If you follow this column and keep a close eye on the cannabidiol (CBD) industry, you know that the FDA deems the sale and marketing of CBD-infused dietary supplements illegal. Due to the fact that CBD was investigated and approved as a brand-new drug component– Epidiolex– prior to CBD was marketed as a dietary supplement, the sale and marketing of these items breaches the FDCA.
Yet, in spite of the FDA’s position, a growing number of CBD stakeholders have been arguing that the Drug Exemption Guideline does not apply to their CBD products offered and marketed as dietary supplements because they consist of full- or broad-spectrum hemp extract, as opposed to CBD isolate, which is the compound that was authorized in Epidiolex.
This difference can be linked to a 2001 court choice, Pharmanex, Inc. v. Shalala, which referred to the status of lovastatin, a substance discovered in red yeast rice. Although red yeast rice had been used for healing functions for thousands of years, the isolated compound was approved by the FDA as a drug ingredient in the treatment of cholesterol.
Following the approval of lovastatin as a drug component, the FDA challenged the usage of this substance in a dietary supplement and prevailed. In addition, the court determined that the item sold as a dietary supplement was a drug since it was expressly marketed as the separated lovastatin substance.
The Pharmanex case could dictate how the FDA deals with hemp CBD dietary supplements, particularly complete- and broad-spectrum hemp extracts.
Hemp, including complete- and broad-spectrum hemp extracts, consists of lots of active substances, consisting of cannabinoids and terpenes. Hemp can be processed in a variety of ways, a few of which will separate those active compounds. The active substances can be isolated through chemical extraction by eliminating water, fiber, and other undesirable materials. Additionally, hemp can be processed without making use of chemicals.
Epidiolex is an example of a CBD isolate. Typically, a CBD isolate includes no other substances. In turn, complete- and broad-spectrum hemp extracts consist of a full series of cannabinoids– minus THC in the case of broad-spectrum hemp extract.
Following the reasoning in the Pharmanex case, CBD isolate might be subject to the Drug Exclusion Guideline, but processed hemp, such as full- and broad-spectrum hemp extracts, may not. Hemp and complete- and broad-spectrum hemp extracts are not the exact same as a CBD isolate. CBD isolate or processed hemp that contains isolated and increased concentrations of CBD would be similar to the isolated lovastatin compound in the Pharmanex case, and hence, might just be lawfully sold as drugs.
The parallels between the Pharmanex case and CBD are difficult to disregard. To my understanding, no CBD company has yet brought forth this legal theory to challenge the FDA’s position in a court of law.
However, it is worth discussing that in its declaration launched soon after the enactment of the Agriculture Improvement Act of 2018 (the 2018 Farm Expense), the FDA recommended that it may consider such argument versus the application of the Drug Exemption Rule to full- and broad-spectrum hemp extracts in controling CBD products:
[P] athways stay offered for the FDA to think about whether there are situations in which particular cannabis-derived substances might be permitted in a food or dietary supplement. Although such items are typically restricted to be presented in interstate commerce, the FDA has authority to release a guideline enabling the use of a pharmaceutical active ingredient in a food or dietary supplement. We are taking brand-new steps to examine whether we ought to pursue such a procedure. (Emphasis added).
Certainly, as the firm described in its 2016 draft assistance for brand-new dietary ingredient notices, the FDA Secretary has the authority to bypass the Drug Exclusion Rule by providing “a policy, after notice and comment, discovering that the ingredient, when utilized as or in a dietary supplement, would be lawful under [the FDCA].”
Furthermore, the current intro in Congress of H.R. 5587, which would exempt hemp CBD from the FDCA’s Drug Exemption Guideline, therefore permitting the sale of hemp CBD as a dietary supplement in interstate commerce, suggests that lawmakers are not pleased with the agency’s existing treatment of hemp CBD items and support the industry’s position that CBD products be managed as dietary supplements.
Only time will tell how the FDA will eventually manage CBD items, but something appears certain: if the FDA opts to keep a strong position and treat all CBD dietary supplements as “drugs,” then the parallels between red yeast rice and hemp CBD will likely be prosecuted to settle this issue.
Nathalie Bougenies practices in the Portland office of Harris Bricken and was named a “2019 Increasing Star” by Super Lawyers Magazine, an honor bestowed on only 2.5%of qualified Oregon lawyers. Nathalie’s practice focuses on the regulative framework of hemp-derived CBD (” hemp CBD”) products. She is an authority on FDA enforcement, Food, Drug & Cosmetic Act and other laws and policies surrounding hemp and hemp CBD items.
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