Migraines, Dietary Supplements, and a Final FDA Rule

by Teri Robert, MyMigraineConnection Lead Expert

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Dietary supplements are an important part of many treatment regimens for headache and Migraine prevention. When we buy supplements, most of us assume that we’re getting exactly what the label says we’re getting. That’s not always the case. Some supplements pose health risks. They may contain harmful ingredients or be improperly manufactured or handled.

On June 22, 2007, the FDA announced a final rule establishing current good manufacturing practice requirements (CGMPs) for dietary supplements. In addition, by the end of the year, industry will be required to report all serious dietary supplement adverse events to FDA.


Ensuring Quality

Under the final rule, manufacturers are required to evaluate the identity, purity, quality, strength, and composition of dietary supplements. Robert E. Brackett, PhD, Director of FDA's Center for Food Safety and Applied Nutrition, stated,

"The dietary supplement CGMPs should increase consumers' confidence in the quality of the dietary supplement products that they purchase… These regulations provide more accountability in the manufacturing process so that consumers can be confident that the products they purchase contain what is on the label."

The final rule aims to ensure that dietary supplements do not have:

  • wrong ingredients
  • too much or too little of a dietary ingredient
  • improper packaging
  • improper labeling
  • contamination problems due to natural toxins, bacteria, pesticides, glass, lead, or other substances


How the FDA Regulates Supplements

The final rule on CGMPs is a critical component of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Under the DSHEA, dietary supplements are regulated like foods, not like drugs. Unlike new drugs, dietary supplements don't have to go through review by FDA for safety and effectiveness or be "approved" before they can be marketed. But manufacturers must provide premarket notice and evidence of safety for any supplements they plan to sell that contain dietary ingredients that were not marketed as dietary supplements before the DSHEA was passed — except that the premarket notice is not needed if the new dietary ingredient had previously been used as in ingredient in food.

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