NPA works daily with Congressional, Senatorial, and Agency offices to help protect and advocate on behalf of their members.
Federal Law and Regulatory background:
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).
The U.S. did not always regulate vitamins and supplements as foods. The regulatory model for dietary ingredients was closer to a drug model requiring a petition process until a 1994 amendment Dietary Supplement Health and Education Act (DSHEA) recognized these health food products as foods rather than something else requiring a full petition process. DSHEA created a separate category of food called dietary supplements to which nutrients, minerals, vitamins, herbal botanical ingredients (traditional Chinese medicines) and amino acids fall under its scope. DSHEA also created a notification system for these dietary ingredients used in supplements over a food additive petition or drug registration process because they are ingredients that have a long history of use as components or constituents in foods and therefore have a much lower safety concern compared to novel foods and ingredients (new food additives, nanoparticle foods) and drugs introduced into the market. 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 + to expand with the position paper and – to collapse
Nutrition Labeling and Education Act of 1990 (NLEA)
Dietary Supplement Health and Education Act of 1994 (DSHEA)
Food Allergen Labeling and Consumer Protection Act of 2004 (Allergen Labeling Law)
