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House Bill does NOT legalize THC, Full Spectrum CBD will still be ILLEGAL

Here is why:

The recent legislation filed by the House does nothing to change the FDA’s viewpoint on the presence of THC in CBD products, which they have classified as a “psychoactive contaminant” in CBD products

In addition, though both CBD and THC are each subject to the drug exclusion clause in the FDCA, the legislation filed in the House only explicitly exempted Hemp-derived CBD in Dietary Supplements and Foods from this clause — the current illegal status of Hemp-derived THC in Dietary Supplements and Foods was not changed by this legislation

“Hemp-derived Cannabidiol” (CBD) is the term used in the bill — CBD will be federally legalized and made exempt from the drug exclusion clause

“Hemp-derived Tetrahydrocannabinol” (THC) is NOT included in the House Bill — therefore, THC will remain federally illegal


Here is a comprehensive article explaining why THC would still remain illegal in Supplements and Foods:

“Peterson’s bill would get around this conundrum by inserting a specific exemption for CBD in the portions of the Dietary Supplement Health and Education Act that pertain to the so-called ‘exclusionary clause.’ The clause would still be in place, and would apply to everything but CBD.”

https://www.nutraingredients-usa.com/Article/2020/01/17/Views-differ-sharply-on-whether-CBD-legislation-is-best-way-to-break-logjam


Here is another article stating the same thing:

“HR 5587, as currently drafted, only would apply to Hemp CBD, not other cannabinoids such as CBN or CBG.”

https://www.cannalawblog.com/will-the-fda-soon-treat-hemp-cbd-as-a-dietary-supplement/


Here is the actual relevant text of the Hemp-derived CBD Legalization Bill:

https://www.congress.gov/bill/116th-congress/house-bill/5587/text

SECTION 1. REGULATION OF HEMP-DERIVED CANNABIDIOL AND HEMP-DERIVED CANNABIDIOL CONTAINING SUBSTANCES.

(a) Inclusion In Definition Of Dietary Supplement.—Section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)(3)(B)) is amended in each of clauses (i) and (ii) by inserting “(other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance)” after “an article”.

(b) Prohibited Act.—Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(ll)) is amended by inserting “(other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance)” after “public”.


The FDA explains that both CBD and THC are subject to the drug exclusion clause right here:

9. Can THC or CBD products be sold as dietary supplements?

A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement. FDA considers a substance to be "authorized for investigation as a new drug" if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.

There is an exception to section 201(ff)(3)(B) if the substance was "marketed as" a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.

FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.

When a substance is excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act, the exclusion applies unless FDA, in the agency’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under the FD&C Act. To date, no such regulation has been issued for any substance.

11. In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?

A. THC (dronabinol) is the active ingredient in the approved drug products, Marinol capsules (and generics) and Syndros oral solution. CBD is the active ingredient in the approved drug product, Epidiolex.

The existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex.


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