Hi Friends – Please read the following post from Dr. Nick Gonzalez. He has outlined the important developments on the recent “consumer protection” bill which would make it virtually impossible to buy supplements without a prescription. WE NEED YOUR VOICE! This bill does NOT protect us. It violates our rights.
Dear Friends:
I am writing to alert you of two assaults against nutritional supplements against which we all need to mobilize. Over the years I have witnessed many serious threats to supplements proposed by members of Congress and the FDA, always presented in the guise of “consumer protection.” Invariably the proposed legislation or regulations have been onerous, repressive, and apparently intended to eliminate or seriously curtail the availability of most nutritional products, forcing the US into a European style situation where nutritionals are either forbidden (as in Norway) or become prescription items, and as a result, to the glee of pharmaceutical companies, their drugs become the primary option. In the past, we here in the US have been able to mobilize to stop such intrusions, such as the ill-conceived McCain bill of a year ago. But once again, the anti-nutrition forces have organized and mobilized, in ways I have not previously seen.
The first threat is Senator Durbin’s noble sounding Senate bill S1310, the "Dietary Supplement Labeling Act," ostensibly prompted because of a recent episode of melatonin tainted brownies. Senator Durbin has long been an aggressive, vocal opponent of supplements and their availability as over the counter products. He has long supported a “strong” FDA and the pharmaceutical industry. In any event, this bill would give the FDA a new set of powers that could easily be used to badger honorable, honest supplement manufacturers providing legitimate and useful products. The FDA needs no new authority in terms of labeling, because it already has enormous power to regulate additives to food, and remove harmful or dangerous supplements from the marketplace. Furthermore, the FDA has already mandated very stringent "Good Manufacturing Practice" regulations that promote standards and require manufacturers of nutritional supplements to provide the highest quality, legitimate products to consumers. I believe this new legislation is part of an ongoing pattern to eliminate the availability of legitimate supplements so that Americans have no choice in their health care.
Senator Durbin, true to form, presented his legislation on the Friday before the July 4th weekend, presumably hoping that no one would notice. But the ever vigilant Alliance for Natural Health learned of the bill almost as soon as it was available, and sent out a much needed warning to begin mobilizing to stop it in its tracks. I would suggest you contact your Senators and Representatives, either by phone or e-mail, expressing your strong opposition to this bill. Public outcry has stopped many similar bills in the past, and we can do it again, but it takes pressure, and effort, and energy. Of course, be polite, but explain that the FDA already has sufficient power to regulate supplements, their labeling, and food additives. And, express your wish that supplements be kept available for your use. Of course no one wants dangerous products in the marketplace, but most manufacturers are honest and honorable, providing health-promoting, high quality supplements.
About the same time Senator Durbin proposed his legislation, the FDA itself announced its plans to enforce an entire new set of regulations on supplement manufacturers that are so onerous, I doubt any company could comply or remain in business. In 1994, Congress passed the “Dietary Supplement Health and Education Act” (DSHEA), which in once sense did protect nutritional supplements available at the time from FDA over regulation, and protected manufacturers from overt FDA harassment. However, the bill also gave the FDA enormous power over any new supplements that might be developed after 1994, with the authority to require the expensive, and time consuming process normally reserved for synthetic pharmaceuticals before these new supplements could be made available to consumers. Basically, if implemented, supplements would remain stuck in 1994, with manufacturers unable to provide new products in response to ongoing research in the field.
Furthermore, by enforcing this provision in DSHEA, the FDA could require supplements available prior to 1994 that have undergone any change whatsoever to undergo review, with the possibility that these products might be removed from the market until the lengthy review was completed. Apparently, even if the particle size of a supplement has changed since 1994, the manufacturer would be required to petition the FDA for approval of the product. As I read the new, complicated regulations, in my opinion any supplement manufacturer might be at risk and few could financially survive should the FDA enforce to the letter the regulations that it presented last week.
Nutritional supplements, because of the concern and integrity of the great majority of manufacturers, are extraordinarily safe and the FDA knows this. Our supplements for example are manufactured at an approved facility in compliance with the strict FDA Good Manufacturing Practices. These products have been life-saving, proving effective even against advanced cancer. We need these supplements for our patients.
The FDA already has the power it needs to "protect" the consumer. These regulations are unnecessarily onerous and unreasonable.
For further information I suggest you consult the following website: http://www.anh-usa.org/
I suggest you write your Senators and Representatives protesting both the Durbin bill and the new FDA regulations. Always be polite. But we need to stop Senator Durbin's bill and fight for the continued availability of nutritional supplements.
Below is a letter I sent my own Senators. Feel free to adopt it as your own
Re: Opposition to Senator Durbin's bill S1310, the "Dietary Supplement Labeling Act."
Dear Senator Gillibrand:
I am writing because I need your help. On the Friday before the July 4th weekend, Senator Durbin - hoping his actions would not be carried in the media before a major holiday - introduced the above referenced legislation, the "Dietary Supplement Labeling Act." Though couched in terms about consumer protection, the bill really seems designed to give the Food and Drug Administration extraordinary new levels of regulatory authority over dietary supplements, which it does not need to perform its job, and which will add new onerous regulatory hurdles onto legitimate, honest supplement manufacturers in this country.
The FDA already has the authority to supervise supplement manufacture and remove harmful or dangerous supplements from the marketplace, It has already put in place very stringent "Good Manufacturing Practice" regulations that promote standards and require manufacturers to provide the highest quality, legitimate products to consumers. I believe this new legislation is part of an ongoing pattern to eliminate the availability of legitimate supplements so that Americans have no choice in their health care.
Americans by the tens of millions use supplements daily, and want these products to remain available to them. As a physician who uses specially designed supplements in his practice, I know the value of properly formulated nutritional products. The supplements I utilize are specially designed according to very strict specifications, and quite literally, the lives of hundreds of my patients depend on these products.
At the same time Senator Durbin proposed his legislation, the FDA itself announced its plans to enforce an entire new set of regulations on supplement manufacturers that are so onerous, I doubt any company could comply or remain in business. It appears, judging by what I have read, the FDA seems intent to use harmless sounding regulations that do not require Congressional approval to eliminate the supplement industry from this country. I can think of no other rational explanation.
Nutritional supplements, because of the concern and integrity of the great majority of manufacturers, are extraordinarily safe and the FDA knows this. The FDA already has the power it needs to "protect" the consumer. These regulations are deliberately onerous and unreasonable.
For further information I suggest you consult the following website: http://www.anh-usa.org/
Please help stop Senator Durbin's bill. Please reign in an out-of-control FDA. My patients need their supplements.
I would be happy to talk to any of your aides, I would welcome a visit to my office to show the results of our practice, and our desperate need that our supplements remain available. .
Sincerely,
Nicholas Gonzalez, MD
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