CBD and hemp supplements: check the drug exclusion before the label, then each state
Answer two federal questions separately, hemp status and supplement status, and plan for the new federal hemp definition scheduled for 12 Nov 2026.
In Short
- Hemp status is not supplement status.
- Hemp definition changes 12 Nov 2026.
- Check each state you sell into.
The Cannabis and Hemp Guide
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The Cannabis and Hemp Guide
Authorised inputs. Tested batches. Packs that meet your market's rules.
Brand owners and contract manufacturers selling hemp-derived products in the US face two separate federal questions: is the plant material hemp, and can the finished product be a dietary supplement? Scheduled change: section 781 of Public Law 119-37, enacted 12 Nov 2025, replaces the federal hemp definition effective 365 days after enactment, which is 12 Nov 2026. It is not in force on the date this guide was checked. Opened: the dietary supplement definition in 21 U.S.C. 321(ff), the prohibited act in 21 U.S.C. 331(ll) and the hemp definition in 7 U.S.C. 1639o from the 2023 edition of the US Code on GovInfo, plus the enrolled text of Public Law 119-37 section 781 on GovInfo. Not opened: FDA statements and warning letters on CBD, FDA's cannabinoid lists or other implementing guidance, USDA rules and any state law. It is orientation, not legal advice. Sources checked 5 Oct 2026.
Two federal questions, two rulebooks
Hemp status is a plant and THC question under agriculture law. Dietary supplement status is a food and drug question under the Federal Food, Drug, and Cosmetic Act.
Two federal questions, recorded separately
More on two federal questions, two rulebooks
Meeting one says nothing about the other. Current through 11 Nov 2026: 7 U.S.C. 1639o(1) defines hemp as the plant Cannabis sativa L. and any part of it, including derivatives, extracts and cannabinoids, with a delta-9 THC concentration of not more than 0.3 percent on a dry weight basis. Scheduled from 12 Nov 2026: section 781 of Public Law 119-37 replaces that wording with a total tetrahydrocannabinols concentration, including tetrahydrocannabinolic acid (THCA), of not more than 0.3 percent on a dry weight basis. It also adds exclusions, including certain intermediate and final hemp-derived cannabinoid products, such as final products with more than 0.4 milligrams combined total THC and similar-effect cannabinoids per container, and products with synthesized cannabinoids. Plan formulas, tests and stock for the change now; counsel decides how it applies.
The drug exclusion in 321(ff)(3)(B)
Section 321(ff)(3)(B) says a dietary supplement does not include an article approved as a new drug under section 355, or an article authorised for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless it was marketed as a dietary supplement or as a food before that approval or authorisation. The Secretary may, after notice and comment, issue a regulation finding the article lawful.
Which question are you answering? (simplified)
- Delta-9 THC definition applies through 11 Nov 2026; total THC including THCA, with product exclusions, from 12 Nov 2026.
- Hemp status does not settle supplement status.
More on the drug exclusion in 321(ff)(3)(B)
FDA has spoken publicly about how this applies to CBD; this guide did not open those statements, so read them directly before deciding a route.
Adding a drug to a food
Section 331(ll) prohibits introducing into interstate commerce any food to which has been added an approved drug, a licensed biological product, or a drug or biological product for which substantial clinical investigations have been instituted and made public. Listed exceptions include the article having been marketed in food first, and a regulation approving its use in food.
More on adding a drug to a food
Because 321(ff) deems a dietary supplement to be a food for most purposes, this provision matters for gummies, drinks and capsules alike. Your counsel decides how it applies to a given product.
State Rules Sit on Top
States regulate hemp-derived products in different ways, and some set their own THC measures, testing, registration or labelling rules. This guide did not open any state law, so it lists none.
Worked Example: Market Matrix for Gummy Lot CBG-0412
| Market | Source checked | Decision |
|---|---|---|
| State A | Statute and agency rule, checked 1 Oct | Counsel: ship |
| State B | Registration rule, checked 1 Oct | Hold until registered |
| State C | Not yet checked | Do not ship |
- State A
- Source checked
- Statute and agency rule, checked 1 Oct
- Decision
- Counsel: ship
- State B
- Source checked
- Registration rule, checked 1 Oct
- Decision
- Hold until registered
- State C
- Source checked
- Not yet checked
- Decision
- Do not ship
More on state Rules Sit on Top
Build a market matrix that names each state you sell into, the source text your adviser checked, the date checked and the decision taken. Treat a missing entry as unknown, not as permission. Update the matrix when a state changes its rules, and keep earlier versions so you can show what applied when a lot shipped.
Records that support the decision
Whatever route counsel chooses, the evidence sits in production records: the hemp source and its certificate of analysis, the cannabinoid and THC results for each lot, the formula version, the label version and the states each lot shipped to. Link them so a person can answer a regulator's or retailer's question about one lot without searching.
More on records that support the decision
A result near a limit, or from a method your adviser has not accepted, needs a named reviewer and a recorded decision before the lot is released.
Questions
Is hemp-derived CBD a lawful dietary supplement because it comes from hemp?
No. Hemp status and dietary supplement status are separate questions. Section 321(ff)(3)(B) excludes certain approved or publicly investigated drugs from the supplement definition, so check that exclusion with counsel.
Does the 0.3 percent delta-9 THC figure still apply?
Through 11 Nov 2026, yes: 7 U.S.C. 1639o(1) uses delta-9 THC. From 12 Nov 2026 the scheduled definition in Public Law 119-37 section 781 uses total tetrahydrocannabinols including THCA, with new product exclusions. FDA lists and later guidance were not opened, so check them with counsel.
What does 21 U.S.C. 331(ll) cover?
It prohibits interstate commerce in food containing an added approved drug, licensed biologic, or publicly investigated drug or biologic, unless one of its listed exceptions applies.
Does V5 decide whether my product can be sold in a state?
No. V5 records lots, test results, formulas, labels and shipments. Your regulatory team and counsel decide where a product can be sold.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
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