If you follow this column and keep a close eye on the cannabidiol (CBD) industry, you understand that the FDA considers the sale and marketing of CBD-infused dietary supplements illegal. Because CBD was examined and approved as a new drug ingredient– Epidiolex– before CBD was marketed as a dietary supplement, the sale and marketing of these items breaches the FDCA.
Yet, despite the FDA’s position, a growing variety of CBD stakeholders have actually been arguing that the Drug Exemption Rule does not apply to their CBD products offered and marketed as dietary supplements due to the fact that they include full- or broad-spectrum hemp extract, as opposed to CBD isolate, which is the compound that was approved in Epidiolex.
This distinction can be connected to a 2001 court decision, Pharmanex, Inc. v. Shalala, which related to the status of lovastatin, a compound found in red yeast rice. Red yeast rice had been utilized for healing functions for thousands of years, the separated compound was approved by the FDA as a drug ingredient in the treatment of cholesterol.
Following the approval of lovastatin as a drug active ingredient, the FDA challenged the use of this compound in a dietary supplement and dominated. In addition, the court determined that the product offered as a dietary supplement was a drug because it was specifically marketed as the separated lovastatin substance.
The Pharmanex case could determine how the FDA deals with hemp CBD dietary supplements, particularly full- and broad-spectrum hemp extracts.
Hemp, consisting of complete- and broad-spectrum hemp extracts, includes numerous active compounds, consisting of cannabinoids and terpenes. Hemp can be processed in a number of ways, some of which will separate those active substances.
Epidiolex is an example of a CBD isolate. Usually, a CBD isolate includes no other compounds.
Following the thinking 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, 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 separated and increased concentrations of CBD would be comparable to the isolated lovastatin compound in the Pharmanex case, and hence, might only be lawfully sold as drugs.
The parallels between the Pharmanex case and CBD are hard to neglect. While this legal argument has merit, it is simply speculative. Indeed, to my understanding, no CBD company has actually yet brought forth this legal theory to challenge the FDA’s position in a court of law.
Nonetheless, it is worth discussing that in its statement released soon after the enactment of the Farming Improvement Act of 2018 (the 2018 Farm Expense), the FDA recommended that it may consider such argument against the application of the Drug Exclusion Guideline to complete- and broad-spectrum hemp extracts in regulating CBD items:
[P] athways remain offered for the FDA to consider whether there are situations in which certain cannabis-derived substances may be permitted in a food or dietary supplement. Such products are typically prohibited to be introduced in interstate commerce, the FDA has authority to provide a policy enabling the use of a pharmaceutical component in a food or dietary supplement. We are taking brand-new steps to evaluate whether we need to pursue such a procedure. (Emphasis added).
Certainly, as the firm described in its 2016 draft guidance for new dietary component alerts, the FDA Secretary has the authority to bypass the Drug Exclusion Rule by providing “a guideline, after notice and remark, finding that the component, when used as or in a dietary supplement, would be legal under [the FDCA].”
Moreover, the current intro in Congress of H.R. 5587, which would exempt hemp CBD from the FDCA’s Drug Exclusion Guideline, therefore permitting the sale of hemp CBD as a dietary supplement in interstate commerce, suggests that lawmakers are not pleased with the firm’s current treatment of hemp CBD products and support the industry’s position that CBD products be managed as dietary supplements.
Only time will inform how the FDA will ultimately control CBD products, but one thing appears specific: 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 litigated to settle this concern.
Nathalie Bougenies practices in the Portland workplace of Harris Bricken and was named a “2019 Rising Star” by Super Attorney Publication, an honor bestowed on only 2.5%of eligible Oregon lawyers. Nathalie’s practice focuses on the regulative framework of hemp-derived CBD (” hemp CBD”) items. She is an authority on FDA enforcement, Food, Drug & Cosmetic Act and other laws and guidelines surrounding hemp and hemp CBD items.
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