Unallowable Ingredient Results in Warning Letter
Here are tips on using FDA’s ingredient directory
FDA cited a company for marketing sulbutiamine, an unallowable ingredient in their dietary supplement. This is different than the standard “drug-spiked” warning letter, where companies were hiding sildenafil and diclofenac in supplements. This company actually labeled their product as Sulbutiamine Plus Brain Support.
I find this warning letter interesting for several reasons. First, I do not see Sulbutiamine listed in FDA’s “Information on Select Dietary Supplement Ingredients and Other Substances” link or in previous warning letters. This link can provide some helpful information to show FDA’s thinking on why certain ingredients may be allowable. Ingredients are listed by category.
Here is the breakdown (from the FDA).
- Category 2: Ingredient is the subject of a safety communication
- Category 3: Ingredient is not a “dietary ingredient” under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
- Category 4: Ingredient is excluded from the dietary supplement definition under section 201(ff)(3) of the FD&C Act
- Category 5: Dietary ingredient has not met the safety standard in section 402(f)(1)(A) of the FD&C Act
- Category 6: New dietary ingredient has not met the safety standard in section 402(f)(1)(B) of the FD&C Act
- Category 7: New dietary ingredient requiring a premarket safety notification under section 413(a)(2) of the FD&C Act, but for which no notification has been submitted
This warning letter does not appear to mention that any commerce or testing occurred. It simply states that the company is selling a product with sulbutiamine, which is not a legal dietary ingredient or food additive. There is no statement such as “we reviewed your website over the past few months and see that you sell a product into interstate commerce.” FDA’s budget has been slashed, and we may see more of these low-lift letters in the future.
I also ran the company’s website through Apex Compliance and found that the company is making disease claims on many other products but no disease claims are mentioned in this warning letter.
I Googled sulbutiamine and found many well-known companies selling this ingredient. I expect more enforcement and private litigation around this ingredient in the near future.
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