There is much confusion and debate swirling around the pending, or near-pending, demise of Senator McCains so-called Dietary Supplement Safety Act of 2010 (S.3002). After Senators John McCain (R-AZ) and Byron Dorgan (D-ND) issued their letter of March 10th, what is clear about the bills status is the following:
S.3002 will wither on the vine in the Senate.
Instead, when the so-called Food Safety Act (S.510) is brought up again in the Senate, there may be a McCain-Dorgan amendment offered to it, which Senators Hatch and Harkin will have to review first.
This amendment could be accepted and added by unanimous consent before S.510 is voted upon.
If it passes the Senate, then the House and Senate leadership would work out any differences and pass it on to Mr. Obama. The best estimates are that this would not happen until after Congress returns in mid-April 2010.
As of today, S.510 is still on the Senate calendar and not scheduled for a vote.
On the issues, the following are the important new points:
In S.510 as written, registration applies only to food companies, not to supplement manufacturers. So, biennial registration for supplement manufacturing, processing, and holding (technically including MLM marketers) would be added, which would overlap with AER requirements.
FDA authority to recall supplements would be granted if found to be adulterated or misbranded for serious adverse event (although the McCain/Dorgan letter says mandatory recall would apply if supplements are either adulterated, misbranded, or cause serious injury or death). This authority already exists under AER law, but the issue here is standards as the current death clause requirement limits its range and impact. Issued regulations would clarify this point. As is often the case, getting approval on regulations will take some time. In the bill, the simple change of one connector word could extend this recall power dramatically, so it must be watched carefully.
For New Dietary Ingredients (NDIs), the FDA has dragged its feet for ten years in issuing an Industry Guidance on what is and what is not needed when filing. This is hardly a new issue, but the McCain/Dorgan letter wants the Senate to hold the FDAs feet to the fire until it does issue guidance.
McCain and Dorgan would also want to amend S.510 to require mandatory notification by the FDA to the Drug Enforcement Agency on any supplements found to contain synthetic anabolic steroid ingredients.
In essence, the compromise substance of the coming McCain/Dorgan/Hatch/Harkin amendment to S.510 is that all of the bad, over-the-top control aspects of Senator Dick Durbins S.510 remain, with the compromise heaping upon it even more reasons for us to oppose this bad bill. The Federation has opposed S.510 from the beginning, and this compromise gives us absolutely no reason to change our position. To the contrary, we will have more reasons to oppose this bill if it is amended.
