Last week, the FDA took off the gloves in its fight against illicit CBD products. The agency updated its consumer advisory on CBD to warn of possible negative side effects and issued 15 warning letters to CBD companies – which is more CBD-related warning letters than the FDA has issued in the past three years. Is the FDA foreshadowing expanded enforcement? Or merely reprimanding a handful of brands that are making egregious claims? Let’s take a deeper dive into the FDA’s latest batch of warning letters.

 

I. FDA Continues to Target Egregious Claims

It is clear that the FDA is continuing to focus on companies that make claims to treat serious diseases. In fact, 12 of the 15 warning letters cited claims to treat cancer.

 

For example: Whole Leaf Organics claimed that one of its CBD products “attacks cancer cells and help those struggling with advanced stage cancers.” Red Pill Medical claimed: “There are numerous anecdotal accounts of CBD doing great things including curing cancer, stopping seizures, chronic pain, treating obesity…the list goes on and on.” Koi CBD claimed that: “Not only does the research show that CBD benefits including being effective in fighting breast cancer cells, data also suggest that it can be used to inhibit the invasion of lung and colon cancer, plus it possesses anti-tumor properties in gliomas and has been used to treat leukemia.”

 

In these recent warning letters, the FDA also flagged claims to treat other serious conditions, including: HIV/AIDS, ADHD, Crohn’s disease, opioid addiction, autism spectrum disorders, diabetes, schizophrenia, and multiple sclerosis.

 

 

 

II. FDA is Concerned about Companies that Market CBD to Vulnerable Populations

 

The FDA also focused on companies that market CBD to vulnerable populations, including infants and children. In a warning letter to Natural Native LLC, the FDA noted:

 

“The Agency is particularly concerned that you market your unapproved new drug products for infants. Specifically, a post to your Facebook page links to an article entitled ‘CBD for Brain-Damaged Babies?’ in which the following statement is made, ‘[t]he launch of a clinical trial examining the use of CBD in newborns suffering from hypoxic ischemic encephalopathy (brain damage caused by lack of oxygen) means new hope for the million plus babies born each year with this condition.’ Your product has not been evaluated by the Agency for safety, effectiveness, and quality. The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations.”

 

In total, six of the 15 warning letters referenced groups considered “vulnerable” by the FDA. See FDA Warning Letter to Infinite Product Company LLLP (company markets “Asteroid Gummies” as “a treat to your kid”) FDA Warning Letter to Healthy Hemp Strategies LLC, doing business as Curapure (company sells “CBD Softgels for Kids, 10 mg”); FDA Warning Letter to Red Pill Medical Inc. (company claims that its products have had “a lot of good success in some older children…with autism”; FDA Warning Letter to Whole Leaf Organics LLC (company claims that one of its products reduces the occurrence of seizures in children); and FDA Warning Letter to Daddy Burt Hemp Co. (company markets products for children with autism).

 

II. FDA Targets Topical Products When They Are Marketed with Impermissible Claims

 

Some believe that the FDA has not targeted topical products. This is untrue. In this latest batch of warning letters, the FDA flags many topical CBD products that are marketed with impermissible claims, including claims to treat aches, pain, and inflammation. Some examples:

 

• Freezing Point CBD Topical Cream: “Freezing Point Cream[.] Freeze away all aches and pains… [P]ainkiller and muscle relaxant.”
• Afterglow Healing Oil 100mg CBD Total: “Great for new tattoos, eczema, psoriasis, acne, scarring, or open wounds.”
• Sunflora CBD Daytime Ageless Moisturizer: “CBD has been shown to promote abnormal cell death in certain skin conditions and long been used as a topical pain and anti-inflammatory solution.”
• CBD Lip Therapy: “Apex CBD Lip Therapy helps cells regenerate…”
• CBD Hemp Lotion: “Apex CBD lotion is the answer for sore muscle aches.”
• CBD Oil Infused Balm: CBD Oil infused balm is a powerful topical cream designed for sore muscles, or areas where pain is felt.”
• Ultra Eye CBD Repair Cream: “Anti-inflammatory properties help reduce puffiness”

 

IV. FDA Flags CBD Added to Conventional Food

Of the 15 warning letters, 11 cited CBD as an ingredient in conventional food products. For example, the FDA warned Organix Industries about its Plant Organix brand CBD peanut butter. It also issued warnings about CBD-infused chocolate bars, gummy bears, water, caramels, and non-dairy creamer. The FDA also noted that it is unable to conclude that CBD is “generally recognized as safe” (GRAS) for use in conventional foods

 

V. FDA Flags CBD Animal Products

Of the 15 warning letters, 13 referenced CBD products marketed for animals. Most animal products were marketed for household pets.

 

However, in its warning letter to Apex Hemp Oil, the FDA flagged a product intended for livestock. In its related news release, the FDA specifically mentioned this product, noting that the agency “remains concerned about the safety of human food products (e.g. meat, milk, and eggs) from animals that consume CBD, as there is a lack of data establishing safe CBD residue levels.”

 

VI. FDA Cites Claims Found in Social Media

Nine of the warning letters cited claims found on social media, including Instagram, Facebook, and Twitter. For example, the FDA flagged the following:

 

• Daddy Burt LLC (September 7, 2019 Twitter post): “Amazing new study from May showing CBD’s potential to help opioid addictions!  Not only can it be a pain reliever to help people avoid them in the first place, but can ease withdrawal as well.”
• Infinite Product Company LLLP (June 21, 2019 Instagram post): “Oxidative stress can trigger serious health issues, like cancer, heart disease, and Alzheimer’s. CBD is a patented neuroprotective antioxidant.”
• Red Pill Medical (August 7, 2019 Facebook post): “Red Pill Medical CBD Formula 1 Full Spectrum 50 mg CBD with less than .3% THC was applied directly to a customer’s presumed skin cancer spot over 3 days.  Day 1 it was inflamed and painful. By day 3, with daily application, the redness and inflammation was drastically reduced and almost gone. And the pain was gone.”

 

Despite the FDA warning letters, as of December 1, 2019, all three of these posts were still active on social media.

 

VII. Conclusion

What have we learned from last week’s FDA crackdown? The agency appears to target companies that: (1) market CBD with egregious claims, including claims aimed at vulnerable populations and claims found on social media; (2) offer more than one violative category of CBD (e.g., companies selling a mix of CBD dietary supplements, conventional foods, and animal foods); and (3) market CBD to new and unstudied groups, including food-producing animals. It is also clear that the FDA targets topical CBD, where it is marketed with problematic claims.

 

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