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FDA Issues Warning Letter for Eyebrow/Eyelash Growth Product Claims
Posted: April 22, 2011
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The FDA therefore finds the products misbranded due to the lack of directions for use under supervision and also for misleading statements regarding the product’s safety and failure to reveal material facts with respect to consequences that may result from the use of the product. The products bear the label “passed the safety status in the US and EU;” however, according to the FDA, it has not been approved based on safety and efficacy.
Finally, the FDA finds that the products are misbranded cosmetics under the section 602(a) of the Act (21 U.S.C. § 362(a)) and that NeuLash and NeuveauBrow are adulterated cosmetics under section 601(a) of the Act (21 U.S.C. § 361(a)). The products are misbranded cosmetics for their failure to disclose facts materials with respect to consequences. In addition, a cosmetic is adulterated if it bears or contains any poisonous or deleterious substance that may render it injurious to users under the conditions of use prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
The FDA has advised the company that it has 15 working days to notify the administration in writing as to what actions will be taken to address the violations. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this warning letter into account when considering the award of contracts.
Actions such as these are yet another reminder to product developers that claims are a crucial component in the cosmetics R&D process and must carefully be considered. Setbacks such as these can fuel arguments from activist groups concerned over a self-regulated industry. However, these incidents also illustrate to such groups that at some level, there is a watchful eye looking at the messages being presented to consumers.