Pre-Market Clearance Required for Colors


As the cosmetic industry entered the 1960s, it faced new regulations on color additives. Public policy debate had turned to the regulation of color additives soon after the passage of the Food Additive Amendments of 1958.

After extensive and spirited hearings focusing primarily on the Delaney clause, the Color Additive Amendments to the Food, Drug, and Cosmetic Act became law in July 1960.

These amendments included the Delaney clause and required pre-market clearance of all color additives used in food, drugs and cosmetics. Under the terms of the statute, the burden of demonstrating the safety of both coal-tar and non-coal tar colors fell to the industry.

All colors that were "commercially established" at the time of the passage of the Color Additive Amendments were provisionally listed for two and one-half years. After this period, FDA had the discretionary authority to continue the provisional listing if testing of a color's safety was being carried out in good faith.

Because of the costs involved in undertaking such a process, the industry was forced to forego testing on certain colors that were deemed expendable to the industry. The Toilet Goods Association (TGA) polled its members to determine which colors to include in the testing. It then established a program to employ an independent testing laboratory that would be funded on a voluntary basis by the industry based on certified color poundage used.

The Association also established a Color Committee to develop the specifics of the program and to report recommendations to the TGA Board of Directors. The Committee divided the colors into five groups, each one to be tested by a different laboratory.

In subsequent years, the Association clashed with the FDA over the latter's interpretation of the 1960 amendments. The FDA maintained that the amendments provided it with the authority to approve any product that contained any of the provisionally listed colors prior to its release in the market.

In 1965, the Association filed suit against the FDA over this issue. TGA's position was ultimately upheld by the U.S. Supreme Court in 1970.