The regulations for starting a natural products-based business can be intimidating to most budding entrepreneurs. Although natural products can range from traditional cosmetics to dietary supplements, the manufacturing, packing and holding of human food, dietary supplements and cosmetics are regulated by the Food and Drug Administration, which is part of the US Department of Health and Human Services.
The regulations concerning dietary supplements stem directly from a different set of regulations than conventional foods. The Dietary Supplement Health and Education Act of 1994 (DSHEA) set forth the original guidelines to the regulations regarding the FDA oversight of these products.
These regulations are vast but easily accessible through the FDA site.
The FDA has numerous resources pages to clarify its expectations for producers and inform consumers
- Title 21 Part 111 Current Good Manufacturing Practices in manufacturing, packaging, labeling, or holding operations for dietary supplements — This lays out the dietary supplement regulations in a code format.
- Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide — Provides great compliance information for small producers.
- Q&A on Dietary Supplements — A great question and answer page for consumers that offers the information in an easier to understand format.