Laws and Regulations

Most natural products sold in the U.S. are subject to U.S. laws and regulations. Foods, dietary supplements (as a subcategory of foods), and cosmetics fall under the Federal Drug, Food and Cosmetic Act of 1934 (FD&C Act) and are regulated by the U.S. Food and Drug Administration (FDA) under Title 21 of the Code of Federal Regulations (CFR). Additionally, consumer products and their marketing and advertising are subject to consumer protections under Federal Trade Commission Act of 1914, which established the Federal Trade Commission (FTC) as its oversight regulatory agency for Title 16 of the Code of Federal Regulations (CFR).

Significant provisions of the Federal FD&C Act that impact the natural products industry include:

Nutrition Labeling and Education Act of 1990 (NLEA): Summary of NLEA

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Bioterrorism Act of 2002

Food Allergen Labeling and Consumer Protection Act of 2004 (Allergen Labeling Law)

Dietary Supplement and Non-Prescription Drug Consumer Protection Act of 2006 (AER Law)
The Adverse Event Reporting (AER) law, which became effective in December 2007, amended the federal Food, Drug and Cosmetic Act to require the reporting of "serious" adverse events for both over the counter (OTC) drugs and dietary supplements.

NPA has comprehensively reported on this regulation from before its implementation and has continually provided assistance and guidance to members after the law went into effect.

NPA aims to provide you with the latest information regarding critical issues affecting our industry.

NDI Draft Guidance
On July 5, 2011, the FDA published the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” in the Federal Register.

Federal GMPs
The FDA's final regulation on good manufacturing practices (GMPs) for dietary supplements established new stringent requirements for companies involved with the manufacturing, packaging, labeling and holding of dietary supplements.

The AER Law
The Adverse Event Reporting (AER) law, which became effective in December 2007, amended the federal Food, Drug and Cosmetic Act to require the reporting of "serious" adverse events for both over the counter (OTC) drugs and dietary supplements.

Regulation of Dietary Supplements

NPA also took the opportunity to correct the common misperception that the industry is unregulated with a handout that points out the numerous laws governing the sale and manufacture of supplements.