Quick Question for Those with Supplement/FDA Business Experience

[Ben Adams]

I'm in the process of starting my own fastlane business, a supplement brand.
Now it seems the FDA is relatively lax with supplements, but they do require a hard copy of a letter sent to them with a list of all the health and structure claims you make on your label, website, etc.. with scientific sources and clinical trials backing up those claims.

I found sources for all of my claims pretty much since i'm not lying in my advertising haha, but does anyone have any experience with submitting one of these?

The guidelines say nothing about how to cite the sources (or if just a link will suffice- this would be a lot easier for me since I have a ton of sources), how many sources are required for each claim, or how to format the document.

If anyone's been through this process and can give their .02 it would be greatly appreciated, I have no idea what to expect in terms of strictness or how close they're going to review the sources.

Thanks

 

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[MoreVolume]

I'm in the process of starting my own fastlane business, a supplement brand.
Now it seems the FDA is relatively lax with supplements, but they do require a hard copy of a letter sent to them with a list of all the health and structure claims you make on your label, website, etc.. with scientific sources and clinical trials backing up those claims.

No they don't. Having that information ready to provide is great, especially if someone challenges your claims in the future. But the FDA doesn't require any of that stuff. As long as your labeling has...your product name, the number of supplements, company, ingredient list and a variation of "dietary supplement" listed on your product, and you dont make false claims you're good in the eyes of the FDA. In all honesty, it'll probably take a while before they even realize that you exist, and even then its a long shot. There are so many supplement companies out there breaking the rules, and nothing has (or probably ever will) happened

 

[U2ForNow]

I'm not aware of the requirement either. I'm not directly in that business, but I do know people that are. Do you have a link to the FDA requirement? I know John McCain was one of the people pushing to regulate all vitamins, so obviously he gets money from big Pharm. It's probably an industry that is going to be regulated at some point with all the relabeling and scams.

 

[Ben Adams]

No they don't. Having that information ready to provide is great, especially if someone challenges your claims in the future. But the FDA doesn't require any of that stuff. As long as your labeling has...your product name, the number of supplements, company, ingredient list and a variation of "dietary supplement" listed on your product, and you dont make false claims you're good in the eyes of the FDA. In all honesty, it'll probably take a while before they even realize that you exist, and even then its a long shot. There are so many supplement companies out there breaking the rules, and nothing has (or probably ever will) happened

Thank you that's reassuring, it's been tough for me figuring this all out on my own since I don't know anyone whose been through the process. I was under the impression that the FDA requires a letter to substantiate claims based on this Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act but maybe it's more of just a recommendation. It's a huge relief that I don't have to do that, and since I compiled a list of sources it'll be convenient for reference.

 

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