1 reply to this topic

[mtelander]

Does anyone know the specific regulation or the verbiage around the 2% rule for dietary supplements?

 

I just know that it applies to processing agents only like Magnesium Stearate, sipernat, that as long as it is under 2% it does not need to be declared on the label but if an ingredient is added to a formula to aid in "flowability" that it needs to be declared even if it is under 2%?

[amathon]

It seems like mentioning an igredient to help product flowability gives it a technical/functional status.

 

Here is a little blurb from Chat GPT (remember, chat GPT can get things wrong):

 

when it comes to product flowability, ingredients used to improve flow (e.g., anti-caking agents or excipients) must be declared if they serve a functional purpose in the final product. If a material impacts the flowability of a dietary supplement or food product, it is no longer considered a processing aid and should be included on the ingredient label. The 21 CFR 101.100 exemptions only apply to substances that don't have a technical or functional effect in the finished product.