FDA Issues New Supplement Rules

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Last week, the U.S. Food and Drug Administration (FDA) announced new standards for the manufacturing of dietary supplements (such as vitamins, minerals, and herbs) to ensure that they are free of contamination and impurities, produced in a quality-controlled environment, and contain exactly what their labels say they contain. These new rules do not, however, go as far as to require that supplements be safe and effective—that is, that they actually have any particular effect in the body.

The new standards include the following requirements:

  • Manufacturers will have to test the identity, purity, strength, and makeup of their dietary supplements.
  • Facilities where dietary supplements are manufactured will have to be designed and constructed to specified standards.
  • Manufacturers will have to follow protocols for record-keeping and handling of customer complaints.
  • All serious “adverse events,” or side effects, related to dietary supplement use will have to be reported to the FDA by manufacturers.

FDA inspectors will check manufacturing plants to make sure that they are complying with these regulations. Violations may be addressed by asking companies to make changes to their manufacturing processes, or by stricter measures including product seizures, depending on their magnitude.

Through these new standards, the FDA hopes to prevent contamination of dietary supplements with toxins, microbes, heavy metals, and other substances and to make sure that the labeling accurately reflects what is found in the supplements. Congress granted the FDA the power to set such standards in 1994, but the agency has not done so until now. Depending on company size, manufacturers will have deadlines ranging from June 2008 to June 2010 to comply with the new regulations, with smaller businesses being given more time to adapt.

Dietary supplements are an $18-billion-a-year industry in the United States, and many supplements are marketed to people with diabetes. Some supplements that DiabetesSelfManagement.com bloggers have written about the past include alpha-lipoic acid (ALA), chromium, and fish-oil supplements.

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