Warning Letters Cite Cosmetics as Adulterated Due to Microbial Contamination

Under the Federal Food, Drug, and Cosmetic Act, it is illegal to market an adulterated cosmetic in interstate commerce [21 U.S.C. 331(a)]. Under the law, one of the ways in which a cosmetic can become adulterated is if "it contains a poisonous or deleterious substance that may render the product injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual" [21 U.S.C. 361(a)]. Such a "poisonous or deleterious substance" may include microbial contamination.

FDA issued Warning Letters to the follow firms, citing cosmetic products as adulterated due to microbial contamination posing a potential health risk for the uses recommended in the labeling:

Untitled Letter

FDA uses untitled letters for violations that do not meet the threshold of regulatory significance for a warning letter and to request correction of these violations. Unlike a warning letter, an untitled letter does not include a statement that warns the individual or firm that failure to promptly correct the violation may result in enforcement action. 

FDA issued an untitled letter to the following firm addressing microbial contamination of cosmetic products:

Page Last Updated: 03/13/2018
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