Feds indict dietary supplement makers
I learned about the new civil and criminal actions against makers of dietary supplements from a press release from US Senator Claire McCaskill, ranking member of the US Senate Special Committee on Aging. The dietary supplement industry, she says, “continues to resemble the Wild West.”
The Department of Justice, Food and Drug Administration (FDA), and Federal Trade Commission (FTC) have initiated enforcement actions against USPlabs, which makes muscle and weight loss supplements such as Jack3d and OxyElite Pro. The charge:
USPlabs engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products. According to the indictment, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.
The indictment also alleges that the defendants sold some of their products without determining whether they would be safe to use. In fact, as the indictment notes, the defendants knew of studies that linked the products to liver toxicity.
The FDA’s statement says that it has warned consumers not to use certain USPlabs products containing a synthetic alkaloid, aegeline, which is so toxic that it induces liver problems so severe that they caused several victims to need liver transplants and one died (the New York Times says more about this).
The FDA says it:
continues to warn consumers about the risks associated with some over-the-counter products, falsely marketed as dietary supplements, which contain hidden active ingredients that could be harmful. In the last year, the agency has warned of more than 100 products found to contain hidden active ingredients. These products are most frequently marketed for sexual enhancement, weight loss, and body building.
Earlier this year, Senator McCaskill:
sent letters to 15 retailers inquiring about their policies concerning dietary supplements and what they do to prevent the sale of harmful or fraudulently marketed products in their stores and on their websites and shows. This inquiry was in response to the discovery of products such as Brain Armor, which was recently removed from the Amazon website, that made false claims about their ability to enhance memory and treat dementia.
wrote FDA Acting Administrator Stephen Ostroff to request that the FDA take appropriate action to suspend sales of any supplement containing picamilon, a product that FDA has determined is not a dietary ingredient. McCaskill also asked for any documents submitted to the FDA as a part of the New Dietary Ingredient notification process that confirm the ingredient’s safety, and for any cases in which picamilon had caused ‘adverse events’ in consumers. After the FDA failed to respond, McCaskill asked retailers to voluntarily remove products containing picamilon from their shelves—an action that many took.
As past Chairman of the Senate’s Consumer Protection Subcommittee, McCaskill has also examined misleading and false claims made by makers of weight-loss products.
Wild West indeed. The supplement industry brought this on itself when it convinced Congress that its products were so safe and so much more effective than prescription drugs that regulations were unnecessary. In 1994, Congress agreed and passed the Dietary Supplement Health and Education Act, which essentially deregulated dietary supplements and, except for egregious instances like this one, forced the FDA to leave supplements pretty much alone.
The industry argues that there are just a few bad apples like these. But how would we know?