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Thursday, February 25, 2010

Information on the bill Senator McCain is attempting to get passed

We did it!
It's all thanks to the action that you took.
Hundreds of thousands of messages poured into the Senate opposing Senator McCain's bill, the bill that would have wiped out current legislative protections for dietary supplements. More and more messages were arriving by the day. The entire Congress began to take note. Senator McCain was embarrassed by our ad whose headline pointed out that he was misrepresenting and did not seem to understand his own bill.
Word is now racing around Capitol Hill that Senator McCain met with Senator Orin Hatch, a champion of natural medicine, and told him that he is withdrawing his support for the bill he authored, the so-called Dietary Supplement Safety Act (S 3002). This means that the bill as written is now dead.
Is this the end of the story? No. Having given his word to a fellow senator, McCain is not likely to resume his support for the bill. But we do need to see a declaration from McCain himself. We will need to see if McCain will try to offer some modified version of the bill. And there has also been no word from the other co-sponsor of the bill, Senator Dorgan.
We will keep you posted. In the meantime, it is time to celebrate your accomplishment. The democratic process worked. The people spoke and a powerful senator reversed course. It was all because of you, the active citizens willing to take time and make the effort to defend natural and sustainable forms of health and health care in the often hostile environment of Washington, DC. As we all know, Washington is ringed today with special commercial interests. They have millions of dollars of campaign contributions to hand out and gigantic lobbying budgets. But in the end, politicians have to answer to the people.
Thank you!
Gretchen DuBeau, Executive Director
Hunter Lewis, President
Alliance for Natural Health USA


March 3 , 2010

As we indicated in a previous post below these bills never get to the floor or to conference the way they were originally written and we now find from our FDA attorney that the bill now indicates that all nutrients that are contained in a food supplement must be approved by the FDA before they can be used.

Further, no nutrients that are currently being used will be grandfathered. Last e-mail was good new, this one is about as bad as it can be. However, as far as we know, no one has signed on to this bill with Senator McCain.

Judging by the latest information, it appears that we all need to contact our U.S. representatives and tell them that this bill is toxic and it restricts our right to choose.

I’m sure you want to know what is behind this and as best we can determine (again at this time), this was generated by all of the professional athletes indicating that they did not know they were taking a drug, they thought it was a supplement.

We all know this is nonsense and this is simply a way for the professional athlete to beat the system.

Again, we are going to spend our money and time to fight this and we urge you and your patients to write a letter to your representative(s) about this toxic bill.

Original post

During the past couple of weeks those I contacted at Biotics Research Inc. (one of the few companies we test products on each patient) have received almost 50 requests for information/our opinion on the bill Senator McCain is attempting to get passed that asks for modifications to The Dietary Supplement Health and Education (DSHEA) act. From those asking Biotics Reps., they have heard everything from – they are going to take away our right to use supplements, limit the amount that can be used in a capsule or tablet and the sky is falling, they attempted to make some sense of the bill, but like most average citizens, they could not; therefore they asked the most prominent FDA attorney in the United States to look at it and provide us with a summary of what he found. He reminded them that his opinion was based on the way the bill was written at this time (this past Tuesday), but like many or most bills there was a possibility that if it passed it would not pass in its current form.

Although many of the changes do not affect Biotics Research as they are already in compliance with the new federal GMPs and DSHEA as written, they want to state emphatically that irrespective of the fact that they, and those of us that use Biotics Research products, will survive this bill in its current form with no problem. However, they sincerely wish that Senator McCain and others would find something important to do and leave the food supplement industry alone.

Currently the federal GMPs and DSHEA do not require expiration dates on supplement labels, however several years ago Biotics Research purchased the equipment that would allow them to do accurate aging studies and thus put accurate expiration dates on their labels. Senator McCain’s bill would require expiration dates and prevent companies from using “Best If Used By” and Manufactured On” on their labels. Best if used by is something that you would expect to see in a grocery store and manufactured on simply tells the doctor and the patient when it was put in the bottle, not that the contents will equal or exceed label claims two years or more down the road. Another area that Senator McCain’s bill covers is the examination for certain toxins. Currently neither the federal GMPs nor DSHEA require that raw material be examined for aflatoxins which are toxic and among the most carcinogenic substances known. Although not required to do so, Biotics Research already assays for this toxin and recently had to destroy a batch of raw material they purchased that assayed for this toxin (by the way, the manufacturer of the material was a GMP approved facility). Another reason the Senator McCain wants expiration dates is that many nutrients lose potency over a period of time. An example of this would be citrus bioflavonoids that many manufactures use in many different products. For Biotics Research to claim 100 mg of citrus bioflavonoids at the two year expiration date for Bio-C Plus and Bio-C Plus 1000 they must put in 150 mg at manufacture. There are other changes in the McCain bill, but for the most part the changes simply close the loop holes in the current federal GMPs and DSHEA and make compliance more difficult for some companies.

Irrespective of the fact that the changes will, in general, favor Biotics Research and make it difficult for some of the other companies, in truth they still wish Senator McCain would find something else to spend his time on.

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