“FDA Went Too Far,” Says Judge

A court has stopped FDA’s latest attempt to censor food and supplement science. 

An FDA disclaimer about green tea and the risk of cancer is so strongly worded that it “effectively negates” the manufacturer’s qualified health claim (QHC) and violates the First Amendment, according to US District Court Judge Vanessa L. Bryant.
QHCs enable companies to make a health claim about a substance in relation to a disease or condition when the supporting science fails to meet the FDA’s “significant scientific agreement” standard, so long as that health claim is “qualified” in such a way as to not mislead consumers. QHCs have been permitted in the US since the 1999 landmark case of Pearson v. Shalala (brought against the FDA by attorney Jonathan Emord on behalf of Durk Pearson and Sandy Shaw, ANH-USA, and others.
In practice, however, FDA rarely approves QHCs: the agency approved only twelve QHCs between 1999 and September 2010—and when they did, they usually created disclaimers that completely reversed the meaning of the claim. It was because of this that ANH-USA sued the FDA over its treatment of the QHC for selenium and cancer. And we were successful in creating a precedent that restricts FDA’s ability to infringe on the right to free speech, a right that is at least in part provided by QHCs.
Fleminger, Inc., sells green tea at TeaForHealth.com and discusses the science of antioxidants and the research on green tea’s anti-cancer properties. Fleminger first submitted a health claim petition to FDA in 2004. A year later, the FDA proposed two disclaimers that stated, in part, “FDA concludes that it is highly unlikely that green tea reduces the risk” of breast cancer or prostate cancer. Fleminger petitioned for an administrative review but it was denied.
In 2010, FDA sent a warning letter to Fleminger threatening to seize its products and insisting it use the exact language set forth in its qualified health claims. Shortly thereafter, however, FDA proposed a revised claim: “Green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim.” This prompted Fleminger’s suit in the US District Court, asserting that FDA was making Fleminger “choose between speaking exactly as [FDA] wishes, remaining silent, or risking adverse action for its own commercial speech in violation of the First Amendment.”
Judge Bryant agreed with Fleminger: The FDA’s language “effectively negates the substance–disease relationship claim altogether….There are less burdensome ways in which the FDA could indicate in a short, succinct and accurate disclaimer that it has not approved the claim without nullifying the claim altogether.” FDA must now draft a new disclaimer statement.
Jonathan Emord found the ruling significant: “This is an important decision that adds to the landmark precedent of the Alliance for Natural Health USA v. Sebelius concerning the limits on FDA discretion in drafting health claim qualifications. Once again FDA is taken to task for using the disclaimer to promote its own agenda rather than constraining itself to a succinct and accurate qualification of the inconclusiveness of supporting science.”
Outside of QHCs, food and supplements are not allowed to speak of the specific health benefits of their products because the FDA takes the position that any such statement magically turns them into drugs. And, as drugs, they would have to go through exorbitantly expensive drug trials, a cost which the manufacturer could never recoup, since food and supplements are natural products and cannot be patented. Without a patent, anyone can sell them, so paying as much as a billion dollars for a drug trial is essentially money down the drain. This is the “Catch-22” we keep talking about.
The great thing about this ruling is that more people may get to learn about the cancer-fighting benefits of green tea. In 2005, UCLA researchers found that green tea extract targeted cancerous cells in the human bladder without harming healthy cells—and made it harder for the cancerous cells to become invasive and spread. And a 2009 study showed that three cups of tea per day reduced younger women’s risk of breast cancer by about 37 percent. Harvard Women’s Health Watch magazine noted that studies found an association between consuming green tea and a reduced risk for several cancers, including, skin, breast, lung, colon, esophageal, and bladder. Green tea has also been found effective in preventing and controlling CLL, a killer blood cancer.
Even under the best circumstances, QHCs are something of a stopgap measure because of the qualification language FDA is still able to use. A bill before Congress, the Free Speech About Science Act, would allow food and supplement manufacturers to cite legitimate peer-reviewed science without turning the product into a drug. The bill amends the appropriate sections of current law to allow the flow of legitimate scientific and educational information while still giving FDA and FTC the right to take action against misleading information and false and unsubstantiated claims.
If you have not done so already, please contact Congress and ask your legislators to co-sponsor HR1364, the Free Speech about Science Act. If it passes, this bill has the potential to transform the healthcare field by educating the public about the real science behind natural health. It’s a small bill with vast potential leverage.