CV Sciences Inc (CVSI)

[Deetew]

Can CBD products be sold as dietary supplements? I have the answer.

Problem Source 1:
CV Sciences ventures into food space following CBD safety assessment

"FDA has asserted CBD can’t be sold in foods or supplements. Its reasoning is tied to clinical investigations instituted by GW Pharmaceuticals plc, which obtained FDA approval in June to market Epidiolex, a CBD drug to treat seizures associated with certain forms of epilepsy."

"FDA has asserted CBD can’t be sold in foods or supplements. Its reasoning is tied to clinical investigations instituted by GW Pharmaceuticals plc, which obtained FDA approval in June to market Epidiolex, a CBD drug to treat seizures associated with certain forms of epilepsy."

“Self-affirmed GRAS status also doesn’t change the fact that the FDA still considers CBD to be a nonpermissible ingredient due to the investigation of a new drug,” Prochnow, a partner with Greenberg Traurig LLP, wrote in an email. “However, if the ingredient investigated by GW Pharma is sufficiently distinguished, it does pave the way for strong arguments about its use in foods and beverages.”

“Is there a lawful basis to market it—a standardized CBD product—in light of GW Pharma?” the regulatory lawyer asked. “It could be the safest ingredient in the whole world. It doesn’t matter.”

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Problem Source 2:
FDA.gov

"12. Can products that contain THC or cannabidiol (CBD) 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 sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, respectively. Under those provisions, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the FD&C Act), 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 outside 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 sections 201(ff)(3)(B)(i) and (ii) 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. For more information on this provision, including an explanation of the phrase "marketed as," see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.

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 sections 201(ff)(3)(B)(i) and (ii) 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 called our conclusions into question."

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So what does the Guidance that the FDA referred to say?

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Solution Source 1:
Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry

"12. May I manufacture and sell a dietary supplement containing a dietary ingredient that was marketed as a food or dietary supplement before it was approved as a drug, licensed as a biologic, or authorized for investigation under an IND?

Yes, in this situation the dietary ingredient may be used in dietary supplements. In considering whether a substance has been “marketed as a dietary supplement or as a food,” FDA looks for evidence of one of the following:

1. Evidence that the substance itself was sold or offered for sale in the U.S. as a dietary supplement, dietary ingredient for use in dietary supplements, or conventional food. For example, a catalog listing a product identified as a “Substance A supplement” would establish the marketing of Substance A as a dietary supplement. Similarly, business records documenting that a substance was sold or offered for wholesale or retail sale for use as an ingredient in a conventional food would establish the marketing of the substance as a food.

2. Evidence that the substance was a component of a food or dietary supplement that was sold or offered for sale in the U.S., and that a manufacturer or distributor of the food or dietary supplement marketed it for the content of the substance by, for example, making claims about the substance or otherwise highlighting its presence in the product. For example, in Pharmanex v. Shalala, the firm marketed lovastatin, a component of its red yeast rice product Cholestin, by promoting the lovastatin content of Cholestin. Merely showing that the substance was present as a component in a marketed food would not be enough to show that the substance was “marketed,” however."

Also,

"FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required."

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Solution Source 2:
CV Sciences ventures into food space following CBD safety assessment

"Expressing a view that he said is “broadly shared by the marketplace,” Tomc said hemp-derived CBD was marketed before any “substantial clinical investigations” began and were publicized."

“The investigations that were publicized were not substantial, due to being limited in number and preliminary in nature, thereby rendering the IND [investigational new drug] preclusion inapplicable,” he added. “Furthermore, the IND preclusion isn’t a new conversation in the dietary supplement industry. Many ingredients such as trans-resveratrol, P5P [pyridoxal-5-phosphate] and DHEA [dehydroepiandrosterone] have been subject to the same scrutiny and continue to be sold as dietary supplements.”

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What about the legality of CVSI's hemp-sourced CBD? What is the DEA's current stance on that?

Solution Source 3:
Retailers seek clarity on CBD

"A national group, Hemp Industries Association, sued the DEA over its scheduling of CBD. The two have since mediated the case, resulting in the DEA issuing an internal directive in May that re-emphasized the legality of hemp products, according to HIA."

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My Take:

I don't know about you, but to me, the article about the FDA questioning the legality of CVSI's product is nothing more than fear-mongering. --At least according to the info found on the FDA's own "FDA and Marijuana: Questions and Answers" site and within the problem source #1 article itself. CVSI was selling CBD as a dietary supplement long before GW Pharma's CBD came into question, so we're headed to Mars fellas. Keep in mind that the passage of the Farm Bill will allow hemp-derived products to be distributed all over the US according to previous DD I have done by reading the actual Agriculture Improvement Act of 2018. Based on this DD, I still advise to buy more shares of CVSI.

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Agriculture Improvement Act of 2018

"HEMP.—The term ‘hemp’ means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis."

"SEC. 12608. CONFORMING CHANGES TO CONTROLLED SUBSTANCES ACT.

(a) In General.—Section 102(16) of the Controlled Substances Act (21 U.S.C. 802(16)) is amended—

(1) by striking “(16) The” and inserting “(16)(A) Subject to subparagraph (B), the”; and

(2) by striking “Such term does not include the” and inserting the following:


“(B) The term ‘marihuana’ does not include—

“(i) hemp, as defined in section 297A of the Agricultural Marketing Act of 1946; or

“(ii) the”.

(b) Tetrahydrocannabinol.—Schedule I, as set forth in section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)), is amended in subsection (c)(17) by inserting after “Tetrahydrocannabinols” the following: “, except for tetrahydrocannabinols in hemp (as defined under section 297A of the Agricultural Marketing Act of 1946)”."

"SEC. 10112. RULE OF CONSTRUCTION.

Nothing in this title authorizes interference with the interstate commerce of hemp (as defined in section 297A of the Agricultural Marketing Act of 1946, as added by section 10111)."