US Censorship of Scientific Free Speech Continues as Bayer Faces Lawsuit over Its Selenium Claims

Bayer Healthcare could face a lawsuit in the US over its claim that selenium may reduce the risk of prostate cancer. Bayer makes that claim on advertisements and labels for its One A Day Men’s multivitamin.
As the Alliance for Natural Health, our European affiliate and a group focused on good science and good law, points out in its excellent story on this subject, there is an extensive body of evidence showing that selenium is vital for healthy function of the immune system and for its cancer protective role. There is also evidence that lower dietary selenium intakes are associated with increased risk of prostate cancer, and that low serum levels of selenium are associated with prostate cancer, though some studies using lower levels of selenium supplements have yielded negative results.
Selenium is currently the only mineral allowed to carry an FDA-approved qualified health claim for general cancer reduction incidence: “Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer [specifically, bladder, prostate and thyroid cancer]. However, FDA has determined that this evidence is limited and not conclusive.”
However, the US Consumer Advocacy Center for Science in the Public Interest (CSPI) has said that such claims are not backed by sufficient science and are deceptive. In fact, CSPI is threatening to sue if Bayer does not remove the claims in their ads. Moreover, the FDA continues to describe the credible scientific evidence for the cancer benefits as “very limited,” and even says that such claims need significant qualifying language, e.g., include the statement that selenium is “highly unlikely” to reduce the risk of prostate cancer.
According to attorney Jonathan Emord, who has been primarily responsible for approval of qualified health claims in the US, “These decisions confirm that censorship reigns supreme in the Obama FDA. . . . [The] FDA engaged in political censorship of scientific speech, discounting supporting evidence [by using] contrived arguments and [by] exaggerating nonsupporting evidence to be the equal of [supporting] evidence, which it was not. The federal courts mandated that FDA adopt the qualified health claims regime to remove FDA from the unconstitutional business of censoring speech concerning the potential of nutrients to affect disease risk. FDA has flouted that direction, has effectively [undermined or disregarded] the qualified health claim, and has moved back to [the] constitutionally infirm [position of] absolute censorship as its lode-stone for decision. FDA has become a court of star chamber. It views itself as above the law.”
The FDA also censors the dissemination of scientific research information. For example, they forbid cherry growers from citing scientific research on cherries. Dietary supplement makers are not allowed to cite independent scientific research on the benefits of their products. Worse, if HR2749 passes without being amended, any violation of that prohibition will be punishable by up to ten years in jail and/or fines of up to $7.5 million.
And then there is the recent cereal debacle. “If ever there was a textbook example of why a free people should think twice before tasking government with a job (much less dedicate an entire agency to it), the Food and Drug Administration’s latest goofball maneuver to classify the breakfast cereal Cheerios as a drug is it!” writes Beverly Eakman, former teacher and retired speechwriter for the heads of three government agencies, in “The Cheerios Charade,” an article published in The New American magazine.
Her article is a blistering indictment of the way the FDA attacks scientific free speech while it neglects the job for which it was created. Eakman is, of course, referring to the FDA’s demand that General Mills obtain an approved drug application in order to market Cheerios legally. The cereal manufacturer had noted the cholesterol lowering properties of a whole grain oat cereal on its box. As Eakman says, “Moreover, the FDA’s Cheerios charade is symptomatic of much more than bureaucratic overkill. It is about a government that is out of control—a government that protects itself, not American citizens.”
Your Cheerios should not be available only by prescription. It is time to restructure and reform the FDA—from the ground up.