Friday, July 10, 2009

Emord to Sue FDA on Claims Denials and GMPS at Urging of Industry

The following is an urgent message that I received yesterday from a dear friend and true champion of health liberty, Jonathon Emord. The author of "The Rise of Tyranny" has a plan to put the FDA back into what is left of its constitutional in order that we may maintain access to dietary supplements.

The FDA is preparing a major assault on manufacturers of herbs, vitamins, minerals and other dietary supplements based on the new GMP guidelines, which would render perfectly safe products "adulterated" for mere paperwork discrepancies. In other words, if your favorite herbal product manufacturer fails to cross a "t" or dot an "i" - the FDA could stop sale and force a recall, which could put 1/3 or more of natural product manufacturers out of business.

Please help Jonathan Emord stop the FDA in its tracks before it is too late! See below and provide support in any way that you can.

Message from Jonathan:

I have been approached by several company executives anxious to have the firm sue FDA again in light of the agency’s recent decisions to roll back the qualified health claims regime ordered by the courts and to ramp up GMP prosecutions.

FDA just handed down a decision to disallow previously approved selenium/cancer and antioxidant vitamin/cancer risk reduction claims and to ratchet up GMP enforcement with at least 200 inspections this year. FDA Commissioner Hamburg has also just appointed as her Senior Advisor Michael Taylor, the anti-supplement aide to David Kessler who left FDA during the Monsanto GMO conflict of interest debacle. These and other moves threaten to censor and destroy many companies in this industry. I agree that action now is imperative.

As many of you know, we defeated FDA in federal court in five of the six health claims suits we brought on behalf of our clients, resulting in the creation of a thing called the qualified health claims regime. Before that FDA had a health claims approval process that only permitted nutrient-disease risk reduction claims proven to a near conclusive degree. FDA censored all claims that accurately reflected the state of emerging science. In Pearson v. Shalala I and Whitaker v. Thompson I, the Courts ordered FDA to allow claims backed by credible science and to rely on reasonable disclaimers to inform the public if the science was inconclusive or if FDA did not support the science. FDA never implemented the Court ordered standard. Instead, bit by bit year after year, it has fled from the Court’s standard to resurrect its old demand for near conclusive proof. FDA has also saddled claims with ridiculously long and negative qualifications that exceed constitutional limits. It has also aggressively moved to declare structure/function claims “implied drug claims,” thus making the universe of what you can say smaller and smaller and smaller. Unless we oppose these measures, more restrictions are likely to follow.

On June 19, 2009, FDA put a bullet in the head of the qualified health claims regime, issuing two decisions, one on selenium and cancer risk reduction claims and one on antioxidant vitamin and cancer risk reduction claims, revoking previously approved claims and denying a series of new ones.

On another front, the FDA is planning to do a minimum of 200 GMP investigations this year. Its rule allows the agency to declare a company’s products adulterated if any recordkeeping violations or other violations exist, even in the absence of any proof that the violations cause products to present a risk of illness or injury to the public. The effect is to destroy the DSHEA adulteration provision and to permit FDA to shut companies down at will. FDA predicts that as many as 1/3 of the supplement companies will be eliminated through enforcement of the GMPs. It also predicts that product diversity will diminish and product cost will increase.

In response to requests that we sue, we have established two attorney trust accounts, one to accept contributions for the claims appeal and one to accept contributions for the GMP appeal. We need your help.

Three parties have pledged a total of $20,000 to support the claims litigation. We need to raise $15,000 more. One party has pledged $10,000 for the GMP appeal. We need to raise $25,000 more.

As soon as we raise the needed funds, we will file suit. The identities of those who contribute to the fund will be kept secret. I cannot emphasize enough the importance of doing this to protect the vital interests of the industry. I urge you to make a contribution at your earliest convenience of $1,000 or more to one or more of the two funds (Claims Appeal or GMP Appeal). We will fight tenaciously against these measures but need your help to do it.

Please make your checks payable to Emord Trust Account and mail them to Emord & Associates, 11808 Wolf Run Lane, Clifton, VA 20124. In the memo section, put Claims Appeal or GMP Appeal or both (in which case funds will be split evenly between the two funds). We need to receive the contributions on or before July 19. The names of all contributors will be kept secret. If we reach the dollar amounts required, we will sue for declaratory and injunctive relief in the U.S. District Court for the District of Columbia.

May I remind you in closing of Thomas Paine’s brilliant call to arms of December 23, 1776:

The summer soldier and the sunshine patriot will, in this crisis, shrink from the service of their country; but he that stands by it now, deserves the love and thanks of man and woman. Tyranny, like hell, is not easily conquered; yet we have this consolation with us, that the harder the conflict, the more glorious the triumph.

The time is now. I will fight vigorously but I need your help.

Please spread this message far and wide. Every health food store, natural practitioner, customer, client or patient should contribute in any way they can, even if it's just telling your neighbor.

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