The U.S. Food and Drug Administration (FDA) has announced plans to ensure that dietary supplements, including those used by people with HIV, are of good quality, free of contaminants, and accurately labeled. However, not all consumer advocacy groups believe that the agency’s new rule establishing good manufacturing practices for these over-the-counter products will do much to ensure their safety or effectiveness.

"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," explains FDA Commissioner of Food and Drugs Andrew C. von Eschenbach, MD.

According to Sydney Wolfe, MD, Director of the Health Research Group at Public Citizen, a national public advocacy organization, the FDA’s rule is long overdue and doesn’t go far enough to protect consumers. “[The] final rule,” he argues, “not only is 13 years late, but will not do anything to ensure that dietary supplements are safe or effective – a critical necessity.”

The FDA says that the regulations will firmly establish good manufacturing practices needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for record keeping and handling consumer product complaints.

“The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” says Robert E. Brackett, PhD, director of FDA’s Center for Food Safety and Applied Nutrition.

“In the absence of regulations,” Dr. Wolfe says, “dozens of dietary supplements have been purposely and illegally laced with prescription drugs in an attempt to make them effective.”

Under the final rule, manufacturers will be required to evaluate the identity, purity, strength, and composition of their dietary supplements. 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 or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

Dr. von Eschenbach adds, “by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.”

Signed by President Clinton on October 1994, the Dietary Supplement Health and Education Act (DSHEA) acknowledged that millions of consumers believe dietary supplements may help augment daily diets and provide health benefits. The DSHEA’s primary intent, a 1995 fact sheet from the FDA explains, “was to meet the concerns of consumers and manufacturers to help ensure that safe and appropriately labeled products remain available to those who want to use them.”

FDA traditionally considered dietary supplements to contain only essential nutrients, such as vitamins, minerals, and proteins. The Nutrition Labeling and Education Act of 1990 expanded the term dietary supplement to include “herbs, or similar nutritional substances.” Through the DSHEA, Congress broadened the definition further to include substances like ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and mixtures of these.

Another provision of the DSHEA was to grant FDA the authority to establish good manufacturing practice regulations governing the preparation, packing, and holding of dietary supplements under conditions that ensure their safety.

“Congress mandated in 1994 that the agency issue a rule governing the manufacturing practices of dietary supplements,” says Dr. Wolfe. “It is baffling that the FDA has taken until 2007 to finalize it. Large businesses have a year to comply; small businesses have another three years to comply, meaning that 16 years will have passed between the time that Congress told the FDA to write the rule and the time it takes effect for all businesses.”

Even with these new manufacturing practices, Dr. Wolfe adds, there will be no assurance that dietary supplements work or are safe. “Because of the same 1994 law, the FDA has no authority to require testing for safety or efficacy of any dietary supplement. We saw with the ephedra-related deaths the dangers that dietary supplements pose. Congress should address this enormous deficiency in the law.”

Source: U.S. Food and Drug Administration. Final Rule for Current Good Manufacturing Practices (CGMPs) for Dietary Supplements [Backgrounder]. Accessed (June 25, 2007) at: http://www.cfsan.fda.gov/~dms/dscgmps7.html