1 reply to this topic

[Brothbro]

Hello all, putting in a bit of work this Christmas Eve before I head home to get the ham started. I work in Dietary Supplements in the USA, and our company is looking into developing some probiotics products. This is new territory for us, so I have a labeling question:

 

In probiotics, some strains are freeze-dried to create a probiotic powder. This powder is treated with a "cryoprotectant", a substance that ensures the stability of the probiotic bacteria over the shelf-life of the product. My question is: does this cryoprotectant need to be listed in the ingredients of a dietary supplement? My thought would be that yes it does, for the same reason you'd need to claim a binder or excipient. This would be in line with 21 CFR 101.4(g) which states:

 

 

 

... Ingredients in dietary supplements that are not dietary ingredients or that do not contain dietary ingredients, such as excipients, fillers, artificial colors, artificial sweeteners, flavors, or binders, shall be included in the ingredient list.

 

When speaking with these suppliers, these cryoprotectants are often brand-named and proprietary. They say they're not required to be listed on ingredients lists, but I can't see how that's in line with the regulation. Am I missing something?

[SophieS]

You're correct that ingredient used in a dietary supplement typically need to be listed on the label under FDA regulations. According to 21 CFR 101.4(g)

If the cryoprotectant is still present in the finished probiotic powder or supplement (even in trace amounts), it must be listed in the ingredients.

Analyze the final product to confirm if the cryoprotectant is detectable in the finished probiotic powder or supplement.

If it's part of a proprietary blend, it can be grouped with other ingredients under the blend, but its specific function should still be clear.