The Food and Drug Administration (FDA) issued warning letters to five companies late last month on Monday, November 21, 2022, claiming that they are illegally selling products containing cannabidiol (CBD). The companies targeted are 11-11-11 Brands, CBD American Shaman LLC, Infusionz LLC, Naturally Infused LLC, and Newhere Inc. dba CBDFX. In its Constituent Update, the FDA states broadly that the companies are selling CBD products “that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.”1
Historically, the FDA has focused its enforcement efforts on CBD products marketed as dietary supplements and on those claiming unfounded medicinal properties. For example, on December 22, 2020, the FDA issued five warnings letters to companies for selling products containing CBD, all addressing the “illegal marketing of unapproved CBD products claiming to treat medical conditions” and the “impermissible marketing of CBD products as dietary supplements.”2 It appears the FDA has continued concerns with unfounded health claims and there is no indication that they will let up on this issue anytime soon. The Constituent Update on the five warning letters issued last month claims the companies are “illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases…”3
In addition to enforcing the unfounded health claims, four of the five warning letters also indicate that the FDA is cracking down on CBD products marketed to children. The FDA states it is particularly concerned that products are in forms “that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children.”4 Some of the noted CBD products at issue are gummies, fruit snacks, gum, candies, lollipops, and cookies. Because CBD has previously been studied as a drug (it is the active ingredient in the approved drug, Epidiolex), the FDA is equating CBD products to untested drugs that can have “unpredictable and unintended consequences, especially in vulnerable populations, such as children.”5
The set of letters issued earlier this week are aggressive and effectively take the position that all CBD use is illegal. The letters collectively cite violations for the introduction of CBD into food products, which appears to be a new enforcement priority for the FDA. Essentially, the FDA is taking the stance that any CBD introduction into food products is a drug that has not gone through the approval process to be generally regarded as being safe. In fact, the FDA is exceptionally concerned that high levels of CBD are harmful, stating “the available data raises serious concerns about potential harm from CBD added to conventional food.”6
Some of the noted concerns are not particularly out of the ordinary, like marketing unsubstantiated health claims or failing to list CBD as an ingredient on the label. However, the FDA has gone a step further with this round of letters by citing a host of dramatic concerns, such as the potential for liver damage, and “interfere[nce] with the development and function of testes and sperm, decrease testosterone levels, and impair[ed] sexual behavior in males.”7 The FDA also mentions its serious concern in “Delta-8 THC ha[ving] psychoactive and intoxicating effects.”8
The table below outlines the issues cited in the recent warning letters:
| 11-11-11 Brands | CBD American Shaman, LLC | Infusionz, LLC | Naturally Infused LLC | Newhere Inc. dba CBDFX | |
| Adulterated Human Foods / Unsafe food additive | X | X | X | X | X |
| Appealing to Children | X | X | X | X | |
| Risk of unintended CBD consumption by consumers | X | X | X | X | X |
| Detrimental health and welfare consequences for animals / Unapproved new animal drug | X | X | X | X | |
| Unapproved new human drug | X | X | X | ||
| Misbranded drug | X | X | X | ||
| CBD product contains caffeine9 | X | X | |||
| Failure to list CBD as an ingredient on the product label | X | X | |||
| Introduction into interstate commerce | X | X | X | X | X |
| Dietary supplement labeling | X | X |
The five companies have fifteen days from receipt of the letter to respond to the FDA with the specific steps taken to correct the violations. Failure to do so may result in legal action including seizure and injunction.
Dykema will continue to monitor and provide updates on FDA's policy and enforcement positions on these matters. CBD manufacturers, wholesalers, and retailers need to be vigilant of FDA policy changes on CBD. CBD products exist in an incredibly complicated regulatory environment given that CBD is an FDA-approved pharmaceutical drug in Epidiolex. Businesses actively involved or seeking to get involved in the multi-billion dollar CBD industry need to ensure that they stay in compliance with a patchwork of varying state and federal laws and regulations. Dykema's Cannabis Industry group consists of experienced FDA and regulatory attorneys that can help guide your business through this regulatory labyrinth.
Footnotes
9 The FDA explains “evidence suggests that CBD may affect caffeine metabolism and may increase and/or prolong caffeine's effects.” https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/11-11-11-brands-627690-11162022
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