FDA’s Early Statements on CBD Regulation, Explained
On April 1, 2019, the U.S. Food and Drug Administration (“FDA”) issued yet another “statement” regarding its ever-evolving position with respect to CBD, again offering little to no information, and providing generally no predictability, to business working with – or considering working with – CBD. Many CBD business owners, entrepreneurs, financiers, and ancillary business owners were left wondering: what does this mean for our business’s future?
The FDA Statement, in short, announces the agency’s “next steps” designed to “advance [the agency’s] consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under existing authorities,” (emphasis added) which are set forth individually and explained in more detail below.
I. Public Hearing
The FDA will hold a public hearing on May 31, 2019 from 8:00am until 6:00pm at the FDA White Oak Campus: 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993.
If you cannot attend the hearing, you may submit your requests to make oral presentations and comments at the public hearing by May 10, 2019. Electronic and written comments will be accepted until July 2, 2019.
Submit your comments electronically by clicking here. Written comments should be submitted to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
II. Internal Agency
The FDA Statement indicates that is in the process of “forming a high-level internal agency working group” to “explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed.” While it is unclear exactly what “high level” tasks this agency will perform, the presumed co-chairs of this group are Principal Deputy Commissioner Amy Abernethy, and Principal Associate Commissioner for Policy Lowell Schiller.
However, and as the FDA Statement acknowledges, “[t]his is a complicated topic and we expect that it could take some time to resolve fully.” It is unlikely we will see any meaningful developments from this group for some time; as some groups are predicting, up to two-to-five years, if not longer.
While some industry hopefuls will wait for these regulations and then enter the marketplace, others are responding to market demand, and have indicated they will be stocking shelves across the country with various CBD products ahead of the FDA’s issuance of applicable language. Last week, both CVS and Walgreens – within days of each other – announced that more than 2,200 stores (between the two nationwide chains) will begin carrying and selling hemp-derived CBD products. However, these national powerhouses are quick to make clear that they will not be selling CBD-containing supplements or food additives at this time.
III. Updates to FAQ
The FDA, like the DEA before the passage of the 2018 Farm Bill, posts “Frequently Asked Questions” and Answers on its website. However, these statements are no more than the FDA’s interpretation of existing law; the FDA (like the DEA) has no power to make law. To the extent the FDA utilizes these questions-and-answers to fill in the blanks left by Congress in the federal legislative scheme pertaining to hemp, or even contradicts the direct intent of Congress, industry participants should take these guidelines with a grain of salt, and seek out and understand the true legal underpinnings at play before making decisions that could greatly affect the legality, or profitability, of their businesses.
IV. Warning Letters
The FDA Statement also indicates that it issued “multiple” warning letters to companies marketing CBD in violation of federal law – there were only three.
With respect to determining the violations which the FDA deems important enough to pick a fight over, the FDA Statement signals its priorities by repeating certain language (ad nauseam); this is not an accident. The FDA is making clear that the making of any health claims with respect to CBD products is prohibited. For example, any claim that a product could diagnose, cure, mitigate, treat, or otherwise prevent disease is absolutely prohibited without FDA approval. In fact, if a product is not approved – but may even appear to have some medical benefits that have not been approved by the FDA – companies are advised to include a disclaimer stating this. (For parallel considerations which underpin this policy, review this body of law around the regulation of dietary supplements.)
Therefore, industry participants should not allow this FDA Statement to cause a chilling effect in the industry. The letters issued to these companies are, in many ways, predictable: the federal government simply will not tolerate, even during this developmental stage of applicable law, the making of health claims with respect to any product, including those containing CBD.
However, the FDA does not have unlimited resources. In reality, the FDA does not have the resources to take federal enforcement action against every company operating in the CBD spaces (especially in light of the recent move by CVS and Walgreens to respond to market demand to stock and sell CBD-based products). The repetitive language contained within the FDA Statement makes clear that it will target companies (a) making “egregious and unfounded [health] claims,” and/or (b) directing such statements to “vulnerable populations.” Engaging in either of these activities will put any company in the crosshairs of federal enforcement agencies. Examples of these statements which the FDA targeted in the three letters include indications that CBD stops the growth of cervical cancer cells; CBD slows progression of Alzheimer’s; CBD blocks pain associated with migraines, fibromyalgia, IBS, and more; CBD reduces withdrawal from, and can be used to avoid, heroin; CBD prevents, treats, or cures psychiatric disorders; and more.
In short, these warning letters should not cause alarm in the industry. It should be widely known that CBD companies should avoid making statements that claim product(s) prevents, diagnoses, treats, or cures serious diseases or other health conditions.
V. Hints & Suggestions
The FDA Statement may also signal – though less expressly – its intent to take another, unspoken “next step.” The letter goes on to contradict its previous statement (“under existing authorities”) indicating the agency is also “consider[ing] whether there are legislative options that might lead to more efficient and appropriate pathways than might be available under current law.” When taken in combination with other statements contained throughout the letter, the FDA seems to also be considering whether a “threshold level” of CBD could be determined and implemented by the legislature, which would allow levels of CBD below this threshold to be allowed in foods or other regulated products without invoking the need for FDA approval.
If you possess information, data, or studies related to this potential threshold, please participate in the public hearing in May and/or the public comment process.
In sum, the FDA Statement is no more than a follow-up of its previous statement following the passage of the 2018 Farm Bill, and a continuing expression of federal enforcement agencies’ current position on CBD: cannabinoids are not, “in their own right,” unlawful; however, when CBD is added to certain products, or certain claims are made with respect to products, the FDA is permitted to regulate this activity. Though this recent “statement” makes clear that meaningful regulation by the FDA is still a long way away.