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FDA To Be Sued for Health Claim Rights, Bills Seek to End Censorship of Health Claims
FDA To Be Sued for Health Claim Rights,
Bills Seek to End Censorship of Health Claims
Washington, D.C.—Last month, WholeFoods reported on the U.S. Food and Drug Administration (FDA)’s attempt to eliminate certain qualified health claims for selenium and reduced risk of cancer (see story). Since then, the plot has thickened. On Friday, July 31, several plaintiffs (all represented by Emord & Associates, P.C. with Attorney Jonathan Emord serving as lead counsel) will bring a lawsuit against FDA claiming the agency’s ban of four such health claims violates the First Amendment. The statements include the use of selenium to reduce the risk of lung/respiratory tract cancers, to reduce the risk of prostate cancer, to reduce the risk of other cancers, and to produce anticarcinogenic effects in the body. The group also feels FDA’s insistence on pairing a fifth claim (site-specific cancer risk reduction) “with an inaccurate and negatively value laden disclaimer” is unjust. The hope is that the U.S. District Court for the District of Columbia will find FDA’s censorship unconstitutional.
The group feels they have a case because FDA essentially required “near conclusive scientific proof” before it would grant the qualified health claims in question. The agency said it would only consider certain types of studies and would reject animal trials, in vitro studies and other studies. This action, according to a legal document prepared by Emord & Associates, directly violates the First Amendment. “There’s a difference between a truthful representation of existing science and a representation of only that science which has been proven to FDA’s satisfaction to be conclusively true,” Emord told WholeFoods. “The difference is an enormous amount of science. In fact, only a small fraction of 1% of all science is what scientists would regard as established to a conclusive degree.”
As a consequence, he says, if consumers are denied information that is less than conclusive, “there is almost nothing on which to make an informed choice in the market.” The First Amendment indicates that it is the consumer’s responsibility to “determine the relative worth of truthful [statements], not for the government to determine whether truthful speech should reach the public based on the government’s view of whether the public will make prudent decisions if given the information,” Emord explains.
In addition, the lawsuit is challenging FDA’s mandate that a specific claim (“Selenium may reduce the risk of colon and digestive tract cancers. Scientific evidence supporting this claim is convincing but not yet conclusive”) be accompanied by what the plaintiffs deem a “negatively value-laden and inaccurate message to the public.” This language is: “Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.”
The plaintiffs are the Alliance for Natural Health US, a Virginia-based non-profit; Nevada scientists and authors Durk Pearson and Sandy Shaw; and the Coalition to End FDA and FTC Censorship.
One day prior to the filing of this lawsuit, Congressman Ron Paul (R-TX) introduced three new bills that are intended to “end FDA censorship of health claims” and “FTC censorship of health information.”
One bill, The Health Freedom Act, takes away FDA’s authority to restrain nutrient–disease relationship claims, but enables the agency to take action against companies that make false claims. The bill hopes to accomplish this by establishing that FDA’s restraint of such claims is a violation of free speech under the First Amendment. A second bill, the Health Information Protection Act, stops the Federal Trade Commission (FTC) from banning advertisements that present health benefits for nutrients, unless the FTC can establish the statement is untrue. The bill would stand by the Fifth Amendment’s burden of proof on the government, rather than constitutionally shifting the burden to advertisers.
Published online ahead of September print edition on July 30, 2009 by WholeFoods Magazine.
From:
http://www.wfcgreenbook.com/default....enbook&he=.com
Bills Seek to End Censorship of Health Claims
Washington, D.C.—Last month, WholeFoods reported on the U.S. Food and Drug Administration (FDA)’s attempt to eliminate certain qualified health claims for selenium and reduced risk of cancer (see story). Since then, the plot has thickened. On Friday, July 31, several plaintiffs (all represented by Emord & Associates, P.C. with Attorney Jonathan Emord serving as lead counsel) will bring a lawsuit against FDA claiming the agency’s ban of four such health claims violates the First Amendment. The statements include the use of selenium to reduce the risk of lung/respiratory tract cancers, to reduce the risk of prostate cancer, to reduce the risk of other cancers, and to produce anticarcinogenic effects in the body. The group also feels FDA’s insistence on pairing a fifth claim (site-specific cancer risk reduction) “with an inaccurate and negatively value laden disclaimer” is unjust. The hope is that the U.S. District Court for the District of Columbia will find FDA’s censorship unconstitutional.
The group feels they have a case because FDA essentially required “near conclusive scientific proof” before it would grant the qualified health claims in question. The agency said it would only consider certain types of studies and would reject animal trials, in vitro studies and other studies. This action, according to a legal document prepared by Emord & Associates, directly violates the First Amendment. “There’s a difference between a truthful representation of existing science and a representation of only that science which has been proven to FDA’s satisfaction to be conclusively true,” Emord told WholeFoods. “The difference is an enormous amount of science. In fact, only a small fraction of 1% of all science is what scientists would regard as established to a conclusive degree.”
As a consequence, he says, if consumers are denied information that is less than conclusive, “there is almost nothing on which to make an informed choice in the market.” The First Amendment indicates that it is the consumer’s responsibility to “determine the relative worth of truthful [statements], not for the government to determine whether truthful speech should reach the public based on the government’s view of whether the public will make prudent decisions if given the information,” Emord explains.
In addition, the lawsuit is challenging FDA’s mandate that a specific claim (“Selenium may reduce the risk of colon and digestive tract cancers. Scientific evidence supporting this claim is convincing but not yet conclusive”) be accompanied by what the plaintiffs deem a “negatively value-laden and inaccurate message to the public.” This language is: “Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.”
The plaintiffs are the Alliance for Natural Health US, a Virginia-based non-profit; Nevada scientists and authors Durk Pearson and Sandy Shaw; and the Coalition to End FDA and FTC Censorship.
One day prior to the filing of this lawsuit, Congressman Ron Paul (R-TX) introduced three new bills that are intended to “end FDA censorship of health claims” and “FTC censorship of health information.”
One bill, The Health Freedom Act, takes away FDA’s authority to restrain nutrient–disease relationship claims, but enables the agency to take action against companies that make false claims. The bill hopes to accomplish this by establishing that FDA’s restraint of such claims is a violation of free speech under the First Amendment. A second bill, the Health Information Protection Act, stops the Federal Trade Commission (FTC) from banning advertisements that present health benefits for nutrients, unless the FTC can establish the statement is untrue. The bill would stand by the Fifth Amendment’s burden of proof on the government, rather than constitutionally shifting the burden to advertisers.
Published online ahead of September print edition on July 30, 2009 by WholeFoods Magazine.
From:
http://www.wfcgreenbook.com/default....enbook&he=.com