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Regulatory Considerations for Running Foreign Clinical Trials to Substantiate US Dietary Supplement Structure Function Claims Marketed to the US Population

Regulatory Considerations for Running Foreign Clinical Trials to Substantiate US Dietary Supplement Structure Function Claims Marketed to the US Population

Deciding to conduct a clinical trial is a risky undertaking. How can you be assured that the data will support your product after a lengthy trial? How much risk are investors or decision makers at your company willing to take? When should you start to worry about the Federal Trade Commission (FTC) and their jurisdictional authorities over whether you have sufficient “competent and reliable scientific evidence,” the substantiation standard in the US. When will FTC begin to paint a target on your back? Which competitors are sending letters to FTC and FDA questioning your evidence? Will the cost of completing a human clinical trial break my budget? It all seems to come down to cost, the Almighty Dollar, and the ultimate value proposition after weighing all of the known risks. There might be a more critical question to consider ― the where ― rather than the “how much”. Does the clinical trial for my dietary supplement (or drug) have to be conducted in North America or can it be conducted exclusively in a foreign country?

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