nutrition-FDA-Proposes-Labeling-and-Manufacturing-Standards

FDA Proposes Labeling and Manufacturing Standards
For All Dietary Supplements

The Food and Drug Administration today took action to help consumers get accurately labeled and unadulterated dietary supplements by proposing a new regulation to require current good manufacturing practices (CGMPs) in their manufacturing, packing, and holding. The proposed rule would, for the first time, establish standards to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities, and are labeled to accurately to reflect the active ingredients and other ingredients in the product.

This proposed rule includes 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.

"Americans must have confidence that the dietary supplements they purchase are not contaminated and that they contain the dietary ingredients and the amounts claimed on the labels," said HHS Secretary Tommy G. Thompson. "Millions of Americans use dietary supplements, and we owe it to them to ensure that they are getting the products they're paying for."

In recent years, analyses of dietary supplements by a private sector laboratory suggest that a substantial number of dietary supplement products analyzed may not contain the amounts of dietary ingredients that would be expected to be found based on their product labels. For example:

Five of 18 soy and/or red clover-containing products were found to contain only 50 percent to 80 percent of the declared amounts of isoflavones. Of 25 probiotic products tested, 8 contained less than 1 percent of the claimed number of live bacteria or the number of bacteria that would be expected to be found in such a product.
FDA has also encountered products being marketed that are not accurately labeled or contain contaminants that should not be present or may be harmful. For example:

One firm recalled its dietary supplements that were contaminated with excessive amounts of lead, which may have posed a health risk to many consumers, especially children and women of childbearing age.
Another firm recalled a niacin product after it received reports of nausea, vomiting, liver damage, and heart attack associated with the use of its product. A dietary ingredient manufacturing firm had mislabeled a bulk ingredient container that subsequently was used by another firm in making a product that contained almost ten times more niacin than the amount that may be safe.

Another firm recalled its product after it was found that a dietary supplement containing folic acid, which is often taken by women to reduce the risk of having a baby with neural tube defects, contained only 35 percent of the amount of folic acid claimed on the label.

Under the CGMP proposal, manufacturers would be required to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and 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. Some product quality problems the CGMPs would help prevent include products that are superpotent or subpotent; that contain the wrong ingredient, a drug contaminant, or other contaminants (e.g., bacteria, pesticide, glass, lead); that contain foreign material; and that are improperly packaged and mislabeled.