• 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.

 

  • We reported on a November 14, 2019 citizen petition submitted to FDA by the Consumer Healthcare Products Associated (CHPA) requesting that the agency issue regulations to establish a clear pathway for the use of cannabidiol (CBD) in dietary supplements.  After public hearings and the first of two Congressionally mandated reports from FDA, discussed here, however, the market for FDA-regulated food and dietary supplement products that contain CBD continues to grow rapidly while a regulatory pathway for lawfully marketing such products still is not in place in the U.S.
  • Undeterred by FDA’s inaction on the CHPA petition, the Council for Responsible Nutrition (CRN) filed a similar citizen petition on June 16, 2020 urging FDA to regulate hemp-derived CBD as a dietary ingredient.  The petition distinguishes “full spectrum” hemp extracts from CBD isolates, which CRN argues is the substance that has been approved for use in a drug and is therefore prohibited from use in a food or a dietary supplement.  Regarding the petition’s focus only on dietary supplements, a CRN spokesperson told Food Navigator that FDA’s report to Congress indicates that FDA’s safety concerns may be limited to food uses of CBD, although CBD-infused beverage brands maintain that both categories can be safely accommodated under the current regulatory framework.  CRN recognizes that its petition could languish with FDA and told Food Navigator that the organization is focusing mainly on legislative initiatives to bypass FDA altogether.
  • A June 17, 2020 letter from the consumer organizations, Consumer Federation of America (CFA), Center for Science in the Public Interest (CSPI), Consumer Reports, and Public Health institute, urged lawmakers not to push FDA to act on CBD before it has adequate data or to by-pass FDA.
  • A group of seven CBD brands (Boulder Botanicals & Bioscience Labs, CBDistillery, CBD American Shaman, Charlotte’s Web Holdings, Columbia Care, HempFusion, and Kannaway) have committed to collectively sponsor ValidCare (a clinical trial outsourcing and market research company) in conducting observational research to evaluate the impact of daily CBD use (both full-spectrum, hemp-derived CBD and CBD isolate) on the liver function of healthy adults.
  • According to a press release issued by ValidCare on June 9, 2019, the liver study, the results of which will be provided to the U.S. Food and Drug Administration (FDA) for consideration in its efforts to regulate CBD, is scheduled to begin in July 2020 and expected to be completed by the end of this year.  The study intends to aggregate data from at least 700 consumers, which will be combined with information regarding personal history, blood tests, and product information.
  • Participants will be provided with oral CBD products from the study’s supporting brands for consumption in connection with the study.  Participants will be required to attest that they have used the products for at least 60 days prior to the start of the study, and continue consuming the products for the duration of the study.  Participants will document their CBD use and any observable effects for 30 days, and provide blood samples.  The study is observational (not a randomized double-blind placebo controlled human clinical study), and FDA’s treatment, consideration, and evaluation of these results has yet to be seen.  As previously reported here on this blog, FDA recently announced that it made “substantial progress” towards a goal of providing additional guidance on ingestible CBD products, but offered no specific details and continued to emphasize its ongoing questions and concerns about the science, safety, effectiveness, and quality of CBD products (which include concerns regarding liver toxicity).
  • We will continue to monitor the situation for any developments.

 

  • After public hearings and the first of two Congressionally mandated reports from FDA, discussed here, the market for FDA-regulated food and dietary supplement products that contain cannabidiol (CBD) continues to grow rapidly while a regulatory pathway for lawfully marketing such products still is not in place in the U.S.  Although FDA has not clearly formulated an interim enforcement discretion policy, its CBD enforcement actions thus far have targeted only CBD-containing products that make disease and health-related claims or contain unsafe contaminants.
  • An FDA spokesperson told Food Navigator-USA last week that the Agency has made “substantial progress” toward a goal of providing additional guidance on ingestible CBD products but offered no specific details and continued to emphasize that FDA has questions about the science, safety, effectiveness, and quality of CBD products.  The FDA spokesperson declined to comment on FDA’s “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry’” which was recently posted as pending review by the Office of Management and Budget (OMB) and was taken as an encouraging sign for industry.
  • It is not clear whether this new guidance document on human clinical studies of CBD represents progress toward a regulatory pathway for food and dietary supplements, since the title suggests that it addresses scientific issues rather than regulatory ones.  Nevertheless, human clinical studies would help address FDA’s safety concerns with the use of CBD in such products (although animal studies would certainly be important too).
  • The FDA issued warning letters to BIOTA Biosciences, LLC and Homero Corp DBA Natures CBD Oil Distribution for selling unapproved products containing cannabidiol (CBD) in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act).
  • The letter issued to BIOTA cited the company for marketing injectable products containing CBD that were advertised to, among other things, “eliminate the global opioid epidemic by providing a safe and natural alternative,” “suppress pain and aid in the detoxification process,” and provide “[i]nstant relief for patients that are symptomatic of inflammatory auto-immune diseases.” The FDA asserted that the CBD products: (1) were unapproved drugs because they were 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 had not been approved or been generally recognized as safe, and (2) were misbranded drugs because they were not labelled with adequate directions for use by laypersons; nor could they be, since the products were not amenable to self-diagnosis and treatment by laypersons.
  • The letter issued to Homero cited the company for marketing various CBD products to both humans and animals— including topicals, oils, and edibles— that similarly claimed to treat disease, and also claimed to aid recovery from opioid addiction. In addition to asserting that the CBD products marketed for humans were unapproved and misbranded drugs, the FDA asserted that (1) CBD products could not be marketed as dietary supplements; (2) the introduction or delivery for introduction into interstate commerce of the products was a prohibited act under Section 301(ll) of the FD&C Act; and (3) the CBD edibles were adulterated foods because CBD is an unapproved food additive. The FDA also asserted that the CDB products marketed for animals constituted unapproved new animal drugs.
  • The letters demonstrate the FDA’s continued concerns regarding the safety of CBD products (see FDA’s March update on potential harms of CBD products) and the public misperception that the safety of CBD products on the market have been evaluated by the FDA.

 

  • We have discussed a public hearing that FDA held on May 31, 2019 to obtain scientific data and safety information on the wide array of FDA-regulated products already on the market that contain cannabidiol (CBD).  This hearing was part of FDA’s effort to explore whether it would be possible to develop a regulatory pathway for CBD-containing foods and dietary supplements to be lawfully marketed.  Subsequently, FDA stepped up its CBD enforcement action last year against a wide array of CBD-containing products making disease and health-related claims, as we reported.  When Congress appropriated funds for hemp/CBD market surveillance activities in December 2019, it directed FDA to report on progress toward obtaining and analyzing data to help determine a policy of enforcement discretion and a process in which CBD will be evaluated for lawful use in FDA-regulated products.
  • FDA’s Report to Congress was publicly revealed on March 5, 2020 and indicated that little actual progress has been made.  The most significant development is that FDA is considering developing a risk-based enforcement policy that could possibly clarify FDA’s enforcement priorities.  Given the widespread availability of such products, however, an informal policy of enforcement discretion has been in place for some time.  Progress toward quickly providing for the lawful use of CBD in dietary supplements and conventional food is not likely, however, as the report makes it clear that FDA remains concerned about the risks of CBD, which include potential liver injury, interactions with other drugs, male reproductive toxicity, and side effects such as drowsiness.  To facilitate obtaining data that would make it possible to determine whether there may be any safe conditions of use for CBD in any FDA-regulated consumer products, aside from the one currently FDA-approved prescription drug use, FDA announced that it will reopen the docket that was created following the May 31, 2019 hearing and that it is working on a process whereby companies can provide proprietary information on specific products on a confidential basis.
  • FDA’s report was only slightly more hopeful about the prospect of future rulemaking or an enforcement policy on the use of CBD in dietary supplements, as compared to conventional foods, for which an eventual FDA clearance seems particularly challenging.  On the whole, the report emphasizes significant obstacles that include FDA’s ability to provide adequate regulatory oversight, workload considerations, and how to make consumers aware of limitations in FDA’s oversight of dietary supplements that may be particularly significant for CBD-containing products, as well as tangential safety concerns like heavy metal contaminants and other impurities or undeclared ingredients.  As to consumer awareness issues, the report also reiterates concerns about false marketing claims for CBD products, cumulative exposure, and use by vulnerable populations. An FDA Statement for the public was issued concurrently with the disclosure of the congressional report to educate consumers on the FDA status of CBD-containing products and warn of potential health risks.
  • Keller and Heckman advises clients regularly on the status of CBD in FDA-regulated products. We will continue to monitor FDA’s development of a potential regulatory framework and the direction of additional enforcement action to assess the risks and opportunities for companies marketing these types of products.
  • A proposed class of consumers is urging a Massachusetts federal judge not to dismiss its suit against a Florida CBD supplement manufacturer over the potency of its products. By way of background, in September 2019, plaintiff Marjorie Ahumada filed suit against Florida-based Global Widget LLC, owner of Hemp Bombs brand, claiming that its products do not contain the advertised dosages. Ahumada claimed to have purchased two packages of Hemp Bombs gummies for about $17 in Massachusetts. The packages were advertised as pure and “high potency,” and that the gummies contained 75 milligrams of CBD, which Ahumada understood to mean 15 milligrams per gummy. According to the plaintiff’s own testing, the gummies contained a much smaller amount of CBD, or even none at all.
  • In their January motion to dismiss, Global Widget argued that Ahumada’s allegations were futile and that the product testing was insufficient. “Despite such bold claims, the complaint fails to describe the alleged laboratory testing or its methodology or allege that the testing was performed on the actual purchased product.” Now Ahumada and the proposed class are asking that the suit not be dismissed, arguing that the testing the proposed class performed on the products is adequate at this point in the case. Ahumada stated that “[t]he [first amended complaint] sufficiently alleges the claims on the CBD products are false and misleading because the products contain less CBD than advertised as demonstrated by plaintiff’s testing.”
  • Additionally, in their motion to dismiss, Global Widget further argued that the court should stay the case pending forthcoming CBD regulations from the FDA. Ahumada, however, argued that any new rules or guidance from the FDA would be forward-looking only and would not impact the lawsuit.
  • The lawsuit is one of a growing number of private actions filed alleging false and misleading CBD product labeling. We will continue to monitor this case as well as other CBD-related lawsuits and regulatory actions.
  • As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marijuana.” As a result, while marijuana remains a Schedule I drug, hemp is no longer a controlled substance under Federal law. However, since CBD has been approved for use in the drug Epidiolex, the Federal Food, Drug, and Cosmetic Act (FD&C Act) has prohibited adding it to a food or a dietary supplement.  Epidiolex is a liquid formulation of pure plant-derived CBD.
  • GW Pharmaceuticals PLC, the manufacturer of Epidiolex, recently submitted a supplemental New Drug Application (sNDA) to expand the label of its Epidiolex cannabidiol oral solution, CV, to include the treatment of seizures associated with Tuberous Sclerosis Complex (TSC). Epidiolex is currently approved in the U.S. for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome. The submission is supported by data from a favorable Phase 3 safety and efficacy study conducted in 2019, which showed that Epidiolex reduced TSC-associated seizures by roughly 48% from baseline. The Phase 3 study also demonstrated that the observed safety profile was consistent with data from prior studies.
  • TSC is a rare genetic disorder that causes predominantly benign tumors to grow in various vital body organs such as the brain, heart, kidneys, and lungs. Affecting more than 40,000 people in the U.S. and nearly one million people around the world, TSC is a leading cause of genetic epilepsy today. More than 60% of individuals with TSC are not able to achieve seizure control via standard methods and treatments. The disorder typically manifests in the first year of life and is linked to an increased risk of autism and intellectual disability in children.
  • Epidiolex has been granted Orphan Drug Designation from FDA for the treatment of TSC. According to GW Pharmaceuticals, FDA approval of the sNDA is expected later this year. Epidiolex is GW’s lead cannabinoid product candidate and the first FDA-approved drug that contains a purified drug substance derived from marijuana.
  • On January 13, 2020, the House Agriculture Committee Chairman Collin Peterson (D- Minn.) introduced H.R. 5587, which would include hemp derived CBD in the definition of dietary supplements under the Federal, Drug and Cosmetic Act.  The bill would also require a study and report from the U.S. Department of Agriculture, which oversees the production of hemp, on the regulatory and market barriers for farmers engaged in hemp production.  This would inform growers and policy makers of the challenges facing this new industry.
  • This bill would essentially amend the Dietary Supplement Health and Education Act (DSHEA) by carving out a specific exemption for hemp derived CBD, as DSHEA currently states that a dietary supplement cannot include an article that is approved or under investigation for use in a new drug or biologic, unless that article was previously included in the food supply.  This will remove the barrier for FDA to consider the use of CBD in food, including dietary supplements; however, food companies that wish to use CBD ingredients in their foods remain subject to the relevant laws and regulations that govern all food products, including those that require that food additives obtain premarket approval or be determined to be Generally Recognized as Safe (GRAS) for their intended use.
  • H.R. 5587 was referred to the House Subcommittee on Health of the Committee on Energy and Commerce, which is scheduled to hold a legislative hearing on cannabis policies next week.  We will continue to monitor any developments.