CSPI rings alarm bell on sexual enhancement supplement

By Clarisse Douaud

- Last updated on GMT

Related tags: Food and drug administration, Fda

The Center for Science in the Public Interest (CSPI) has asked FDA
and FTC to immediately analyze a dietary supplement - marketed as a
sexual stimulant for men - for the presence of prescription drugs,
and is simultaneously lauding Health Canada's pre-market screening
system as superior for weeding out illegal products.

In a letter to FDA (US Food & Drug Administration) and FTC (Federal Trade Commission), CSPI asked the agencies to investigate Zencore Tabs for the presence of drugs and to put a stop to sales and advertising for the product until the manufacturer can demonstrate it is not adulterated. CSPI has also brought a similar product, Axcil, to the attention of the federal agencies. This represents only one in a string of instances in which a group has either set off alarm bells about a sexual health product, or in which FDA or FTC have denounced such a product. But CSPI is now also putting forth the notion that Health Canada's warning have preceded FDA's one too many times. "It's unfortunate that Americans have to rely on Health Canada to learn about a dishonestly labeled, potentially dangerous American-made dietary supplement like Zencore Tabs,"​ said David Schardt, senior nutritionist at CSPI. "The Canadian government has twice found this US company's supplements to be adulterated with a prescription drug, yet the supplements continue to be sold here and advertised in the Washington Post, USA Today, and other media."​ A spokesperson for the FDA said: "FDA will review their letter and give the concerns raised careful consideration."​ A respondent at Zencore Tabs' call centre number told NutraIngredients-USA.com that company executives could only be reached via a PO box. Unlike the post-market approval system for dietary supplements in the US, in Canada such products are regulated in a pre-market system that more closely resembles the US' regulatory framework for over-the-counter drugs. Health Canada routinely issues preventative warnings on products - in what some would say is a more preventative stance, as opposed to a more reactive one. While industry advocates say FDA is seriously underfunded, impinging on its capacity to fulfill its true regulatory scope over dietary supplements, the authority has nonetheless moved to get products off the market. In 2006, FDA clamped down on several sexual health supplements sold over the Internet, following a first-of-its-kind survey of such products. At the time, the agency warned consumers not to buy or consume 4EVERON, Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, or Actra-Rx, because they contain active ingredients "similar or identical" to some found in prescription drugs. FTC carried out a similar example-making sweep of dietary supplements in January. The federal agency, which deals with how products are advertised or marketed, ushered in 2007 with a warning to misleading advertising and the sale of supplements. In this case, it was for dietary supplements marketed for weight loss. FTC announced settlements totalling $25mn with the marketers of Xenadrine EFX, One A Day Weight Smart, Cortaslim and TrimSpa. The companies were ordered to change their ad claims and cough up the heafty fines for both civil penalties and consumer redress. There are similarities between the underbelly of the weight loss and sexual enhancement dietary supplement industries - both target problems that constitute deeply emotional issues for many consumers and tap into their vulnerabilities, making them easier prey to false advertising. In CSPI's letter to the authorities, it underscores both the contents and advertising of the products in question. "We would like to alert you to a dietary supplement that appears to be deceptively labeled and advertised and to contain a drug approved for sale only by prescription,"​ CSPI stated in its letter to FDA and FTC. "The product has been called Encore Tabs and Zencore Tabs and is claimed to be a 'powerful sexual performance supplement for men'." ​ The letter then drawns on Health Canada's warning to Canadian consumers not to use these products because that agency found them to contain tadalafil, known in the branded form as Cialis. The Health Canada warning reads: "The use of Encore Tabs for Men could pose serious health risks, especially for patients with existing medical conditions such as heart problems, those taking heart medication, or those at risk of stroke."​ CSPI also accuses the marketer of misleading consumers through their advertising. "The marketing of Zencore Tabs appears to violate laws and regulations prohibiting the deceptive labeling and advertising of dietary supplements and the marketing of prescription drugs in non-prescription products,"​ says the letter. CSPI is requesting that FDA, in collaboration with FTC: analyze the composition of Zencore Tabs and Axcil; order the manufacturers not to sell the products until such a time as it is determined they are free of prescription drugs; stop the companies from marketing the benefits of these products until such a time as reliable clinical trials can back up such claims.

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