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FDA Dietary Supplement Warning Labels

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Brothbro

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Posted 01 December 2022 - 07:18 PM

Hi All,

 

I have a question about the FDA requirements for warnings on dietary supplement labels. Specifically, the warnings typically posted to "Keep out of reach of children", "Stop use if unusual symptoms occur", and "Consult a physician before using if pregnant". Are these warnings actually required on the label by the FDA? My firm and many others have these warnings on their label, but I have recently noticed that some do not. Reviewing the labeling requirements from the FDA, I see no mention of these warnings. Is this just an industry commonplace, rather than a regulatory requirement? Labeling laws are so convoluted, even FDA inspectors have been unable to give straight answers at times.

 

I would also be interested to hear the Canadian and EU perspective on these warning labels.

 

Thank you!



Scampi

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Posted 01 December 2022 - 08:33 PM

It appears a warning is required for iron-containing supplements

 

https://www.fda.gov/...information#8-2

"However, by law, FDA does not approve dietary supplements or their labeling, although certain types of claims sometimes used in dietary supplement labeling require premarket review and authorization (e.g., health claims)."https://www.fda.gov/...ary-supplements

 

As for the other warning statements, my gut tells me it's a non regulated CYA statement

 

It took a bit of digging in Canadian regulations-but here you are 

https://www.canada.c...ngredients.html

 

https://laws-lois.ju....html#h-1372682

 

https://canadagazett...ors169-eng.html


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Brothbro

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Posted 01 December 2022 - 09:59 PM

Thanks Scampi, especially for digging up the info on the Canadian rules for "Cautionary Statements". It's interesting to see so many statement requirements related to specific vitamin content thresholds. In the US, I don't believe the FDA has this kind of requirement. Instead, some industries have regulated themselves internally (e.g., warning labels on energy drinks required by American Beverage Assoc members)


Edited by Brothbro, 01 December 2022 - 10:08 PM.


Scampi

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Posted 02 December 2022 - 02:45 PM

Happy to help

 

Looking from the outside--it appears that the FDA is almost afraid to make, never mind enforce, rules!


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