Another Delta 8 Warning Letter
Repeat warning letters can have serious consequences
FDA recently sent out another delta 8 warning letter. This is interesting because it's the second warning letter this company has received. The last one was in 2019 and was disease-claim-related, while this recent letter only cites the company for selling delta 8.
🔷 Repeat warning letters can lead to serious ramifications such as product seizure, injunction, or criminal prosecution.
🔷 This company is actually lucky FDA also didn't cite them for disease claims. I ran Apex Compliance, my subscription compliance program, on their website and found several issues. Learn more about Apex Compliance.
🔷 Delta 8 is a potential problem for several reasons, including concerns about safety, residual solvents, intoxication, and dangers to children. I write more about this here.
🔷 What "tipped the scale" into warning letter territory is the marketing of products that are favorable to children, such as gummies and "pot rocks" candy. Based on the recent delta 8 letters, I am unsure if a capsule or tincture product would have attracted the same attention. The takeaway here is that companies selling delta 8 are a high risk for FDA enforcement, especially if they sell products in forms favorable to children, such as gummies and candy. This includes platform sites like a mini Amazon that sell other brands products.
Here are some other reasons to avoid warning letters.
🔹 Requires legal resources to respond to
🔹Distributors, insurance, and credit card companies can drop you
🔹Scares away investors and strategic partners
🔹Triggers plaintiff lawsuits
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.