Enhancing Drug Safety and Innovation Act

The Honorable (Representative First and Last Name)

Dear Representative (Last Name);

The Energy and Commerce Health Subcommittee is preparing to markup several FDA bills in late June or thereafter. These relate to FDA prescription-drug and medical-device user fees, pediatric medical therapies, generic drugs, direct to consumer advertising, food safety, and H.R. 1561 on reforming FDA drug-safety and post-marking processes.

It is not clear if the recently-passed Senate bill S.1082, the FDA Revitalization Act, will be used as a vehicle for these Committee measures when being marked-up. In either case, I am writing to support the current House bill language in H.R.1561 regarding the scope of the proposed Reagan-Udall Institute for Applied Biomedical Research (the “Foundation”).

I am concerned, though, that S.1082, as it is currently written, will enable the FDA to use this legislation to undermine my access to safe and effective dietary supplements. Therefore, it is important that you and your colleagues in the House reject the Senate version and push forward the current House version with one change.

Importantly, the House bill language does not include the words "food and food ingredients" in the mission of the Foundation. The Senate added these words when it passed S.1082. But foods and, more importantly, dietary supplements are not prescription drugs and are not biological products. The inclusion of this wording in the Senate bill would open the door to the over-regulation of dietary supplements and with the imposition of drug-like risk-management practices upon food supplements. I am strongly opposed to this unnecessary over-regulation.

During Senate consideration, a colloquy between Senators Hatch and Harkin, and Kennedy and Enzi, the floor managers, expressed the Senate's intent that the activities of the Foundation should not apply to food supplements. The exclusion of the words "food and food ingredients" in the mission of the Foundation in the House bill will clearly address this issue.

However, to be absolutely sure of the House’s intent in this regard, this issue is easily addressed with the following amendment, which will not in any way prevent the FDA from identifying and taking action against those contaminated foods that threaten human health:

Proposed amendment to S.1082 and H.R.1561: “The bills are hereby amended to prohibit the Foundation or Institute from evaluating the health benefit or efficacy of foods, dietary ingredients, and dietary supplements and to limit review of foods, dietary ingredients and dietary supplements to a determination of whether they are safe. In assessing whether dietary ingredients and dietary supplements are safe, the Foundation or Institute shall not compare product risks with health benefits or efficacy. Instead, the Foundation or Institute shall determine whether the product presents a significant risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are recommended or suggested in labeling, under ordinary conditions of use.”

Sincerely,