By Byron J. Richards, CCN

May 16, 2007

NewsWithViews.com

Senators were taken off guard by the public outrage over the passing of bill S.1082 with language that can be used to seriously harass dietary supplements by enabling the FDA to apply drug-related risk analysis to the safety of food and food ingredients (and thus dietary supplements). Senators are also struggling to defend the fact they enabled the creation of the Reagan-Udall Foundation for the FDA, having been conned into believing this foundation was for the purpose of improved safety when in fact its mission is to assist the FDA to develop the next generation of drugs with drastically reduced safety or effectiveness testing. These issues are fully explained in Part 1 of this article, if you would like to know the details in greater depth.

This week the Senate has unleashed a damage control campaign, sending out numerous e-mails to those who have been complaining over the past few weeks. The goal of these letters is to calm apprehensions about dietary supplements and seek to convince everyone that dietary supplements are not in any danger. I thank those of you who have sent me your Senator’s spin, and no letter was better than the one I received from my Senator, Norm Coleman (R-MN). I am taking the liberty of answering his form letter publicly, as it is reflective of the arguments the Senate is using to confuse and pacify the American public. The following Coleman statements are extracted from his e-mail.

Coleman: I am very concerned with the Food and Drug Administration's (FDA) efficiency in reviewing prescriptions drugs as well as its track record on appropriate enforcement.

Richards: Then why didn’t you vote for the Grassley and Durbin amendments that would have given some real meaning to drug safety at the FDA? And why didn’t you or any one of your colleagues raise a single question about the Reagan-Udall Foundation for the FDA and its desire to help the FDA bring drugs to the market with far less safety and effectiveness testing?

Coleman: I understand that concerns have been raised regarding the bill's proposal for the Reagan-Udall Foundation and dietary supplements. First, I want to assure you that this bill does not regulate or restrict access to dietary supplements in any way.

Richards: It is true that the bill does not directly state that it intends to regulate or restrict access to dietary supplements. However, language within the section establishing the Regan-Udall Foundation grants the FDA new regulatory power to brand food ingredients (and thus dietary supplements) as unsafe utilizing the Critical Path Initiative drug-related risk assessment technology.

Coleman: Second, the bill would establish the Reagan-Udall Foundation as a non-government entity that would have no control over the FDA, industry, or consumers.

Richards: Excuse me Senator – did you read the bill? The board of directors is composed of the Commissioner of the FDA, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, the Director of the Agency for Healthcare Research and Quality, 4 representatives from Big Pharma and Big Biotech, 3 representatives from academia (which is funded by Big Pharma), 2 more from the FDA and NIH, 2 from consumers groups, and 1 from health care providers. This means that the FDA/Big Pharma/Big Biotech voting block always has 13 votes – to at the most 3. Who are you kidding? This front group foundation is run by the FDA in combination with the industry it is supposed to be regulating. This makes the FDA part of the drug business as a drug company.

Coleman: Furthermore, the Foundation will not be involved in drug development but will help provide new tools for improving safety in regulated product development.

Richards: Now I’m sure you didn’t read the bill. It says the Foundation will ensure that “action is taken as necessary to enable the licensing of inventions developed by the Foundation or with funds from the Foundation; and (C) executed licenses, memoranda of understanding, material transfer agreements, contracts, and other such instruments, promote, to the maximum extent practicable, the broadest conversion to commercial and noncommercial applications of licensed and patented inventions of the Foundation.” Since the Foundation is responding to the needs of the Critical Path Initiative, and that initiative is primarily about the development of new drugs, it is clear that the Foundation will not only help with drug development but it will have significant business relationships as a result. Are you not aware of the fact that non-profits are the new vehicle by which multi-national corporations shelter their inventions from international competition?

Coleman: I have also heard concerns with provisions in the mission of the Foundation related to food and food ingredients. This has to do with food safety, and not with dietary supplements. As the recent disease outbreaks associated with spinach and peanut butter have shown, food safety tools are lacking. The Foundation would undertake research to help make food safer but it would have no regulatory authority.

Richards: Americans do not trust the FDA. By law, dietary supplements are food and food ingredients. I am all in favor of the FDA being better able to identify contamination in food that poses a risk to human health. At least we agree on that point. The point we don’t agree on is the fact the technology in question relies on drug risk analysis and can be used to claim that a nutrient that is not in any way contaminated is unsafe, thus undermining the very foundation of food and drug law. The Foundation is being positioned as a major tool for the FDA to implement its opinionated use of this technology, which can easily be used to attack dietary supplements.

Since you and every other Senator that has been questioned on this issue would like to deny there is any problem with this legislation regarding dietary supplements, why don’t you help put some language into this legislation that will satisfy all of our concerns. After all, what harm is there in taking some action to SHOW THE PEOPLE that you truly are not interested in allowing the FDA to have new power to harass dietary supplements and suppress freedom of choice relating to health care options.

The following simple amendment has been prepared by noted attorney, Jonathan Emord.

Purpose of Amendment

The purpose of the amendment is to ensure that foods, dietary ingredients, and dietary supplements are not treated like drugs when evaluated by the Food and Drug Administration. Since the turn of the Twentieth Century, the Supreme Court and most of the lower federal courts have accepted the principle first articulated by Paracelsus in the 16th Century that dose determines toxicity. That bedrock principle underlies all of adulteration law. The FDA has unilaterally removed that principle from the law of adulteration as it pertains to dietary ingredients and dietary supplements. In its place, FDA has required dietary ingredients and dietary supplements to be treated like drugs when evaluating whether they are adulterated. In particular, FDA for the first time in its history now holds a dietary ingredient or dietary supplement adulterated at every dose level if at some dose level it can be shown to present even an infinitesimal risk if it concludes there to be no substantial health benefit from the supplement.

Because all dietary ingredients, dietary supplements, and foods present a risk to health at some level of ingestion, the FDA’s new position permits the agency to declare any dietary ingredient or dietary supplement adulterated at its whim or caprice. The drug risk-benefit comparison was until recently reserved exclusively for drugs because under the FDCA foods, food ingredients, and dietary supplements are presumed safe in light of their ubiquitous presence in the food supply and history of safe ingestion. Consistent with the plain and intended meaning of the Dietary Supplement Health and Education Act, a dietary supplement is not adulterated unless FDA proves by a preponderance of the evidence that the supplement presents a significant or unreasonable 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. FDA’s imposition of a drug standard risk-benefit comparison on dietary supplements is not sanctioned by the Act and exceeds the statutory limits on FDA’s power. That imposition violates the plain and intended meaning of the dietary supplement adulteration provision adopted by the Congress in the DSHEA. This amendment ends that violation by removing the term “unreasonable” as a modifier of risk, making it clear that the focus of the statute is on significant risk, not on a comparison of risk with benefit.

To ensure that the Foundation or Institute created by the bill does not undermine Congress’s plain and intended meaning, this amendment also prohibits that entity from evaluating the health benefit or efficacy of foods, dietary ingredients, and dietary supplements by limiting its review to determining whether those ingredients or supplements present 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.

Changes in Existing Law [Read]

The following provides a print of the existing statute or part or section thereof to be amended or replaced (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, existing law in which no change is proposed is shown in roman):

CHAPTER IV – FOOD

SEC. 402

(f) –

(1) If it is a dietary supplement or contains a dietary ingredient that –
(A) presents a significant [or unreasonable] risk of illness or injury under—

(i) conditions of use recommended or suggested in labeling, or
(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use:

Changes in Proposed Bills

Proposed amendment to S 1082 and HR 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.

Health Freedom is on the Line

It is vitally important to send the following message to all members of the House and keep flooding the Senate (as there will be a conference committee). It is also important to send this message to Senators Hatch and Harkin (the original designers of DHSEA) and Kennedy and Enzi (who claim they are not trying to regulate dietary supplements with this legislation). These Senators must hear from the American public as they will determine the fate of this amendment when it reaches the conference committee. Success will require significant support from the people. Thank you.

To get information on contacting Senators, click here.

To contact your House Representative, click here.

Please send the following message.

HR 1561 (senate bill S.1082) - Please Amend to Protect Dietary Supplements

May 16, 2007

The Honorable (Representative or Senator First and Last Name)

Address
Address

Dear Representative (or Senator) Last Name;

The Senate has recently passed bill S1082, commonly known as the FDA Revitalization Act. I am concerned that the legislation, as currently written, opens the door for considerable regulatory confusion enabling the FDA to use this legislation to undermine my access to safe and effective dietary supplements.

There must be no confusing the safety of drugs and the safety of food and food ingredients – which are governed by different laws. I am sure you and other members of Congress are not intending to create such concern among the 150 million Americans who rely on dietary supplements to assist their health, and this matter is easily corrected with the following amendment, which will not in any way stop the FDA from identifying truly contaminated food that poses a risk to human health.

Changes in Existing Law

The following provides a print of the existing statute or part or section thereof to be amended or replaced (existing law proposed to be omitted is enclosed in black brackets, existing law in which no change is proposed is shown in roman):

CHAPTER IV – FOOD

SEC. 402
(f) –

(1) If it is a dietary supplement or contains a dietary ingredient that –
(A) presents a significant [or unreasonable] risk of illness or injury under—

(i) conditions of use recommended or suggested in labeling, or
(ii) if no conditions of use are suggested or recommended in the

labeling, under ordinary conditions of use:

Changes in Proposed Bills

Proposed amendment to S 1082 and HR 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. Please help preserve my rights and support this amendment. For part 1 click below.

Click here for part -----> 1,

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