Dietary supplements are subject to the Food and Drug Administration’s Dietary Supplement Current Good Manufacturing Practices (Dietary Supplement cGMP’s).
The Dietary Supplement cGMP’s require manufacturers, packers, labelers, distributors, and warehouses to follow specific requirements to ensure the safety and quality of the dietary supplements they are distributing or selling.
Frequently Asked Questions
What is a dietary supplement?
They are products intended to be marketed, sold, and used as dietary supplements. Dietary supplements are products intended for ingestion, are not the sole item of a meal, and contain one or more of the following ingredients:
- Vitamins
- Minerals
- Herbs or other botanicals
- Amino acids
- A dietary substance used to supplement the diet by increasing the total dietary intake
- A concentrate, metabolite, constituent, extract, or a combination of any of the ingredients mentioned above
A company’s website or advertising material for a product is an extension of the dietary supplement label. Health claims made about the product would be considered part of the label regardless of where the claims are made.
Who is exempt from this regulation?
Dietary ingredient suppliers that provide raw materials (i.e., single ingredients) without manufacturing a finished product are exempt from the Dietary Supplement cGMP’s.
Do the Dietary Supplement cGMP’s apply if all sales are directly to the end consumer?
Not if selling prepackaged dietary supplements at retail to the end consumer. However, the Dietary Supplement cGMP’s do apply to retail establishments that perform any on-site manufacturing operations.
I would like to manufacture a dietary supplement with CBD and/or THC from cannabis, which agency should I contact?
The Minnesota Office of Cannabis Management regulates the production and sale of cannabinoid products. For additional information, visit Hemp in Food FAQs.
