Julia Belluz on the FDA cracking down on companies that sell bogus dietary supplements. These pills have not been scientifically proven to work — in fact, they cause harm, because they’re not tested as rigorously as they should be.
Before USPLabs agreed to pull OxyElite Pro from store shelves, the product sickened dozens of people, leading to acute liver failure, hepatitis, liver transplants, and, in at least one case, death. Meanwhile, instead of actually discontinuing distribution of the product, the Department of Justice says the company “engaged in a surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible.”
USPlabs also allegedly knew about the potential for liver toxicity. But the company didn’t properly test its products. In a weird twist, people who worked at the company are accused of simply testing products on themselves and then selling “the ones that made them feel good,” Mizer said.
Supplements are a $30 billion/year industry, right up there with homeopathic products on the unregulated-ripoff roster.
Yet these pills undergo limited scrutiny by regulators. The FDA treats them like food — not like drugs — under the Dietary Supplement Health and Education Act of 1994. Supplement manufacturers can put a wide variety of claims on their bottles, so long as there’s at least some research to back them up and so long as they’re honest about their ingredients. There’s no requirement for manufacturers to specify the quantity ingredients or to warn consumers about potential side effects. What’s more, there are no regulators checking to make sure these manufacturers are telling the truth about what’s in their products before they hit store shelves.
To remove a supplement from the market, the FDA first has to prove that it’s not safe — which is what happened in the case of OxyElite Pro. This is basically the opposite of how pharmaceuticals are regulated. There, drugmakers need to prove their medicines are safe and effective through high-quality scientific studies before they ever reach consumers.
The burden should not be on the FDA to prove something doesn’t work or is harmful — it should be on the companies that make and sell these products to an uninformed public which, no doubt, assumes that it must be safe or it wouldn’t be allowed on store shelves.
Previously on Harris Online…