Company: TCRG
Filing Date: 2025-03-21
Form Type: 10-K
Source: 0001185185-25-000206
Chunk: 7

Company: Cannaisseur Group Inc.
Filing Date: 2025-03-21
Form: 10-K
Item: Item 1
Chunk 7
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 supplements or as food because CBD is
subject to statutory exclusions designed to protect the integrity of the drug approval process.

7

Specifically,
the statutory definition of a “dietary supplement” excludes an “article” that has been approved as a drug
under section 505 of the FDCA. The term “dietary supplement” also excludes “an article” if (1) it has been authorized
for investigation as a new drug; (2) substantial clinical investigations have been instituted on the article and their existence made
public; and (3) it was not marketed as a food or dietary supplement prior to being authorized for investigation as a new drug. For purposes
of this exclusion, the FDA has interpreted “authorized for investigation as a new drug” to mean that an Investigational New
Drug application (“IND”) has been submitted for the active ingredient or active moiety.

FDA
has taken the position that hemp-derived CBD cannot be marketed as dietary supplement because a CBD isolate has been approved as a drug,
Epidiolex, and prior to approval, was subject to substantial clinical investigations under an IND. Further, FDA has stated that it has
not been provided with the evidence needed to overcome this exclusion. The FDA asserts this same position with regard to products marketed
as food under a separate, but identical, statutory provision applicable to “food” broadly. As such, FDA takes the position
that hemp-derived CBD products intended for ingestion may be adulterated.

That
being said, FDA has yet to take enforcement action against CBD products and has initiated a regulatory process to determine whether there
is a regulatory pathway to permit the marketing of these products. Indeed, FDA in recognizing the significant increase in hemp-derived
CBD products on the market, the Agency held a public meeting on May 31, 2019 requesting scientific information and data regarding
the safety, manufacturing, product quality, marketing, labeling, and sale of products containing hemp-derived CBD. It further requested
that comments be filed with the agency by July 2, 2019. This meeting and request for comments signaled FDA’s intent to consider
various regulatory options for CBD products, including but not limited to (1) requiring companies to seek approval to market such product;
(2) issuing regulations setting forth the conditions which such products may be marketed in food and dietary supplements; or (3) prohibiting
the use of hemp-derived CBD in foods and dietary supplements. With that said, there is significant regulatory uncertainty around
this category which makes it difficult