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) NPA analysis
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. Dietary Supplement and Non-Prescription Drug Consumer Protection
Act of 2006
NPA has comprehensively reported on this regulation from before its implementation and has continually provided assistance and guidance to members once the law went into effect. This section provides the latest news and key information regarding the law and NPA actions regarding it. Click here for more information about the AER Law and NPA Comments.
The Natural Products Association always aims to provide you with the latest information regarding critical issues affecting industry.
Federal
GMPs
The U.S. Food and Drug Administration's (FDA) final regulation on good manufacturing
practices (GMPs) for dietary supplements establishes 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.
