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 (http://tinyurl.com/n5xq2e6). 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
(http://tinyurl.com/kntalmv) about FDA
warning letters sent to Avon and Lancôme 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.” (http://tinyurl.com/mqrgzno).
The other interesting article in Cosmetics Design is titled, “PCPC ‘extremely disappointed’ in FDA’s
cosmetics legislation decision” (http://tinyurl.com/lsgzb8m). 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 (http://tinyurl.com/nydrdgv). 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
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Best regards,
Evelyn and Associates
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