The FDA is ramping up its enforcement in the area of dietary supplements, due to industry growth and widespread acceptance of supplements by the public. Before a firm markets a dietary supplement, the firm is responsible for ensuring the following:

  • the products it manufactures or distributes are safe
  • any claims made about the products are not false or misleading
  • the products comply with the FTC and FDA regulations, as well as DSHEA (Dietary Supplement Health and
  • Education Act of 1994. Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices under 21 CFR Part111)
  • manufactured per GMP guidelines
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