Rep. Frank Pallone (D-N.J.) and Rep. Brett Guthrie (R-Ky.) have sent the following letter to the Food and Drug Administration reminding the agency that Congress has not forgotten about the draft NDI notification guidance. The letter is bipartisan and signed by key members of Congress (27 offices) on the Energy and Commerce Committee, the Dietary Supplement Caucus, and many legislators who the Council for Responsible Nutrition met with during its annual Day on the Hill.
July 9, 2013
The Honorable Margaret Hamburg, M.D.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Dear Commissioner Hamburg:
Congress, FDA and the dietary supplement industry all agree that guidance for industry on the New Dietary Ingredient (NDI) notification process is needed. We note that FDA and industry have been working for over a year on this topic since the release of the Draft NDI Guidance in July 2011 and the close of the comment period in December of that year. The agency and industry have had three substantive discussions to date and another is planned in the near future. In addition, industry continues to submit comments to the docket to facilitate a more definitive record of its recommendations for improvements.
We appreciate the agency's willingness to engage with industry on this important issue and work toward a revised guidance that reflects a fair and workable NDI notification system, based on the principles outlined in the Dietary Supplement Health and Education Act (DSHEA). We are also pleased that you are dedicating staff time to work cooperatively with industry. However, we remain concerned about the speed of progress on these discussions and when we can expect the agency to release a revised guidance.
Therefore, we encourage the agency to continue its efforts to bring clarity to this area of regulation, as it is critical to ensure consumers have access to safe and affordable dietary supplement products. We hope that you will work toward completion in a timely manner.
Thank you in advance for your attention to this matter. We look forward to an update on these efforts.
Frank Pallone, Jr.
Michelle Lujan Grisham
Howard “Buck” McKeon