CV Sciences Inc (CVSI)

[Deetew]

Why CVSI is not breaking the Law

In an attempt to unravel this master jigsaw puzzle surrounding the recent DEA order to re-schedule Epidiolex, I present to you the laws that currently stand on the books. This information is worth gold in my opinion.

Problem:
Schedules of Controlled Substances: Placement in Schedule V of Certain FDA-Approved Drugs Containing Cannabidiol

"As further indicated, any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana set forth in 21 U.S.C. 802(16), including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA. Thus, persons who handle such items will continue to be subject to the requirements of the CSA and DEA regulations relating to schedule I controlled substances."

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Solution 1:
Hemp Industries Association Reaches Settlement with DEA and Affirms Victory from 2004 Hemp Foods Rules Challenge

“We are grateful to our counsel for successfully negotiating the necessary clarification in this matter and we will remain the first line of defense to ensure the undisrupted continuance of the hemp industries as we bring new economic opportunities to farmers and entrepreneurs, and also healthy U.S. made food products to the American marketplace and eventually around the world.”

Please read the entire source of "Solution 1" by heading to the link and clicking the "Hemp Industries Association Reaches Settlement with DEA and Affirms Victory from 2004 Hemp Foods Rules Challenge" link.

Or

You can view it here as an image: When the DEA got Beat in Court by the Hemp Industries Association

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Solution 2:
DEA Internal Directive Regarding the Presence of Cannabinoids in Products and Materials Made from the Cannabis Plant

This DEA Internal Directive resulted from the court case regarding "Solution 1:"

"DEA Internal Directive Regarding the Presence of Cannabinoids in Products and Materials Made from the Cannabis Plant
(May 22, 2018)

In 2004, the U.S. Court of Appeals for the Ninth Circuit enjoined DEA from enforcing certain regulations with respect to tetrahydrocannabinols (THC). See Hemp Industries Ass'n v. DEA, 357 F.3d 1012 (9th Cir. 2004). The government did not seek Supreme Court review of that decision. In response to various inquiries, DEA hereby issues to DEA personnel the following internal directive on how to carry out their duties in light of the Ninth Circuit's decision.

The Ninth Circuit enjoined enforcement of what is now 21 C.F.R. § 1308.11(d)(31) (drug code 7370) with respect to products that are excluded from the definition of marijuana in the Controlled Substances Act (CSA). DEA thus does not enforce that provision as to such products.

Consistent with the Ninth Circuit's decision, DEA does not enforce 21 C.F.R. § 1308.35.

Products and materials that are made from the cannabis plant and which fall outside the CSA definition of marijuana (such as sterilized seeds, oil or cake made from the seeds, and mature stalks) are not controlled under the CSA. Such products may accordingly be sold and otherwise distributed throughout the United States without restriction under the CSA or its implementing regulations. The mere presence of cannabinoids is not itself dispositive as to whether a substance is within the scope of the CSA; the dispositive question is whether the substance falls within the CSA definition of marijuana.

The Controlled Substances Import and Export Act incorporates the schedules of the CSA. See generally 21 U.S.C. §§ 951-971. Accordingly, any product that the U.S. Customs and Border Protection determines to be made from the cannabis plant but which falls outside the CSA definition of marijuana may be imported into the United States without restriction under the Controlled Substances Import and Export Act. The same considerations apply to exports of such products from the United States, provided further that it is lawful to import such products under the laws of the country of destination.

This directive does not address or alter DEA's previous statements regarding the drug code for marijuana extract and regarding resin. See Establishment of a New Drug Code for Marihuana Extract, 81 Fed. Reg. 90194 (Dec. 14, 2016); Clarification of the New Drug Code (7350) for Marijuana Extract. As DEA has previously explained, the drug code for marijuana extract extends no further than the CSA does, and it thus does not apply to materials outside the CSA definition of marijuana."

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Solution 3:
Hemp CBD Market Grows Increasingly Competitive, Sales Growing

"As for the legality of CBD, Syed says its status in the U.S. will be determined “in a court of law.” “Hemp and hemp extracts are federally legal,” she says. “The debate, however, around exactly how FDA will view isolated cannabidiol (CBD) will on only be determined in the court of law.” She notes that CV Sciences’ PlusCBD Oil products, which are sold in health food stores nationwide, are made from “lawfully imported” industrial hemp."

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Solution 4:
CV Sciences launches CBD gummy, marketed as functional food

"In terms of notable challenges formulating CBD into a gummy, typical hurdles included taste—especially when working with a full-spectrum product like PlusCBD, which utilizes the whole hemp plant and therefore inevitably has the notable flavor and odor of hemp. “Because we use the seed, the stem, and the stalk, we do get this noted taste we believe is coming from the hemp seeds and the shells themselves and even the waxes and longer-chain saturated fats that are in the stem and stock,” explains Tomc. By using its Gold line of hemp-derived CBD, however, CV Sciences started with the most distilled and concentrated version of its product, compared to its Red and Green lines, which are rawer."

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Solution 5:
DEA RESCHEDULES EPIDIOLEX – NO IMPACT ON HEMP-DERIVED CBD

"This past June, the Food and Drug Administration (FDA) issued its long-expected approval of GW Pharmaceutical’s Epidiolex, a cannabidiol (CBD) oral solution for certain acute medical conditions. (Read more about it here.)

As a consequence of the FDA’s action, the Drug Enforcement Administration (DEA) today re-scheduled Epidiolex, and any future FDA-approved CBD drug, under Schedule V of the Controlled Substances Act. Read the full unpublished order here.

Concerns about how hemp-derived CBD products might be treated in this context prompted the US Hemp Roundtable to hire the law firm of Amin Talati Upadhye to counsel on FDA-related issues. Here is their analysis of today’s DEA order:

--Today the DEA announced that Epiodiolex, a highly purified, pharmaceutical firm of CBD, will be placed under schedule V of the Controlled Substances Act. In doing so, DEA noted that the drug no longer meets the criteria for schedule I, following FDA’s approval of the drug for certain medical conditions. DEA also indicated that any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana set forth in 21 U.S.C. 802(16), including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA.

--The placement of Epidiolex under schedule V – the least restrictive schedule – recognizes the proven health benefits of CBD and its low potential for abuse. Of note, DEA’s scheduling determination is limited to only Epidiolex and generic versions of the same formulation. Therefore it is our opinion that DEA’s announcement and related statements have no bearing on the status of hemp-derived CBD.""

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My Take:

Based on the information above, I am confident that CVSI is still not breaking the law with any of their products. I hope this clears up some of the ambiguity. I will continue to invest my money in this amazing company that has been cleverly playing their cards right.