Suppliers Express Confidence With FDA Safety Review

United States

Frustrated by its inability to regulate ephedra, the US Food and Drug Administration is developing a template to assess the safety of six "controversial" supplements. If this initial review is successful, FDA will use the framework to review the safety of a far broader number of nutritional supplements.

The six supplements under initial review were chosen because they encompass a variety of types and uses and also have been associated with some adverse effects. They are chaparral, chromium picolinate, glucosamine, melatonin, saw palmetto and shark cartilage.

"This comes under DSHEA implementation; it's FDA's job to protect public health and they need a mechanism to deal with these things," said Steven Dentali, a member of the review committee and vice president of scientific and technical affairs for the American Herbal Products Association. "This is a common-sense mechanism to identify any supplements that might be unsafe."

Under the 1994 Dietary Supplement Health and Education Act (DSHEA), the burden of proof falls on FDA to show that a supplement is unsafe, in which case FDA can order it off the market.

Despite the possibility of FDA using this as a tool to potentially pull products from shelves, suppliers and manufacturers expressed confidence in the safety of their ingredients.

"It is part of FDA's role and responsibility to make sure products out there are safe," said Leo Cullen, vice president of Buckton Scott Nutrition in New Jersey. "We have no problem whether it's FDA or any other regulatory or scientific bodies confirming glucosamine's safety to the consumer."

The review is being conducted by the Institute of Medicine, a branch of the National Academy of Sciences. Its aim is to establish guidelines for the FDA to review supplements, including a credible report on a serious adverse event in humans associated with the supplement, evidence of harm in laboratory animal studies and the presence of constituents similar to known toxic or harmful compounds.

If FDA is satisfied with the review, it could ask manufacturers to voluntarily supply safety information on their products to help in its assessment.

Nutrition 21, a New York supplier of chromium picolinate, recently announced its Chromax chromium picolinate has been GRAS approved. The company plans to provide the IOM with data on the safety of its ingredient.

"We have already made a substantial investment in conducting toxicology studies and clinical research to support our product and label claims, and have sought third-party confirmation of our findings," said Nutrition 21 President and CEO Gail Montgomery of its GRAS status. "It gives us confidence the IOM will reach the same conclusions."

Of the six ingredients, chaparral is alleged to cause liver toxicity, chromium picolinate to promote kidney toxicity and insulin regulation problems among diabetics, glucosamine to increase insulin resistance, melatonin various complications, saw palmetto berry to cause heart problems and shark cartilage to cause hepatitis.

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