By Norman F. Estrin, James M. Akerson
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Extra info for Cosmetic regulation in a competitive environment
No better medium of control and consumer protection exists than the Food and Drugs Act. It is logical to extend the provisions of the statute to cover cosmetics. As an example of the type of product which would be contraband under the amended statute, the depilatory known as “Koremlu Cream” may be cited. This product, represented as entirely harmless and actually beneficial to the skin, contained a highly poisonous chemical—thallium acetate. Its widespread utilization for the removal of superfluous hair caused many cases of severe injury to users before the manufacturer was forced into bankruptcy by accumulation of damage suits.
That Delaney Clause was in turn subsequently incorporated into the Color Additive Amendments of 1960 and has become a major focus of the regulation of color additives. The color additive bill initially forwarded to Congress by the Department of Health, Education, and Welfare (HEW) contained no anticancer clause. It contained provisions comparable to the food additive legislation, requiring industry to prove the safety of a color additive before FDA could permanently list it for approved uses. These provisions were not controversial and were contained in the final version of the statute.
That report also stated that the parallel cosmetic provision Page 8 is to operate in precisely the same fashion as was indicated in our discussion … with respect to food, and is intended to insure the safety of cosmetic products by the elimination of poisonous ingredients or by restricting them to safe tolerances. The establishment of tolerances for such ingredients would be of especial benefit to producers of cosmetic preparations containing them since it would render definite the requirements of the law with respect to their use, thereby eliminating the uncertainty with which manufacturers might regard the applicability of [the general cosmetic adulteration provision] .
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