A federal judge recently held that the disclaimer required by the FDA for a qualified health claim about green tea and the risk of cancer is so strongly worded that it “effectively negates” the manufacturer’s claim.

Note that the case involves a qualified health claim (QHC) and not the typical structure / function claim that people at Whole Foods or other health food stores typically see on the dietary supplement label.  The QHC is different in that:

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….

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.”

According to a U.S. GAO document entitled Food Labeling: FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims

 FDA is responsible for ensuring the proper labeling of food, and the use of structure/function claims is subject to the general statutory requirement that labeling not be false or misleading. However, FDA has not given companies guidance on the scientific support needed to prevent false or misleading information in a structure/function claim for food. FDA has guidance for the dietary supplements industry on the scientific support needed to prevent false or misleading information for a structure/function claim for dietary supplements…

The GAO compares FDA and FTC authority to the regulatory system used in the European Union:

Unlike FTC, which may require companies to provide the evidence to support their advertising claims, FDA bears the burden of proving that a structure/function claim is false or misleading without having the authority to compel companies at the investigation stage to produce the evidence that the companies assert as support for their advertising claims. According to senior attorneys in FDA’s Office of the Chief Counsel, FDA’s efforts to meet that burden are hampered by the lack of access to the evidence that a company relies on to make such a claim. In particular, while FDA may ask a company to provide its evidence, FDA does not have express legal authority to compel the company to provide information. To support an action, FDA may need to review the scientific literature to determine whether the literature supports a claim—an effort that may be time consuming and labor intensive. FDA may also need to establish through research how consumers perceive the claim. If the structure/function claim, or any claim for that matter, is one for which there is little publicly available information, it can be difficult for FDA to develop the evidence needed to support an enforcement action. It also can be difficult to evaluate the support for a structure/function claim when the functions, such as “immunity” or “attention,” do not have generally established measures for the claimed benefit. For example, it is not necessarily clear what outcome measures would be a valid means of assessing whether a food “improves vitality.”

Furthermore, in contrast to the United States, the EU follows a different course: EU Commission officials told us the responsible EU food agency must preapprove the type of food claims that FDA calls structure/function claims before they can be used. EU Commission officials also stated that their scientific review agency rejected 85 percent of structure/function claims companies have submitted because of the lack of scientific support. Canada is also reviewing structure/function claims food companies have submitted by developing a list of approved claims; it too has rejected most claims, including some found on labels in the United States, according to a Canadian official. To protect the public from false or misleading claims, the Canadian food labeling agency is working with the Canadian agency that regulates advertising to develop a framework for regulating structure/function claims.

The above is positive in terms of pushback against the FDA from a free speech perspective, though again, it deals with qualified health claims and not structure/function claims. 

Qualified health claims are health claims that characterize the relationship of a food component to a disease or health-related condition, as modified with a disclaimer or otherwise qualified by FDA to characterize the strengths and limitations of the scientific support to address the claim’s potentially misleading nature. For example, the following is a qualified health claim allowed by FDA characterizing the relationship between the consumption of tomatoes and the risk of gastric cancer:1 “Four studies did not show that tomato intake reduces the risk of gastric cancer, but three studies suggest that tomato intake may reduce this risk. Based on these studies, FDA concludes that it is unlikely that tomatoes reduce the risk of gastric cancer.” Qualified health claims for food are not provided for in statute. Instead, they came about as a consequence of FDA’s decisions following a 1999 federal appeals court ruling (Pearson v. Shalala). The court held that the First Amendment does not permit FDA to prohibit a potentially misleading health claim on a dietary supplement label unless FDA considers whether qualifying language on the label could negate the potentially misleading nature of the claim. (Dietary supplements are products that contain certain dietary ingredients such as vitamins, minerals, or herbs, intended to supplement the diet, and are labeled as dietary supplements.)

Notes one commentator:

The FDA still has authority to regulate structure / function claims and may treat them as disease claims if they reference an underlying disease or condition (such as obesity or diabetes, for example).  Note that there are also FDA and FTC substantiation requirements with regard to structure / function claims, even though not as strict as for QHCs.

If you are involved in manufacturing or distributing dietary supplements or other natural products, be sure to contact an experienced health care lawyer who is familiar with the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) review of dietary supplement claims and labels.

Contact our legal team today.