FDA proposes cGMPs for dietary supplements

04/01/2003

By Mark A. DeSorbo

ROCKVILLE, Md.—Amid a revamp of pharmaceutical aseptic processing regulations for human and veterinary medicines, the Food and Drug Administration (FDA) has proposed current good manufacturing practices for dietary supplements—like St. John's Wort and calcium—which remained exempt from federal mandates despite a 1994 House measure that gave health officials the power to crack down on negligent nutraceutical makers.

"We've been pushing for current good manufacturing practices (cGMPs) for dietary supplements," says Allen Montgomery, executive director of the American Nutraceutical Association (Birmingham, Ala.). "It's late in coming, but we congratulate the agency for putting this into play."

Previously, dietary supplements have not been subject to mandatory standards for manufacturing or labeling. Congress, however, gave the FDA the authority to develop and implement cGMPs as part of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Now, under the FDA's proposal, the $19 billion industry would be required to "evaluate the identity, purity, quality, strength and composition of their dietary ingredients and dietary supplements. The draft outlines requirements for designing and constructing physical plants, establishing quality control procedures and testing manufactured dietary ingredients and dietary supplements. It also includes proposed requirements for maintaining records and for handling consumer complaints related to cGMPs.

"If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated," the FDA says.

The agency believes that some product quality issues that cGMPs would help prevent include products that are "superpotent" or "subpotent," which contain too much, not enough or the wrong ingredient; drug contamination by mislabeled ingredients, bacteria, pesticides, glass and lead; and improper packaging and labeling.

According to the FDA, recent analyses of dietary supplements by a private laboratory suggest products being marketed are not accurately labeled or contain contaminants that should not be present or may be harmful.

The analysis from the unidentified third-party lab also indicated that a substantial number of dietary supplement products did not contain the amounts of dietary ingredients indicated on product labels.

For example, one firm recalled its dietary supplements that were contaminated with excessive amounts of lead, which may have posed a health risk to children and women of childbearing age especially.

"Consumers should have access to dietary supplements that are accurately labeled and are free from contaminants," says FDA commissioner Mark B. McClellan. "Too often, consumers purchase dietary supplements based on inaccurate or incomplete information on what they are getting."

The FDA proposal also permits more informative research on dietary supplements to improve and make nutraceuticals safer and more effective.

"We commend FDA for proposing good manufacturing practices that will help ensure that all dietary supplements are of the quality that the public deserves," says Stephen Straus, director of the National Center for Complementary and Alternative Medicine at the National Institutes of Health (Washington, D.C.). "These practices will also speed our ability to provide the public with more definitive data about the safety and effectiveness of popular dietary supplements."

Montgomery, of the American Nutraceutical Association, agrees, saying cGMPs hold nutraceutical makers accountable.

"It raises the bar of confidence in dietary supplements," he says. "It's essential to have the assurance that the industry is following uniform standards."

Written comments from the public and industry will be accepted until 90 days after the date of publication in the Federal Register and may be addressed to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.