If you follow this column and keep a close eye on the cannabidiol (CBD) market, you know that the FDA deems the sale and marketing of CBD-infused dietary supplements illegal. This reasoning comes from an exclusion stipulation in the definition of “dietary supplement” under the Food, Drug and Cosmetic Act ( FDCA) that generally disallows the use of an FDA-approved “drug” as a dietary supplement (the Drug Exclusion Guideline). Specifically, the Drug Exemption Guideline provides that a short article can not be marketed as a dietary supplement if it was examined or authorized as a drug prior to the article was marketed as a dietary supplement (or food). Consequently, because CBD was investigated and approved as a new drug ingredient– Epidiolex– prior to CBD was marketed as a dietary supplement, the sale and marketing of these products violates the FDCA.
Yet, in spite of the FDA’s position, a growing number of CBD stakeholders have been arguing that the Drug Exclusion Guideline does not use to their CBD items offered and marketed as dietary supplements due to the fact that they consist of complete- or broad-spectrum hemp extract, instead of CBD isolate, which is the compound that was approved in Epidiolex.
This difference can be connected to a 2001 court decision, Pharmanex, Inc. v. Shalala, which related to the status of lovastatin, a compound discovered in red yeast rice. Red yeast rice had been used for recovery functions for thousands of years, the separated compound was authorized by the FDA as a drug active ingredient 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 dominated. The court held that the lovastatin discovered in the dietary supplement was not in its natural type due to the fact that its manufacturer intentionally picked and used a method to produce specific levels of lovastatin that were greater 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 could dictate how the FDA treats hemp CBD dietary supplements, specifically complete- and broad-spectrum hemp extracts.
Hemp, including complete- and broad-spectrum hemp extracts, includes many active substances, consisting of cannabinoids and terpenes. Hemp can be processed in a number of ways, a few of which will isolate those active compounds. The active substances can be separated through chemical extraction by eliminating water, fiber, and other unwanted products. Additionally, hemp can be processed without using chemicals.
Epidiolex is an example of a CBD isolate. Typically, a CBD isolate consists of no other compounds.
Following the thinking in the Pharmanex case, CBD isolate may be subject to the Drug Exclusion Rule, however processed hemp, such as full- and broad-spectrum hemp extracts, might not. Hemp and complete- and broad-spectrum hemp extracts are not the same as a CBD isolate. CBD isolate or processed hemp that contains isolated and increased concentrations of CBD would be comparable to the isolated lovastatin substance in the Pharmanex case, and hence, could just be legally sold as drugs.
The parallels between the Pharmanex case and CBD are difficult to neglect. To my understanding, no CBD business has actually yet brought forth this legal theory to challenge the FDA’s position in a court of law.
Nevertheless, it is worth mentioning that in its statement released shortly after the enactment of the Farming Improvement Act of 2018 (the 2018 Farm Costs), the FDA recommended that it may consider such argument versus the application of the Drug Exclusion Rule to full- and broad-spectrum hemp extracts in regulating CBD items:
[P] athways stay offered for the FDA to consider whether there are situations in which particular cannabis-derived substances may be permitted in a food or dietary supplement. Such items are normally prohibited to be introduced in interstate commerce, the FDA has authority to release a guideline enabling the use of a pharmaceutical component in a food or dietary supplement. We are taking brand-new steps to examine whether we must pursue such a process. (Focus added).
Certainly, as the company described in its 2016 draft assistance for new dietary ingredient notices, the FDA Secretary has the authority to override the Drug Exemption Rule by issuing “a regulation, after notice and remark, discovering that the ingredient, when used as or in a dietary supplement, would be legal under [the FDCA].”
Additionally, the current introduction in Congress of H.R. 5587, which would exempt hemp CBD from the FDCA’s Drug Exclusion Guideline, thus allowing the sale of hemp CBD as a dietary supplement in interstate commerce, recommends that lawmakers are not pleased with the company’s existing treatment of hemp CBD items and support the industry’s position that CBD items be managed as dietary supplements.
Only time will tell how the FDA will eventually regulate CBD items, however one thing seems particular: 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 prosecuted to settle this concern.
Nathalie Bougenies practices in the Portland office of Harris Bricken and was called a “2019 Rising Star” by Super Attorney Magazine, an honor bestowed on only 2.5%of qualified Oregon attorneys. Nathalie’s practice focuses on the regulatory framework of hemp-derived CBD (” hemp CBD”) products. She is an authority on FDA enforcement, Food, Drug & Cosmetic Act and other laws and guidelines surrounding hemp and hemp CBD products.
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