Companies with unique ingredients or end products could gain government-sanctioned, near-proprietary marketing tools under the liberalised health claims system introduced by the US Food and Drug Administration in September, according to a leading industry analyst.
Speaking at the recent Natural Products Expo East trade show in Washington, DC, Loren Israelson, president of Utah-based LDI Group, highlighted the commercial potential of qualified health claims. Qualified claims are based on ?good, but not entirely conclusive? evidence and, if accepted by the FDA, will receive an A-to-D grading depending on the scientific strength of the petition. The FDA says it will process all claims within 270 days.
Israelson believes dietary supplement and functional foods manufacturers as well as ingredient suppliers have been presented with an opportunity to gain a competitive edge.
?The FDA?s view is that it has to be a generic claim that doesn?t relate to a specific branded product or ingredient,? said Israelsen. ?But I think there is an opportunity if there aren?t too many ingredients or products of that kind on the market to get a generic claim that is quite specific to a particular product or ingredient.
?It could distinguish it from everybody else in the market and until competitors have demonstrated equivalence they can?t use that claim. I venture very few folks understand the ramifications of this while others are going to jump on it and gain that commercial advantage.? One company to have jumped already is Israeli ingredient supplier Lycored Natural Products which, together with Heinz and other unnamed companies, is putting together a submission based on the cancer-fighting properties of Lycored?s natural tomato complex, Lycomato.
Lycopene, the antioxidant found in tomatoes, is well known to have cancer-fighting capabilities, but because Lycored and Heinz will apply for the claim in relation to Lycored?s particular product, Lycomato, synthetic lycopene manufacturers may be precluded from attaching the claim to their products.
There is, however, concern over the new system. Two groups, the Center for Science in the Public Interest (CSPI) and Public Citizen, have taken legal action against the FDA for failing in its duty to protect consumers. ?The FDA is illegally putting consumers? health at risk and allowing food companies to turn the supermarket aisle into a Tower of Babble,? said a CSPI spokesperson. In the middle ground are those who see both boon and bane with the looser requirements. ?More information is good for consumers, but we don?t know how valuable it really will be,? said Kim Smith, director of legislative affairs at the National Nutritional Foods Association. ?The FDA?s qualifying language takes away quickly what they?ve given.?