The House has passed a revised version of the Medical Marijuana and Cannabidiol Research Expansion Act, HR 8454, sending it back to the Senate for action. With previous bipartisan approval, the legislation is expected to soon head to the President’s desk.  The bill is a critical step forward in federal legalization and regulatory science of medical marijuana and cannabidiol (CBD), aiming to ease restrictions on the research and commercialization of medical marijuana and CBD products. 

According to the National Conference of State Legislatures, medical marijuana is currently permitted in 37 states, three territories and the District of Columbia.  The issue of gaps in marijuana research came to the nation’s attention in 2020, when the House Committee on Energy and Commerce hosted several hearings focused on the availability of such research. Public health experts, government agencies, and others testified, urging Congress to act to address legal and regulatory barriers that present challenges to advancing marijuana research.

Several other countries are ahead of the curve in encouraging marijuana research, as well as contributing to the scientific knowledge base for the potential of these products.  Israel, for example, became the first country to allow medical research and marijuana cultivation in 2007 and currently hosts the world’s largest number of medical marijuana clinical trials.  Over the past 15 years, Israel has reformed its approach to medical grade marijuana (to improve ease of access) and has authorized exports of medical marijuana.  Other countries with active marijuana research sectors include Uruguay, Canada, the Netherlands, and the Czech Republic.

In an effort to meet US demand, Congress has fast-tracked the bill, which would:

  • Through a registration program with the US Department of Justice (DOJ), create a pathway for marijuana research without violating the Controlled Substances Act.  Marijuana, and its derivatives, is a Schedule I drug under the Controlled Substances Act (CSA) and is illegal to possess or distribute under US federal law.  See 21 U.S.C. § 802(16).  This classification extends essentially to “all parts of the plant Cannabis sativa L,” as well as synthetic equivalents and extracts.  The bill would amend the CSA to require DOJ to receive applications to conduct marijuana and CBD research as well as applications to manufacture marijuana for research.  DOJ must approve or deny such appplications within 30 days of receipt.
  • Require DOJ to assess and address any shortages of supply of marijuana for research purposes.  DOJ, along with the Department of Health and Human Services (HHS), would be required to make this determination on an annual basis and, if there is a shortage, outline the specific steps to “restore an adequate an uninterrupted supply of marijuana, including of specific strains, for research purposes.”
  • Encourage communication between patients and physicians about the potential harms and benefits of cannabis.  The bill explicitly provides that a state-licensed physician does not violate the CSA by discussing currently known potential harms and benefits of marijuana and marijuana derivatives (including CBD) with patients (or the parents of minor patients).
  • Clarify that companies can manufacture FDA-approved drug products.  The bill would explicitly permit manufacturers to apply to commercially manufacture an approved drug containing or derived from marijuana, as well as to import marijuana products for both research and as an ingredient in FDA-approved drug products.
  • Require HHS and the National Institutes of Health (NIH) to report cannabis medical research.  The Bill would require analysis and submission of information on “the potential therapeutic effects of cannabidiol or marijuana,” the potential effects on the human body, and the barriers associated with marijuana research in states that have legalized marijuana use.

Outside of the proliferation of marijuana products in the US because of non-federal legalization, the potential that marijuana may one day be de-scheduled raises the inevitable question of how those products would be regulated.  Regulatory science is a key component of the answer.  NIH has previously identified priority areas of interest to include “evaluating the endocannabinoid system as a new target for pain and addiction therapies,” “disentangling the distinct therapeutic benefits and potential health risks of different component compounds within cannabis as they relate to pain,” and “evaluating the effects of cannabis and exposures to other substances during vulnerable periods of development.” 

Should the bill become law, the American public may be one step closer to understanding the benefits and risks of medical marijuana and CBD.

At the federal level, multiple agencies have oversight over the marketing, sale, distribution, and transportation of hemp-derived CBD products.  The chart below offers a high-level summary of these federal agencies’ current positions on products containing hemp-derived CBD.

Note that we intend this chart to provide general insights based on public commentary, enforcement actions and guidance from federal agencies; it is not intended to provide legal advice. Federal and state laws, regulations, rules and policies regarding hemp-derived CBD products are continuously evolving; given that, before you proceed with the sale or introduction of hemp-derived products, we recommend seeking legal advice.

Food and Drug Administration (FDA)
APPLICABLE PRODUCTS

Drugs, food, dietary supplements, cosmetics, animal foods, animal drugs

CURRENT POSITION[1]
FDA generally prohibits hemp-derived CBD from being added to dietary supplements, foods, and OTC drugs intended for use by humans or animals.  FDA says in a public statement, “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 (including dietary supplements), and, separately, because CBD is the active ingredient in Epidiolex, an FDA-approved prescription drug product to treat rare, severe forms of epilepsy.”

FDA has reiterated that CBD may not be added to dietary supplements due to the prior drug exclusion under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)] given research involving CBD and given the approval of Epidiolex.

Regarding conventional foods, CBD is similarly prohibited via the prior drug exclusion under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), given research involving CBD and the approval of Epidiolex.  FDA has concluded that CBD was not marketed in food or dietary supplements before Epidiolex was approved or before substantial clinical investigations involving CBD had been instituted.

In addition, regarding conventional foods, CBD is not an approved food additive, nor is FDA aware of any conclusion that CBD is GRAS for use in conventional foods. The latest commentary from FDA indicates that the agency does not believe existing data provides an adequate basis to conclude that CBD is GRAS.  Similarly, FDA has not approved CBD as a new dietary ingredient (NDI) for use in dietary supplements.

Notably, FDA does permit the use of certain hemp seed-derived ingredients – including hulled hemp seed, hemp seed protein powder and hemp seed oil – which have been deemed generally recognized as safe (GRAS) and which may therefore be legally marketed in human foods for the uses described in FDA’s GRAS notices.

Regarding OTC drug products (including certain topical creams), FDA has reiterated that new human and animal drugs must be approved by the FDA or conform to a “monograph” for a particular drug category before they can be legally marketed as drugs. CBD was not an ingredient considered under the OTC Drug Review.  CBD may not be added as an “active” ingredient to OTC drug products, nor as an inactive ingredient, given that CBD has known pharmacological effects on humans as well as demonstrated risks and therefore cannot be regarded as safe and suitable as an inactive ingredient.

Although FDA does not expressly prohibit CBD in cosmetic products, the agency has indicated that it may take action regarding such products if it has information that an ingredient or cosmetic is unsafe for consumers. In particular, cosmetic products containing cannabis or cannabis-derived ingredients must not be injurious to users under the conditions of use prescribed in the labeling of the product or the customary use of the product.

As to Delta-8 THC, FDA recently exercised its enforcement authority under the FD&C Act in issuing a number of warning letters to companies manufacturing products containing Delta-8 THC. In those warning letters, FDA clarified that like CBD, the use of Delta-8 THC in food products qualifies as a food additive. Delta-8 THC has not been recognized as GRAS and introducing food products with Delta-8 THC into the market violates the FD&C Act. In its warning letters, FDA also stated that like CBD, products with Delta-8 THC which are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body” are unapproved new drugs (whether intended for humans or animals), and products containing Delta-8 THC which are offered to treat conditions not amenable to self-diagnosis and treatment by lay persons are misbranded human drugs.

[1] The information contained herein is current as of the date of publication.

Key FDA Sources

 

Federal Trade Commission (FTC)
APPLICABLE PRODUCTS

All products

CURRENT POSITION[1]
CBD products of any type are not permitted to make scientifically unsupported health claims (i.e., claims that a product can prevent, treat, or cure serious medical conditions). Such claims, whether represented directly or indirectly, expressly, or by implication, are deemed to be unfair or deceptive acts or practices in violation of the Federal Trade Commission Act.

In December 2020, FTC announced Operation CBDeceit, its first law enforcement crackdown on deceptive claims in the CBD product space.  The FTC took action against six sellers for making a number of “scientifically unsupported claims” about CBD products’ ability to treat a variety of health conditions, among them cancer, heart disease, diabetes, hypertension, Alzheimer’s disease and anxiety.

These products also made comparative health claims stating that CBD products were able to treat pain better than prescription medications and that CBD products were safe for all users. The FTC approved final administrative consent orders against these sellers in March 2021.

In May 2021, FTC continued its enforcement under Operation CBDeceit with another round of enforcement targeting the online CBD store Kushly. The agency reiterated that CBD products are subject to the FTC Act.

Throughout 2021, FTC also issued a number of warning letters to manufacturers and sellers of CBD products who had made similar unapproved drug and dietary supplement claims.

Through this activity, the FTC is affirming that CBD products which make health claims will be “held to the highest substantiation standards” and that marketers “can expect careful scrutiny” of promises made in connection with CBD products.

[1] The information contained herein is current as of the date of publication.

Key FTC Sources

 

US Department of Agriculture (USDA)
APPLICABLE PRODUCTS

Not applicable

CURRENT POSITION[1]
The 2018 Farm Bill legalized hemp by removing it from the definition of marijuana in the Controlled Substances Act.  Under the revised definition, hemp means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis Thus, states may not prohibit the interstate transport or shipment of hemp and derivatives of hemp lawfully produced under the 2018 Farm Bill.  Notably, the 2018 Farm Bill does not address CBD consumer products, such as foods, dietary supplements, cosmetics, or OTC drugs.

On January 19, 2021 (effective as of March 22, 2021), USDA published a final rule setting forth regulations for the production of hemp in the United States. Importantly, the rule “does not address ‘in-process materials,’ processors, end-products, processing of CBD or other cannabinoids or anything that may contain hemp or hemp byproducts.”

The final rule requires producers to dispose of plants which contain THC in excess of 0.3%, with producers subject to negligent violations if found to have produced (and failed to dispose of) plants with THC of 1% or more. Producers may only receive one negligent violation in a growing season.

The final rule also sets forth sampling and harvesting requirements (for example, hemp crops must be harvested within 30 days of sampling and testing). Hemp crops must also be tested using DEA-registered laboratories, although in recognition of the insufficient number of DEA registered labs, enforcement flexibility allowing testing at non-DEA registered labs has been extended until January 1, 2022.

Additionally, in May 2019 the Office of General Counsel issued a legal memorandum summarizing new hemp authorities,  which states USDA’s legal conclusions regarding the 2018 Farm Bill, including: (i) as of the Bill’s enactment, hemp is no longer a controlled substance under schedule I of the Controlled Substances Act; (ii) states and Indian Tribes may not prohibit interstate transport or shipment of hemp lawfully produced under a state or tribal plan or under a license issued under the USDA plan or lawfully produced under the 2014 Farm Bill; and (iii) a person with a state or federal felony conviction related to a controlled substance is subject to a 10-year ineligibility restriction on producing hemp.

On April 25, 2022, USDA published questions and answers related to the Hemp Production Program on its website (the “Q&A”). The Q&A restates the agency’s position that hemp is deemed to be cannabis sativa L. and “’any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers,’ with no more than a 0.3 percent concentration of THC.” It provides further details regarding plan management, obtaining a grower’s license, sampling and testing, import, export, shipping, and other matters pertinent to the Hemp Production Program. The Q&A refers individuals to FDA’s published questions and answers for more information on cannabis derived products including CBD.

[1] The information contained herein is current as of the date of publication.

Key USDA Sources

 

Drug Enforcement Administration (DEA)
APPLICABLE PRODUCTS

All products

CURRENT POSITION[1]
The 2018 Farm Bill expressly excluded hemp from the definition of marijuana, and therefore hemp is not regulated as a controlled substance.

In August 2020, DEA published an Interim Final Rule (IFR) to implement conforming changes to its regulations as a result of the 2018 Farm Bill. Consistent with the 2018 Farm Bill, the DEA IFR modifies the listing of “tetrahydrocannabinols” on the Schedule of Controlled Substances by adding the following stipulation:  “Tetrahydrocannabinols does not include any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639o.”

DEA’s position in the IFR is that the “definition of hemp does not ‘automatically’ exempt any product derived from a hemp plant”; instead, a cannabis derivative, extract, or product that exceeds 0.3% Delta 9 THC is a Schedule I controlled substance, even if it was derived from a legal hemp plant containing 0.3% or less of Delta 9 THC.

Notably, the DEA provides through the IFR that the 2018 Farm Bill does not impact the control status of synthetically derived tetrahydrocannabinols, and all synthetically derived tetrahydrocannabinols remain schedule I controlled substances.  There is an ongoing court case in the D.C. Circuit regarding the IFR and whether hemp extracts with elevated THC levels are illegal, even if derived from hemp. See Hemp Industries Association et al. v. U.S. Drug Enforcement Administration et al., No. 21-5111 (D.C. Circuit).

On the topic of Delta-8 THC, DEA has provided commentary in the form of a letter response to the Alabama Board of Pharmacy’s inquiry regarding the control status of Delta-8 THC. In that letter, DEA explained that Delta-8 extracted from hemp would still meet the definition of hemp and thus would not be controlled under the Controlled Substances Act.  In the letter, DEA also further clarified that Delta-8 THC that is “synthetically produced” from non-cannabis materials would be a controlled substance.  While DEA’s public commentary provides relevant insight, the absence of rulemaking or formal guidance on this topic has led to a patchwork of inconsistent state approaches in regulating Delta-8 THC.

[1] The information contained herein is current as of the date of publication.

Key DEA Sources

 

Alcohol and Tobacco Tax and Trade Bureau (TTB)
APPLICABLE PRODUCTS

Wine, beer, other malt beverages, distilled spirits

CURRENT POSITION[1]
TTB follows FDA’s position that hemp-derived CBD is not permitted in foods, and the agency has stated in Industry Circular 2019-1 that hemp-derived CBD is not permitted in alcoholic beverages.  This means that TTB will not approve a formula containing hemp-derived CBD.  As noted by TTB, formula approval technically applies to both interstate and intrastate sales (“In the interim, we note that alcohol beverages containing ‘hemp’ ingredients (including alcohol beverages sold exclusively in intrastate commerce) continue to require formula approval under TTB regulations”).  Applicants will have the option of resubmitting the formula to TTB upon receipt of a favorable individual determination from FDA on the regulatory status of their ingredients.

Ingredients from hemp seeds or hemp seed oil are permitted in alcoholic beverages.

TTB is in the process of updating its 2018 Guidance on the use of hemp ingredients in alcohol beverages to reflect the recent changes to the law.  Per TTB, the 2019-1 Circular reflects TTB’s most recent guidance.

[1] The information contained herein is current as of the date of publication.

Key TTB Sources
United States Postal Service (USPS)
APPLICABLE PRODUCTS

All products

CURRENT POSITION[1]
In June 2019, USPS added a section for Hemp-based Products (453.37) in its Publication 52.  This section provides that hemp and hemp-based products, including CBD with THC concentration not exceeding 0.3% on a dry weight basis, are permitted to be mailed when: (1) the mailer complies with all applicable federal, state and local laws pertaining to hemp production, processing, distribution and sales; and (2) the mailer retains records establishing compliance with such laws, including laboratory test results, licenses or compliance reports, for no less than two years after the date of mailing.

With respect to vaping products specifically, the USPS issued a Final Rule on October 21, 2021 that  prohibits the mailing of ENDS (electronic nicotine delivery system) products through USPS, including hemp vape products.  The Final Rule clarified that hemp and hemp derivatives containing less than 0.3 percent THC by dry weight, including hemp-derived CBD products, are generally mailable (consistent with Publication 52) unless the hemp is incorporated into an “electronic device that delivers” the hemp “through an aerosolized solution,” i.e., an ENDS product. The Final Rule also states that items that are used with hemp, i.e., hemp pipes and accessories, “may fall outside the definition of drug paraphernalia” if not mailed with a controlled substance, and thus, are also mailable.

[1] The information contained herein is current as of the date of publication.

Key USPS Sources

 

US Customs and Border Protection (CBP)
APPLICABLE PRODUCTS

All products

CURRENT POSITION[1]
CBP has not issued regulations or formal policies with respect to the import or export of finished consumer products containing hemp-derived CBD.  In informal FAQ guidance, Customs and Border Patrol has publicly acknowledged only that hemp seeds and hemp plants can be imported into the United States pursuant to the 2018 Farm Bill.

Thus, some uncertainty remains around importing finished CBD consumer products into the United States. There still is significant confusion among regulators regarding such things as differentiation between marijuana and hemp based on currently available analytical methods. These uncertainties may lead to the risk of seizure. Companies should consider obtaining a Ruling Letter from CBP to confirm the tariff classification of the proposed shipment of CBD products pursuant to 19 CFR Part 177.  Such Ruling Letters have been issued to companies proposing to import CBD Oil and CBD in bulk powder (isolate) form.

With respect to importation of hemp seeds and hemp plants, CBP posted online a temporary policy titled “Importing hemp seeds and hemp plants into the United States” on January 11, 2022.  Under this temporary policy, CBP was accepting electronically produced copies of phytosanitary certificates through March 31, 2022.  However, this temporary policy has been withdrawn and currently, USDA/APHIS and CBP will only accept original phytosanitary certificate and forms for plant commodities.

[1] The information contained herein is current as of the date of publication.

Key CBP Sources

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