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The Insider's Insight from Loren Israelsen

Loren IsraelsenRecent statements by FDA officials suggest they intend to push some sensitive buttons when GMPs kick in. For proprietary blends, suppliers may have to reveal precise formulations to a customer in order to satisfy the requirement that the material meets specification. This could wipe out the only meaningful IP protection many suppliers and manufacturers have under DSHEA. Suppliers would have to hand over carefully protected formulations to customers who would have to show them to an FDA inspector on request. I cannot imagine a case where an exclusive formulation will be handed over to anybody. Now is the time to explain this to the FDA and find another means of assuring conformity to specification.

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