- 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.
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FDA Issues Warning Letters to Four Companies Selling Unapproved CBD Products for Food-Producing Animals
- 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.
FDA and FTC Issue Warning Letters to CBD Companies
- 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.
House Introduces Bill to Regulate CBD in Food
- 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.”
FDA Reaffirms Need for More Safety Data on CBD
- 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.
CBA Calls on FDA to Regulate CBD 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 Unveil Draft Bill with Pathway for CBD
- 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.
New Bipartisan Senate Bill Seeks Movement on CBD
- 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.
FDA Issues Warning Letters to Companies Selling CBD Products for Pain Relief
- 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.
CBD Suit Stayed Pending Further Action from FDA or Congress
- 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.