‘FUNCTIONAL FOODS’: Sidestepping FDA Rules
Claiming its new food bar, that contains L-arginine, "can ease symptoms of heart disease," a small California company is "sidestepping the usual rules that govern health claims for foods and drugs" by declaring its HeartBar a "medical food." The Wall Street Journal reports that by placing the food bar in such an "obscure category," Cooke Pharma Inc. can "make much more specific health claims" than can the makers of dietary supplements. The company is planning "an advertizing blitz" touting a recent Mayo Clinic study that found two bars'- worth of L-arginine "could improve coronary blood flow 150% and reduce angina symptoms 70%." The Journal reports that if "the company is successful, it could prompt other companies to position their products as medical foods, thus avoiding some government regulatory hurdles." Pharma Cooke founder John Cooke received a patent for the use of L-arginine as a way to induce clogged blood vessels to function normally, but could not find a drug company that wanted to market the substance. He said "an FDA official suggested that he market the product as a medical food," which would be subject to less strict regulation under the 1988 Orphan Drug Act. The act "defines medical foods as products to manage diseases that have specific nutritional requirements," and allows them to be sold without a prescription. Some FDA officials, however, say they want to make sure HeartBar is a medical food and wonder if "medical food should be subject to the same standards drug companies must meet to support a claim." FDA Deputy Commissioner for Policy William Schultz said, "The reason the FDA has taken as long as it has (to focus on this category) is that companies haven't exploited it" (Sharpe, 12/10).
Today's Wall Street Journal takes a look at the marketing of "so-called functional foods," including Kellogg's Ensemble, "a line of pasta, frozen meals, chips and cookies" whose packaging claims they are "great-tasting foods made with natural soluble fiber that actively works to lower cholesterol." To promote the new products, Kellogg wants to distribute an "Ensemble Action Pak" to patients with known cholesterol problems, and is even considering "offering telephone coaching to consumers for a fee." The article also discusses the "behind the scenes" marketing approach being undertaken by Johnson & Johnson's MacNeil Consumer Healthcare division for its new product Benecol, a line of margarine and salad dressings made with stanols, naturally-occurring plant-based substance shown to lower cholesterol. The company had "intended to market Benecol as a dietary supplement," the Journal reports, but the FDA in October "said it views the product as a food," which lowers the standard for health claims. In coming months, J&J plans to "unleash its more than 300 salespeople to storm doctors' offices touting" the benefits of Benecol (O'Connell, 12/10).