Diet Drug & Dietary Supplement General Info

What is a Dietary Supplement?

The Dietary Supplement Health and Education Act of 1994 (“DSHEA”) was enacted by Congress and amended the Food, Drug and Cosmetic Act. It defines a dietary supplement as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” include vitamins, minerals, herbs, or other botanicals, amino acids, enzymes, organ tissues, glandulars and metabolites.

How are Dietary Supplements Regulated?

Under DSHEA, the FDA has no pre-market oversight or approval authority. Dietary supplement products may be sold unless the supplement, or an ingredient in the supplement is shown to present significant or unreasonable risk of illness or injury. There is no pre-market requirement for testing for safety or efficacy. Effectively, the public is used just like lab rats. The FDA acts after there are reports of death and injuries.

Do Manufacturers Have to Show Evidence of Safety?

No. There is no provision under any law or regulation that requires a manufacturer to prove, through testing or otherwise, that a dietary supplement is safe for the consuming public before the product is sold. There is virtually no safety testing in the dietary supplement industry.

Do Manufacturers Have to Show Evidence to Substantiate Claims of the Purported Benefits of Their Product?

No. As with safety, there is no provision under any law or regulation that a manufacturer must prove that a dietary supplement works before the product is marketed to the consuming public. Efficacy studies are almost non-existent in the dietary supplement industry.

Can Dietary Supplements be Marketed as a Treatment or Cure for a
Disease?

No. Under DSHEA, dietary supplements cannot be promoted to treat, prevent or cure any specific disease or condition. If these types of claims are made, the product is then considered an unapproved illegal drug.