Unallowable Ingredient “Enough” to Trigger Regulatory Action
Delta-8 is a high-risk ingredient
There has been a recent enforcement trend where having an unallowable ingredient in a product can result in a warning letter, even if no disease claims or GMP violations are mentioned.
This warning letter is the sixth CBD or delta-8 related warning letter this year, which shows that FDA is still taking this enforcement seriously, especially when delta-8 is added.
Here’s a recent write-up on an unallowable (or possibly an un-submitted NDI) ingredient triggering a warning letter. I usually don’t call out company or product names, but this one is too strange to pass up.
From warning letter: “Trippy Smak’d Fuk’d Blend Watermelon 1500 mg Gummies”
I would call this letter a “low effort” warning letter, but FDA actually purchased the product and tested it for delta-8. The moral of the story is that any company selling delta-8, even if they are not making disease claims, should be put on notice that the FDA is paying attention, especially if the delta-8 products are in packaging and formats favorable to children.
Learn more about FDA’s position and its safety concerns here.
Read the letter here.
Written by
