Is CBD Legal? Part II: The FDA

After reading Part I of the Is CBD Legal series, you may be prepared to defend the statement that hemp-derivatives sourced from hemp grown pursuant to a pilot program under the 2018 Farm Bill are perfectly legal at the federal level and that CBD is legal. “Not so fast,” says the United States Food and Drug Administration (“FDA”).

What is the FDA?

The Food and Drug Administration is an agency of the United States Department of Health and Human Services, an executive branch office. The head of the FDA is the Commissioner of Food and Drugs, who is appointed by the President. The current commissioner, Scott Gottlieb, M.D., has occupied the role since May 2017.

The FDA’s mission statement relays that the agency is “responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.” FDA regulations cover a myriad of products, including tobacco, food, vaccines, medical devices, prescription drugs, over the counter drugs, dietary supplements, animal food, veterinary products, cosmetics, and more. Congress approved FDA oversight of these items when it charged the FDA with enforcing the Federal Food, Drug and Cosmetic Act, among other laws.

On December 20, 2018, the same day President Trump signed the Agriculture Improvement Act of 2018, P.L. 115-334 (the “2018 Farm Bill”), FDA Commissioner Scott Gottlieb reiterated that the FDA would not back down on its stance that CBD and THC are illegal additives to products subject to the Food and Drug Cosmetics Act (“FD&C Act”). Today, we review what the FDA’s stance on CBD is and how that stance has impacted the states. As you read through our analysis, keep in mind that when we use terms like “drug,” “device,” “food additive,” and “dietary supplement,” we are using these terms in accordance with their legal definitions under the FD&C Act and not in accordance with some of the more common, colloquial understandings of the terms. With that principle in mind, let’s jump in to flesh out the FDA’s stance on CBD and THC.

What is the FDA’s Position on THC and CBD?

Prior to passage of the 2018 Farm Bill, the FDA sent several warning letters to companies advertising CBD products in conjunction with health claims. The FD&C Act prohibits unapproved products from being labeled or marketed as “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” 21 USC § 201(g)(1)(B). Recipients of prior FDA warning letters made statements on their websites such as, “CBD may reduce symptoms of schizophrenia . . .” and “[s]tudies show CBD is a natural anti-inflammatory with great potential towards issues including anti-anxiety, anti-pain, anti-psychosis, anti-spasm, and more.” Because these statements discuss treatment and mitigation of disease in relation to a product that is neither an approved “drug” nor “device” under the FD&C Act, they constituted a violation.

Is CBD or THC a Dietary Supplement?

It’s no secret that the FDA will enforce the directive that health claims stating that CBD or THC products may be used to cure, treat, prevent, or mitigate a disease are illegal, but why does the FDA maintain that CBD and/or THC cannot be added to certain food and beverage products? Once again, the FD&C Act plays a role here too.

The Dietary Supplement Health and Education Act (DSHEA), which governs dietary supplements, is incorporated into the FD&C Act. Since the FDA has authority under the FD&C Act over dietary supplements, products containing CBD or THC marketed as a dietary supplement fall under its purview. Let’s start with the argument that CBD or THC are dietary supplements.

What is the legal definition of a dietary supplement? The term “dietary supplement”

(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);

(2) means a product that– (A)(i) is intended for ingestion in a form described in section 350(c)(1)(B)(i) of this title; or (ii) complies with section 350(c)(1)(B)(ii) of this title; (B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and (C) is labeled as a dietary supplement; and

(3) does–

(A)

(B) not include–

(i) an article that is approved as a new drug under section 355 of this title, certified as an antibiotic under section 357 of this title, or licensed as a biologic under section 262 of Title 42, or

(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.  See 21 U.S.C.A. § 321.

Let’s take a look at (1)(c) of the above definition:

“dietary supplement (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: … (c) an herb or other botanical.” Id.

“Aha! CBD and THC are extracts from the botanical plant Cannabis sativa L. so they qualify as a dietary supplement,” you may exclaim. To use a local Texas idiom, hold your horses. We still have more to unpack in that lengthy definition of “dietary supplement”. Note that the FD&C Act provides that a dietary supplement does not include “an article that is approved as new drug” or “an article 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.” What does “authorized for investigation as a new drug mean?” It means that the substance has been the subject of an Investigational New Drug application (IND) approved by the FDA.

So Why are THC and CBD Excluded as Dietary Supplements?

We have established that THC and CBD are products that may be intended to supplement the diet that are an extract of the botanical plant Cannabis sativa L. (hemp). However, both THC and CBD are subject to one of the exclusions discussed above. THC is an active ingredient in several prescription drugs, including Marinol and Syndros. Thus, THC meets the statutory definition of an “an active ingredient in a drug product that has been approved under the FD&C Act.” Because of this, the FDA maintains that THC is excluded from the statutory definition of “dietary supplement.”

As for CBD, the FDA states that at least two substantial clinical investigations have been conducted on CBD: GW Pharmaceuticals’ investigations on Sativex and Epidiolex. Sativex was approved for clinical investigation in 2006, while Epidiolex received IND approval in May of 2014. Epidiolex was further approved by the FDA as a prescription drug on June 25, 2018.

What about the Source of the CBD or THC?

Part I of this series distinguished that cannabinoids derived from marijuana still remain a Schedule I substance, unless they are extracted from the exempted portions of marijuana plant identified in 21 U.S.C.A. § 802. However, the FDA makes no distinction as to the source of the cannabinoid. To be clear, the FDA maintains that both marijuana-derived cannabinoids and hemp-derived cannabinoids are illegal food additives and that neither are “dietary supplements.”

What about the FD&C Act Exclusionary Rule?

DSHEA contains an exclusionary rule that allows substances marketed as a dietary supplement or conventional food before the drug was approved or before the IND was approved to qualify as a dietary supplement. Section 201(ff)(3)(B)(ii) of the FD&C Act excludes from the definition of “dietary supplement” “an article 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,” unless the article was previously marketed as a dietary supplement or as a food. Certainly, it seems plausible that one may prove to the FDA that THC and CBD were marketed as dietary supplements before 2004, the earliest date of the Sativex IND.

One of the most famous cases dealing with hemp is Hemp Industries Ass’n v. Drug Enforcement Administration, 333 F.3d 1022 (9th Cir. 2003). Even in 2003, members of Hemp Industries Association, the Petitioner, included companies manufacturing, distributing, marketing and selling, edible hemp seeds, hemp oil, and food and beverage products containing processed hemp seed or oil extracted from previously exempted portions of the Cannabis sativa L. hemp plant. The Ninth Circuit recognized in this and later versions of this case that these products contain trace amounts of cannabinoids, namely naturally occurring THC. Id.

However, here is all that the FDA has to say on the issue so far: the “FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue.  Our continuing review of information that has been submitted thus far has not called our conclusions into question.”

Why Can’t We Add CBD or THC to Food?

The FD&C Act defines “food” as “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” 21 U.S.C.A. § 321 (f). The FD&C Act prohibits adding a drug or substance subject to an IND to food:

“The following acts and the causing thereof are prohibited…

the introduction or delivery for introduction into interstate commerce of any food to which has been added a drug approved under section 355 of this title …or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless–

(1) such drug or such biological product was marketed in food before any approval of the drug under section 355 of this title, before licensure of the biological product under such section 262 of Title 42, and before any substantial clinical investigations involving the drug or the biological product have been instituted …” 21 U.S.C.A. § 331

As you see, the same exclusionary rule impacting dietary supplements applies to food additives: if the substance was marketed in food before the drug was approved or before substantial clinical investigations involving the drug were instituted it can be added to food. Once again, the FDA invites interested parties to submit evidence that they believe has bearing on the issue. However, for now, the FDA has concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. Thus, until the FDA changes its stance, the FDA considers CBD and THC as illegal food additives.

How has Congress Reacted?

At least two Senators, Ron Wyden and Jeff Merkley, have urged the FDA to reconsider its stance to permit hemp-derived ingredients to be included in food, beverages, and other items governed by the FD&C Act. Senators Wyden and Merkley were both original drafters of the text that was incorporated into the 2018 Farm Bill regarding hemp cultivation. In their letter, they state that it was “Congress’ intent to ensure that both U.S. producers and consumers have access to a full range of hemp-derived products, including hemp-derived cannabinoids.”

Because the FDA was operating with limited staff due to the government shutdown, the Senators provided a thirty-day response time frame for the FDA to answer the following questions:

1) What steps is FDA advancing to clarify to the public the authority the agency has in the production and marketing of hemp, specifically Cannabis sativa L. and its derivatives?
2) What lawful pathways are currently available for those who seek approval to introduce Cannabis sativa L. and its derivatives as a food, beverage or dietary supplement, including into interstate commerce?
3) Are there circumstances in which Cannabis sativa L. and its derivatives may be permitted as a food, beverage or dietary supplement by the agency?
4) Will the agency consider issuing a regulation, or pursing a process, that would allow Cannabis sativa L. and its derivatives in food, beverages or dietary supplements that cross state lines?

A copy of the letter may be found here. Stay tuned to see how the FDA responds.

How are States Reacting to the FDA Stance on CBD?

Several states are playing it safe and have begun banning CBD additives in edibles due to the FDA’s stance that CBD is illegal as a food additive. In a move that surprised many New Yorkers who were accustomed to enjoying CBD lattes, brownies, cocktails, meals, and more, the New York City Department of Health ordered multiple restaurants in the area to cease use of CBD as a food additive. The Department crackdown included embargoes on CBD food goods (meaning the goods cannot be sold) and warnings that fines would be imposed for violations. A spokesperson for the NYC Department of Health stated that, “[r]estaurants in New York City are not permitted to add anything to food or drink that is not approved as safe to eat. Until cannabidiol … is deemed safe as a food additive, the department is ordering restaurants not to offer products containing CBD.”

Maine, a recreational use state, quickly followed suit by announcing a ban on CBD edibles. State environmental health inspectors instructed businesses that all foods, tinctures, and capsules containing CBD must be removed, as the Maine Department of Health and Human Services determined that CBD is not a federally approved food additive. Not to be left out, North Carolina is poised to follow suit. The North Carolina Department of Agriculture and Consumer Services is aligning itself with the FDA and mailing out warning letters demanding that businesses stop selling CBD edibles or face fines for violation.

Not surprisingly given its staunch approach to CBD regulations, Ohio is demanding CBD edibles, and all CBD products for that matter, be removed from the shelves of stores that are not licensed dispensaries. Georgia has also fallen in line, with the Georgia Department of Health stating that CBD is not an approved food additive under FDA guidelines.

For transparency in the state round-up above, it is important to note that California has banned CBD as a food and beverage additive since last Fall.

What can we do to Change the FDA’s Stance?

The FDA’s website notes that any interested party that has evidence that CBD or THC derived from hemp was marketed as a dietary supplement or as a food additive before the applicable dates for the exclusionary rules is welcome to submit their evidence to the agency for consideration.  If you are a hemp company or company that marketed CBD or THC cannabinoids as a dietary supplement or included it as a food additive before 2004, the earliest IND date on which the FDA can rely for its position, the industry needs you. You can submit your evidence directly to the FDA for consideration. Additionally, we can all contact our federal legislators and ask them to join Senators Ron Wyden and Jeff Merkley in putting the pressure on the FDA.

Up next, we are reviewing the state of hemp and hemp-derivatives in Texas and whether CBD is legal in Texas. Stay tuned!

 

Chelsie Spencer is a hemp lawyer who represents hemp and legal cannabis businesses for their business, transactional, and compliance issues. She also focuses on hemp and cannabis branding issues and manages worldwide trademark portfolios for hemp and cannabidiol companies, among others. She is very active in legislative activity impacting the hemp and cannabis fields and frequently writes, speaks, and presents on issues affecting these industries across the United States.

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