• 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.
  • A bipartisan group of members of Congress sent a letter to FDA on September 19 urging the Agency to quickly provide legal clarity and establish a regulatory pathway for food products containing hemp-derived cannabidiol (CBD). “We appreciate FDA’s proactive approach towards pursuing a legal pathway for the production of hemp-derived products containing CBD … However, FDA’s current regulatory posture on CBD has created significant regulatory and legal uncertainty for participants in this quickly evolving industry,” wrote the lawmakers.
  • Expressing concern about FDA’s estimate that a rulemaking process could span 3 to 5 years, the lawmakers stated, “We believe there are more expeditious measures that FDA could take that would establish regulatory clarity while pursuing enforcement actions against bad actors.” These include: first, announce a policy of enforcement discretion and, second, consider issuing an interim final rule to establish a clear regulatory framework for CBD as a dietary supplement and food additive.
  • This is not the first request from Congress to FDA to provide legal clarity on the use of CBD in foods and dietary supplements.
    • As previously reported on this blog, in a January 12, 2019 letter to FDA Commissioner Scott Gottlieb, Senators Ron Wyden (D-OR) and Jeff Merkely (D-OR) urged the Commissioner to update federal regulations governing the use of certain hemp-derived ingredients in food, beverages, and dietary supplements.
    • Congresswomen Chellie Pingree (D-Maine), who was the lead author on the September 19 letter, points out in a press release that she first wrote to FDA in February 2019 requesting guidance on legal pathways for food products containing CBD.
    • Last week, we reported on an amendment to the Senate appropriations bill that would require FDA to issue temporary guidance on enforcement related to products containing cannabidiol (CBD).
  • We will continue to report on developments in the regulation of CBD by FDA.
  • Senate Majority Leader Mitch McConnell (R-KY) has introduced language into a Senate appropriations bill that would require FDA to issue temporary guidance on enforcement related to products containing cannabidiol (CBD). 
  • The amendment, which was shared with the U.S. Hemp Roundtable, would require FDA to provide Congress with a report on how it will develop its enforcement discretion policy and how it will evaluate CBD for use in FDA-regulated products within 90 days of passage.  Within 120 days, FDA would be required to issue its enforcement discretion policy for CBD. 
  • The market for CBD products is rapidly increasing, and the regulation of CBD in foods and supplements has not kept pace.  McConnell has shown a great interest in limiting the regulatory uncertainty faced by hemp farmers in his state of Kentucky, where hemp production is replacing tobacco production. 

 

  • CBD-infused products continue to flood the market as the U.S. Food and Drug Administration (FDA) explores additional regulatory pathways for hemp products containing cannabidiol (CBD). Currently, under the Federal Food, Drug and Cosmetic Act, CBD cannot lawfully be added to a food or marketed as a dietary supplement.
  • On September 10, 2019, the Federal Trade Commission (FTC) sent warning letters to three unnamed companies that sell oils, tinctures, capsules, “gummies,” and creams containing CBD. The FTC said the three companies advertised that their CBD products treated or cured serious diseases and health conditions. For example, one company’s website claims CBD “works like magic” to relieve “even the most agonizing pain” better than prescription opioid painkillers. The letters warn the companies that it is illegal to advertise that a product can prevent, treat, or cure human disease without competent and reliable scientific evidence to support such claims.
  • Earlier in March 2019, the FTC and FDA sent similar warning letters to three companies. According to those advertisements, the products can effectively treat diseases, including cancer, Alzheimer’s disease, fibromyalgia, and “neuropsychiatric disorders.” Moving forward, expect both the FTC and FDA to continue using their enforcement authority to ensure that CBD-containing products are advertised truthfully.
  • As previously reported on this blog, state regulators want a role in the regulation of CBD-infused food, beverages, and supplements. And while industry has been pressuring FDA to create a pathway for the lawful use of CBD in food and dietary supplements, currently, under the Federal Food, Drug and Cosmetic Act (FD&C Act), CBD (or cannabidiol) cannot lawfully be added to a food or marketed as a dietary supplement.
  • Washington State Department of Agriculture (WSDA) updated its website this month to clarify that hemp-derived CBD is not permitted as a food ingredient or additive. WSDA points out that while food processors licensed in the state of Washington may currently use certain hemp products in foods—such as hulled hemp seeds, hemp seed protein power, and hemp seed oil—”[o]ther parts of the hemp plant, including CBD, cannot be used as a food ingredient under a Washington State Food Processor License.” The department further states, “Recognizing that these recent changes in law may have caused some confusion in the manufactured-food industry, WSDA has been reaching out to the industry so they can take appropriate actions, such as removing CBD ingredients from their products or discontinuing distribution of CBD-containing food products in the state.”
  • As recently as last week, Cara Welch, FDA’s Acting Special Assistant to the Deputy Commissioner for Policy Legislation & International Affairs, reminded attendees at the American Herbal Products Association Hemp-CBD Supplement Congress that it is prohibited to add CBD to food. Noting that, “There is still a significant amount of missing data to better understand the effects on human exposure and the long-term effects of regular consumption,” Welch pointed out that some studies show some toxic effects on the liver in high doses, and there is inadequate research about the use of CBD by pregnant or nursing mothers or people with low immunity (see U.S. News). She added, “We’re trying to be as transparent and informative as possible on these issues, and to resolve open questions quickly, efficiently, but also thoughtfully.”
  • Preliminary data on the growth of hemp-derived CBD was presented during the AHPA Congress. AHPA reports in a press release on the Hemp-CBD Congress that, hemp-derived CBD sales ballooned to $238 million, an increase of 57% in 2018 over the previous year, according to Nutrition Business Journal. Additionally, hemp acreage under license across the U.S. increased nearly five-fold in the past year from 112,000 acres in 2018 to 480,000 acres in 2019, according to data gathered by advocacy group votehemp.com. We will continue to report on developments in the regulation of CBD-infused food, beverages, and supplements.
  • In testimony before the U.S. Senate Committee on Agriculture, Nutrition, and Forestry on July 25, FDA’s Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., reiterated that FDA “is committed to advancing hemp products through the Agency’s existing regulatory pathways.” She added that the Agency is “further exploring whether it would be appropriate to make additional regulatory pathways available to hemp products such as those containing cannabidiol (CBD).” However, she did not provide any details on those pathways.
  • While any CBD food or purported dietary supplement products in interstate commerce is a violation of the Food, Drug, and Cosmetic Act (FD&C Act), FDA’s biggest concern in the marketing of CBD products is with unsubstantiated therapeutic claims to prevent, diagnose, mitigate, treat, or cure serious diseases, Dr. Abernethy told the Senate Committee. She noted several additional concerns, which are described below.
    • Lack of good manufacturing practices (GMPs) in the production of these products since laboratory analysis have shown that some of the CBD products on the market do not contain the amount of CBD that was listed on the label and confirm the presence of substances, such as THC, not listed on the label.
    • The use of CBD in non-drug products will have wider distribution than its use in drugs, to include sensitive populations.
    • The possibility that allowing CBDS to be marketed as a dietary supplement or in a food will deter clinical research to substantiate additional therapeutic uses for cannabis-derived compounds.
  • As previously reported on this blog, FDA held a public hearing on May 31, 2019, to obtain scientific data and information about the safety of FDA-regulated products containing CBD. FDA opened a public docket to collect comments as part of that hearing. The Agency received 4,492 comments by the time the docket closed on July 16, 2019. In a July 23 press release concerning a warning letter that FDA sent to a company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain, and pet anxiety, Dr. Abernethy explained that FDA remains committed to evaluating the Agency’s regulatory policies related to other types of CBD products. With respect to a timeline, she stated, “We plan to report our progress by early this fall as we expedite our work to address the many questions about CBD.”  Keller and Heckman attorneys are well versed on the regulation of CBD and other cannabis-derived products.