• 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.
  • As our readers may recall, on November 25, FDA issued warning letters to 15 companies for illegally selling a variety of FDA-regulated products (for humans and animals) containing cannabidiol (CBD), in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA emphasized that CBD lacks an appropriate regulatory status for use in these products, and in some cases they bear impermissible drug claims, thereby rendering them unapproved new drugs that are also deemed misbranded and adulterated.
  • FDA sent a warning letter to, among others, Koi CBD LLC (Koi), referencing products such as balms, vape oils, tinctures, lotions, gummies, and beverage shots (for humans), and pet sprays and soft chews (for pets). FDA cited claims on the company’s website that CBD could be used to treat diseases and medical conditions such as various cancers, diabetes, multiple sclerosis, post-traumatic stress disorder, schizophrenia, opioid addiction, and Crohn’s Disease.
  • On December 5, 2019, plaintiffs Calley Fausett and Leigh Good filed a putative class action complaint against Koi in California federal court (Central District), alleging the company intentionally marketed and sold illegal products containing CBD. Among other things, plaintiffs allege the marketing and sale of these products constitute false, deceptive, and misleading practices and advertising; that plaintiffs would not have purchased the products (or would have paid less) had they been fully informed; and that the products lack adequate directions for use. The lawsuit is one of a growing number of private actions filed as a result of FDA’s recent warning letters that allege the use of CBD as an ingredient runs afoul of federal regulations. We will continue to monitor this case as well as other CBD-related lawsuits and regulatory actions.
  • As our readers may recall, on November 25, FDA issued warning letters to 15 companies for illegally selling FDA-regulated products containing cannabidiol (CBD) in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA alleged that CBD lacks an appropriate regulatory status in the products and, in some cases along with product claims, causes them to be marketed unlawfully.
  • One of the warning letters was sent to Infinite Product Company LLLP DBA Infinite CBD, in which FDA alleged Infinite was marketing unapproved drugs containing CBD. The FDA cited claims on the company’s website that CBD could alleviate symptoms of autism and can treat diseases like hepatitis, cancer, and Tourette’s syndrome.
  • On November 27, plaintiff Adam DaSilva filed suit against Infinite Product Co alleging the company sells food, supplement and cosmetic products that are unapproved new drugs in violation of federal law. DaSilva said in the proposed class action suit that Infinite Product’s CBD products are misleadingly labeled and are illegal to sell. In the complaint, DaSilva pointed to the FDA’s recent warning letter to Infinite Products, detailing numerous violations regarding its products, including skin creams and gummies. According to the complaint, there are “[m]any unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD.” Indeed, DaSilva noted that, in a revised Consumer Update, FDA stated that it “is not aware of any basis to conclude that CBD is [generally recognized as safe (GRAS)] for use in conventional [human or animal] food.”
  • The lawsuit appears to be one of the first private actions filed as a result of FDA’s recent warning letters that allege the use of CBD runs afoul of federal regulations. We will continue to monitor this case as well as other CBD-related lawsuits and regulatory actions.
  • On November 25, 2019, FDA issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The products cited in the warning letters cover a wide range of forms including oils, drops, dietary supplements, conventional food (including gummies, peanut butter, and water), vape pens, oral sprays, creams, and pet treats. In all cases, FDA alleges that CBD lacks an appropriate regulatory status in the products and, in some cases along with product claims, causes them to be marketed unlawfully. FDA repeats its long-standing position that CBD is not eligible to be used as an ingredient in conventional foods and dietary supplements, although the letters invite companies to submit evidence to rebut this conclusion.
  • FDA also published a revised Consumer Update detailing its continued safety concerns about CBD products more broadly. Notably, for the first time FDA has directly stated that it “is not aware of any basis to conclude that CBD is [generally recognized as safe (GRAS)] for use in conventional [human or animal] food.” In a statement, FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D noted, “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’”
  • These latest warning letters suggest that FDA may be taking more aggressive enforcement action and increasing its scrutiny of CBD-containing products. The statement about the absence of a basis for GRAS status for CBD in food is significant because even if the ineligibility issue can be overcome, FDA’s view is that CBD would need to be the subject of an approved food additive regulation before it could be used in human or animal food.
  • The Agency continues to defer fulfilling its commitment to report on its progress in evaluating potential regulatory pathways for CBD products. In its press release discussing the warning letters, FDA states that it now “plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.” Given FDA’s ongoing safety concerns and the present conclusion about the lack of GRAS status in food, it is clear that establishing a regulatory pathway for CBD in food and dietary supplements will need to address numerous significant challenges.
  • 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.
  • In the wake of rapidly increasing sales, FDA has continued to maintain that dietary supplements containing hemp-derived cannabidiol (CBD) are illegal under the Federal Food, Drug & Cosmetic Act. FDA officials have previously stated that the agency is exploring additional regulatory pathways available to hemp products containing CBD, but predicted that completing a potential rulemaking proceeding could span 3 to 5 years even under the best of circumstances.
  • Amidst Congressional pressure for FDA to act quickly in establishing a regulatory framework for CBD and outside efforts urging Congress to pass legislation that would make CBD derived from hemp a legal dietary ingredient, the Consumer Healthcare Products Associated (CHPA) submitted a citizen petition to FDA requesting that the agency issue regulations to establish a clear pathway for the use of CBD in dietary supplement manufacturers. CHPA expressed a preference for an interim final rule as opposed to full notice and comment rulemaking but asked that if notice and comment rulemaking was used that FDA issue guidance or an enforcement discretion position at the same time.
  • Under CHPA’s proposal, FDA should require manufacturers of CBD-containing dietary supplements to submit a new dietary ingredient notification (NDIN) for CBD and comply with other applicable laws, including using appropriate labeling and claims, adhering to GMPs, and reporting serious adverse events. The petition notes that requiring NDINs would provide FDA with much-needed data on CBD that could help inform FDA’s broader regulatory framework for CBD products. CHPA’s petition is consistent with the approach that we believe FDA is considering as it evaluates whether CBD can be authorized for use in dietary supplements.
  • On October 10, the FDA and FTC sent a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved drug products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), Parkinson’s and Alzheimer’s disease, among other conditions.
  • As described in the warning letter, the FDA and FTC stated that the company used its website, online store, and social media sites to make unfounded claims about its CBD products, some of which were also unlawfully marketed as dietary supplements. Examples of the claims include:
    • “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
    • “Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive and safe option for children.”
    • “CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson’s and Alzheimer’s disease.”
    • “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”
  • Additionally, the FTC was concerned that one or more of the efficacy claims cited may not be substantiated by competent and reliable scientific evidence. Under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence that substantiates the claims made.
  • The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. However, as our readers may recall, in July 2019, the FDA announced their commitment to evaluating potential regulatory pathways for CBD products to be lawfully marketed, and that the Agency would report their progress by early fall 2019. As of today’s blog, the Agency has yet to advise on such pathways. Nonetheless, in a press release related to the October 10 warning letter, Acting FDA Commissioner Ned Sharpless, M.D. stated that the CBD-related warning letters “should send a message to the broader market about complying with FDA requirements.” Additionally, he noted that as the Agency continues to examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains top priority.  We will continue to report on developments that impact the use of CBD in FDA regulated products.
  • On October 8, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the United Natural Products Alliance – a group of trade associations representing the dietary supplement and natural products industries, sent a letter to all 535 members of Congress urging them to pass legislation that would make cannabidiol (CBD) derived from hemp a legal dietary ingredient for use in dietary supplements.

 

  • The letter requests that Congress carve out a statutory pathway for the lawful introduction of CBD-containing supplements into the marketplace. Specifically, the proposed law would create a limited waiver of § 201(ff)(3)(B) of the Food, Drug, and Cosmetic Act (FDCA), which FDA has previously used to support its position that CBD may not be used in dietary supplements because it is an active ingredient in an FDA-approved drug and has been the subject of substantial clinical investigations. CBD derived from hemp would be exempt from this section, provided that the products meet established safety and quality criteria and comply with all other provisions of the FDCA. The letter also calls for increased funding on top of the $2 billion provided to FDA to address the issue of hemp-derived CBD in the FY 2020 Agriculture and Related Agencies Appropriations bills.

 

  • In the wake of rapidly increasing sales of hemp-derived CBD products, Congress has repeatedly pressured FDA to act quickly in establishing a regulatory framework for CBD. Thus far, FDA has stated that it is exploring additional regulatory pathways for CBD products, but that this process is likely to take 3 to 5 years. FDA maintains that dietary supplements containing hemp-derived CBD are illegal under the FDCA. Meanwhile, the Federal Trade Commission has stepped up enforcement against CBD products that are promoted via health-related claims.