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FDA cracks down on sildenafil analogues

Despite users' skepticism, the federal agency is taking adulteration of dietary supplements seriously.

The Food and Drug Administration continues to crackdown on adulterated dietary supplements. In its most recent round, agency warnings prompted RockHard Laboratories to issue a voluntary recall in late December of certain lots of its RockHard Weekend and Pandora products.

Independent testing found the products contain an analogue of Sildenafil, an FDA-approved drug used as treatment for male erectile dysfunction. The ingredient is not listed on the product labels.

Earlier in December, Intelli Health Products expanded its recall of Duro Extend Capsules for Men to include all lot codes. This comes in the wake of FDA lab analysis that showed the products also contained a Sildenafil analogue. In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.

Beyond libido

Libido products aren't the only ones facing scrutiny. The government has discovered dozens of weight-loss products that contain sibutramine, or closely related drugs. Examples include Slimming Beauty, Solo Slom, and Slim-30.

Then last fall, the agency sent out a rash of warning letters to manufacturers of body-building supplements, whose products were found to contain ATD, an anti-aromatase. ATD does not meet the FDA's definition of a dietary ingredient, therefore making the products in violation of the Food, Drug and Cosmetic Act.

The ingredient is usually listed on product labels as 1,4,6 etioallocholan-dione or 3,17-keto-etiochol-triene, but is known by consumers as simply "ATD."

The warning letters have a slew of voluntary product recalls. Among the products containing ATD, voluntarily recalled by their manufacturers since September, include:

  • Novedex XT by Gaspari Nutrition, marketed for "increasing natural testosterone production"
  • Reversitol by iForce Nutrition, marketed for "promoting hormonal regulation"
  • Several products by Advanced Muscle Science (Arom-X, Arom-X UTT, Arom-XL, 4-AD and Decavol), marketed as natural testosterone boosters and libido enhancers
  • Off Cycle II Hardcore by Fizogen Precision Technologies, marketed to support "production of endogenous testosterone"
  • ArimaDex by Genetic Edge Technologies, marketed as a "pharmaceutical-grade anabolic supplement to enhance testosterone levels"
  • Clomed by KiloSports, marketed as "a must for anyone taking pro-hormones or pro-steroids"

What's so bad about ATD?

According to the FDA, ATD can cause decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure and liver dysfunction.

"These products were labeled to contain ingredients that are not dietary ingredients and represent a significant health risk," explained Sioabhan Delancey, spokesman for the FDA. "The products are all labeled to contain an aromatase inhibitor, which are steroid-like in their activity."

"In 2009, the FDA issued a public health advisory warning consumers to stop using any body building products that are represented to contain steroids or steroid-like substances. ... they are potentially dangerous and may result in permanent harm and adverse events, such as infertility, kidney failure, liver dysfunction, aggressive behavior and adrenal insufficiency."

Insiders in the body-building world disagree. An article on, for example, hails ATD as the "new craze to hit the bodybuilding world!"

"ATD has many benefits to bodybuilders, which can lead to very significant gains whilst also countering certain side effects, which you would most certainly not want to occur," the article states. It goes on to claim that ATD can increase natural testosterone levels by 400 percent, making it "indeed a bit of a 'miracle' or 'magic' supplement." Anthony Roberts, author of Anabolic Steroids: Ultimate Research Guide, criticizes the recent FDA crackdown as a waste of money and time.

"I guess we are getting to the point where all ATD products are to be pulled off the market," he laments on his Web site, Muscle Evolution. "I'm sure there'll still be some small brands carrying the ingredient, but at this point, it's being recalled, and I believe the stuff will be (almost) completely gone from the market by the end of the year."

Roberts predicted that consumers of the recalled products would rush out and buy up all remaining stocks they could find – rather than send them back to manufacturers for a refund.

FDA, industry unite

Despite users' skepticism, the federal agency is taking adulteration issues like these seriously.

At a symposium with the Council for Responsible Nutrition in September, the agency's Principal Deputy Commissioner, Dr. Joshua Sharfstein, said the practice of hiding drugs and chemicals in dietary supplements is the agency's biggest concern for the supplements industry.

“Over the past several years, FDA has found hundreds of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals,” Sharfstein said to NewHope360. "The challenge here is not with companies that are responsible; it’s with companies that are not responsible [but are] putting the reputation of your products on the line."

On Oct. 27, the FDA met with five U.S. supplement trade associations to discuss what can be done about the problem. The meeting included the United Natural Products Association (UNPA), the Council for Responsible Nutrition (CRN), the American Herbal Products Association (AHPA), the Natural Products Association (NPA) and the Consumer Healthcare Products Association (CHPA).

An outcome of this meeting is an FDA guidance letter, issued Dec. 15, warning manufacturers that the agency is going to be working with trade associations to increase company vigilance and protect the public. The agency also established a new RSS feed to warn consumers more quickly about tainted products marketed as dietary supplements.

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