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  • On July 20, U.S. Senators Ron Wyden, D-Ore., Rand Paul, R-Ky., and Jeff Merkley, D-Ore., and U.S. Representative Earl Blumenauer, D-Ore., reintroduced legislation, called the “Hemp Access and Consumer Safety Act,” to ensure hemp-derived CBD products are regulated by the FDA like other substances used in dietary supplements and foods. In summary, the Act would:
    • Give hemp-derived CBD products an opportunity to lawfully be used in foods and dietary supplements under the FD&C Act;
    • Prioritize consumer safety, requiring manufacturers to comply with all existing federal regulations for the products that contain CBD; and
    • Ensure that these CBD products are properly labeled.
  • The reintroduction of the Act comes six months after FDA’s January 2023 statement regarding the Agency’s approach towards CBD and its application in the food and drug industry. Specifically, the FDA, with the help of a high-level internal working group, concluded that a new regulatory pathway for CBD was needed and that the Agency expects to collaborate with Congress on this matter, although a timeline for action was unknown.
  • Of the Act, Senator Wyden stated that “[d]espite being legally grown in the United States for nearly five years, hemp and hemp-derived CBD are still in a regulatory gray zone that puts consumers at risk and holds producers back. […] The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD.” The bill is endorsed by various advocacy organizations and trade associations, including U.S. Hemp Roundtable, Wine and Spirits Wholesalers Association, Vote Hemp, and numerous others.
  • Keller and Heckman will continue to monitor and report on the progress of the bill.
  • A high-level internal working group that FDA convened to explore potential regulatory pathways for cannabidiol (CBD) products announced by way of a January 26, 2023 statement that existing regulatory pathways are not appropriate for CBD.  As reported on this blog, the FDA working group examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies conducted and commissioned by FDA, and concluded it is “not apparent how CBD products could meet the safety standards for dietary supplements or food additives.”  FDA’s January statement also announced that the Agency is prepared to work with Congress on legislation to create a new CBD-specific regulatory pathway that is necessary to move forward. 
  • On May 25, 2023, in the last of three webinars intended to address lingering questions following its January statement, FDA reiterated that it is up to Congress to create a legal status for CBD and other hemp-derived cannabinoids.  FDA’s Stakeholder Webinar: “A New Way Forward for Cannabidiol (CBD) and Other Hemp Products” outline the factors that lead FDA to conclude statutory barriers prevent the regulation of these products as a food or dietary supplement.  Specifically, FDA cited CBD’s inherent risk profile (e.g., liver injury, interactions with certain medications, and possible harm to the male reproductive system) and the limited risk management options for the food ingredient and dietary supplement pathways (i.e., the inability for FDA to weigh any potential benefits against the safety risks).  FDA’s webinars advocate for the creation of a “harm reduction” approach for regulating CBD and other hemp-derived cannabinoids that would permit the Agency to set rules addressing known issues with current products, e.g., variable CBD content, incomplete ingredient labeling, contamination, and the risk of ingestion by children.  While recognizing the growing popularity of CBD and other hemp products, FDA insists it can take the harm reduction approach only if Congress enacts legislation for a specific new regulatory framework. 
  • Although there has been bipartisan interest in breaking the current stalemate, the timing for any new legal framework for CBD is unclear.  For the foreseeable future, FDA will continue to monitor the market and target enforcement efforts at products that pose the greatest risks.  Examples noted in FDA’s webinar slides are unapproved new drugs that purport to contain CBD, products that have been associated with serious adverse events, and products that are packaged and labeled to resemble cereal, candy and cookies that appeal to children.  
  • On November 21, 2022, FDA posted warning letters that had been issued to 11-11-11 Brands, Naturally Infused LLC, Newhere Inc dba CBDFX, Infusionz LLC, and CBD American Shaman, LLC for illegally selling CBD-containing products. Collectively, the warning letters raised several legal objections to the sale of CBD in human and animal food and drugs, and dietary supplements, including the following:
    • The sale of a CBD-containing food or animal food renders that food or animal food adulterated because CBD has not been authorized for use by a food additive regulation, subject to a prior sanction, and does not satisfy the criteria for GRAS. On the contrary, FDA noted that the “available data raises serious concerns about potential harm from CBD added to conventional food,” including potential for livery injury, harmful interaction with certain drugs, and interference with sexual development, function, and behavior.
    • The sale of CBD in a human or animal product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body, and that has not been approved by FDA, is an unlawful introduction into interstate commerce of an unapproved new human drug or animal drug. The only CBD-containing drug approved by FDA is Epidiolex, which is approved to treat severe epilepsy.
    • It is unlawful to market any CBD-containing product as a conventional food or dietary supplement because CBD has been approved for use as a drug.
    • When a drug is used to treat a condition which is not amenable to self-diagnosis or treatment (e.g., sleep apnea), as was the case with many of the products at issue, that drug is misbranded if it does not include adequate directions for use. FDA-approved prescription drugs are exempt from this requirement, but none of the products at issue have been approved by FDA.
  • FDA was particularly concerned with some of the products at issue that appeal to children (e.g., candies, cookies, and gummies) as children may be at greater risk to adverse effects from consumption of CBD. Additionally, in the Naturally Infused LLC Warning Letter, FDA objected to the presence of Delta-8 THC, noting that its use in food renders that food adulterated because it is not authorized by a food additive regulation, the subject of a prior sanction, or GRAS. Indeed, FDA noted that the available data raises “serious concerns” about its use, including “potential for adverse effects on the central nervous and cardiopulmonary systems” and gestational neurodevelopment interference.
  • FDA has already issued a number of warning letters to companies using CBD in various products this year (see here and here) and the safety concerns raised by the Agency suggest that it will be a continuing enforcement priority. Keller and Heckman will continue to monitor and report on regulatory developments related to CBD.
  • On May 26, 2022, FDA issued warning letters to Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD, and Kingdom Harvest, alleging, among other things, that the companies were illegally selling unapproved animal drugs with cannabidiol (CBD) intended to be used in food-producing animals. While some of the companies claim that the drugs are used to “[help] farm animals with stress [and] anxiety,” these drugs have not been reviewed by the FDA to evaluate their safety and effectiveness with respect to the animals themselves, as well as the potential risks raised by the presence of CBD in human food derived from these animals.
  • FDA further challenged the positioning of some of these companies’ products as human dietary supplements, noting that they do not meet the definition of dietary supplements under the Dietary Supplement Health and Education Act. The agency also noted its concern that animal owners will rely to their detriment on unsubstantiated claims of alleviating anxiety in animals instead of seeking professional medical care when their animals are in distress.
  • Keller and Heckman will continue to monitor developments in FDA’s treatment of various CBD-containing products.
  • On March 28, 2022, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) jointly issued seven warning letters to companies marketing cannabidiol (CBD) products with COVID-19 related claims.
  • Specifically, the agencies warned the following companies regarding the promotion of their respective products with claims that they cure, mitigate, treat or prevent COVID-19: Cureganics, Heaven’s Organics LLC, Functional Remedies, LLC D/B/A Synchronicity Hemp Oil, Greenway Herbal Products LLC, CBD Social, UPSY LLC, and Nature’s Highway. Examples of claims include: “Our research suggest that CBD . . . can block SARS-Cov-2 infection at early and even later stages of infection. . .”, “Studies Show CBD Compounds Prevent COVID Cells From Replicating”, and “Can CBD Help with the Fight Against COVID? Some of the worst effects of COVID are caused by inflammation, and CBD is a potent anti-inflammatory.”
  • By way of background, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products intended to cure, treat, mitigate, or prevent disease are considered drugs and are subject to the requirements that apply to drugs. Therefore, the agencies classified the products as unapproved and misbranded drugs that may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.
  • The letters included a cease-and-desist demand from FTC, prohibiting the companies from making such COVID-19 related claims. The companies were provided with 48 hours to respond with specific steps that were taken to correct the violations.
  • On December 2, a bipartisan group of U.S. Representatives introduced the “CBD Product Safety and Standardization Act of 2021” which would establish federal standards and require the FDA to regulate cannabidiol (CBD) in foods and beverages. The Act was introduced by Rep. Kathleen Rice (D-NY), along with Reps. Angie Craig (D-Minn.), Morgan Griffith (R-VA.), and Dan Crenshaw (R-Texas).
  • The Act would allow FDA to regulate CBD as a food additive. If passed, it would require the Agency to issue regulations specifying the maximum amount of CBD derived from hemp per serving, labeling and packaging requirements, and conditions of intended use.
  • In a press release, Representative Rice stated that “CBD products are exploding in popularity, but the lack of federal regulation surrounding them has put consumers at risk and left businesses looking for clarity. The bipartisan CBD Product Safety and Standardization Act will establish the clear regulatory framework needed to provide stability for business and ensure unsafe products stay off the shelves.”
  • In support of the Act, the U.S. Hemp Roundtable, the hemp industry’s national advocacy organization, stated “[t]he hemp industry is grateful to Reps. Kathleen Rice, Morgan Griffith, Angie Craig and Dan Crenshaw for their introduction of the CBD Product Safety and Standardization Act. We strongly support requiring the FDA to regulate hemp extracts like CBD as food and beverage ingredients.”
  •  Previous New Dietary Ingredient Notifications (NDINs) for cannabidiol (CBD) products, i.e., NDINs #984, #1116, #1117, #1128, and #1135, were not filed based solely on FDA’s determination (discussed here) that with limited exceptions, a substance such as CBD, which is an active ingredient in an approved drug (i.e., Epidiolex) or has been the subject of substantial, publicly known clinical investigations, is excluded from the legal definition of “dietary supplement.”  Although FDA has also consistently maintained there are substantial safety gaps that need to be addressed, these previously submitted NDINs were refused without a safety evaluation.
  • In a departure from previous responses that refused NDINs solely on the basis that CBD products are excluded from the dietary supplement definition, FDA’s letters dated July 23, 2021 and posted on August 11, 2021, responding to NDIN #1199 for Irwin Naturals – “Full Spectrum Hemp Extract” and NDIN #1202 for Charlotte’s Web – “Full Spectrum Hemp Extract,” indicate that FDA went on to review the safety data and found it did not reach the “will reasonably be expected to be safe” standard.  Safety data gaps noted in FDA’s letters include:
    • Evidence on a general history of use was vague and did not provide an adequate description of the cannabis preparations (e.g., composition), serving levels, or frequency and durations of use for comparison to the currently proposed ingredient use.
    • Preclinical and clinical studies on different phytocannabinoid mixtures were, in some cases, not completely characterized and could not be compared to the current ingredient.
    • Most importantly, certain reported toxicity endpoints of CBD such as hepatotoxicity and reproductive toxicity, were not adequately addressed.
  • FDA’s taking the additional step of commenting on safety, after concluding that CBD is not an eligible dietary ingredient, reinforces that unresolved safety concerns could prevent the legal marketing of dietary supplements (as well as food) containing CBD, even if legislative action were to otherwise clear a regulatory pathway.  Keller and Heckman will continue to monitor and report on developments that impact the use of CBD in FDA regulated products.
  • In letters to Acting FDA Commissioner Janet Woodcock and Senator Ron Wyden (D – OR), the Consumer Brands Association (CBA) renewed its call for government action on cannabidiol (CBD) regulation in order to ensure consumer safety. CBA endorsed Senator Wyden’s Hemp Access and Consumer Safety Act to establish uniform CBD regulations and argued that a federal regulatory framework should empower federal regulators to:
    • Identify data that is needed to support the safe marketing of foods and dietary ingredients that contain CBD;
    • Establish the infrastructure and processes to review safety data and allow the lawful marketing of CBD-containing ingredients that are safe;
    • Ensure products are made in full compliance with existing and applicable manufacturing, processing, distributing, and product claim requirements;
    • Provide guidelines to protect trademark and intellectual property;
    • Align on how the current marketplace will transition to meet the requirements established through the new federal regulatory framework, in partnership with stakeholders.
  • CBA also advocated for federal funding of federal regulators to establish such a system. CBA proposed a two-prong approach for Congress to clarify the CBD marketplace: (1) Congress should ensure adequate funding for federal research on the health and safety of CBD products in order to allow regulators to make informed decisions; and (2) Congress should ensure that FDA has the resources to engage in market surveillance and undertake enforcement activities. CBA expressed support for the House Appropriation Subcommittee’s decision to allocate an additional $5 million to FDA’s CBD enforcement capacity in FDA’s 2021 budget.
  • CBA recently published the report “Unregulated and Exploding: How the CBD Market Is Growing Amid a Labyrinth of State Approaches and Rampant Consumer Confusion,” which explores consumers’ lack of understanding of the CBD market. For instance, the report found that on a scale of one to ten, consumers regarded their knowledge of CBD at an average of 3.3. Additionally, while 28% of Americans have used CBD, 74% of consumers were unsure if CBD is federally regulated. CBA asserts that while FDA’s use of warning letters may curb bad actors, a clear regulatory framework is needed to address consumer confusion created by the multitude of state approaches. Keller and Heckman will continue to report on developments that impact CBD and other cannabinoids.
  • Senators Chuck Schumer (D-NY), Cory Booker (D-NJ), and Ron Wyden (D-OR) unveiled a lengthy discussion draft titled the Cannabis Administration and Opportunity Act on July 14. The draft language is meant to spur and inform discussions as the senators work to create a final legislative proposal to be introduced as a formal Senate bill.
  • Section 505 of the discussion draft proposes creating a legal pathway for cannabidiol (CBD) in dietary supplements. Specifically, the draft proposes amending the definition of “dietary supplement” in 21 U.S.C. § 321(ff) to except CBD derived from hemp from the prohibition against using substances that have been approved as drugs. The draft also proposes a section that states dietary supplements would be adulterated if they contain more CBD than a limit to be set by the Secretary of the Department of Health and Human Services. Additional language would give FDA enforcement authority over noncompliant products containing CBD that are improperly labeled as dietary supplements and give FDA the authority to require safety-related labeling or packaging as needed for CBD-containing dietary supplements. The proposed language limits the possibility of CBD in dietary supplements to CBD derived from cannabis plants, limiting opportunities for synthetically-produced CBD.
  • Other provisions in the draft would decriminalize marijuana by removing “marihuana” and “tetrahydrocannabinols” from the list of Schedule I controlled substances at 21 U.S.C. § 812, expunge non-violent marijuana crimes, and allow compliant cannabis businesses access to financial services, among other items.
  • The sponsoring senators request comments from stakeholders. A comprehensive summary of the discussion draft is available here. If final language is developed and a bill is introduced, the bill would join S. 1698 and H.R. 841, other bills introduced in Congress this session that seek movement on CBD. We will continue to monitor movement on these proposals.
  • U.S. Senators Ron Wyden (D-OR), Rand Paul (R-KY) and Jeff Merkley (D-OR) introduced S. 1698 on May 19, a bill to allow the use of cannabidiol (CBD) and other hemp derivatives in foods and dietary supplements. As our readers know, FDA has stated it does not consider CBD to be a legal food additive or dietary ingredient because it has previously been the subject of clinical investigations for use in drugs and is currently the active ingredient in the approved drug Epidiolex, marketed by GW Pharmaceuticals for treatment of seizures related to epilepsy.
  • If passed, the Hemp Access and Consumer Safety Act (bill text available here) would specifically amend the definition of a dietary supplement in 21 U.S.C. § 321(ff)(3)(B) to except “hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp” from the requirement that dietary ingredients may not include articles that have been approved as new drugs. It would also except the same substances from the requirement in 21 U.S.C. § 331(ll) that foods may not contain articles that have been approved as drugs or the subject of substantial clinical investigations. It would further permit FDA to establish requirements for labeling and packaging of dietary supplements and foods containing hemp and hemp derivatives and take enforcement actions regarding products that are labeled as dietary supplements but that do not meet the definition of dietary supplements in § 321(ff)(3)(B).
  • The bill would allow firms to move forward with submissions to FDA seeking an appropriate clearance for CBD as a dietary ingredient or food additive through existing pathways, such as through a New Dietary Ingredient Notification, Food Additive Petition, GRAS Notice (a submission demonstrating that a food additive is “generally recognized as safe” for its intended use). It would also allow FDA to begin inspecting manufacturing facilities where hemp derivatives and related products are made.
  • S. 1698 has bipartisan support in Congress and industry backing. It joins a CBD-focused House bill, H.R. 841, that was introduced in February and seeks to allow CBD for use in dietary supplements only. We will continue to track CBD-related legislation and report on the progress of these bills.