10 Companies Cited for NDIs and Impermissible Ingredients

The FDA issued ten warning letters to companies selling products with New Dietary Ingredients (NDIs) and other impermissible ingredients such as hordenine HCl.

I see these ingredients in two categories.

• NDIs: Higenamine, hordenine, octopamine
• Impermissible dietary ingredients: 5-alpha-hydroxy-laxogenin, higenamine HCL, and hordenine HCL

FDA differentiates NDIs such as higenamine from impermissible dietary ingredients (higenamine HCl). You will notice that “HCL” (hydrochloride) here is the difference between an NDI and an impermissible ingredient.

Here is how FDA helps to define a dietary ingredient.

From Warning Letter: Higenamine is a “dietary ingredient” under section 201(ff)(1)(F) of the FD&C Act [21 USC § 321(ff)(1)(F)] because it is a constituent of aconite, asarum, lotus, and other botanicals.

Most of these warning letters include impermissible ingredients and NDIs with disease claims. There is one notable exception. This is the first time I’ve seen FDA issue a warning letter solely for using a New Dietary Ingredient (NDI) without a disease claim. This is surprising! Read this letter.

So what can we learn?

1) Companies should ensure they are not selling products containing any of these ingredients. I spoke about this “warning to industry” in a Warning Letter Wednesday post six months ago. 

2) As I say each week, removing disease words helps to reduce risk. Here is a video about tips for understanding if a claim is made. 

3) Most of these ingredients were removed from FDA’s Dietary Supplement Ingredient Advisory List. Just because ingredients are removed from this list, this action shows FDA. is still serious about removing them from the food supply. Find the list here.

Here is FDA’s constituent update.