USFDA Modifies Language about Active
Pharmaceutical Ingredients Masquerading as Dietary Supplements
The USFDA’s Center for Drug Evaluation and Research (CDER) has changed
the wording on its website1 listing potentially unsafe products with hidden ingredients that are marketed to
consumers as dietary supplements. The new terminology – “tainted products
marketed as dietary supplements” – is a more accurate description of these
products, which may not contain any dietary ingredients at all.
Comment: The illegal sale of active pharmaceutical
ingredients (APIs) as dietary supplements has been an ongoing issue for the
dietary supplement manufacturing industry, raising questions about the safety
of products sold as dietary supplements, in particular in the weight loss, male
enhancement, and bodybuilding categories. Representatives of the responsible
sector of the dietary supplement industry have pointed out for some time that
such products are not dietary supplements. According to a report by Stephen
Daniells, the change in terminology was initiated after requests by the
American Herbal Products Association.2 It may have been even more
appropriate to modify the new terminology to “pharmaceutical products illegally
marketed as dietary supplements,” since this more accurately describes the regulatory
state of these products.
References
1.
US Food
and Drug Administration. Tainted products marketed as dietary supplements_CDER.
Available at: http://www.accessdata.fda.gov/scripts/sda/sdnavigation.cfm?filter=&sortColumn=1d&sd=tainted_supplements_cder&displayAll=true. Updated December 29, 2015. Accessed January 6, 2016.
2.
Daniells
S. Legal dietary supplements vs illegal drug-spiked products: FDA clarifies its
language. NutraIngredients-USA website. Available at: http://www.nutraingredients-usa.com/Markets/Legal-dietary-supplements-vs-illegal-drug-spiked-products-FDA-clarifies-its-language. Published December 7, 2015. Accessed January 6, 2016.
