07/09/2019

What’s the Latest on CBD?

FDA Stance Remains Unchanged – For Now

This article is intended to be informational only. Legal information is not the same as legal advice, which is the application of law to an individual’s specific matter, situation, or circumstances. Legal advice may be given only on the basis of specific facts relayed by a client to an attorney. The MAC goes to great lengths to make sure our information is as accurate, useful, and up to date as possible. We recommend, however, that you consult an attorney if you want or need professional assurance that our information, and your interpretation of it, applies to your specific legal situation. Additionally, the Michigan Department of Licensing and Regulatory Affairs (LARA) encourages licensees to seek legal counsel to ensure compliance with applicable law.

Key Takeaways

• FDA recently held their first public hearing on CBD
• FDA leadership: Committed to “sound, science-based policy on CBD”
• USDA position: Hemp (and hemp extracts) removed from schedule I of the Controlled Substances Act
• Members of Congress getting involved
• Due to regulatory chaos, the MAC still has questions

Many of you have been following the ongoing legal saga surrounding the possession and sale of products containing cannabidiol (CBD), an extract of the cannabis plant that many of our members are interested in selling in their practices for its potential to relieve such conditions as chronic pain and inflammation. Over the past two months, a lot has happened, but we are still struggling to find answers to the many questions surrounding the legality of selling CBD products in a chiropractic or medical office.

FDA’s First Public Hearing: 10 Hours, 100+ Speakers, Still Unanswered Questions

On May 31, the U.S. Food and Drug Administration (FDA) held a public hearing “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” Despite 10 hours of testimony from more than 100 individual stakeholders, the hearing left most of the relevant questions unanswered, as it was merely the first step on the long road to establishing regulations for CBD.

In his opening remarks prior to the public hearing, FDA Acting Commissioner Dr. Ned Sharpless reiterated the FDA’s position that foods and dietary supplements containing CBD are illegal, and that FDA continues to have authority over such products. He also stated:

“FDA is aware that some companies appear to be marketing products containing cannabis and cannabis-derived compounds in ways that violate the law. FDA has issued warning letters to companies selling unapproved CBD products. Our biggest concern is the marketing of products that put the health and safety of consumers at risk, such as those claiming to prevent, diagnose, mitigate, treat, or cure serious diseases, such as cancer, in the absence of requisite approvals. Selling unapproved drug products with unsubstantiated therapeutic claims is a violation of the law, and puts patients at risk.”

Warning Letters

FDA has issued three such “warning letters” in 2019, including one to an LLC that owns a number of pain management centers in New Jersey that sold “CBD salve” and “CBD oil” products. These products were marketed as treating such conditions as chronic inflammation and chronic pain,” stating:

• “Studies suggest that cannabinoids may be a new class of drugs for the treatment of chronic pain.”
• “Due to its anti-inflammatory effect, cannabinoids may provide relief of joint pain and swelling, and decrease joint destruction and disease progression.”

In the letter, FDA states that these CBD products were considered drugs “because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body.” The one letter FDA issued in 2018 also cites claims regarding the treatment of such conditions as “back pain” and “aching, painful joints, muscles and tissues” as the reason for their warning.

FDA Voices: Perspectives from FDA Leadership and Experts

Nearly three weeks after the public hearing, FDA published an article entitled “FDA is Committed to Sound, Science-based Policy on CBD.” Dr. Amy Abernathy, the FDA’s principal deputy commissioner and acting CIO, who is leading a working group to explore how CBD products could be sold legally, writes: “We recognize that there is significant public interest in these products, for therapeutic purposes and otherwise. At the same time, there are many unanswered questions about the science, safety, and quality of many of these products. As we approach these questions, we do so as a science-based regulatory agency committed to our mission of protecting and promoting public health.”

Other points made in the article include:

• If a product is being marketed as having a therapeutic effect, FDA regulates it as it would a drug, and it generally cannot be sold without FDA approval (or, in the case of an over-the-counter drug, an FDA monograph).
• Food and dietary supplements are regulated differently, but with the same
  “overarching goal of protecting consumers.” Among other things, it is currently illegal to put into interstate commerce a food to which CBD has been added, or to market CBD as, or in, a dietary supplement. Essentially, the relevant statutory provisions prohibit these uses of CBD because CBD was the subject of substantial clinical investigations into its potential medical uses before it was added to foods and because CBD is the active ingredient in an FDA-approved prescription drug.

The article concludes: “While the Agency continues to believe that the drug approval process is the best way to ensure the safety of new drugs, including those made with CBD, the Agency is committed to evaluating the regulatory frameworks for non-drug uses, including products marketed as foods and dietary supplements.”

USDA Weighs In

In late May, the U.S. Department of Agriculture’s (USDA) Office of the General Counsel issued a legal opinion to address questions raised by several provisions related to hemp contained in the 2018 Farm Bill. One of the opinion’s key conclusions reads: “As of the enactment of the 2018 Farm Bill on December 20, 2018, hemp has been removed from schedule I of the Controlled Substances Act and is no longer a controlled substance.” In a footnote within the USDA opinion, the author states that hemp extracts, which while not specifically mentioned would presumably include CBD derived from hemp, have also been removed from schedule I.

Congressional Involvement

Frustrated with the regulatory confusion and uncertainty surrounding CBD, Members of Congress are getting involved. In late June, U.S. Senate Majority Leader Mitch McConnell of Kentucky, who was a driving force behind the language legalizing hemp in the 2018 Farm Bill, met with Acting FDA Commissioner Dr. Ned Sharpless to discuss the need for a regulatory framework for CBD. In a statement, Sen. McConnell said:

“While the 2018 Farm Bill included my provision to remove hemp, and its derivatives like CBD, from the list of controlled substances, CBD food and dietary supplement products remain in a gray area without clarification from the FDA. Congress’ intent was clear with the passage of the Farm Bill that these products should be legal, and our farmers, producers and manufacturers need clarity as well as a workable pathway forward regarding the Agency’s enforcement and potential regulatory plans for certain CBD products. I appreciate Acting Commissioner Sharpless meeting with me today to discuss this important issue. Like my constituents, I am anxious to know the FDA’s plans to ensure public access to safe CBD products.”

Senator Ron Wyden of Oregon also recently pressed FDA to end the uncertainty and to update the regulations governing CBD and other hemp-based derivatives. In a letter to Department of Health and Human Services (HHS) Secretary Alex Azar and Acting Commissioner Sharpless, Wyden urged the FDA to promptly issue guidance that ensures the regulatory pathway Congress intended for the lawful use of hemp-derived CBD as a food additive and as a dietary ingredient in dietary supplements.

Noting that he finds FDA’s indication that it may take three to five years to issue a final regulation authorizing the lawful use of hemp-derived CBD in foods and dietary supplements “fully unacceptable,” Wyden requested that FDA issue its updated policy by August 1, 2019. He also requested that – pending publication of a permanent final rule – the agency initiate rulemaking to allow the manufacturing and sale of products containing hemp-derived CBD under the existing statutory and regulatory frameworks applicable to food and dietary supplements.

A full copy of Senator Wyden’s letter can be found here.

Conclusion

The MAC still has a number of questions regarding the legality of our members selling CBD products in their offices, including whether CBD products that claim a “therapeutic benefit” such as pain relief need FDA approval. As always, the MAC strives to provide information that steers our membership clear of legal issues. This is one of those issues where our guidance errs on the conservative side.

We are aware that there are chiropractors and other health care professional who are currently using/selling CBD products in their offices. We would like to reiterate that those who do so make be facing legal risk. Exactly what sort of legal risk is unclear. To date, aside from the aforementioned warning letters, FDA has taken no legal action against anyone selling CBD.

Until further clarification from the DEA, FDA, Michigan Department of Licensing and Regulatory Affairs, and other state and/or federal stakeholders, the MAC as an organization still has questions regarding the legality of our members selling CBD products in their offices, and we continue to urge caution. We will keep you informed as events and additional information warrants.

Sources:

FDA Voices: Perspectives from FDA Leadership and Experts, “FDA is Committed to Sound, Science-based Policy on CBD,” Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner, and Lowell Schiller, J.D., Principal Associate Commissioner for Policy, June 19, 2019

U.S. Department of Agriculture’s Office of the General Counsel, “Legal Opinion on Certain Provisions of the Agriculture Improvement Act of 2018 Relating to Hemp,” May 28, 2019

Sen. Mitch McConnell Press Release, “Leader McConnell Discusses Hemp, CBD with Acting FDA Commissioner,” June 27, 2019

Sen. Ron Wyden Press Release, “Wyden Presses FDA to End the Uncertainty, Promptly Update Regulations on CBD, Other Hemp-based Derivatives,” June 25, 2019