| New FDA Standards for Supplements | |
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March 10, 2003
According to Prevention Magazine's 2002 National Survey on Self-Care Movement, 158 million consumers use dietary supplements, spending $8.5 billion annually. The survey also reported that an estimated 11.9 million consumers have experienced adverse reactions from using herbal remedies, and 6.5 when using specialty supplements.
A significant percentage of headache and Migraine sufferers use dietary supplements such as magnesium, vitamin B2, calcium, Coenzyme Q10, feverfew, butterbur, and others. There are many "specialty" supplements advertising a "cure" for headaches and Migraine disease. The question is: How do we know what's actually in them and if they're safe?
The Food and Drug Administration took action last week 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. For the first time, the proposed rule would 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.
Health and Human Services Secretary Tommy G. Thompson stated,
"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. Millions of Americans use dietary supplements, and we owe it to them to ensure that they are getting the products they're paying for."
Once in effect the rule would set unprecedented requirements for designing and constructing physical plants, establishing quality control procedures, and testing manufactured dietary ingredients and dietary supplements. It would also set requirements for maintaining records and for handling consumer complaints related to CGMPs.
Under the CGMP proposal, manufacturers would be required to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. Dietary supplements containing contaminants or not containing the dietary ingredient they are represented to contain, would be considered by the FDA to be adulterated. Some quality problems the CGMPs would help prevent include products that:
- are superpotent or subpotent
- contain the wrong ingredient, a drug contaminant, or other contaminants (e.g., bacteria, pesticide, glass, lead)
- contain foreign material
- are improperly packaged and mislabeled.
Some consumers have all along been under the impression that dietary supplements came under the same scrutiny as medications, but this is not the case. The proposed regulation would still not subject supplements to the standards set for medications, but would definitely help assure the quality of supplements and ensure more accurate labeling.
Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs, commented,
"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 ... Consumers should have access to dietary supplements that are accurately labeled and are free from contaminants."
For more information, see:
~ Teri Robert
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