If you follow this column and keep a close eye on the cannabidiol (CBD) market, you know that the FDA considers the sale and marketing of CBD-infused dietary supplements unlawful. Since CBD was examined and authorized as a brand-new drug active ingredient– Epidiolex– before CBD was marketed as a dietary supplement, the sale and marketing of these products breaches the FDCA.
Yet, despite the FDA’s position, a growing number of CBD stakeholders have been arguing that the Drug Exclusion Rule does not apply to their CBD products offered and marketed as dietary supplements because they contain full- or broad-spectrum hemp extract, as opposed to CBD isolate, which is the compound that was authorized in Epidiolex.
This distinction can be linked to a 2001 court decision, Pharmanex, Inc. v. Shalala, which pertained to the status of lovastatin, a compound found in red yeast rice. Although red yeast rice had been used for healing functions for countless years, the separated substance was authorized by the FDA as a drug component in the treatment of cholesterol.
Following the approval of lovastatin as a drug ingredient, the FDA challenged making use of this substance in a dietary supplement and prevailed. The court held that the lovastatin discovered in the dietary supplement was not in its natural form since its manufacturer intentionally chosen and utilized a technique to produce specific levels of lovastatin that were higher than those naturally present in red yeast rice. In addition, the court determined that the product sold as a dietary supplement was a drug due to the fact that it was specifically marketed as the isolated lovastatin compound.
The Pharmanex case might dictate how the FDA treats hemp CBD dietary supplements, specifically complete- and broad-spectrum hemp extracts.
Hemp, including full- and broad-spectrum hemp extracts, includes numerous active substances, consisting of cannabinoids and terpenes. Hemp can be processed in a number of methods, some of which will separate those active substances.
Epidiolex is an example of a CBD isolate. Usually, a CBD isolate consists of no other substances.
Following the reasoning in the Pharmanex case, CBD isolate may be subject to the Drug Exemption Rule, but processed hemp, such as full- and broad-spectrum hemp extracts, might not. Hemp and full- and broad-spectrum hemp extracts are not the same as a CBD isolate. CBD isolate or processed hemp that consists of isolated and increased concentrations of CBD would be similar to the separated lovastatin compound in the Pharmanex case, and hence, might only be legally sold as drugs.
The parallels in between the Pharmanex case and CBD are tough to neglect. While this legal argument has benefit, it is purely speculative. To my understanding, no CBD business has yet brought forth this legal theory to challenge the FDA’s position in a court of law.
Nonetheless, it deserves discussing that in its declaration released shortly after the enactment of the Farming Enhancement Act of 2018 (the 2018 Farm Expense), the FDA recommended that it might think about such argument against the application of the Drug Exemption Rule to full- and broad-spectrum hemp extracts in managing CBD items:
[P] athways remain offered for the FDA to think about whether there are situations in which specific cannabis-derived substances might be permitted in a food or dietary supplement. Such items are generally restricted to be introduced in interstate commerce, the FDA has authority to issue a regulation enabling the use of a pharmaceutical component in a food or dietary supplement.
Undoubtedly, as the agency explained in its 2016 draft guidance for new dietary component notices, the FDA Secretary has the authority to override the Drug Exclusion Rule by issuing “a regulation, after notice and comment, finding that the component, when utilized as or in a dietary supplement, would be legal under [the FDCA].”
Moreover, the recent introduction in Congress of H.R. 5587, which would excuse hemp CBD from the FDCA’s Drug Exemption Guideline, therefore allowing the sale of hemp CBD as a dietary supplement in interstate commerce, suggests that lawmakers are not pleased with the company’s current treatment of hemp CBD items and support the market’s position that CBD items be managed as dietary supplements.
Only time will inform how the FDA will eventually manage CBD items, but something appears certain: if the FDA opts to maintain a strong position and treat all CBD dietary supplements as “drugs,” then the parallels in between red yeast rice and hemp CBD will likely be litigated to settle this problem.
Nathalie Bougenies practices in the Portland office of Harris Bricken and was called a “2019 Rising Star” by Super Attorney Publication, an honor bestowed on only 2.5%of qualified Oregon lawyers. Nathalie’s practice focuses on the regulatory structure of hemp-derived CBD (” hemp CBD”) products. She is an authority on FDA enforcement, Food, Drug & Cosmetic Act and other laws and regulations surrounding hemp and hemp CBD items.
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