Hoodia gordonii products do not require a formal FDA authorization to be marketed.

As Hoodia gordonii products are considered dietary supplements, they must fulfill the provisions stated in the DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994.

FDA traditionally considered dietary supplements to be composed only of essential nutrients, such as vitamins, minerals, and proteins. The Nutrition Labeling and Education Act of 1990 added "herbs, or similar nutritional substances," to the term "dietary supplement." Through the DSHEA, Congress expanded the meaning of the term "dietary supplements" beyond essential nutrients to include such substances as ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and mixtures of these.

The DSHEA established a formal definition of "dietary supplement" using several criteria. A dietary supplement:

• is a product (other than tobacco) that is 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.
• is intended for ingestion in pill, capsule, tablet, or liquid form.
• is not represented for use as a conventional food or as the sole item of a meal or diet.
• is labeled as a "dietary supplement."
• includes products 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).

Source DSHEA