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Unauthorized NDI Leads To Warning Letter

Only use permitted dietary ingredients or face regulatory issues

Unauthorized NDI Leads To Warning Letter

Warm greetings from 35,000 feet, as I am flying back from a 3-day whirlwind trip to participate in the Vitafoods Startup Award finals in Geneva.

This company received a warning letter for using N-Methyltyramine, an unauthorized New Dietary Ingredient (NDI), in its products. This shows that FDA is getting serious about enforcing the unauthorized NDI requirement.

FDA has sent warning letters for Hordenine (a similar molecule to N-Methyltyramine) in the past, but using these types of ingredients typically isn’t enough to attract a letter unless disease claims or GMP violations are present. In this instance, there were no disease claims or GMP violations present which should give companies pause before using certain NDI ingredients.

Read this WLW post about hordenine warning letters.

I predict this may be paving the way for more CBD and kratom letters, even if there are no disease claims present.

A similar ingredient to N-Methyltyramine is listed in FDA’s Information on Select Dietary Supplement Ingredients and Other Substances document. This includes some “off limits” products such as DMAA but also includes commonly used dietary ingredients like biotin. I would like to see this list clarified to show what FDA considers lawful dietary ingredients, unauthorized new dietary ingredients, and unallowed ingredients such as DMAA.

Read the 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.

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