Hordenine HCL Ingredient Leads To Warning Letter
Ensure ingredients are lawful for supplements
The product in this warning letter contains hordenine HCL, which FDA does not consider a dietary ingredient. Adding this into a supplement makes it an adulterated product which is a violation that, although unlikely, could potentially lead to other penalties such as criminal action.
👉From warning letter. "Because hordenine HCl does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your …. products are adulterated "
I see ingredients like this in two categories.
🔷NDIs: Hordenine, higenamine, octopamine
🔷Impermissible dietary ingredients: Hordenine HCL, higenamine HCL
The FDA differentiates NDIs such as hordenine from impermissible dietary ingredients such as hordenine HCl. You will notice that "HCL" (hydrochloride) is the difference between an NDI and an impermissible ingredient.
Here is a warning letter where FDA states hordenine in an NDI. This is really interesting.
The reason this company received a warning letter is simply because they added this impermissible ingredient into a supplement. This letter does not contain disease claims or reference the use of pharmaceutical drugs like sildenafil, which is rare. I ran Apex Compliance, my compliance program, on their website and found several disease claims that surprisingly went undiscovered by FDA. This is a great reminder that now is the time for an online compliance tune-up. This is a service I offer, or this program will be available in just a couple of weeks.
In a bizarre warning letter notation FDA writes that the company's terms and conditions state they are the property of another company. FDA contacted this other company, who said they have no relationship with the company in this letter. I can only guess this company may have copied another's terms and conditions without changing names. Who knows, but it is worth reading here. Read the full warning letter here.
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.