Terra Sigillata

…if they contrain sibutramine.

Sold under the trade name of Meridia in the US and Reductil in Europe, this prescription appetite suppressant for weight loss was recently detected in an apple cider vinegar supplement called MetaboSlim sold by Confidence, Inc. An alert by the FDA notes that the affected lot was only sold in Canada but we are fortunate to have a good number of Canadian readers.

This episode is yet another in a long string of reports of dietary supplements being adulterated with prescription drugs, intentionally or accidentally. Interestingly, Confidence Inc. was also the target for another such product withdrawal in June when its “Long Weekend” product was found to contain the prescription erectile dysfunction drug, tadalafil. Coincidence? Are there any consequences for repeat offenders?

It is egregious for companies to take advantage of the weak provisions of the Dietary Supplement Health and Education Act (DSHEA), then spike their products with prescription drugs with activity against the same indication. While many critics of botanical and dietary supplement credit any reported activity of these remedies to the placebo effect, the adulteration with prescription drugs can obviously contribute to anecdotal reports of supplement effectiveness. This bodes poorly for the entire industry, some of whose leading companies are committed to good scientific investigation of their products.

By the way, you may wonder what apple cider vinegar supplements have to do with weight loss; admittedly, I had not heard of such claims before this episode. Here is what the Confidence website says:

Apple Cider Vinegar can transmit orders to the fat cells to drain and send fat to the muscles through the bloodstream. This redirected fat can be eliminated by the muscles as they burn calories.

Vinegar is primarily acetic acid, which becomes acetate when bound to sodium in the bloodstream. However, there is no evidence that acetate can influence fat metabolism outside of higher plants. The Confidence website link to their research offers no information on the MetaboSlim product. Unfortunately, lack of efficacy or scientific research are not grounds for product recall under the provisions of the DSHEA legislation. Only evidence of lack of safety is permits the FDA to initiate dietary supplement recalls.

Here’s the complete press release from the FDA Medwatch program:

Confidence Inc. informed consumers and healthcare professionals that the company is recalling one lot of METABOLISM Apple Cider Vinegar Brand Dietary Supplement Capsules (Lot: 3001006, Exp. 10/2009) because the product contains the undeclared drug ingredient sibutramine, an FDA approved drug used as an appetite suppressant for weight loss. The FDA has not approved METABOLISM Apple Cider Vinegar Brand Dietary Supplement Capsules as a drug, therefore the safety and effectiveness of this product is unknown. [Note: "METABOLISM" should be 'MetaboSlim."]

The use of sibutramine may pose a threat to consumers because it is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Consumers should return any unused product to the manufacturer.

Read the complete MedWatch 2007 Safety Summary including a link to the manufacturer’s Recall notice at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Confidence

Comments

  1. #1 syncopee
    August 22, 2007

    Wait…are you telling me that this company has had two Rx adulterations of two products in just the last 3 months? What has to happen for the FDA to shut them down?!?

  2. #2 John Johnson
    August 22, 2007

    I’m confused by what you think should be the case. In the US, the FD&C act defines a drug based on marketing claims, and drug have very strict rules on how they are produced and manufactured to prevent mislabeling and misbranding. If anyone tries to sell apple cider capsules with the weight loss claim, it’s a drug under the FD&C act and thus is required to follow the rules for drugs (including premarketing approval). The FDA can also recommend recalls (it almost never requires them, although it can do nastier things if the company doesn’t comply) or seize products, with further legal action. Given there was a active pharmaceutical ingredient involved, the FDA was authorized to take action anyway. While the system isn’t perfect, I do think that in this particular case the FDA has the authority you think it should have.

  3. #3 Abel Pharmboy
    August 23, 2007

    John, this is an odd issue relating to how supplement manufacturers are allowed to sell their products under DSHEA. They are not permitted to make disease treatment claims, otherwise they would be selling an unapproved drug. So, instead, they make “well-being” or “structure-function” claims that allow them to sell in the supplement category.

    Although you and I would say the intention to sell this product is for a drug claim, the company offers it for “reducing weight and increasing energy” and not the treatment of obesity. In addition, they add a disclaimer of the indication in small print at the bottom of their webpage (and on the product) the DSHEA language, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease. The FDA has not evaluated this statement.” This then puts the FDA in a different position than if the product were an unapproved drug; it was only by the adulteration with a prescription drug that the FDA was authorized to step in.