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10 things Fabricant told the industry this week

Wondering about the status of NDIs? Former FDA supps chief Fabricant says they "should be out this year." And nine other regulatory intel insights, right here.

Expo East appearance:
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For the last three years, Daniel Fabricant, Ph.D., was the U.S. Food and Drug Administration’s director of the division of dietary supplement programs. He now serves as CEO and executive director of the Natural Products Association. At Ingredient Marketplace in New York City this week, Fabricant gave a short address on what he learned at the agency. Here's a top 10 list. (With apologies to David Letterman, who's Late Night studio was just a few blocks away.)

  1. “The FDA responds to political pressure.”
  2. “For a $30 billion-plus industry, it’s not a big sum what the industry gives to politicians. We are about 50th in industry sectors, behind the cruise ship sector. It’s something we need to readjust.”
  3. “NDIs should be out this year.”
  4. “If one company files an NDI and another party says they have something that ‘looks like’ another NDI that has been filed and they don’t file, that does not cut it.”
  5. Of the 50 NDI applications per year received by the FDA, 19% receive “good day” letters, while 56% receive Inadequate Letters (IALs), which means there are concerns with identity, chemistry, toxicology or safety.
  6. “There is something to be said for working with the agency in advance of submitting your NDI application,” said Fabricant. He said that companies that do communicate with the FDA before they submit an application almost always get approved. Even if you get the common 56% IAL, you have the opportunity to go back and have a conversation and re-submit, but companies almost always do not. “But they should!”
  7. On claims, softer verbs are better: stimulate, maintain, support, regulate, promote, helps, mild & occasional.
  8. On national GMO legislation: There should be a hearing in the Energy & Commerce Committee later this summer.
  9. On “Natural”: “You have a lot of cases of companies suing each other. This one gets a little trickier because the FTC sometimes gets involved.” 
  10. Top 5 key issues at the FDA: GMPs, NDIs, claims, Adverse Events Reports, tainted products.




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