Understanding DSHEA: The Framework for Dietary Supplement Regulation in the U.S.

What is DSHEA?

The Dietary Supplement Health and Education Act (DSHEA) of 1994 is a U.S. federal law that defines and regulates dietary supplements. Passed as an amendment to the Federal Food, Drug, and Cosmetic Act, DSHEA established a distinct regulatory framework for dietary supplements, separate from foods and drugs.

Key Definitions Under DSHEA

• Dietary Supplement: A product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. This includes vitamins, minerals, herbs, amino acids, enzymes, and other substances.
• Dietary Ingredient: A vitamin, mineral, herb or other botanical, amino acid, dietary substance for use by man to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of any ingredient described above.

Regulatory Responsibilities

Under DSHEA, the U.S. Food and Drug Administration (FDA):

• Does not approve dietary supplements before they go to market.
• Can take action against any unsafe supplement after it reaches the market.
• Regulates labeling and claims, ensuring they are not false or misleading.

Manufacturers are responsible for:

• Ensuring the safety of their products.
• Proper labeling, including ingredient list and the disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
• Submitting a New Dietary Ingredient (NDI) notification to the FDA if introducing an ingredient not marketed in the U.S. prior to 1994.

Claims Allowed Under DSHEA

Manufacturers can make structure/function claims, such as “supports immune health” or “helps maintain healthy cholesterol levels.” However:

• They cannot claim to diagnose, treat, cure, or prevent any disease.
• Claims must be substantiated and submitted to the FDA within 30 days of marketing.

Labeling Requirements

• Product name and that it is a “dietary supplement.”
• Net quantity of contents.
• Supplement Facts panel with active ingredients.
• Other ingredients listed in descending order by weight.
• Name and place of business of the manufacturer, packer, or distributor.

Impact of DSHEA

DSHEA has played a major role in shaping the modern U.S. supplement market, empowering consumers with more choices while placing the burden of safety and labeling on manufacturers. It has also spurred ongoing debates around the need for more premarket oversight and transparency.

Cosmereg Can Help

Cosmereg provides regulatory guidance for dietary supplement companies navigating DSHEA, including:

• NDI submissions
• Label compliance
• FDA registration and U.S. Agent services

Need help complying with DSHEA regulations?
Talk to Cosmereg’s dietary supplement compliance team today, contact us