•  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.
  • Last week the FDA issued warning letters to Honest Globe, Inc. (March 15, 2021) and Biolyte Laboratories, LLC (March 18, 2021) for selling products containing cannabidiol (CBD) in violation of the Federal Food, Drug and Cosmetic Act (the “Act”).
  • A principle issue addressed by FDA in the letters is the sale of the CBD containing products as unapproved drugs. The CBD products at issue claimed to provide pain relief as well as a variety of other beneficial effects (e.g., anti-inflammatory, anxiety and depression treatment).  Examples of claims include: “Elixicure pain relief with CBD”, “Deep-penetrating natural pain relief . . . non-addictive pain relief”, “relieving depression, lowering anxiety, lowering blood pressure, lowering intestinal inflammation and more”, “demonstrates antiviral, antibacterial, and antifungal effects for virtually every surface and tissue in the body”, “for temporary relief of occasional . . . minor aches and pains . . . Stiffness of muscles, joints and tissues.”  Therefore, consistent with the definition of drug,  the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the body. Both letters also state that the products do not meet the requirements under section 505G of the Act which would allow them to be marketed without an approved new drug application. Specifically, among other shortcomings, the active ingredient, CBD, was not an active ingredient in any applicable final monograph or tentative final monograph (TFM). Further, even if CBD was considered an inactive ingredient, the products would still not qualify for the 505G exception because CBD does not conform with the general requirement that it be safe and suitable since it has known pharmacological activity with demonstrated risks.
  • The letters also address a number of other deficiencies and violations, including failure to comply with current good manufacturing practices.
  • As we have previously reported, FDA taken the position that CBD is not a lawful dietary ingredient or dietary supplement, but has focused its enforcement efforts on Warning Letters against companies making unsubstantiated health claims. These letters are consistent with that policy. We will continue to monitor and report on any development in CBD regulation and enforcement.
  • On March 3, 2021, the U.S. District Court for the Central District of California invoked the primary jurisdiction doctrine to stay a consumer class action asserting various causes of action against Infinite Product Company, LLC (Infinite) related to the allegedly improper sale of cannabidiol (CBD) products. (See order; law360 subscription required)
  • As we have previously covered in our blog, the federal regulatory framework for CBD remains uncertain. The FDA has taken the position that CBD is not a lawful dietary or food ingredient, even while the market is flooded by CBD products and individual states, such as New York, are forging ahead with their own regulatory frameworks. And while industry had hoped that draft CBD enforcement guidelines—which had been under review by the White House Office of Management and Budget (OMB) since July 2002—would provide clarity, the draft guidelines were withdrawn in January following the change in administration. No timetable for their release, or for any other FDA regulatory or Congressional action has been announced.
  • The class action had alleged that Infinite improperly and misleadingly marketed CBD products, including labeling of the products as dietary supplements when they were in fact (allegedly) misbranded drugs. The court found that it could not adjudicate the claims “given the lack of clarity as to which of Defendant’s CBD products are drugs, dietary supplements, or food products, and what standards apply to those Products.” Instead, the court held that the primary jurisdiction doctrine, which allows courts to stay cases pending resolution of an issue within the special competence of an administrative agency, was properly invoked because both FDA and Congress have expressed interest in regulating CBD and uniform regulation of CBD is necessary, especially given the potential safety concerns. Therefore, the case was ordered stayed “until the FDA completes its rulemaking and/or Congress passes legislation regarding the definitions, marketing, and labeling of CBD products.”
  • While the order states that the stay will be in effect until Congress or FDA act, it is likely that prolonged inaction might also result in a reversal of the stay. Many courts had initially stayed “natural” class actions pending FDA guidance on the definition of “natural,” but in light of continued FDA inaction, courts have reversed course and refused recent requests to stay. Keller and Heckman will continue to monitor the regulation of CBD products and class-actions relating to their sale.
  • New York Governor Andrew Cuomo announced on February 22, 2021 that businesses seeking to operate as cannabinoid hemp processors, retailers, or distributors can now apply for a license through the New York State Department of Health (NYDOH). Any business intending to manufacture, distribute, or sell cannabinoid hemp products in New York State must be licensed.
  • Manufacturers can choose between two types of licenses, which are valid for two years. One license allows processors to extract or isolate cannabinoids, including cannabidiol (CBD), from hemp to create an oil, distillate, isolate, or other product and manufacture the intermediary product into a finished product. The second type of license is for manufacturers that purchase intermediary products and manufacture them into a finished product. Applicants must provide documentation including a description of the products, information about the source hemp, and evidence showing the facility follows current good manufacturing practices. Manufacturers seeking to engage in direct retail sale must separately apply for a retail license.
  • As we have previously reported, the NYDOH published proposed regulations to implement the NY Cannabinoid Hemp Program in October 2020. The rules provide for facility manufacturing guidelines, packaging and labeling standards, and laboratory testing specifications. We will continue to report on developments regarding CBD marketing and manufacturing.
  • On January 8, 2021, FDA commissioner Stephen M. Hahn, M.D. released a statement entitled “Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products”, which details the “knowledge gaps” that remain as the FDA works to develop a framework for the regulation of CBD products.
  • As many of our readers know, the 2018 Farm Bill removed “hemp” from the definition of “marijuana” under the Controlled Substance Act, thus removing one legal obstacle from marketing CBD commercially. However, CBD still needs an appropriate regulatory status for its use in conventional foods and dietary supplements. FDA has taken the position that CBD is not a lawful dietary ingredient or food ingredient based on two timing provisions found in the Federal Food, Drug, and Cosmetic Act.  While a regulatory pathway for CBD is under consideration and safety data is generated, FDA has focused its efforts on Warning Letters against companies making unsubstantiated health claims.
  • Dr. Hahn’s statement declared that the FDA still has a “limited understanding of the safety profile of CBD” and that important questions remain, including the risks associated with long-term use of CBD products. While acknowledging industry’s efforts to engage with and provide information to FDA, Dr. Hahn cautioned that filling the gaps “will not be a trivial exercise.” The statement describes a framework in which real-world data (RWD) can be used to answer outstanding questions on CBD products including how to understand the safety profile of CBD in the general population and potentially in specific populations. In particular, Dr. Hahn announced the following principles and goals that will guide FDA work in this area:
    • Research projects should contribute to development of more sophisticated data infrastructure for understanding the safety and quality of CBD products;
    • Research projects should yield information to help refine future studies, such as subpopulations that are most important to study;
    • Research projects should be designed to complement the existing work of other stakeholders;
    • More systematic data is needed as existing data largely comes from spontaneously reported adverse events;
    • The development of specific codes in data sets is needed to identify specific CBD products;
    • Longitudinal studies are needed to learn more about the long-term health effects of CBD use.
  • The latest statement from FDA makes clear that a lawful regulatory position for CBD will still take some time to develop and that FDA believes there are substantial safety gaps that need to be addressed. We are also awaiting FDA’s draft enforcement guidance that has been at OMB since July. Keller and Heckman will continue to monitor and report on developments that impact the use of CBD in FDA regulated products.
  • On October 28, 2020, the New York State Department of Health announced the release of the state’s cannabidiol (CBD) proposed regulations to regulate CBD hemp products in New York.  Once finalized and in effect, these new regulations would reverse New York State’s early 2019 ban on the sale of hemp-derived CBD-infused products.
  • By way of background, the U.S. Food and Drug Administration (FDA)’s current position is that CBD does not qualify for use in food or dietary supplements. FDA is investigating whether it can develop a regulatory framework that would permit the use of CBD under the Food Drug and Cosmetic Act, but the Agency has identified numerous safety questions that need to be addressed (discussed previously on this blog here) and little progress has been made to resolve them.  New York indicated that these proposed regulations would fill the regulatory void left by FDA’s refusal to set national standards.
  • The proposed rules reflect legislation enacted in December 2019 that called for the establishment of a Cannabinoid Hemp Program, setting out licensing requirements and quality control standards for both CBD hemp processors and retailers, as well as packaging and labeling requirements that all CBD products must meet.
  • The proposed rules
    • Require all hemp CBD products to be manufactured using good manufacturing practices based on the end product’s intended use.
    • State that individual food or beverage products cannot contain more than 25 milligrams of total CBD per product and supplements would be limited to 3,000 milligrams per product. In addition, products cannot exceed 0.3% total Δ9- Tetrahydrocannabinol (THC) concentration.
    • Clarify that foods and drinks infused with CBD and other hemp derivatives must be packaged by the manufacturer and cannot be added at the retail level or in restaurants.
    • Prohibit the addition of CBD to alcohol products.
    • State that product labels must contain the total amount of CBD in the product, the number of cannabinoids per serving, a nutritional or supplement fact panel, and information on whether it contains THC.
    • Require products to include warnings that state the product has not been evaluated by FDA, is not intended for children, and that it may cause drug test failures.
    • Require labels to caution pregnant or nursing women to consult a healthcare provider before use.
    • Require hemp producers to conduct lab tests for the CBD profile and for heavy metals, microbial impurities, mycotoxins, pesticides, and residual solvents.
    • Require companies to make the testing information retrievable by consumers through a QR code or corresponding link on the product label.
    • Bar claims that suggest CBD will diagnose, cure, mitigate, treat, or prevent disease.
  • New York Department of Health will take comments on the proposed regulations through January 11, 2021.  We will continue to monitor any developments.
  • We have discussed the slow progress toward a regulatory pathway for lawfully marketing FDA-regulated food and dietary supplement products that contain cannabidiol (CBD).  While CBD products remain technically illegal (aside from one FDA-approved drug), FDA is gathering information and has taken action so far only against CBD-containing products that make disease and health-related claims or contain unsafe contaminants such as heavy metals and pesticides.  Product labeling that may be false and misleading with regard to CBD content has meanwhile been the subject of a growing number of private lawsuits, such as the proposed class action discussed here.
  • The most recent Cannabis Law Report covers independent testing sponsored by Leafreport finding that of 22 beverages tested, only 4 (13%) contain the amount of CBD stated.  Three products (13%) were reported to contain a level of CBD that is 20% more (2 products) or less (1 product) than stated.  One product (5%) was reported to contain a level of CBD that is 30% more than stated.  Fourteen products (65%) were reported to have a CBD content that differed by more than 30% from the stated level, with 3 beverages containing more CBD than stated, 9 containing less CBD than stated, and 2 products containing no detectable amount of CBD.
  • The results of independent testing indicating inaccurate labeling for CBD beverages is unsurprising given that FDA’s own market survey data, as discussed in a July 2020 report to Congress, has revealed that of 78 products tested which claim to contain CBD, most contained a level of CBD that differed from the labeling by more for 20%.  Eleven such products contained no detectable CBD and 46 contained some level of tetrahydrocannabinol (THC), a narcotic, including one product with THC levels so high that it was referred to the Drug Enforcement Agency (DEA) for potential action.  Until there is an FDA regulatory framework for foods or dietary supplements containing CBD, however, buyers need to be cautious.