Check that health claim at the door

by Eric Schroeder
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In a competitive food and beverage industry where grabbing consumers’ attention is paramount to success in the marketplace, several factors come into play. Unique packaging and innovative flavors stand out as examples of popular marketing tactics. Another effort that has gained traction in recent years is the addition of health claims that point out the benefits of a given product.

Health claims show a relationship between a nutrient or other substances in a food and a disease or health-related condition. In past years, claims have ranged from "low fat" to "high fiber." Companies recently have become more proactive in attempting to gain health credibility for their products, using resources such as industry associations and councils to promote their cause.

Earlier this year, the Natural Marketing Institute (N.M.I.), Harleysville, Pa., issued its "Health & Wellness Trends Database," a report exploring what types of products consumers are looking for. Based on its findings, the N.M.I. predicted 2006 would see the continued propagation of specific nutrient platform drivers across food, beverages and nutritional supplements. The report, which covered seven years of consumer health and wellness trends, was based on research from more than 15,000 U.S. households. In 2005, 57% of consumers indicated they looked for foods that have a specific claim relating to health issues as compared with 69% in 1999, the N.M.I. said. The Institute also noted in the report there have been slight declines over the past seven years, indicating that the true role of functional foods and beverages continues to exhibit challenges, though the preference for condition-specific dietary supplements remains on the rise.

"This desire for health claims is evident across many consumer packaged goods," said Maryellen Molyneaux, president of the N.M.I. "For example, with over 29 million people suffering from food allergies, allergen-free foods will continue to experience solid growth. Introductions of gluten free foods alone have shown a 50% compound annual growth over the past six years and generate U.S. re tail sales in excess of $400 million Another nutrient to watch in 2006 is probiotics, which has shown annual awareness increases of 27% since 2002."

Manufacturers, for their part have taken additional steps to incorporate wide ranging nutrients into foods related to specific health conditions. Among the most popular nutrients being added fish oil, lutein, lycopene, probiot ics and plant sterols.
"While consumers may lack understanding of the specific health benefits of some nutrients savvy manufacturers and marketers will use this opportunity for continued education to raise the value of their nutrient-rich products in the eyes of the consumers," Ms. Molyneaux said. The F.D.A. takes action For its part, the Food and Drug Administration has not only been forced to take a more active role in monitoring health claims, but the agency is finding itself pressed for time in ruling on certain issues.

In the past year alone, the F.D.A. has denied health claims sought for lycopene and green tea, while approving a claim for barley. In the case of lycopene, the F.D.A. said it found "no credible evidence to support a qualified health claim for tomato lycopene." However, the F.D.A. did not completely disregard the claims, responding to each by stating that although the evidence was inconclusive, lycopene may reduce the risk of prostate cancer.

In the case of green tea, the F.D.A. concluded that it was "highly unlikely" to reduce the risk of breast cancer, rejecting a petition that had sought to allow health claims on green tea touting the beverage’s heart health benefits.

But the F.D.A. has not been just a "no" organization when it comes to health claims. In May, the F.D.A. finalized a rule that allows foods containing barley to claim they reduce the risk of coronary heart disease. To qualify for the health claim, whole grain barley and dry milled barley products such as flakes, grits, flour, and pearled barley, must provide at least 0.75 grams of soluble fiber per serving.

"F.D.A. is pursuing new initiatives to help consumers improve the choices they have for healthy and nutritious diets," said Scott Gottlieb, F.D.A. deputy commissioner for medical and scientific affairs. "We firmly believe that one of the best ways to encourage healthier eating habits is to help consumers get truthful, up-to-date, science-based information about food products so they can make choices that are based on a better understanding of the health consequences of their diets."

G.M.A. advice under review

Count the Grocery Manufacturers Association among those industry groups pushing the F.D.A.’s buttons to improve understanding of health claims going forward.

After submitting oral comments to the F.D.A. in November 2005 on consumer perceptions of health and disease claims the G.M.A. in January followed up with written comments that it believes may enhance consumer understanding.

Among the actions the G.M.A. suggested was a three-tier sys tem for health claims: one tier for unqualified health claims and two tiers for qualified health claims. As an example, the G.M.A. said the unqualified claims could contain the language "conclusive scientific evidence shows," the first tier of qualified health claims "strong scientific evidence shows," and the second tier of qualified health claims "limited and preliminary scientific evidence shows."

The association stressed in its comments, though, that the use of the three terms — conclusive, strong and limited scientific evidence — must be presented in a context that consumers understand as relating to the claim, and not the quality of the product itself. One possibility would be a labeling format with the appropriate level for the claim being checked. "At G.M.A., we want to make sure health claims communicate the health benefits of foods," said Alison Kretser, senior director of scientific and nutrition policy, G.M.A. "We’d love to see F.D.A. do testing, to have a checkmark. What it means is that our members are willing to make changes to unqualified claims to meet requirements."

Ms. Kretser added, "Health claims can be a tool to motivate manufacturers to change the food supply as well. That is why we’ve been very interested in making changes. The food label reaches all Americans, including those who don’t have access to other nutrition information and who carry the greatest burden of chronic disease in this country. Clearly we want to make sure that information is accurate and not misleading."

Ms. Kretser in her January letter to the F.D.A. also encouraged the federal government to use independent expert panel reports as an adjunct to health claim petitions. Under the G.M.A.’s recommendations, the F.D.A. also would be required to respond in a specified time or the petitioner would be free to use the claim.

"G.M.A. believes such an approach should not be necessary if industry and F.D.A. can work together to improve these petitions and the expert analysis included in them in such a way as to relieve some of the agency’s review burden," Ms. Kretser wrote.

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