It
has been many months since we’ve posted anything on cosmetic regulations.
This edition is to make you aware of recent FDA enforcement actions and some
proposed legislation that you should be aware of.
We
have had discussions with many of our clients about ‘wrinkle claims’. Typically
we note that cosmetic regulations allow claims regarding how a product cleanses,
beautifies, promotes attractiveness, or alters appearance or fragrance and that
claims about wrinkle reduction are therapeutic or drug claims. Many of
you have responded with questions similar to ‘what about all the big guys and
the stuff they say in their commercials?’ Well, a few of the big guys
received warning letters from FDA regarding their claims.
In
October FDA sent Avon a warning letter regarding claims made on their website
about their Anew line of products. The letter lists a number of claims
including
“Rebuild collagen to help plump out lines and
wrinkles.
Stimulate elastin to help improve elasticity
and resilience.
Regenerate hydroproteins to help visibly
minimize creasing.”
The
letter also notes claims comparing Avon products to botox and goes on to say,
“Your products are not generally recognized among qualified experts as safe and
effective for the above referenced uses and, therefore, the products are new
drugs as defined in section 201(p) of the [Food Drug and Cosmetic] Act.”
In
September Lancôme also received a warning letter noting numerous drug claims on
their Genefique line of products. While one claim cited in the letter did
discuss wrinkles, “See significant deep wrinkle reduction in UV damaged skin,
clinically proven,” the Lancôme website claimed that their products stimulate
stem cells. It may be that it was the stem cell claims that prompted FDA
to act but the fact that wrinkle claims were also cited is noteworthy.
Cosmetics
may be promoted to reduce the appearance of wrinkles but not to repair,
correct, plump or make them go away.
Now
for the future: Last April US Congressman Leonard Lance of New Jersey
introduced a Bill in the US House of Representatives. The Cosmetic Safety
Amendments Act of 2012 proposes “to establish new procedures and requirements
for the registration of the cosmetic product manufacturing establishments, the
submission of cosmetic product and ingredient statements, and the reporting of
serious and unexpected cosmetic product adverse events, and for other
purposes.”
For
a number of years FDA has had the Voluntary Cosmetic Registration Program
(VCRP) in place. This program is ‘regulations light’ but mirrors the drug
listing and registration program. I have heard rumors that cosmetic good
manufacturing practice regulations have been written but have not seen them
published this year; which is not surprising since much in government was on
hold in 2012 due to the Presidential election and remains on hold awaiting the
outcome of Congressional efforts to address looming budget cuts and tax
changes. Nevertheless, it is important for cosmetic companies to be aware that
they will be affected by future increased regulation.
To
learn more about the VCRP, visit http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/default.htm.
To
read the proposed legislation visit http://www.gpo.gov/fdsys/pkg/BILLS-112hr4395ih/pdf/BILLS-112hr4395ih.pdfhttp://www.gpo.gov/fdsys/pkg/BILLS-112hr4395ih/pdf/BILLS-112hr4395ih.pdf
.
To
read an intelligent and information article about the legislation, visit
FDALawBlog at http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/04/representative-leonard-lance-r-nj-introduces-industry-supported-bill-to-modernize-cosmetics-regulation.htmlhttp://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/04/representative-leonard-lance-r-nj-introduces-industry-supported-bill-to-modernize-cosmetics-regulation.html
To
read the Avon warning letter visit http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323738.htm
To
read the Lancôme warning letter visit http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm318809.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm318809.htm
I
hope you find these periodic posts informative and interesting. If
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Contact
us with any questions you have regarding cosmetic, food or dietary supplement
regulations.
