The US market is large, accessible, and frequently misunderstood. There is no pre-market approval for a dietary supplement or a botanical ingredient in the way there is for a drug. That does not mean no rules: cGMP, labeling, claim substantiation, and new-ingredient notifications all apply, and retailers add their own document requirements on top.
The framework in brief
Dietary Supplement Health and Education Act (DSHEA)
DSHEA, passed in 1994, placed dietary supplements in a category of food. The manufacturer is responsible for safety and for the accuracy of label statements. FDA can act after a product reaches the market, but it does not approve labels or ingredients in advance.
Current Good Manufacturing Practice — 21 CFR 111
The cGMP rule covers the finished supplement, including identity testing of incoming ingredients, specification setting, batch records, and quality control. An ingredient supplier supports this by providing a lot-specific COA, a specification, and identity documentation. The finished-product manufacturer remains responsible for its own release decision.
New dietary ingredient (NDI) notification
An ingredient marketed in the US before 15 October 1994 is generally not subject to the NDI notification requirement. Ingredients introduced later may require a notification to FDA at least 75 days before marketing, unless the ingredient is reasonably expected to be safe because it has been present in the food supply as an article used for food in a form in which the food has not been chemically altered. Whether a specific botanical requires an NDI notification is a finished-product and regulatory question.
Structure/function claims and the DSHEA disclaimer
Structure/function claims describe how a nutrient or ingredient affects normal body function. They must be truthful, not misleading, and accompanied by the DSHEA disclaimer stating that the statement has not been evaluated by FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease. Disease claims turn a supplement into a drug.
Labeling and allergens
Supplement labels must follow FDA labeling rules, including the Supplement Facts panel, ingredient declarations, allergen labeling under FALCPA, and appropriate net quantity and storage statements. Carriers and minor ingredients count as ingredients and must be declared.
Documents we can supply
The exact pack depends on the grade, the application, and your customer's requirements. These are the documents that typically travel with a botanical extract lot.
- Batch-specific COA against the agreed specification
- Technical data sheet with plant part, carrier, and solubility
- Safety data sheet
- Allergen and GMO statements
- Heavy-metal, microbiological, and solvent results as agreed
- Pesticide residue report where the buyer or retailer requires it
- Origin and traceability record
What your team still needs to confirm
Confirm whether the botanical or extract requires an NDI notification for your intended use and dose.
Have your regulatory advisor review structure/function claims and the DSHEA disclaimer.
Check that the supplier's COA covers identity, not only assay.
Confirm allergen and carrier declarations for the exact grade, not the category.
Check retailer-specific document requirements before the first PO.
Official sources
- FDA — Dietary supplements
- 21 CFR Part 111 — Current Good Manufacturing Practice
- FDA — New dietary ingredient notification process
- FDA — Structure/function claims
Important
Not legal advice
This page is a business-to-business orientation, not a legal opinion. Ingredient status, permitted claims, limits, and notification duties depend on the specific extract, dose, finished product, and current rules. Confirm with a qualified regulatory advisor in the destination market before launch.
Cite this page
Rainwood Botanical. "Botanical extracts for the United States market." Regulatory notes, October 2026. https://ingredients.rainwoodbio.com/resources/regulatory/united-states/