NIH's Dietary Supplement Label Database

Earlier this summer the US National Institutes of Health (NIH) launched the Dietary Supplement Label Database (DSLD).  This website provides label information from supplement products marketed in the US. The database is easily searchable by ingredient, product name and company name and provides a summary of information on the labels as well as label images.  Based on my casual perusal of the database it is clear that very few of the labels would serve as good examples of compliant labels.  Nevertheless, the database has been made available to help medical professionals and researchers know what products are on the market in the US.  It may also serve as a tool for supplement manufacturers wishing to do a bit of market research.

I contacted the NIH with a few questions about this website and received the following response from Therapeutic Research, the contractor responsible for adding and updating dietary supplement labels for the DSLD:

“The primary way we gather and keep labels up to date is through our Manufacturers Connect program. Through this program, we pair one of our research associates with each manufacturer or distributor of dietary supplements. The research associate will contact the company at least annually to determine if there are new or updated products. Additionally, this provides the manufacturer with a single point of contact through which they can notify us of any changes to their formulations.

We ask manufacturers to send us a current list of all dietary supplement products and a clean image or physical copy of the product label for each of the current products. Then our staff will add all of the new products and review any existing entries to ensure the entire product line is up-to-date in the DSLD. We like to have a point of contact with each manufacturer that we can reach out to with any questions that may come up during the entering/updating process. Manufacturers often reach out to us when a product is launched, reformulated, or goes off market. This allows manufacturers to ensure their entries are current throughout the year and not just during the annual review process.”

You may already know whether your labels have become part of this database. Nonetheless, you may follow this link to view the database: http://dsld.nlm.nih.gov/dsld/index.jsp

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Wrinkles and FDA Cosmetic Update

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 you  would like to be added to our newsletter distribution list, please reply to this post. 

Contact us with any questions you have regarding cosmetic, food or dietary supplement regulations.