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Government Reform Committee holds supplement meeting.

The same day FDA issued a warning to companies selling illegal steroid products as supplements, a Government Reform Committee hearing was convened to discuss the state of dietary supplement regulation. A majority of the meeting focused on steroids masquerading as supplements and ephedra. In his testimony to the committee, Robert Brackett, director of FDA's Center for Food Safety and Applied Nutrition (CFSAN), told the House Government Reform Committee hearing that current law gives regulators sufficient authority to enforce supplement regulations "From October 2002 through February 2006, FDA has conducted 588 domestic inspections of dietary supplement manufacturers, issued more than 350 warning letters and cyber letters to marketers of dietary supplement products, seized products worth more than $13.4 million, supervised the voluntary destruction of more than $3 million worth of products marketed as dietary supplements that were promoted with unsubstantiated claims or that were unapproved drugs or were unsafe, and obtained permanent injunctions against five firms distributing misbranded or unapproved drugs as dietary supplements."

About the long-awaited cGMPs for dietary supplements, Mr. Brackett offered, "Under DSHEA, another important tool of FDA's regulatory and surveillance activities to help ensure the safety of dietary supplement products is its authority to promulgate regulations for dietary supplement current good manufacturing practices (cGMPs). Such regulations will help ensure product quality and consistency. This regulation is under review at the Office of Management and Budget. FDA will continue to take action against dietary supplement products that threaten the public health, and we believe that the new cGMP regulations will provide another level of safety for the American public."

In the same meeting, FTC also offered its perspective on dietary supplement regulation. Lee Peeler, deputy director of FTC's Bureau of Consumer Protection, said, "Although many supplements offer the potential for real health benefits to consumers, unproven products and inaccurate information can pose a threat to the health and well-being of consumers and cause economic injury." The FTC has filed 14 complaints in the past year against companies making allegedly unsubstantiated or false advertising claims for dietary supplements and other natural healthcare products, including oral sprays, creams and patches. Also, in the past year, FTC obtained orders against 40 companies and 44 individuals, which prohibited the unlawful practices and required the defendants to pay a total of $35.5 million in consumer redress, disgorgement and civil penalties. FTC's testimony noted that, "Products are promoted to adults not just to maintain basic health and nutrition, but also for weight loss, to build muscle, cure sexual dysfunction, treat and prevent colds and flu, and even reverse arthritis, cure cancer, and treat many other serious diseases. Products promoted specifically for children also extend beyond traditional multivitamins to include treatment and cures for a variety of childhood ailments ranging from colds to more serious conditions such as attention deficit/hyperactivity disorder (AD/HD)." The testimony further highlighted recent examples of FTC cases, consumer education efforts, and partner cooperation that illustrated the commission's multi-faceted approach.

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Title Annotation:INDUSTRY NEWS
Publication:Nutraceuticals World
Geographic Code:1USA
Date:May 1, 2006
Previous Article:NutraCea, StoneBridge Pharma sign letter of intent.
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