July 11, 2013
Dear Mr. …:
Thank you for your comments regarding proposals to further regulate dietary and nutritional supplements. I appreciate hearing from you.
As you may know, on July 1, 2011, the Food and Drug Administration (FDA) published guidelines clarifying the definition of new dietary ingredients (NDI) and requirements surrounding NDI notifications for dietary supplements. NDIs are ingredients used in dietary supplements that were not marketed in the United States before October 15, 1994. The regulations would require a manufacturer to notify the FDA at least 75 days before the dietary supplement containing a NDI is marketed in the United States. The notification must include the NDI and dietary supplement description, specifications of manufacturing methods, and dietary ingredients in order to determine the safety of the product’s ingredients.
Last Congress, Senator Dick Durbin (D-IL) introduced the Dietary Supplement Labeling Act (S. 1310), which would have required manufacturers of dietary supplements to register their products with the FDA. The bill would have also changed the labeling requirements for dietary supplements. Currently, dietary supplement manufacturers are not required to register their products with the FDA, yet they are responsible for ensuring that dietary supplements are safe before they are marketed.
During consideration of the FDA Safety and Innovation Act (Public Law 112-144), Senator Durbin offered S. 1310 as an amendment to the bill. The amendment was tabled by a vote of 77 to 20. I voted to table (or kill) the Durbin amendment. S. 1310 expired at the end of the 112th Congress and similar legislation has not yet been introduced during this Congress.
We must ensure that dietary supplements are safe for consumer use, while also preventing unduly burdensome federal mandates on product manufacturers. Please know that I will keep your comments in mind should the Senate consider this issue in the future.
Again, thank you for taking the time to contact me. As your Senator it is important for me to hear from you regarding the current issues affecting our state and nation. Please do not hesitate to be in touch again if I can be of any further assistance.
Kelly A. Ayotte
U. S. Senator