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June 4, 2025 By: Asa Waldstein

Delta-8 Inhalable Product

Takeaway -

Dangerous products will be cited even if they do not contain disease claims

Shocking warning letter! After writing this post for over 200 weeks, I am rarely surprised. However, this warning letter highlights some truly audacious and potentially extremely unsafe THC and mushroom vape products.

FDA cited this company for selling an inhalable delta-8 THC product called “D9 Smashers Peach Mango Delta-8.” However, I found some even more over-the-top products on their website, such as these products. Some of these ingredients I’ve never heard of, and I doubt their inhalant safety has been verified.

From website (product contains):“ Mushroom Extract, THC-A Diamonds, THC-P D8 & D10 THC, CBD Live Resin” and “ Loaded with Delta 11, Delta 8 Live Resin, HHC., THC-P., & THC-JD.”

There are also candy bars containing high amounts of THC and mushroom extracts in packaging that are considered “favorable to children.” Some of the product labels also contain cartoon characters with titles like “Darth Vapor.” Read about FDA/FTC’s thoughts on this and delta-8 safety.

In previous FDA/FTC warning letters, the FTC used Section 5 as a rationale for deceptive marketing allegations when delta-8 was sold in formats favorable to children, like gummies. I find this approach fascinating and clever.

“Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. This prohibition includes practices that present unwarranted health or safety risks….. preventing practices that present unwarranted health and safety risks, particularly to children, is one of the Commission’s highest priorities.”

So, what can we learn other than the obvious takeaways? FDA reviewed this company’s website over a long period in May and December of 2024 and then again in January 2025. I assume if the company had “gotten its act together,” it could have avoided this letter. I am not an expert on FDA processes and resource allocations, but it seems this letter should have been issued long ago. I am curious what resources we can lobby for that will help FDA get these bad products off the market sooner.

I ran Apex Compliance® on their website and found disease claims that, surprisingly, were not mentioned in this warning letter. If you are interested in a copy of the scan, send me a note.

Read the full FDA warning letter

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.

Written by

Asa Waldstein
Asa Waldstein
Asa Waldstein is a 24-year veteran of the dietary supplement industry, with experience spanning manufacturing, marketing, and regulatory compliance. He is the principal of Apex Compliance, a software company dedicated to streamlining regulatory marketing compliance for the dietary supplement and natural products sectors. Asa also leads Supplement Advisory Group, a boutique consultancy focused on marketing risk analysis, labeling, and practical compliance strategies for websites and social media. Asa has helped oversee three FDA GMP inspections with no 483s and was honored with the 2023 AHPA Herbal Hero Award and the 2024 What's Up Supps Policy and Change Agent Award. He currently serves as Chair of the American Herbal Products Association’s (AHPA) Cannabis Committee, helping shape policy and industry best practices