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Is Nerve Renew FDA approved?



 Not at all. It’s a vitamin supplement, so it’s not “FDA approved” as much as it is considered GRAS, since the FDA doesn’t approve supplements.


They’ll spout how it’s formulated in an FDA registered facility, but that’s just a paperwork thing. The FDA has the right but not the responsibility to inspect the facility for things like cleanliness - that’s the “GMP certified” part, which just means “good manufacturing practice.” So the place may never have been visited by the FDA at all, just that a registration form has been filed at some point.


From the FDA site:  Is Nerve Renew FDA approved


“FDA doesn’t approve dietary supplements.


Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety and effectiveness. Unless an exception applies, dietary supplements that contain a new dietary ingredient (a dietary ingredient not marketed in the United States before Oct. 15, 1994) require a notification to FDA at least 75 days before marketing.


The notification must include the information that provides the manufacturer’s or distributor’s basis for concluding that the dietary supplement will reasonably be expected to be safe. When public health concerns arise about a dietary supplement after the product is on the market, FDA evaluates the product’s safety through research and adverse event monitoring.”

and…


“FDA doesn’t approve companies.


FDA does not “approve” health care facilities, laboratories, or manufacturers. FDA does have the authority to inspect regulated facilities to verify that they comply with applicable good manufacturing practice regulations.


Owners and operators of domestic or foreign food, drug, and most device facilities must register their facilities with FDA unless an exemption applies.”

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