CBD warning letters are up 420% this year, and this recent batch of five warning letters has some excellent learning opportunities.
Here are some key takeaways from the recent “Big Five” FDA warning letters.
🔷One of the warning letters did not include disease claims. This is rare!
🔷CBD in food products that are favorable to children, like lollipops and cookies, is top of mind for FDA.
🔷FDA purchased and tested all five products.YouTube claims continue to be cited, even old videos.
🔷40% of warning letters include CBD and animal products!
🔷OTC products with CBD, like sunscreen, are very risky.
The biggest news is one of these letters does not include disease claims. There may have been one or two CBD letters ever that did not include risky claims. The products cited are beverages that contain some caffeine and hemp extract. FDA’s concern is related to CBD posing delayed caffeine metabolism. If you sell CBD and caffeine products, I would remove them from the market asap. This warning letter confirms that the labeled “hemp extract” is CBD by testing, citing a COA on the website, and citing blogs on the website. It’s interesting to see how FDA “ties it all together.” I ask, “If there was no caffeine in the product, would the company have been issued a warning letter?”
Here is the letter. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/11-11-11-brands-627690-11162022
Many of these letters include CBD in food products such as lollipops, cookies, and infused sugar. This is a problem for FDA because these food formats are favorable to children who may consume too much CBD resulting in a possible health concern. These are not form factors used in the supplement industry; they seem unnecessary and poor formats for delivering CBD.
FDA purchased and tested products from all five companies that received warning letters. I have not seen a reference to the FDA purchasing and testing products in any 2022 warning letters. What are your thoughts on this?
Two of these warning letters reference five-year-old social media posts. Here’s a post about this. https://www.asawaldstein.com/warning-letter-wednesday/6-year-old-social-media-posts-%26-hashtags-in-warning-letter
One warning letter mentions Delta-8. Here’s a video about Delta-8 enforcement. https://www.youtube.com/watch?v=Ut4um-udniQ
More YouTube claims are cited, including a 3-year-old video in this letter. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/newhere-inc-dba-cbdfx-629243-11162022
When social media and YouTube claims are mentioned in letters, FDA demonstrates the commercial bridge with statements like this “which direct consumers to your website to purchase your products.” Here is a post about this. https://www.asawaldstein.com/warning-letter-wednesday/youtube-claims-lead-to-warning-letter
From one of the warning letters. “From your YouTube social media” “July 16, 2019 video – “CBD has been shown to help with a lot of different things like anxiety, stress, pain, and inflammation, and even help with seizures.”
40% of this year’s CBD warning letters involve CBD and animal products, which continue to attract increased scrutiny. The FDA seems to have a lower “allowance” for claims about CBD and animal products. For example, “anxious feelings” for pets may be enough to attract a warning letter, whereas it’s unlikely this statement would trigger a human product warning letter on its own. Here’s a post and video about animal and CBD claims enforcement. https://www.asawaldstein.com/warning-letter-wednesday/fda-crackdown-on-cbd-in-animal-products
Two of the letters include references to OTC drugs, including one involving sunscreen and CBD. This letter cites CBD as an active ingredient in the sunscreen product, a huge error. Anyone who has been paying attention knows FDA takes an unfavorable stance on CBD as an active or an inactive ingredient in OTCs. I write more about this here. https://www.asawaldstein.com/warning-letter-wednesday/marketing-cbd-in-otc-drugs-is-risky Here’s the warning letter that mentions sunscreen. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cbd-american-shaman-llc-628753-11162022
Here’s FDA’s constituent update on these warning letters. https://www.fda.gov/food/cfsan-constituent-updates/fda-warns-companies-illegally-selling-food-and-beverage-products-contain-cbd
Kind regards,
Asa Waldstein
https://www.AsaWaldstein.com
Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.
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