing about cosmetics. The Pure Food and Drugs Act of 1906 required truthful labels on foods and drugs, but it gave the government no authority over cosmetics, medical devices or advertising.^[1]

A face cream could contain mercury, a hair remover a rat poison, an eyelash dye could blind, and none of them could be taken off the market.^[1]

In 1933 the Food and Drug Administration’s chief education officer, Ruth deForest Lamb, and its chief inspector, George Larrick, built a travelling exhibit of about a hundred dangerous, deceptive or worthless products that the agency had no power to remove.^[2] One panel was headed “Cosmetics Are Not Subject to the Present Law—Some Are Dangerous,” over a photograph of a woman’s almost bald head and another of a woman’s damaged eyes.^[3]

The cosmetics on show were real cases. Lash Lure, an eyelash and brow dye, had damaged women’s sight, even to blindness. Koremlu, a hair remover launched in the spring of 1930, sold more than 120,000 jars within a year; its depilatory agent was thallium acetate, a common rat poison. Othine, a cream sold to lighten the skin, relied on mercury.^[2] Koremlu went only when women sued its maker into bankruptcy in 1932; the agency could do no more than refer inquirers to the Journal of the American Medical Association.^[4]

In 1933, too, the agency recommended a complete revision of the 1906 Act, and the first bill was introduced in the Senate, opening a legislative battle that lasted five years.^[5] The first version was known as the ‘Tugwell Bill’, after Rexford Guy Tugwell, the Assistant Secretary of Agriculture who initiated it; one of the eventual Act’s chief supporters, Senator Royal S. Copeland, a physician, died days before it became law.^[6]

What moved it in the end was a medicine. In 1937 Elixir Sulfanilamide, made with the poisonous solvent diethylene glycol, killed 107 people, many of them children.^[5] The public outcry reshaped the bill’s drug provisions and, in the agency’s own account, propelled the bill itself through Congress.^[7]

Franklin Roosevelt signed the Federal Food, Drug, and Cosmetic Act on 25 June 1938, and it brought cosmetics and medical devices under federal control for the first time.^[9] Its cosmetic sections were meant to keep harmful ingredients out of cosmetics and perfumes, to forbid deceptive and slack-filled packaging, and to require labels giving the name of the product, of its maker, packer or distributor, and the quantity inside.^[10]

Colour came under control too. Coal-tar dyes had to come from approved lists, graded by whether they could be used in foods, drugs and cosmetics, in drugs and cosmetics only, or only externally, and some cosmetics had to be reformulated to remove colours that were no longer allowed.^[10] The Act also drew the line between cosmetic and drug by what a product claimed: a hair preparation that promised beauty was a cosmetic, one that promised to treat dandruff a drug, and more tightly controlled.^[10]

Advertising went elsewhere. Early drafts of the bill had covered it, but the Act as passed gave the FDA the labels only. The Wheeler-Lea Act of 21 March 1938 let the Federal Trade Commission act against false advertising of cosmetics because it deceived the public, without having to show, as before, that a competitor had been harmed.^[11] Both agencies came down hard on the idea that a cream could feed the skin.^[11]

Elizabeth Arden, much to her annoyance, had to stop advertising that her products “furnish nourishment to the skin”, and her Orange Skin Food became Orange Skin Cream.^[11] Her agreement with the Commission also covered Eight Hour Cream, introduced in 1930 and described by Arden as “a highly medicated salve”: it could no longer be advertised as an effective remedy for pimples, rashes, cold sores and eruptions.^[12]

The first product seized under the new Act was Lash Lure, the eyelash dye that had blinded women five years before.^[13] In November 1938 the agency made its active ingredient, paraphenylenediamine, illegal in cosmetics.^[14]

The Act did not require a cosmetic to be approved before it was sold. It made manufacturers legally responsible for the safety of their products, set standards for ingredients and required a list of coal-tar colours certified as “harmless and suitable” — but hair dyes were exempt, which is why the chemistry that blinded Lash Lure’s customers stayed legal on the scalp.^[13]

The Act’s effect on sales is uncertain. Sales of American skin creams were reported to have declined for some fifteen years afterwards; Bennett suggests that the limits on nourishing claims may be why, and allows that it may be a coincidence.^[15]

Some details differ between accounts. The Elixir Sulfanilamide deaths are given as 107 in one FDA history and as “over 100” in another.^[16][17] The exhibit is described as travelling^[18] and as appearing at the Chicago World’s Fair of 1933;^[19] the two are not exclusive, and the sources used here do not list where else it went.