Therapeutic Solutions International Inc (TSOI)

[agribusiness72]

Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.Also, manufacturers need to register themselves pursuant to the Bioterrorism Act with FDA before producing or selling supplements.

https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements