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How Does the FDA Regulate Nutritional Supplements

Some people often believe that the Food and Drug Administration (FDA) does not regulate nutritional supplements. However, this can be further from the truth. The FDA has been regulating dietary supplements since 1994 through the Dietary Supplement Health and Education Act or DSHEA.

While the law does not require supplement manufacturers to subject their products to the same kind of testing as pharmaceutical products, there are still regulations in place to ensures that supplements are safe and effective.

If you’re new to the nutritional supplement industry, you should know that the FDA has guidelines to regulate nutritional supplements. They have guidelines on selling, marketing, ingredient safety, and manufacturing. Here are five specific ways that the FDA regulates the supplement industry:

5 Ways the FDA Regulates Nutritional Supplements

  1. They monitor the marketing claims made by dietary supplement companies. This prevents businesses from making false claims that their products can prevent, reduce the symptoms or, or cure diseases.
  2. They review and approve the introduction of new ingredients to the market. New ingredients are given GRAS (generally recognized as safe) or NDI (new dietary ingredients) status once they pass the testing set by the FDA.
  3. They establish supplement label warning requirements if there is evidence that an ingredient is harmful. If necessary, they may also order the mandatory removal of an ingredient from the marketplace.
  4. They inspect manufacturing facilities and look for deficiencies, if there are any, to ensure a company’s compliance with Good Manufacturing Practices (GMPs). They check for the following:
  • Equipment
  • Cleaning and sanitation practices
  • Employee hygiene practices
  • Manufacturing processes
  • Quality control procedures

If a manufacturer is found to be lacking in certain areas, they will be asked to correct their deficiencies and comply with the GMPs

5. They regulate various factors of your business. This includes raw material verification, finished product testing, and accurate labeling. Such guidelines help ensure that supplements in the market are safe and effective for human consumption.


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