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FDA cracks down on nutrition industry for tainted dietary supplements

 

 fda   

 by Joseph Ernest  December 16, 2010

                     

Newscast Media -- Manufacturers of nutritional products across America were targeted on Dec. 15, 2010, by the Food and Drug Administration (FDA) in an effort aimed at keeping consumers safe from harmful products that are marketed as dietary supplements and that contain undeclared or deceptively labeled ingredients. The FDA has found that these products are often promoted for weight loss, sexual enhancement, and bodybuilding.

 

This action might have a cross-over effect for those who sell edible products online. The implication of this is that even those who sell legitimate products online that are organic, like emergency food supplies, freeze dried meals, heirloom seeds for people to grow their own gardens and so forth, may soon be under the microscope or required to get FDA approval before they can sell foods online that are pre-packaged for emergency purposes. Right now the FDA is only focused on dietary supplements, but it wouldn't be surprising if they shift their focus to others in the food industry.

The new steps FDA has taken include:

  • A letter from Commissioner of Food and Drugs Margaret A. Hamburg to the dietary supplement industry emphasizing its legal obligation and responsibilities to prevent tainted products from reaching the U.S. market.
  • A new rapid public notification system6 (RSS Feed) on its website to more quickly warn consumers about these products.
  • A mechanism for industry to alert FDA about potentially tainted products and about the firms that make them.

Among the substances found in products that are marketed as dietary supplements and that contain hidden or deceptively labeled ingredients are

  • the active ingredients in FDA-approved drugs or their analogs (closely-related drugs).
  • other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients. 

Where FDA investigations have discovered tainted products marketed as dietary supplements, the agency has issued warning letters and conducted seizures and criminal prosecutions. 

FDA has also alerted consumers to hundreds of products with these often deceptively labeled and harmful ingredients, including more than 80 products marketed for sexual enhancement, more than 70 products marketed for weight loss, and more than 80 products marketed for bodybuilding.

Michael Levy, director of FDA's Division of New Drugs and Labeling Compliance, says labeling of these tainted products may claim that they are "alternatives" to FDA-approved drugs, or "legal" alternatives to anabolic steroids.

"Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs," Levy says. "Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails."

The FDA has enlisted the support of five industry trade associations and is in the process of issuing warning letters to manufacturers and distributors.

It's warning that companies that sell and market tainted dietary supplements will face product seizures, injunctions and criminal prosecution.

Sexual enhancement, weight loss and bodybuilding products are the most common supplements to contain illegal, deceptive or undeclared products, notes the FDA.

"The labelling of these tainted products may claim that they are 'alternatives' to FDA-approved drugs, or 'legal' alternatives to anabolic steroids," notes the FDA's director of drug evaluation and research, Michael Levy.

The FDA move is applauded by Consumers Union, the organization the publishes the Consumer Reports.

"Tainted dietary supplements can send you to the hospital or kill you," said Ellen Bloom, senior director of policy at Consumers Union.

"The FDA should be commended for prioritizing this issue and alerting consumers about dangerous supplements. Unfortunately the challenge is that more dangerous products keep popping up."

In all, consumers should heed these potential warning signs of tainted products marketed as dietary supplements.

  • Products claiming to be alternatives to FDA-approved drugs or to have effects similar to prescription drugs.
  • Products claiming to be a legal alternative to anabolic steroids.
  • Products that are marketed primarily in a foreign language or those that are marketed through mass e-mails.
  • Sexual enhancement products promising rapid effects such as working in minutes to hours, or long-lasting effects such as 24 hours to 72 hours.
  • Products that provide warnings about testing positive in performance enhancement drug tests.

Generally, if you are using or considering using any product marketed as a dietary supplement, FDA suggests that you

  • check with your health care professional or a registered dietician on any nutrients you may need in addition to your regular diet
  • ask yourself: Does it sound too good to be true?
    • Be cautious if the claims for the product seem exaggerated or unrealistic
    • Watch out for extreme claims—for example, "quick and effective," "cure-all;" "can treat or cure diseases; or "totally safe"
    • Be skeptical about anecdotal information from personal “testimonials” about incredible benefits or results obtained from using a product
  •  ask your health care professional for help distinguishing between reliable and questionable information.     

The implication of this is that even those who sell legitimate products online that are organic, like emergency food supplies, freeze dried meals, heirloom seeds for people to grow their own gardens and so forth, will soon be under the microscope or required to get FDA approval before they can sell foods online that are pre-packaged for emergency purposes.               Add Comments>> 


 

 

 

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