Industry officials agreed in the wake of an FDA meeting on November 17th, 2005, that the agency’s current policy on the wording of qualified health claims is untenable; but views diverged on how label language can be made clearer. The meeting in College Park, MD, featured presentations on five separate studies looking at consumer perceptions of various supplement labeling schemes, all aimed at conveying as clearly as possible the degree of scientific evidence behind those qualified claims.
Jonathan Emord, a Washington, D.C.-based attorney who filed the original lawsuit in the late 1990s that forced the FDA to begin approving qualified claims, and who has represented many of the supplement companies subsequently filing applications for claims, says the FDA is trying to use the studies to prove that labels cannot be used to communicate to consumers the complicated science behind qualified claims. Unfortunately, this might push the agency to stop approving such claims. “The FDA has done a horrendous job of communicating the basic nutrient-disease relationship information, choosing instead to saddle a simple statement that a claim is inclusive with extensive disclaimers,” said Mr. Emord. “The FDA is operating from the fundamentally flawed notion that you can fully educate consumers on the uncertainty of the scientific evidence. After you say the evidence is inconclusive, then it should be up to public to determine the extent of the uncertainty.”
Andrew Shao, vice president of scientific and regulatory affairs, Council for Responsible Nutrition (CRN), Washington, D.C., is not nearly as critical of the FDA as Mr. Emord. He thinks the FDA is capable of putting together a credible scheme for qualified claims, and believes the public has confidence in the FDA as a disinterested arbiter of supplement effectiveness. He does agree, however, that the FDA’s efforts so far on qualified health claims leave a lot to be desired, and could lead to skepticism about its intentions. “One could take away from the meeting that the FDA wants to conclude that information about a qualified claim cannot be communicated, so let’s close the books on them,” he added.
In agreement with Mr. Shao is Dan Murray, associate director of nutrition at Lonza, Allendale, NJ, who says the industry definitely needs this system, it is just a matter of figuring out a way to make it work for FDA, industry and consumers. “I definitely think we need this plan. However, I also think FDA was forced into accepting and creating a qualified health claims system that it was not prepared to handle,” he said. “What I think opponents of this system need to acknowledge is the history of how this system came to be.” He added, “So far, I have been disappointed with some of the claims people have been seeking and the evidence they have offered in support of those claims. I believe a lot of companies are asking for far more than they can substantiate.”
Mr. Murray believes companies must be realistic about submitting claims and think long and hard about what they can substantiate. They also have to recognize that FDA is not going to accept animal data for human risk reduction or human data on treatment to substantiate a human risk reduction claim. He pointed out that “most companies have a model of risk reduction and prevention in animals and treatment in humans, if they’re lucky. Companies are able to go to market with this, but apart from third party literature the only thing they can do is make structure/function claims.”
In his testimony at the mid-November meeting, David Seckman, executive director and CEO of the National Nutritional Foods Association (NNFA), Washington, D.C., said consumers are either being confused by the wordy claims or are not being provided with health claim information because manufacturers forego them. Ultimately, he believes consumer comprehension is linked to an educational component and that FDA must consider dedicating resources to that aspect of determining health claim language.
The FDA has approved 13 qualified health claims since 2000 for supplements, and in 2002 it extended the opportunity to foods as well. The approved claims deal with cancer and cardiovascular disease risk, cognitive function and neural tube birth defects. The latest approval came in November when, based on the available evidence, a very limited claim was awarded based on the relationship between tomato products containing lycopene and cancer.
LycoRed Natural Products, Ltd., Beer Sheva, Israel, along with companies like Heinz, Pittsburgh, PA, Morningstar Farms, Battle Creek, MI, and The Prostate Cancer Foundation, Santa Monica, CA, submitted a qualified claim petition over two years ago scientifically substantiating the relationship between lycopene in foods and supplements and prostate cancer risk reduction. After six extensions, FDA finally came out with its ruling. The claim that manufacturers are permitted to use in the case of prostate cancer reads: “Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little evidence to support this claim.”
American Longevity, San Diego, CA, eventually submitted its own petition describing the relationship between lycopene in foods and supplements and the prevention of a variety of cancers. In the realm of ovarian cancer, FDA awarded the following claim: “One study suggests that consumption of tomato sauce two times per week may reduce the risk of ovarian cancer; while this same study shows that consumption of tomatoes or tomato juice had no effect on ovarian cancer risk. FDA concludes that it is highly uncertain that tomato sauce reduces the risk of ovarian cancer.”
In response to FDA’s ruling, LycoRed president and CEO Morris Zelkha said in a company statement: “There are two human clinical trials underway in the U.S. studying the relationship between prostate cancer and LycoMato whole tomato complex, which is available in supplement form. We hope that the results from these studies will help further refine research that has been conducted to date on whole tomato complex.” According to LycoRed, it will continue to push forward with its own clinical research for lycopene and eventually re-file a petition with FDA to obtain a stronger claim, which includes supplements.
Steve Wallach, general manager of American Longevity, argues the FDA decision on the lycopene qualified claim greatly misleads the American consumer. “The American public is entitled to the whole truth and we will do all we can to prevent FDA from keeping this scientific information from the American people,” he said.
CRN’s Mr. Shao agrees with Mr. Emord, who filed the lycopenes applications on behalf of American Longevity, that it would be “a step in right direction” if the FDA did not require such involved disclaimer language on qualified health claims. Companies apply for qualified health claims when they do not have enough data to meet a standard of “significant scientific agreement among qualified experts that the claim is supported by the totality of publicly available scientific evidence,” which is what the FDA needs to grant an unqualified health claim, also called an authorized health claim. Because they are partially supported by scientific evidence, qualified health claims must be accompanied by a disclaimer or other qualifying language to accurately communicate the level of scientific evidence supporting the claim.
The FDA internally rates the strength of the scientific evidence behind health claims as either A, B, C, or D, with D being the weakest. Applications with “A” evidence become unqualified health claims (authorized health claims). The agency then approves appropriate wording and associated disclaimers for the qualified claims.
One suggestion Mr. Shao and others advanced at the November 17th meeting was to clear up the language for unqualified health claims so that it could perhaps serve as a “gold standard” for future unqualified claims. As an example, he suggested that an unqualified claim for calcium could be changed from “calcium reduces the risk of osteoporosis” to “there is strong and conclusive evidence indicating that calcium reduces the risk of osteoporosis.”
A staff-done study the FDA released at the end of last September, and which was one of the five discussed at the November 17th meeting, showed that consumers often think a “B” or “C” qualified claim is stronger than an unqualified claim (“A” rated claim), leading to Mr. Shao’s suggestion of strengthening the unqualified claim language. FDA showed 1920 volunteers four hypothetical dietary substance/disease relationships (calcium/ osteoporosis, omega 3 fatty acids/heart disease, selenium/cancer and lycopene/ cancer), which spanned a range of scientific certainty. Participants were shown mockup labels for familiar types of products (orange juice, tuna, eggs and tomato sauce), which carried a health claim. When respondents saw B and C report card grade disclaimers appropriate for the “correct” level of scientific support for the claim, they became more certain about the scientific evidence supporting that claim than when they saw an unqualified, “A” level health claim.
The debate over qualified health claims stretches back to the 1993 regulations implementing the Nutrition Labeling and Education Act (NLEA). It established the “significant scientific agreement” (SSA) yardstick for unqualified health claims for food only. Mr. Emord filed a lawsuit soon after and in 1999 a federal court issued the Pearson v. Shalala decision, which forced FDA to find a way to communicate qualified health claims. The agency issued guidance in July 2003 on what it referred to as an interim system based on the four levels of evidence. At the same time it instituted this interim system, FDA developed a consumer studies research agenda designed to identify the most effective ways to best present scientifically based, truthful and non-misleading information to consumers and to identify the kinds of information known to be misleading to consumers.
The FDA has no intention of changing its labeling policy at the moment. Steve Bradbard, the FDA official who led the November 17th meeting, said only that the agency will be embarking on two additional studies on consumer perceptions of qualified health claims.