FDA rule on supplements: 'Only a first step,' urologists say

August 1, 2007

Recently released FDA regulations requiring current good manufacturing practices for dietary supplements take an important first step in ensuring the quality of supplements, but fall short of making manufacturers accountable for the products' safety and efficacy, according to urologists familiar with the regulations.

Rockville, MD-Recently released FDA regulations requiring current good manufacturing practices for dietary supplements take an important first step in ensuring the quality of supplements, but fall short of making manufacturers accountable for the products' safety and efficacy, according to urologists familiar with the regulations.

"This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label," said FDA Commissioner Andrew C. von Eschenbach, MD. "In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement-related adverse events to FDA."

Actions fall short

The rule does not address the safety of supplements' ingredients or their effects on health. That, according to urologists interviewed by Urology Times, is where FDA's actions fall short.

"While I think this is a positive first step, it's only a first step," said Philip M. Hanno, MD, MPH, professor of urology at the University of Pennsylvania, Philadelphia, who has worked at FDA and served on the FDA urology advisory committee. "There is nothing to ensure the safety and efficacy of supplements so far. Patients believe they work because of the disingenuous way they're advertised."

Franklin C. Lowe, MD, MPH, who serves as chair of AUA's Complementary and Alternative Medicine Committee, said the new rule could not come soon enough.

"Following some good manufacturing practices and having reliable amounts of materials present in each of the dietary supplements is a great boon for patients and very helpful for the physicians who care for them," added Peter N. Schlegel, MD, professor and chairman of the department of urology, Weill Medical College of Cornell University, New York.

"In the end, we probably need to be closer to the requirements that are necessary for drug testing. If we're going to actually say that a supplement promotes prostate health or promotes fertility, then we ought to have more data for dietary supplements, just as we do for drugs," said Dr. Schlegel, who serves on the medical advisory board of Theralogix, a manufacturer of dietary supplements.