HomeFDA & hemp
FDA & hemp
What the statute means for a bulk isolate supplier.
This is a brief written for counsel. The dates and scopes below are public record. Peregrine sells ingredients from labs in Canada and the United States; we do not sell a finished drug or a dietary supplement, and we make no sleep claims.
Drug
A drug goes through an FDA premarket pathway. Peregrine does not sell one.
Dietary supplement
FDA regulates finished supplements. A bulk isolate is an ingredient, not a finished supplement, so the buyer owns that regulatory file.
Cosmetic
A cosmetic is described by appearance and feel. Meliora is our cosmetic line, still in development and not yet for sale.
Research ingredient
This is what we sell: research-grade isolate with identity and assay on the COA and the available masses on each product page.
23 April 2026
The U.S. Department of Justice issued a final order placing two categories of marijuana into Schedule III of the Controlled Substances Act: (1) FDA-approved drug products containing marijuana, and (2) marijuana products under a qualifying state-issued medical marijuana license. A broader adult-use rescheduling hearing was scheduled separately and is a different proceeding from this order.
What that order did not do
- It did not reschedule hemp. Hemp is excluded from the CSA definition of marijuana.
- It did not move adult-use cannabis out of Schedule I.
- It did not move synthetically derived THC out of Schedule I.
- It did not make a bulk hemp isolate an FDA-approved drug.
- It did not authorize sleep, mood, or disease claims on a wholesale SKU.
- It did not replace the 2018 Farm Bill or FDA’s food, supplement, cosmetic, or drug authorities.
FDA still regulates ingestible hemp
The 2018 Farm Bill did not repeal FDA’s authority over foods, dietary supplements, cosmetics, or drugs that happen to be hemp-derived. Adding CBN to a gummy does not create a structure/function claim or an NDI on its own. Peregrine lots are specified as ingredients, and the buyer owns the finished product’s regulatory path.
How we handle a lot
- 01
Identity and assay are on the COA before a mass tier is marked available or contact for pricing.
- 02
Isolate pages carry no sleep, mood, cognitive, or disease language.
- 03
THCV and isomer-adjacent materials require a destination jurisdiction on the inquiry.
- 04
Coming Soon means the lot does not exist yet and cannot be ordered.
- 05
Meliora stays labeled in development until there is a finished jar to sell.
Common questions
- Did April 23 legalize hemp supplements?
- No. The order addressed certain marijuana drug products and qualifying state medical-marijuana licenses. Hemp, excluded from the CSA definition of marijuana, was not rescheduled by that order.
- Does Peregrine sell FDA-approved drugs?
- No. We sell research-grade ingredients, and Meliora is a cosmetic line in development. A finished drug requires an FDA pathway, and nothing on this site claims one.
- What about the 2018 Farm Bill?
- Hemp is still defined as Cannabis sativa L. at or below the statutory THC threshold. Destination law applies on top of that, especially for THCV and isomer-adjacent lots, so we ask you to confirm the jurisdiction on your inquiry.
- Will the November 2026 hemp-definition changes affect what you sell?
- Congress narrowed which intermediates and non-naturally-produced cannabinoids count as hemp. Any lot whose status is unclear under the new definition will stay marked Coming Soon until we have confirmed it. Check this page after the effective date.
- Is Sleepz an FDA-authorized sleep aid?
- No. Sleepz is a finished formula still in development, and the CBN isolate we sell is an ingredient with no sleep claim attached. Neither has been evaluated by FDA as a drug.