Supplement: FDA Proposes Labeling and Manufacturing Standards for All Dietary Supplements
FDA Proposes Labeling and Manufacturing Standards for All Dietary Supplements
The Food and Drug Administration (FDA) recently took action to help consumers get accurately labeled and unadulterated dietary supplements by proposing a new regulation to require current good manufacturing practices (GMPs) in their manufacturing, packing, and holding. The proposed rule, in development since the release of the Dietary Supplement Health and Education Act in 1994, would establish standards to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities, and are labeled 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 GMPs.
In a press release posted on its web site, the American Botanical Council in Austin, TX, is among several organization to point out that "¼ many responsible manufacturers in the herb and DS [dietary supplement] industry have not waited for FDA’s publication of GMPs and have voluntarily increased their GMPs to meet or exceed what the FDA is projected to be proposing. Also, some manufacturers, because they produce over-the-counter (OTC) drug products, already operate under high level GMPs.
Need for Manufacturing Standards
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 50-80% of the declared amounts of isoflavones.
- Of 25 probiotic products tested, eight contained less than 1% of the claimed number of live bacteria or the number of bacteria that would be expected to be found in such a product.
FDA also has 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 10 times more niacin than the amount that may be safe.
The Proposed Regulation
"This proposed regulation is another major step in our efforts to help Americans take more control over their own health. Too often, consumers purchase dietary supplements based on inaccurate or incomplete information on what they are getting. This proposed regulation would require that dietary supplements provide accurate information on the type and amount of ingredients they contain and that dietary supplements are produced using safe methods," said Mark B. McClellan, MD, PhD, Commissioner of Food and Drugs. "Consumers should have access to dietary supplements that are accurately labeled and are free from contaminants."
FDA’s action also will permit more informative research on dietary supplements, to improve the science available on their safety and effectiveness. "We commend FDA for proposing good manufacturing practices that will help ensure that all dietary supplements are of the quality that the public deserves. Since credible research studies cannot be performed using many of the current, highly variable products, these practices will also speed our ability to provide the public with more definitive data about the safety and effectiveness of popular dietary supplements," said Stephen Straus, MD, Director, National Center for Complementary and Alternative Medicine at the National Institutes of Health.
This proposed regulation follows the agency’s consumer initiative announced last December intended to improve FDA’s policies on providing information about health consequences of food and dietary supplements and to increase enforcement efforts to prevent misleading health claims made by certain dietary supplement manufacturers. By putting in place requirements that will ensure universal good manufacturing practices, the proposed regulation should serve to eliminate the guesswork for consumers about which dietary supplements may or may not be of high quality. In turn, manufacturers of dietary supplements will have to compete based on the quality of their products, not through potentially misleading labels or inexpensive, but less safe, manufacturing processes.
Manufacturers’ Obligations
Under the GMP proposal, manufacturers would be required to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. In addition, manufacturers would be required to:
- Employ qualified employees and supervisors;
- Design and construct physical plants in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging, and holding;
- Use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use;
- Establish and use a quality control unit and master manufacturing and batch production records;
- Hold and distribute materials used to manufacture, package, and label dietary ingredients, dietary supplements, and finished products under appropriate conditions of temperature, humidity, light, and sanitation so that their quality is not affected;
- Keep a written record of each consumer product quality complaint related to GMPs; and
- Retain records for three years beyond the date of manufacture of the last batch of dietary ingredients or 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 GMPs would help prevent include products that are super-potent 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.
This proposal is intended to cover all types of dietary supplements. However, to limit any disruption for dietary supplements produced by small businesses, FDA is proposing a three-year phase-in of a final rule for small businesses. The proposal includes flexible standards that can evolve with improvements in the state of science, such as in validating tests for identity, purity, quality, strength, and composition of dietary ingredients.
FDA is soliciting comments from the public and industry on how this proposed regulation can best achieve the goals of promoting accurate labeling information and preventing adulteration without imposing unnecessary regulatory burdens. Written comments will be received 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.
Additional information, including the proposed rule, may be found on FDA’s web site: www.fda.gov/bbs/topics/NEWS/2003/NEW00876.html.
FDA proposes labeling and manufacturing standards for all dietary supplements. Altern Med Alert 2003;6(4 Suppl):S1-S2.Subscribe Now for Access
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