US Department of Justice Brings Criminal Charges against
Manufacturers of Adulterated Dietary Supplements
On
November 17, 2015, The US Department of Justice (DOJ) and its federal partners,
the US Food and Drug Administration (FDA) and the US Federal Trade Commission
(FTC) among others, pursued civil and criminal cases against more than 100
manufacturers and marketers of dietary supplements. The most prominent charges
are against USPlabs (not to be confused with the laboratories of the United
States Pharmacopeia[USP]) and several of its officers. The company allegedly changed labels with regard to
ingredients, knowingly and willfully sold products containing toxic substances,
and made false claims about the effectiveness of its products. According
to the DOJ, “USPlabs has engaged in a conspiracy to import ingredients from China
using false certificates of analysis and false labeling, and lied about the
source and nature of its ingredients after it put them into products.” The
indictment also alleges that USPlabs misled some of its retailers and
wholesalers by telling them it used natural plant extracts when the company in
fact was using stimulants synthesized in a Chinese chemical manufacturing
company, such as the use of 1,3-dimethylamylamine (DMAA) labeled as “Geranium
flower (HG) powder extract” in USPlabs products.
Comment: The actions of companies such as USPlabs reflect
badly on the dietary supplement industry as a whole and, as such, the news of
the USPlabs indictment was welcomed by representatives of the leading trade
organizations.1 The DOJ has clearly established that the sale of
pure synthetic substances labeled as herbal extracts is illegal, even if such
compounds are naturally occurring in a plant species. This is not only a matter
of deceiving the public, but it is first and foremost a safety concern, since
many of these synthetic compounds have not been evaluated for toxicity. The
case does not address the use of highly purified natural compounds obtained
directly from herbal material, such as epigallocatechin gallate (EGCG) sold as
green tea (Camellia sinensis, Theaceae) extract, 5-hydroxytryptophan
sold as Griffonia simplicifolia,
Fabaceae) extract, or ellagic acid sold as pomegranate (Punica
granatum, Lythraceae) extract, in dietary supplements. Still a matter of
debate is at what point exactly in the purification process an herbal extract
becomes a pure compound and needs to be labeled as such.
Reference
1. Schultz H. DOJ indicts USPLabs as part of
nationwide crackdown on fraudulent ingredients, illegal claims. NutraIngredients-USA
website. Available at: http://www.nutraingredients-usa.com/Regulation/DOJ-indicts-USPLabs-as-part-of-nationwide-crackdown-on-fraudulent-ingredients-illegal-claims. Published November 17, 2015.
Updated November 20, 2015. Accessed May 10, 2016.
