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August 4, 2011
As we wrap up a month of spirited, informative editorial on NDI draft guidance, one thing is clear: Not a lot is clear. Heck, I'm still trying to figure out if "draft guidance" is capitalized.
Lost in the analysis, worrying, and style questions is something worthwhile. For years, industry opponents have been whining about how the natural products industry is "unregulated," that it's a Wild West or some other not-so-clever description. After the past month, who can say that now?
The FDA released the draft guidance on July 1st. About three seconds later, all kinds of meetings and workshops were announced to help adjust to the changing landscape. Companies began to ask questions. FDA offered to answer them. CRN, AHPA, UNPA, NPA, and CHPA just petitioned the agency to extend the time allowed for comments.
All these actions provide a wonderful opportunity to educate detractors that the industry answers to a higher power.
If I ran a supplement company--a truly frightening prospect, but bear with me--I would reach out to any mainstream publication or public figure that took a swipe at the industry: "See, we're working with FDA right now. We have always played by the rules. Do you also know about GMPs? DSHEA? Oh, and FDA''s supplement honcho worked for an industry trade association for years. We've come a long way, and we're not done yet."
(Or something along those lines. You should probably be a smidge more diplomatic in your correspondence.)
Is there a silver lining to NDI draft guidance? Will it make the industry better? Or is this the beginning of something massively unpleasant? Comment below or start a new discussion.
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