There’s a huge market for “supplements.” It’s a multibillion dollar market; what’s more, it’s shockingly unregulated. As a result, there are no requirements or labeling standards; a bottle might tell you that you’re getting “all natural ginseng,” when you get nothing of the sort, and there isn’t even a trace of ginseng in the water pills you just bought.
A perfect example of this is a recent debacle involving a weight-loss supplement called Oxy ELITE Pro Super Thermogenic. According a new FDA report, an analysis of the weight-loss supplement showed that it contained a drug called fluoxetine — better known as Prozac.
The FDA report noted that a lab analysis confirmed the presence of Prozac in the “supplement,” and it also highlighted why this is a problem:
FDA laboratory analysis confirmed that Oxy ELITE Pro Super Thermogenic (Lot# 216732, Exp. 04/17) contains fluoxetine. Fluoxetine is an FDA approved drug in a class of drugs called selective serotonin reuptake inhibitors (SSRIs) used for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphonic (sic) disorder (PMDD).
Uses of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur.
In the notification, the FDA also said that it’s part of a “growing trend of dietary supplements or conventional foods” to come with “hidden drugs and chemicals.” They’re often marketed for “sexual enhancement, weight loss, and body building.” The FDA “[I]s unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.”
i09 notes that in 2013, Oxy ELITE pro wound up pulled from the shelves in Hawaii after it was implicated in 29 cases of liver failure, including at least one death. It’s basically the same product, just without the fancy “super” and “thermogenic” technobabble. This stuff is modern snake oil no matter how you slice it.
And here’s the most interesting twist: According a press release by the makers of Oxy ELITE Pro, USPLabs, the version the FDA tested was a counterfeit version.
Company spokesperson Michael Petruzzello released a statement, noting that the drug in question was no longer produced.
On Saturday, February 28, 2015, the Center for Drug Evaluation and Research (CDER) issued a Public Notification on the contamination of a dietary supplement product labeled as OxyElite Pro Super Thermogenic (referred to below as “OEP”) with a prescription drug active ingredient, fluoxetine. USPlabsimmediately conducted an investigation and determined that the product shown in the Public Notification and tested by FDA was not manufactured or distributed by or for the Company. It is a counterfeit.
The genuine OEP has not been manufactured since October 2013. OEP has always been labeled with a three year expiration date. The last lot manufactured had an expiration date of 10/16. The counterfeit product expiration date of 04/17 is therefore obviously fraudulent.
The genuine OEP, made in capsules, uniformly had lot numbers beginning with the numeral “4”. The counterfeit product lot number of 216732 is therefore obviously fraudulent. The Company has verified that no OEP product (or other Company product) has ever had the lot number of 216732.
Neither USPlabs nor its contract manufacturers has ever ordered or in any way handled fluoxetine for any purpose of any kind.
The Company has encountered counterfeit versions of its dietary supplement products in the past, and has reported these problems to FDA as well as to State and other Federal officials.
Although USPlabs discontinued the manufacture and distribution of its products containing DMAA in October 2013, other companies did not. Numerous dietary supplement products containing DMAA are still available through the internet. The Department of Defense Human Performance Resource Center website lists 43 such products, and the National Medicines Comprehensive Database lists 313. A Brazilian website, as example, offers OEP for sale and that may well have been the source of the counterfeit product that FDA tested. The Supplement Facts for the counterfeit OEP product shown in the Brazilian website are not the same as the genuine USPlabs version. And, in fact, online complaints about the Brazilian counterfeit OEP can be found identified by lot number 216732 and expiration date 04/17 — the same identifiers as the counterfeit tested by FDA.
USPlabs has offered to work with the FDA to help prevent the distribution of counterfeit versions of its dietary supplement products.
The moral of this story is to approach all supplements with caution. If the real ones are enough to cause liver failure, imagine how dangerous the fake ones are.
Last Week Tonight’s John Oliver did a report on dietary supplements in the past; you can watch it below: