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The committee that controls FDA’s purse strings is now turning up the pressure. Will we see change at last?
Action Alert!

The House Agriculture Appropriations Committee has released a report that, among other things, chastises the FDA for stalling on the second draft of their New Dietary Ingredient (NDI) guidance. The committee directed the FDA to end this “regulatory uncertainty,” issue a timeline for the NDI guidance, and include stakeholders in the process.

Specifically, the committee told FDA to report back by September 1 on how the agency plans to “develop new methods of communicating with its stakeholders on future actions including estimated timeframes for when regulations, advisories, and guidances are planned for release.” (NDI is included as an example of “guidances.”) The agency was also told to report back within sixty days of enactment of the Agriculture Appropriations bill with “a timeline on how it intends to re-engage the dietary supplement community to develop a final guidance on what constitutes a NDI.”

This is a tremendously important development.It was ANH-USA’s work with the committee that got them to compel a second draft of the guidance, and it was our lobbyists who helped include the important language in this new report.
This would not have been possible without your support and activism! THANK YOU!

You would think that because the House Ag Appropriations Committee controls the FDA’s purse strings, the agency would
have to listen to them. However, this same committee directed them to act before, and FDA did very little. Now, because the committee is turning up the volume, it pressures FDA to take action. FDA has now been specifically asked to provide a timeline, which would be hard for them to circumvent. We think it’s likely FDA will recognize that the committee is serious about all of this, and we hope that FDA will stick to the timeframe they provide.

The committee’s mention of an “uncertain regulatory environment” refers to the FDA dragging its feet on the NDI draft guidance. It has been close to two years since FDA submitted its initial draft guidance, and the agency has been promising to work with the supplement community on a second draft since October 2012-eight months ago!

An uncertain regulatory environment is, of course, not good for business. Companies don’t know what they can sell (and invest in) and what they can’t. Manufacturers will be less likely to submit NDIs for new supplements if they are unclear on what the requirements are. This will stifle innovation. And once again, consumers will be the losers.