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About Nutritional Supplements – Regulations in the Supplement Industry

The FDA has the authority to ensure the safety of all dietary supplements. All supplements must conform to federal regulations that control manufacturing, labeling and advertising practices.

Under the Dietary Supplement Health Education Act (DSHEA) legislation the FDA has the power to remove products from the market if it believes a product is unsafe. In addition DSHEA ensures that manufacturers report when a new ingredient is being taken to market along with the scientific proof of its efficacy.

Additionally, the dietary supplement industry is taking strides to implement strict standards for self-regulation. For more information review our section on supplement certification.

What is DSHEA?

The Dietary Supplement Health Education Act (DSHEA) was signed On October 25th, 1994. This legislation defines supplements, regulates health claims and labeling of supplements, encourages research and provides for good practice in the manufacture of dietary supplements.

This office resides within the National Institute of Health and advises the Secretary of Health and Human Serves on supplement regulation, safety and health claims.

What is a dietary supplement?

A dietary supplement as defined by DSHEA is a product taken by the mouth that contains an ingredient that is intended to supplement the diet. This includes:

  1. a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.
  2. a product intended for ingestion in pill, capsule, tablet, or liquid form.
  3. a product not represented for use as a conventional food or as the sole item of a meal or diet.
  4. a product labeled as a “dietary supplement.”
  5. a product such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).

Where can I find more information about DSHEA?

For more information about the Dietary Supplement Health Education Act please visit the FDA’s website.