Health Claims Protected by Court Action

FDA Health Claims

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WholeFoods Magazine Staff
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WholeFoods Science Editor, Richard A. Passwater, Ph.D. reports that the District Court in Washington, D.C., has ordered the U.S. Food and Drug Administration (FDA) to take corrective action to restore first amendment protection and allow reasonable and truthful health claims. This order is the result of legal action by the law firm of Jonathan Emord and Associates on behalf of several clients specifically in regards to the FDA’s censorship of 10 selenium-cancer risk reduction claims, but, in the broader scope, the suit served to protect our first amendment rights and the concept of truthful health claims in general. Dr. Passwater and Dr. Gerhard Schrauzer provided the scientific support for both the legal suit and the application for extended selenium health claims.

Passwater states, “It has been a long battle, with the latest skirmish starting in December 2007 with the FDA’s false report in the Federal Register. Hopefully, this latest victory will be sufficient for the FDA to follow the law.”

The lawsuit won by Emord and Associates over the FDA (referenced as “Alliance for Natural Health v. Sebelius”) was argued before the United States District Court for the District of Columbia. The decision issued on May 27, 2010 upsets FDA's attempt to overturn the six prior decisions the law firm has won against the FDA's prior censorship of health claims. It reaffirms that the FDA is subject to the strictures of the First Amendment in its evaluation of health claims and it faults FDA for failing to follow that standard, holding its suppression of the selenium-cancer risk reduction claims unconstitutional.

Dr. Passwater points out,  ”The FDA has been censoring truthful scientific information for decades with disastrous adverse effects on Americans. As a few examples of the harm that the FDA has caused by censoring truthful scientific information, consider the following:

  • Between 1992 and 1996, FDA prohibited companies that sell folic acid from telling women of childbearing age that 0.4 mg of folic acid daily before pregnancy could reduce the incidence of neural tube defects (including spina bifida and encephaly) by 40%. FDA’s censorship contributed to a preventable 10,000 neural tube defect births. For each of the seven years the FDA blocked the claim, an estimated 2,500 preventable neural tube defect births occurred and countless related abortions also occurred. Indeed, the censorship of the folic acid-neural tube defect claim affected many Americans and has left a legacy of life-long, costly medical care for the children and families affected.  
  • Between 1994 and 2000, FDA prohibited companies that sell fish oils from telling Americans that fish oils could reduce the incidence of coronary heart disease by as much as 50%. FDA censorship contributed to a preventable 1.8 million sudden death heart attacks.
  • Between 2000 and the present, FDA prohibits companies that sell saw palmetto from telling Americans that saw palmetto reduces enlarged prostates and relieves related symptoms. About 50% of men 50 years of age and older suffer from enlarged prostates and are denied access to this information.
  • Between 2000 and the present, FDA prohibits companies that sell glucosamine and chondroitin from telling Americans that those dietary ingredients treat osteoarthritis and relieve osteoarthritic pain and stiffness. About 20 million Americans suffer needlessly from osteoarthritis.   
  • The FDA claims it is unlawful for members of our industry to tell the scientific truth that niacin lowers elevated blood cholesterol.”

Emord and his law firm sought to stop harmful censorship practice of the FDA by successfully suing the FDA to allow scientific truthful health claims for nutrients. As a result, one of the first health claims was a qualified health claim acknowledging that selenium nutrients may help prevent certain cancers. WholeFoods discussed this breakthrough in the September 2003 issue with an interview with Jonathan Emord entitled “Bringing the FDA into Compliance.”

There have been several indications that the FDA was very unhappy with allowing health claims – especially one that dealt with the prevention of cancer. Events suggested that Big Pharma was also greatly displeased with nutrient health claims.

The desire for the FDA to whittle away and eventually neutralize or do away with health claims became apparent in the Dec 2007 Federal Register when the FDA served notice it was “reviewing” the selenium qualified health claims based on what was false information. (Federal Register 72(245): 72738-72740) The FDA incorrectly claimed in the Federal Register that an independent review found that the strength of the evidence supporting selenium’s role in preventing cancer was “low.”

Passwater reports, “Two scientists, Dr. Gerhard Schrauzer and I, acting as independent scientists on our own behalf rebutted the assertions made by the FDA in the Federal Register and provided updated information based on recent research to fortify the existing qualified health claim.  Dr. Schrauzer and I, each separately and independently, petitioned the FDA in support of the body of science that demonstrated selenium’ role in reducing cancer. In our March 2008 petition, we submitted over 150 peer-reviewed scientific publications supporting the risk reduction relationship between selenium and cancer (see Docket No. FDA-2008-Q-0323). Additional studies were submitted later. During this process, we sought to extend and clarify the role of selenium nutrients in the prevention of cancer and called upon the services of Emord and associates who processed the original qualified health claim to also petition for the extended qualified health claims.”

The FDA responded to the new petition in a letter dated June 19, 2009 in which the FDA announced that it had denied the new qualified health claims and was going to further restrict the existing qualified health claim. In this response letter, the FDA demonstrated that they did not have an accurate understanding of selenium biochemistry and were also erroneously interpreting the studies that they did attempt to evaluate. The major errors in selenium biochemistry were discussed in the November 2009 issue of WholeFoods in a article entitled “Why the FDA is Confused About Selenium.”

As a result, the only logical course of action was to sue the FDA to have the courts order the FDA to comply with the law and the constitution. This was discussed in WholeFoods in another interview with Emord in September 2009.

Emord and Associates including attorneys Peter Arhangelsky, Chris Niederhauser and Jonathan Emord supplied the bulk of the legal effort for the suit which was filed on July 31, 2009 and reported in WholeFoods. Schrauzer and Passwater supplied the scientific effort as independent scientists. Others, who suffered commercial damage as a result of the illegal FDA censorship sponsored the effort.

Soon after the June 19, 2009 letter of rejection of claims from the FDA, an anti-supplement group pretending to be in the public’s interest threatened to sue a vitamin manufacturer for “falsely” claiming that selenium nutrients reduced the risk of certain cancers.

Passwater concluded, “The body of scientific evidence continues to grow in support of selenium nutrients preventing cancer, and the pace of supportive research is quickening. It is important for the health of all people to be aware of this important research and health benefits of this essential trace mineral.”

 

Published in WholeFoods Magazine Online, June 1, 2010