If You Export Dietary Supplements to the US

Dietary supplements and dietary ingredients fall under the category of complementary and alternative medicine. They are considered as “food” under the Food Drugs and Cosmetics Act (FDC Act) and the Public Health Service Act (PHS Act). Under the FDC Act, a dietary ingredient means a vitamin, a mineral, an herb/botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing total dietary intake, a concentrate, metabolite, constituent extract or combination of any of the previous items. Additionally, dietary supplements (and ingredients) are subject to the Dietary Supplement Health & Education Act 1994 (DSHEA).

How do these laws affect dietary supplements (and ingredients) exported to and marketed in the US?

  • All food imported into the US requires the submission of prior notice to the FDA, even when marketed through the internet or as online sales (which is considered as introducing or delivering for introduction into interstate commerce in the US).
  • All the ingredients of dietary supplements have to be declared.
  • The FDA can remove such items from market if they are adulterated (“unsafe”) or misbranded (“false or misleading labeling”). In addition to safety issues, the FDA will also look at labeling.
  • The FTC will look at advertising (including marketing on the internet) and advertisers must comply with truth-in-advertising laws.
  • In 2016, the FDA ruled that New Dietary Ingredient[1] (NDI) requires 75 days premarket notification.
  • All food must be produced by facilities that comply with HACCP (hazard analysis & critical control point) system requirements.
  • The FDA can inspect the facility to check if it complies with CGMP (current good manufacturing practices).

[1] A new dietary ingredient is a dietary ingredient not marketed as a dietary ingredient in the US before 15th October 1994, except for a dietary supplement that contains only dietary ingredients that have been present in the food supply as articles used as food in a form in which the food has not been chemically altered.

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