More Congressional Voices Protesting the NDI Draft GuidanceApril 3, 2012
Our campaign is catching fire, and Congress is continuing to drive the message home to the FDA. Action Alert!
This week fourteen members of Congress—all of them members of the House Energy and Commerce Committee—wrote to the FDA, raising their concerns about the NDI guidance which threatens our access to supplements. They highlighted many of our major concerns about the guidance:
- It doesn’t allow innovation: “We believe that regulations should provide useful clarity to the regulated industry [and] allow innovation and market forces to prevail,” they write. “The draft guidance on new dietary ingredients falls short on these criteria.”
- It is contrary to the intent of Congress: “Above all, [the guidance should] remain grounded in the statutory authority provided by Congress to the regulators….The draft guidance released by FDA in July of 2011 appears to undermine DSHEA in a number of critical respects….Congress expects and the industry needs FDA to develop a reasonable guidance document on this matter….that is consistent with the DSHEA.”
- It is a de facto pre-market approval process that is more appropriate to a food additive market: “FDA may in effect be establishing a pre-market review process for dietary supplements and impos[ing] standards that were deemed suitable for food additives.”
- It will cost jobs and harm the economy: “Imposing these regulatory requirements on products that have a long history of safe use will increase costs on manufacturers at a time when we should be encouraging, rather than hindering, their efforts.”
- It is redundant: “It appears that this guidance will require multiple filings for the same ingredient…which is at odds with the statute.”
- It is beyond FDA’s resources: “Given the FDA’s current workload, it does not seem prudent to follow this course of action.”
- It needs to be rewritten, with input from stakeholders: “We respectfully request FDA to reexamine and significantly rework this guidance so it does not undermine consumer access to safe, affordable dietary supplement products….It is our hope that the FDA will engage in meaningful dialogue with the relevant stakeholders in industry.”
It is clear that Congress is now seeing the huge regulatory burden of NDI guidance, not to mention its cost to the economy and the loss of jobs. We also expect more individual Congress members to write to the FDA.
In October of last year, the committee announced it would start investigating legislation that is redundant and threatens jobs and the economy. The NDI draft guidance is a perfect example of this, as we pointed out in our economic analysis, and it is heartening to see that Congress recognizes it too.
As you know, the NDI comment period is now closed, and FDA is in the review period. It could take months or years before FDA issues final guidance (if ever—the agency can try to stall), but the more pressure Congress can put on the FDA, the better.
Please write to the House Energy and Commerce Committee, thank them for writing the letter, and ask them to encourage their colleagues to raise their voices in agreement. Please take action immediately!