New Hope Network is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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.

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.