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Thursday, March 27, 2014

FDA and Cosmetic Industry Controversies: Anti-aging claims and ingredient safety

Recently the trade publication, Cosmetics Design, published two articles that caught my eye.  One discussed FDA’s Import Alert on cosmetics labeled as anti-aging creams (  The import alert is FDA’s guidance to their staff that inspect imported products.  FDA lists the reason for the alert as,
“There are numerous skin care products on the market with exaggerated "anti aging" claims which cause the products to be unapproved new drugs. Examples of such claims are that the products "counteract," "retard," or "control" the aging process. Claims that the product will "rejuvenate," "repair," or "restructure" the skin may also be drug claims. A claim such as "molecules absorb and expand, exerting upward pressure to 'lift' wrinkles upward" is a claim for an inner structural change that would usually cause a product to be a drug.”
The import alert instructs FDA staff to refuse entry of products with these claims.

This view of anti-aging claims, while in conflict with the marketing programs of many cosmetic manufacturers, is not new to FDA.  In December of 2012, we published a blog post ( about FDA warning letters sent to Avon and LancĂ´me due to their anti-aging and anti-wrinkle claims.  It is important to note that while imported products have a greater chance of being subject to FDA enforcement actions based on anti-aging claims, products produced and sold domestically in the US are subject to the same rules.  As stated in the Cosmetics Design article the import alert, “is a good reminder for any company.” (   

The other interesting article in Cosmetics Design is titled, “PCPC ‘extremely disappointed’ in FDA’s cosmetics legislation decision” (  The PCPC is the Personal Care Products Council and is the leading cosmetic industry group in the US.  The group has long had a cooperative relationship with FDA to determine the safety of cosmetic ingredients and has been working with FDA on potential updates to cosmetic regulations.  With a little searching I was able to find that in September of 2013 FDA Commissioner Margaret Hamburg sent a letter expressing disappointment with PCPC for being “unable to proceed toward legislation on the basis of the framework agreement” between the two sides.  Earlier this month, Deputy Commissioner Michael Taylor, sent a similar letter that also included a critique of the draft legislation proposed by the cosmetic industry ( Based on this letter it seems that the crux of the disagreement between FDA in industry is on the issue of ingredient safety. 

Industry has apparently proposed that chemicals deemed safe for use in food, drinking water, as well as some ingredients used in drugs, be deemed safe for use in cosmetics.  FDA’s position is that safety for ingestion is not the same as safety for topical use and gives examples of some that would not necessarily also be safe in cosmetics.  For example, the Deputy Commissioner notes that sodium hydroxide and ascorbic acid may be used as buffering and neutralizing agents in foods without restrictions but that both chemicals have been associated with harm to hair and scalp due to high levels that have been used in some hair straightening and relaxing products.  It should be noted that the high levels of these ingredients that would be used in hair relaxing/straightening products go well beyond buffering and neutralizing effects to make either very alkaline or very acidic solutions.  Accordingly, it seems to me that if used only as buffers and neutralizers in cosmetics, sodium hydroxide and ascorbic acid could be safe for use in cosmetics without restriction just as for food while leaving room to restrict uses at levels that exceed those neutralizing effects.  It could be very difficult and expensive for the cosmetic industry if an agreement on how to determine which cosmetic ingredients are safe cannot be reached.

Deputy Commissioner Taylor’s letter also discusses objections FDA has to industry proposals for cosmetic product registration and listing as well as for facility inspections, adverse event reporting and recalls.  I will save discussion of those other topics for another message.

All in all, it is clear from the tone of the FDA letter that there has been a breach of trust.  In fact, Mr. Taylor states, “Because your proposal meets none of the safety goals on which we had all agreed last year, I have difficulty seeing a path forward in this process.”  In the Cosmetic Design article PCPC President Lezlee Westine is quoted as responding, “We are extremely disappointed that FDA has indicated they will not participate in further discussions with the cosmetics industry regarding cosmetic legislation and have taken such a hard line approach to our efforts to operate in good faith.”

I hope for the sake of the cosmetic industry and consumers that FDA and cosmetic industry representatives can overcome their disappointment and renew the good working relationship they previously had.

As always, it is my hope that you find these occasional updates interesting and informative. If so, you may use this link to subscribe to our occasional email newsletters regarding FDA regulations and other topics of interest to FDA-regulated companies.  We send messages targeted to the dietary supplement, cosmetic, food, OTC drug and medical device industry sectors.  You may subscribe to one or all of the newsletters and you may unsubscribe at any time. Please post any questions you may have. My associates and I stand ready to help you with your FDA regulatory issues.

Best regards,
Evelyn and Associates

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