WASHINGTON -- Amid the inevitable controversies over dietary supplement product claims and the public's demand for health solutions at a low cost, the retailer should proceed cautiously, according to some who participated in New York-based Strategic Research Institute's Food Labeling and Health Related Claims Conference here.
The conference, Jan. 26 and 27, drew some 50 delegates from leading food and nutritional-supplement manufacturers, as well as other executives from the neutraceutical field.
What's referred to as "emerging science" has often left the dietary-supplement industry and the government's efforts to regulate it in a quandary when it comes to benefit claims. Discussed was the issue of how manufacturers should use emerging science -- scientific-based evidence that links supplements to health benefits. Claims about antioxidants, folic acid and Omega 3s were cited specifically. These particular nutriments drew industry attention last year as a result of the landmark "Pearson vs. Shalala" verdict which, among other findings, determined that benefit claims being made for these supplements by scientists Durk Pearson and Sandy Shaw could not be arbitrarily dismissed by the Food and Drug Administration based on what it termed was a lack of "significant scientific agreement." A sticking point for the FDA was not being able to define what "significant scientific agreement" means.
"FDA has classically taken the position that until [a consensus] is full-blown you can't say anything," said Peter Barton Hutt, a partner at the food and drug law firm of Covington & Burling, also based here. "But the courts now say 'if it's emerging, you can still say something, but you have to explain it -- that it's emerging."'
The U.S. Appeals Court ruled the FDA's decision in rejecting Pearson and Shaw's health claims was unconstitutional and in violation of the First Amendment and the Administrative Procedure Act. It ordered the FDA to define what it means by "significant scientific agreement" for health claims on dietary-supplement labels and to allow the use of disclaimers on labels, rather than suppress claims outright.
Some feel a gray area has arisen due to the new FDA structure/function final rule regulations, published Jan. 6 in the Federal Register, which narrow the definition of disease and expand what are considered structure function claims. Hutt, who spoke during the conference about significant FDA actions during 1999, said that rather than a clear dividing line there is a "zig-zag line" between the two.
Despite the gray area, sales indicate dietary supplements are the most active growth sector under the neutraceuticals umbrella -- comprised of fortified foods and dietary supplements. Fernando Agos, director of research and analysis at the Consumer Goods division of London-based Datamonitor, a market analysis firm that has operations in New York City, presented the growth figures.
"Over the past five years," he said, "compound annual growth rate [the average growth each year for dietary supplements] has been 14%." Within that category, herbal supplements have shown a CAGR of 34%. "This is significant," he said.
What should retailers do given the combination of a regulatory gray area and "significant" supplement growth? Be conscientious regarding claims made by the manufacturer but promote the products, sources said.
Asked if it was appropriate for the items influenced by emerging science -- such as antioxidants -- to be promoted, Jeff Nedelman, president of Strategic Communications, Vienna, Va., said, "Absolutely." Nedelman spoke at the conference about marketing neutraceuticals to the aging population. "The economic realities of the marketplace are so strong that supermarket retailers -- if they choose to avoid these categories -- do so to their own detriment," he told SN.
"These are high-margin products. They are high-demand and high-value and they bring into the store the wealthiest, most educated people who are looking for value," he said. "It's an enormous economic opportunity."
For example, given the amount of science that says vitamin E, an antioxidant, is beneficial for the heart, a study that counters that evidence should not be a deterrent. "Neither retailers nor consumers can make purchasing decisions based upon one study," Nedelman said. "You have to look at the totality of the evidence on vitamin E. If you go to a cardiologist and you've got a heart history, he's telling you to take vitamin E and that's good advice."
Emerging science as it relates to the benefits of folic acid, found in multivitamins and B-complex vitamins, is being promoted by the Council for Responsible Nutrition here. The CRN has released a modification of the Food Guide Pyramid and included folic acid in the foundation of the pyramid. The second level of the four-level graphic is calcium; then, on the third level, are antioxidants. In addition, the CRN posts on its Web site reports about studies showing the benefits of folic acid.
Although "the heavy burden of validating the science falls on the manufacturer," said Nedelman, one area where a claims burden may fall on the food retailer marketing a whole-health strategy is private label. "In the case where the retailer is the manufacturer through private label, they have a responsibility there," Nedelman stated.
Some feel there is room for supermarkets to inform customers regardless of their position as retailer or manufacturer. "I have always thought that the food retailer ought to be the primary place where useful structure-function information can be provided to the consumer," Hutt told SN. "It's quite clear there's not enough room on every package to get across the complete story on nutritional information, particularly where it involves emerging science.
"We are going to see more and more pamphlets and leaflets and other off-label information that will convey this type of information," he continued, "and that, of course, is where the supermarket comes into play."
Nedelman added that there is more than one way supermarkets can educate their shoppers. "They have the pharmacists," he said. "They have the shelf space, computer [kiosks] and they can develop third-party literature. The retailer can customize for each consumer the kind of information they ought to have."
However, if retailers want to go further in offering off-label information specifically relating to benefit claims, they should "look very hard at anything that is bordering a disease claim" said John Cassens, president of Cassens Consulting, Norwood, N.J., an intermediary between neutraceutical innovators and manufacturers. "If I were a retailer," Cassens said, "I would look very hard at the manufacturer -- whoever's making the claims -- they are the ones who have the responsibility to comply with the law."
He added that it might be too early for supermarkets using a whole-health strategy to promote specific products based on benefit claims that cite emerging science. He also recommended legal counsel if retailers are interested in purveying claim information. "If a retailer were to take a stand, they would need an interpretation of the law."
