There is a great deal of confusion on Capitol Hill and on the internet about the status of Senator McCain’s mis-named Dietary Supplement Safety Act, the anti-supplements bill. Some of this confusion has been deliberately created by Senator McCain.
Hundreds of thousands of messages pouring into Senate offices in support of supplements have convinced Senator McCain that his bill is dead. He is backing away from it. This is your victory. All of you who sent messages to the Senate should be very proud of what you have accomplished. Democracy is working.
But why do we say that Senator McCain is backing away from his bill? Where is the evidence? First we know that Senator McCain met with Senator Hatch, a staunch defender of supplements, and said that he was giving up on his bill. Senator Hatch wrote a letter to McCain confirming this and Senator McCain posted the letter on his website. Senator Dorgan’s office (Dorgan co-sponsored the bill) also confirmed to ANH-USA that he and Senator McCain would not pursue their bill further.
Neither Senator McCain nor Senator Dorgan confirmed any of this publicly. In what we believe is a face-saving gesture, McCain has also written his own letter to Senators Harkin (another defender of supplements), Hatch, and Enzi. This letter states that the four senators have agreed to strengthen supplement regulation through the pending FDA Food Modernization Act (S. 510), commonly referred to as “Food Safety”. This letter has led some voices on the internet to attack Senators Harkin and Hatch as traitors to supplements. But please do not be taken in. Senators Harkin and Hatch have not gone over to the anti-supplement side. Far from it. They remain staunch defenders of supplements and natural health. Here are the facts.
1) The very worst provisions of the McCain-Dorgan bill are not in the Food Safety bill. Nor have Harkin or Hatch agreed to put them in. As you will recall, these provisions included:
- Wiping out the current protected list of supplements (those supplements sold before 1994)
- Wiping out the supplement industry’s current right to create new supplements if the ingredient has been in the food supply and has not been chemically altered.
- Mandatory reporting of even minor or incidental adverse events (reporting of serious adverse events is already required)
- Requiring retailers to confirm that supplements and ingredients have been registered with the FDA (which would put a tremendous legal liability on retailers and push them away from dealing with small supplement companies)
2) None of the provisions of the McCain bill are likely to be added to the Food Safety Bill. Senator McCain has been able to obscure this important point because two of his bad provisions are already in the Food Safety Bill! In other words, this is not a compromise in which McCain gets his provisions into Food Safety in exchange for dropping his own bill. McCain is simply taking credit for what is already in Food Safety.
3) What are the bad provisions already in Food Safety that are also in the McCain bill? Two big ones. First, the Food Safety bill requires the registration of supplements with the FDA. This is bureaucratic make-work but won’t destroy the supplement industry. The McCain version of it is worse and there is no reason to think that it will get into Food Safety.
Second, there is a supplement recall provision. The Food Safety bill says that supplements may be recalled if there is a reasonable probability that the supplement could cause serious health consequences and is adulterated or fails to follow labeling laws for food allergens, one part of the definition of “misbranded” under the Food Drug and Cosmetic Act. We don’t like the words “reasonable probability” because the FDA is biased against supplements and it gives the FDA too much scope.
The McCain bill version of this is much worse. It says the FDA can recall a product if there is a reasonable probability of harm or the supplement is adulterated or misbranded. This substitution of “or” for “and” is very important. Why? Because the FDA may deem a supplement “adulterated” if there is a minor paperwork violation, and the general term “misbranded” is referenced, as opposed to the discreet sub-part pertaining to food allergen labeling. This means a product could be recalled even if the seller is making entirely truthful statements about the science behind the product.
Here is the interesting point: in his letter, McCain suggests that the senators together have agreed on the “or” language that is in the McCain bill, and further, that they have agreed to include the general term “misbranding”. This is quite false. The senators have not agreed to change the Food Safety bill to pick up McCain’s language. Is this just sloppiness on the part of the McCain staff? Have they not noticed that their version of the recall provision is quite different from the provision currently in Food Safety? Or is this an effort to sneak McCain’s version of the recall provision into Food Safety without Harkin and Hatch noticing the difference? If it is the latter, rest assured that it won’t work. We are in contact with both Senator Harkin and Hatch.
Where do we go from here? We will be following every move in this game. We think the worst features of the McCain bill are now dead. But if they come back in any form, we will immediately alert you and ask you to help.
We will also of course keep a very close watch on the Food Safety bill. Although ANH-USA succeeded in changing some critical language in that bill, we are still opposed to it for reasons that go beyond supplements. We will continue to oppose it and send you more information about it whenever it seems likely to be brought up for a vote. We will also be especially watchful about what is added to it from this point forward and report back on that.
With your help, we will keep our access to supplements. We will not allow the FDA to impose a European style regime with a short approved list of supplements and doses in this country. Real healthcare is preventive in focus and relies on diet, supplements, and lifestyle. Government approved disease-care, provided in alliance with the drug and surgical equipment manufacturers, will not keep us well.