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Where can I find the restrictions the FDA places on the

manufacturers of dietary supplements with...
Where can I find the restrictions the FDA places on the manufacturers of dietary supplements with respects to such spuulements' health benefits. I've looked on www.fda.gov but have not found what I am looking for.
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Answered in 1 day by:
11/18/2017
Amber E.
Amber E., Attorney
Category: Legal
Satisfied Customers: 1,497
Experience: Experienced practitioner in areas of Divorce, Custody, Social Security, and Contract disputes.
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Good evening,

Unfortunately, you won't find that information because the law does not require manufacturers of dietary supplements to prove to FDA's satisfaction that their claims with respect to health benefits are accurate or truthful prior to their being sold, so there are no specific restrictions as to those benefits beyond limiting what can be said about them. Specifically, manufacturers cannot market their supplements as being a treatment or cure for any particular disease. Besides that, the FDA's primary role is to ensure that quality control measures are met and that the products are not dangerous, and they do that by monitoring any reports of "adverse events" that may appear once the supplements reach the consumers and by enforcing what regulations there are with respect to quality, which can be found here (https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm238182.htm). Additional information and resources can be found on the main page here (https://www.fda.gov/Food/DietarySupplements/).

Amber E.
Amber E., Attorney
Category: Legal
Satisfied Customers: 1,497
Experience: Experienced practitioner in areas of Divorce, Custody, Social Security, and Contract disputes.
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Customer reply replied 7 months ago

Hi Amber, Excellent response. I did not word my question properly. I knew the following: "Specifically, manufacturers cannot market their supplements as being a treatment or cure for any particular disease." What I was looking for was the source for this. You provided two links which I have printed out. If the source is in one of these links, please provide the section and paragraph. Otherwise please provide a third link. I don't mind an additional charge if this is considered a new question. I'm going to give you top marks in any event. Thank you. Dick H**********

Customer reply replied 7 months ago

Hi Amber, Excellent response. I did not word my question properly. I knew the following: "Specifically, manufacturers cannot market their supplements as being a treatment or cure for any particular disease." What I was looking for was the source for this. You provided two links which I have printed out. If the source is in one of these links, please provide the section and paragraph. Otherwise please provide a third link. I don't mind an additional charge if this is considered a new question. I'm going to give you top marks in any event. Thank you. Dick H**********

You're welcome. If you are looking for information specifically about that issue, then I would recommend that you look here (https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm103340.htm#N_1_) as the entire page is dedicated to that topic in greater detail. And what is great about it is that it both explains the limitations regarding how supplements may be described in plain language as well as provides citations and links to the relevant guidelines.

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Customer reply replied 7 months ago

Amber, Thank you. I am printing this out now and will review it over the next 12 hours. I will have a new question that I expect to pay an additional fee for. How do I start this second question so that I get you as my expert. I won't be ready to post this second question for maybe 12-24 hours. Thanks again for the great service. Dick H***********

You're very welcome. You will simply post a new question and include "For Amber" in the question. Thank you!

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Customer reply replied 7 months ago
Amber, your last post was more valuable to me than I was expecting. I want to increase my tip for you. How do I do that. Plus, having read the Guidance for Industry document, I don't need to pose the question I referenced in my last post. However, I will have a different "other" question for you after I do a bit more research on my end.

Thank you so much. I am not sure how that would be done, but I will forward your comment to our moderator for assistance. Thank you again!

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Customer reply replied 7 months ago
Amber, I want to tip you an additional $50, your last response was so valuable to me. Once we figure out how to do that, I've got another question. I will be out of the office for most of tomorrow, so please be patient with my next response.Thanks again.
Dick
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