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One who asks a question is a fool for five minutes; one who does not ask a question remains a fool forever.— Chinese Proverb
I recently received an e-mail from an Ohio high school senior. She found my name on the New York Society of Cosmetic Chemists Web site (www.nyscc.org), and she had questions toward fulfilling her vocational studies senior project: cosmetic chemistry. A number of her questions closely reflect issues that many consumers wonder about, and others are frequently asked by students interested in cosmetics as a profession but who have no idea how to enter the field.
In addition, reaching students such as this and mentoring them through entry level job opportunities or through formal academic programs is an important way to provide the fresh blood needed to keep the cosmetic industry staffed with intelligent and motivated scientists for the future.
Below is our correspondence.
1. How long does it normally take and what are the processes of getting products approved by the FDA?
The FDA does not approve products. The two key laws concerning cosmetics marketed in the U.S. are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).
The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Violations of the Act are subject to regulatory action. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives.
Cosmetic companies are responsible for substantiating the safety of their products before marketing. Failure to do so causes the product to be misbranded, unless the following warning statement appears on the product’s label:
“Warning: The safety of this product has not been determined.”1 For OTC products such as sunscreens, antiperspirants and antidandruff shampoos, there are FDA monographs. As long as the monograph is followed, the products can be placed on the market with no specific approval.
2. What makes certain products hypoallergenic?