By Mike Montemarano, Associate Editor11.28.22
The U.S. Food and Drug Administration (FDA) recently sent warning letters to five companies selling products containing cannabidiol (CBD). The five warning letters were issued to: 11-11-11 Brands; Naturally Infused LLC; Newhere Inc dba CBDFX; Infusionz LLC; and CBD American Shaman LLC.
In each warning letter, FDA said it was concerned that consumers could confuse the listed products for conventional foods and beverages, resulting in unintentional consumption or overconsumption of CBD. This is especially true for gummies, hard candies, and cookies containing CBD, which the agency said are appealing to children.
The agency said it was concerned with CBD’s potential effects on reproduction, the liver, and drug interactions, and noted there is still insufficient safety data for human consumption.
In some letters, FDA alleged that companies violated other areas of the federal Food, Drug, and Cosmetic Act. Some products allegedly claimed to cure, mitigate, treat, or prevent various diseases, while other companies added CBD to animal foods such as pet treats.
FDA doesn’t consider CBD to be a legal dietary ingredient in accordance with the Dietary Supplement Health and Education Act (DSHEA), because it was first approved as a drug called Epidiolex. The agency rejected two New Dietary Ingredient Notifications (NDINs) for CBD products last year.
Earlier this year, the agency also sent five warning letters to companies marketing products containing CBD and delta-8 tetrahydrocannabinol (THC) as dietary supplements.
“Many of these products can easily be mistaken for conventional foods that are commonly consumed by children and may cause harm,” they said in a joint statement. “Food ingredients must be shown to be safe to be lawfully added to food […] this safety standard considers both potential exposure and different types of consumers, such as someone who consumes it every day throughout their lifetime or throughout pregnancy.”
Further, using food as a means of administering CBD makes it difficult for a person to control how much CBD they’re taking, they noted. “We’re holding CBD to the same standard that we would any other substance that is intentionally added to food, like sweeteners or preservatives,” they wrote.
Key Takeaways
This is the first round of warning letters related to CBD in which the agency called out specific products because they might appeal to children or might be confused with “traditional foods,” said Rend Al-Mondhiry, partner at Amin Talati Wasserman.
“Also, in contrast to previous warning letters, these letters do not focus as heavily on disease claims, or don’t mention disease claims at all. This is the first time we’ve seen FDA raise concerns about CBD’s interaction with caffeine. It seems FDA is sending a clear, focused message regarding its concerns with these types of CBD products […] Currently, there is no clear pathway for either CBD food or supplements but the agency seems to be signaling greater concerns with CBD foods/beverages specifically.”
According to Asa Waldstein, compliance and regulatory consultant and principal of Supplement Advisory Group, through warning letters, FDA is signaling that it’s increasingly impatient with companies (of all sizes) that sell CBD in foods and beverages; make disease-related claims; and sell products containing Delta-8 THC, which has “obvious intoxicating and residual solvent safety concerns.”
Waldstein noted that FDA sent over four times as many CBD-related warning letters in 2022 than in 2021.
“All five of these letters show that FDA purchased and tested their products for CBD, which is not mentioned in any other warning letters this year,” Waldstein noted. “Also, four of the five warning letters mention CBD and animal claims which is a continued enforcement trend. Claims made about animal benefits have been mentioned in 40% of this year’s CBD warning letters. Interestingly, even mid-risk animal and CBD claims such as ‘anxious feelings’ can tip the scale into warning letter territory.”
FDA has also been more active in voicing interpretations of the drug preclusion provision of DSHEA in cases besides CBD, including N-acetyl-cysteine (NAC) and nicotinamide mononucleotide (NMN).
“FDA’s actions in the case of NAC and most recently NMN raise significant concern for the industry and are likely to discourage innovation and more importantly, the filing of NDI notifications—a significant threat to the industry overall,” said Al-Mondhiry. “Beyond simply avoiding disease claims, express and implied, companies should be reviewing the regulatory status of all dietary ingredients they sell and ensuring the safety of each. But absent a statutory fix to the drug preclusion, it’s possible additional ingredients may be at risk.”
“Although one company’s NMN ‘good-day’ acknowledgement letter now seems to be in vain, preparing safety data and submitting new dietary ingredient notifications to FDA is still the best way to inform FDA of a product’s safety if it was marketed in its current form after Oct. 15, 1994,” said Waldstein.
Warning letters are important to continuously review when developing product claims. Most recently, FDA issued a batch of warning letters to showcase problematic claims related to cardiovascular health.
“These letters are a good reminder to review FDA’s guidance on structure/function claims and the final rule itself (21 CFR 101.93), as these resources provide important insights into how the agency distinguishes between disease claims and structure/function claims, including implied disease claims which can be tricky,” said Al-Mondhiry. “It’s also a reminder to review not only product label and website claims, but also all social media sites as well as retailer product pages that the company controls.”
In each warning letter, FDA said it was concerned that consumers could confuse the listed products for conventional foods and beverages, resulting in unintentional consumption or overconsumption of CBD. This is especially true for gummies, hard candies, and cookies containing CBD, which the agency said are appealing to children.
The agency said it was concerned with CBD’s potential effects on reproduction, the liver, and drug interactions, and noted there is still insufficient safety data for human consumption.
In some letters, FDA alleged that companies violated other areas of the federal Food, Drug, and Cosmetic Act. Some products allegedly claimed to cure, mitigate, treat, or prevent various diseases, while other companies added CBD to animal foods such as pet treats.
FDA doesn’t consider CBD to be a legal dietary ingredient in accordance with the Dietary Supplement Health and Education Act (DSHEA), because it was first approved as a drug called Epidiolex. The agency rejected two New Dietary Ingredient Notifications (NDINs) for CBD products last year.
Earlier this year, the agency also sent five warning letters to companies marketing products containing CBD and delta-8 tetrahydrocannabinol (THC) as dietary supplements.
Safety Data Is Still Lacking
Douglas Stearn, deputy center director for regulatory affairs at FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Kristi Muldoon Jacobs, deputy office director at FDA’s Office of Food Additive Safety, discussed the rationale for the recent warning letters in more detail.“Many of these products can easily be mistaken for conventional foods that are commonly consumed by children and may cause harm,” they said in a joint statement. “Food ingredients must be shown to be safe to be lawfully added to food […] this safety standard considers both potential exposure and different types of consumers, such as someone who consumes it every day throughout their lifetime or throughout pregnancy.”
Further, using food as a means of administering CBD makes it difficult for a person to control how much CBD they’re taking, they noted. “We’re holding CBD to the same standard that we would any other substance that is intentionally added to food, like sweeteners or preservatives,” they wrote.
Key Takeaways
This is the first round of warning letters related to CBD in which the agency called out specific products because they might appeal to children or might be confused with “traditional foods,” said Rend Al-Mondhiry, partner at Amin Talati Wasserman.
“Also, in contrast to previous warning letters, these letters do not focus as heavily on disease claims, or don’t mention disease claims at all. This is the first time we’ve seen FDA raise concerns about CBD’s interaction with caffeine. It seems FDA is sending a clear, focused message regarding its concerns with these types of CBD products […] Currently, there is no clear pathway for either CBD food or supplements but the agency seems to be signaling greater concerns with CBD foods/beverages specifically.”
According to Asa Waldstein, compliance and regulatory consultant and principal of Supplement Advisory Group, through warning letters, FDA is signaling that it’s increasingly impatient with companies (of all sizes) that sell CBD in foods and beverages; make disease-related claims; and sell products containing Delta-8 THC, which has “obvious intoxicating and residual solvent safety concerns.”
Waldstein noted that FDA sent over four times as many CBD-related warning letters in 2022 than in 2021.
“All five of these letters show that FDA purchased and tested their products for CBD, which is not mentioned in any other warning letters this year,” Waldstein noted. “Also, four of the five warning letters mention CBD and animal claims which is a continued enforcement trend. Claims made about animal benefits have been mentioned in 40% of this year’s CBD warning letters. Interestingly, even mid-risk animal and CBD claims such as ‘anxious feelings’ can tip the scale into warning letter territory.”
The Broader Context
There has been an uptick in FDA activity in terms of warning letter batches that represent issues of concern to the agency.FDA has also been more active in voicing interpretations of the drug preclusion provision of DSHEA in cases besides CBD, including N-acetyl-cysteine (NAC) and nicotinamide mononucleotide (NMN).
“FDA’s actions in the case of NAC and most recently NMN raise significant concern for the industry and are likely to discourage innovation and more importantly, the filing of NDI notifications—a significant threat to the industry overall,” said Al-Mondhiry. “Beyond simply avoiding disease claims, express and implied, companies should be reviewing the regulatory status of all dietary ingredients they sell and ensuring the safety of each. But absent a statutory fix to the drug preclusion, it’s possible additional ingredients may be at risk.”
“Although one company’s NMN ‘good-day’ acknowledgement letter now seems to be in vain, preparing safety data and submitting new dietary ingredient notifications to FDA is still the best way to inform FDA of a product’s safety if it was marketed in its current form after Oct. 15, 1994,” said Waldstein.
Warning letters are important to continuously review when developing product claims. Most recently, FDA issued a batch of warning letters to showcase problematic claims related to cardiovascular health.
“These letters are a good reminder to review FDA’s guidance on structure/function claims and the final rule itself (21 CFR 101.93), as these resources provide important insights into how the agency distinguishes between disease claims and structure/function claims, including implied disease claims which can be tricky,” said Al-Mondhiry. “It’s also a reminder to review not only product label and website claims, but also all social media sites as well as retailer product pages that the company controls.”
