CBD and the FDA- What Should the Hemp Industry Expect?

Editor’s note: I originally wrote this article for the Florida Hemp Industries Journal and am happy to announce that it was published yesterday by my friend, Sean Hocking, for the Cannabis Law Journal. In it, I tease out some of the technical pieces of the FDA’s position on CBD. I also predict the likely direction the FDA will take with respect to CBD in food. In the latter sense, this article is a follow-up to one I wrote last week, “Top 5 Cannabis Predictions for 2020” . I hope it helps you gain a better understanding of the FDA’s current and likely future role in CBD policy. -Rod Kight

INTRODUCTION

Is CBD legal?

This remains one of the most common questions I am asked as an attorney representing businesses in the cannabis industry. The answer is perhaps more complex than it should be and depends on a number of factors, including what is meant by “legal” and, if selling CBD to consumers, how and where it is intended to be marketed. In this article I will focus my legal “lens” on addressing these factors in the context of the Food and Drug Administration (FDA). Although a number of federal and state agencies will ultimately influence CBD policy, the FDA is poised to be the primary regulatory body governing and setting policy for consumer sales of CBD in the USA.

SUMMARY

Under the hemp provisions of the Agricultural Improvement Act of 2018 (2018 Farm Bill), CBD is not a controlled substance when derived from hemp.[1] It may lawfully be transported throughout the country.[2] Additionally, it may be manufactured, sold, and used in most states, though the rules governing each these activities and the enforcement of the rules by an array of state and federal agencies varies considerably depending on a number of circumstances and factors.

While the rules regarding CBD will likely always retain a degree of complexity, the FDA is under significant pressure to create parameters for allowing CBD in food.[3] As recently as November 25, 2019 the FDA stated that it is “exploring potential pathways for various types of CBD products to be lawfully marketed.”[4] Meanwhile, products formulated with hemp extracts that contain CBD among other phytonutrients will likely thrive and remain in a regulatory “grey” zone for the foreseeable future.

THE FDA REGULATES ALL CBD INTENDED FOR HUMAN AND ANIMAL USE

The FDA, which enforces and creates regulations for the Food, Drug & Cosmetic Act (FDCA), regulates CBD products. The following is Q&A number 8 on the FDA’s CBD FAQ website as of December 5, 2019:

Q. Is it legal for me to sell CBD products?

A. It depends, among other things, on the intended use of the product and how it is labeled and marketed. Even if a CBD product meets the definition of “hemp” under the 2018 Farm Bill (see Question #2), it still must comply with all other applicable laws, including the FD&C Act.

Unlike the CSA, which governs CBD based on its source, the FDCA governs it based on its intended use. Specifically, the FDA has consistently held the position that it is an unlawful act to use CBD as a food ingredient or market it as a dietary supplement, and no therapeutic claims can be made about it. This may seem surprising or not well-founded, particularly given that the World Health Organization (WHO) recently released two comprehensive reports[5][6] about CBD, both of which found that it is non-toxic[7], non-addictive, non-psychoactive, and appears to have significant potential for therapeutic use. However, the FDA is not bound by the WHO and its influence on CBD policy in the United States is unrivaled by the WHO or, indeed, any other governmental (quasi or otherwise) body except Congress.

The FDA’s position on CBD is based on the FDCA. With respect to its position on the use of CBD as a food ingredient or marketed as a dietary supplement, the FDA contends these intended uses are prohibited because CBD was not marketed as a food or dietary supplement before it became the subject of substantial clinical investigations that were made public. The clinical investigations at issue are the ones for Epidiolex, a CBD based drug indicated for treating certain severe seizure disorders. With respect to marketing CBD as a food, the FDA states,

Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.[8]

 With respect to marketing it as a dietary supplement, the FDA states,

 if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement.[9]

The FDCA provides an exception from the above prohibitions if the substance (CBD) was marketed in food or as a dietary supplement before the substantial clinical investigations involving the drug were instituted. However, the FDA has concluded that CBD was not marketed in food or as a dietary supplement prior to the initiation of the Epidiolex test trials.[10] Thus, its position is that the exception does not apply.

Finally, the FDA prohibits therapeutic claims about products that contain CBD. Any CBD products making therapeutic claims are considered “new drugs” under section 201(p) of the FDCA, 21 U.S.C. 321(p). According to the FDA,

New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.[11]

Aside from Epidiolex for use in treating seizure disorders, the FDA has not approved any uses for CBD. For this reason, no therapeutic claims about CBD may be made about products that contain it. This is true even if there is credible evidence, such as a peer reviewed studies, that the claims are accurate.

The FDA has not taken a particularly aggressive stance towards companies that use CBD as a food ingredient in their products. To date, it has exercised its discretion primarily to enforce its prohibitions on making improper claims, marketing CBD as a dietary supplement, and improper labeling. This enforcement has taken the form of dozens of warning letters over the years, including twenty-two in 2019 as of this writing.[12]

The FDA’s lax enforcement on the use of CBD as a food ingredient has allowed a large market in CBD food products (edibles) to emerge and thrive. However, the official prohibition continues to restrain large investment in CBD edibles. For this reason, the FDA has received significant pressure to revise its stance and create a pathway to regulate CBD in food.[13] For its part, the FDA held a public hearing on the subject in May, 2019. I testified at the hearing[14] and noted that all participants, regardless of their respective interests, demanded FDA regulation of CBD.

This raises two issues: (1) The use of CBD in cosmetic products, and (2) distinguishing CBD from hemp extracts that contain it.

The use of CBD in cosmetic products

First, the FDA has concluded that CBD is not prohibited in cosmetic products:

Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. (emphasis added)[15]

This makes sense. By definition, cosmetics are not foods or dietary supplements, so those FDA prohibitions are not implicated. Additionally, the FDA is clear that a CBD product, including a cosmetic, that “is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, [] is a drug[.]” In other words, a cosmetic product with these types of claims is an unapproved drug. Otherwise, it is lawful under the FDCA.

Distinguishing CBD from hemp extracts that contain it

Second, with respect to CBD as a food, there is an important factual and legal distinction between “CBD” (referred to in the market as “CBD isolate”) and hemp extracts that contain CBD[16]. Specifically, CBD isolate is the specific compound (the “article”) used in the Epidiolex clinical trials. On the other hand, hemp extract contains CBD in conjunction with other compounds in hemp, such as cannabinoids, terpenes, sesquiterpenes, etc. Although the FDA has not acknowledged this distinction, it clearly exists. As I stated in my testimony to the FDA, section 301(ll) of the FDCA prohibits a drug from being added to food only if the substance

is intended to diagnose, cure, mitigate, treat, or prevent disease through its use in the food, as shown objectively by marketing and labeling representations; and is the exact same moiety as the active ingredient in an approved drug and is added to the food in the same dosage range as authorized by the new drug approval. (emphasis added)[17]

Hemp extract as a food is an exception to section 301(ll) notwithstanding that it contains CBD. As I have previously discussed in the context of red rice yeast here, this is because CBD is a naturally occurring constituent inherent in hemp, which has been marketed and used at least since the Civil War. The prohibition on marketing a drug in food applies only to a substance that is added to food and does not apply to a substance that is in food, even where the substance is identical to an approved drug. Additionally, hemp extract contains dozens of compounds and is not the same moiety as the FDA approved CBD drug.

This raises important and unanswered questions about the various forms of hemp extract currently on the market, including full and broad spectrum, “T-Free” distillate, phytocannabinoid rich oil, etc. While a pure “squeeze” of the hemp flower might produce an extract with a true, naturally occurring amount of CBD, most of the current extracts are produced using highly sophisticated extraction and processing techniques. Some of these techniques isolate the cannabinoids and then recombine them with terpenes and other compounds to produce novel formulations. Does this make a difference? The FDA has not addressed this issue and no courts have ruled on it.

FDA’S FUTURE REGULATION OF CBD

The FDA is likely to create a narrow pathway for the lawful use of CBD as a food ingredient and/or dietary supplement. Although it has clarified its position over the years through various channels, the FDA has not significantly modified it. And, despite significant pressure, the FDA is taking its time exploring a potential regulatory path. Moreover, it has announced health and safety concerns about CBD and its strong commitment to preserving the integrity of the clinical trial process.[18] For these reasons, it is unlikely that the FDA will make a significant change to its official policy.

On the other hand, the proverbial genie is out of the box. The CBD market is large and growing rapidly. The FDA has indicated it understands the strong demand for regulation of CBD products and that it is exploring pathways for them. For these reasons, it is difficult to imagine the FDA attempting to stifle the industry by trying to put the genie back in the box. A likely middle ground would be to allow CBD in food and/or dietary supplements under limited parameters, such as requiring it to be manufactured in cGMP facilities, capping CBD concentrations, and defining purity standards. I believe that this is the path that the FDA will take. In the meantime, the CBD cosmetics sector will grow quickly since the FDA has acknowledged its legal status.

The “wild card” is what, if anything, the FDA will do about products containing hemp extract with CBD. For the reasons discussed above, these products are not implicated by the FDA’s prohibition on the use of CBD in food. The FDA may attempt to bring these products into the fold and regulate them the same the same as it does with products to which CBD has been added. This would be problematic given that hemp extracts are different, both factually and legally, from products to which CBD has been added. Alternately, the FDA could expressly authorize hemp extract products; however, taking that action would likely throw fuel on the fire of a nascent industry that the FDA almost certainly is concerned about being able to control. At a minimum, it would require the FDA to expend additional resources to create and police a separate policy for this class of products.

For these reasons, I expect that the FDA will maintain its posture of continuing to utilize the term “CBD” while not making a distinction between food products formulated with purified CBD “isolate” and products formulated with hemp extract that contains CBD. By not officially recognizing the distinction, the FDA can maintain some control over this sector of the hemp industry. Meanwhile, not attempting to enforce its prohibitions on CBD with respect to hemp extract will allow the sector to continue operating, albeit it in a perpetual legal “grey” zone.

ENDNOTES:

[1] 2018 Farm Bill, section 10113.

[2] 2018 Farm Bill, section 10114(b). See also, 7 CFR Part 990, Part VI, and the USDA General Counsel’s Legal Opinion on the Authorities for Hemp Production at https:// www.ams.usda.gov/content/legal-opinionauthorities-hemp-production

[3] See, eg., the “Dear Colleague” letter dated September 19, 2019 by two Members of Congress at https://hempsupporter.com/wp-content/uploads/2019/09/Pingree_Comer_CBD_letter.pdf

[4] https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details

[5] Pre-Review Report, November 2017: https://www.who.int/medicines/access/controlled-substances/5.2_CBD.pdf

[6] Critical Review Report, July 2018: https://www.who.int/medicines/access/controlled-substances/CannabidiolCriticalReview.pdf

[7] The FDA does not agree with the WTO on the toxicity finding. On November 25, 2019 it issued the following notice: “CBD has the potential to harm you, and harm can happen even before you become aware of it.

• CBD can cause liver injury.
• CBD can affect the metabolism of other drugs, causing serious side effects.
• Use of CBD with alcohol or other Central Nervous System depressants increases the risk of sedation and drowsiness, which can lead to injuries.”

[8] https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd

[9]  See FN8.

[10] https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd

[11]  See FN8.

[12] https://cannabusiness.law/fda-steps-up-cbd-enforcement-with-new-warning-letters/

[13] See FN3, above.

[14] https://cannabusiness.law/fda-wants-your-comments-on-cbd/

[15]  https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd

[16]  Note that in this context I am not referring to hemp seed oil, an extract of hemp seeds that generally contains minimal, if any, detectable levels of CBD. The FDA has determined that hemp seeds and their oils are generally recognized as safe (GRAS), a legal category that broadly allows them as food.

[17]  https://cannabusiness.law/fda-wants-your-comments-on-cbd/

[18] https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

January 8, 2019

Rod Kight is an international cannabis and hemp attorney. He speaks at cannabis conferences across the country, drafts and presents cannabis legislation to foreign governments, is regularly quoted on cannabis matters in the media, and maintains the Kight on Cannabis legal blog, where he discusses legal issues affecting the cannabis industry. You can contact him here.