Regulations: The Times They Are A-changing

Bob Dylan probably was not thinking about health claims when he recorded this classic song, “The Times They Are A-Changing.” The dynamic and rapid pace of regulatory change in the area of qualified health claims by the Food and Drug Administration (FDA) is reshaping food companies' strategic planning and development of new products. As the number of qualified health claim petitions submitted to FDA continues to grow, it is important to know what is coming and how to maximize the opportunities the current regulatory environment offers.

By way of background, in a remarkable shift in regulatory policy, FDA announced in December 2002 that it would consider petitions seeking qualified health claims on the basis of scientific evidence short of “significant scientific agreement.” Since enactment of the Nutrition Labeling and Education Act of 1990 (NLEA), FDA had steadfastly insisted that it would authorize only health claims that met this scientific evidence gold standard.

FDA permits qualified health claims through exercise of its “enforcement discretion,” whereby a petitioner is advised that the requested claim may be communicated via the food label, provided the claim is “qualified” to convey the limits of the underlying scientific evidence. In contrast to the maximum of 540 days by which FDA must act to finalize an unqualified health claim (i.e., a claim supported by significant scientific agreement), the qualified health claim process can be completed in nearly half that time. FDA has already allowed several qualified health claims which include: phosphatidylserine and dementia/cognitive dysfunction; selenium and risk of certain cancers; and antioxidant vitamins C and E and the risk of certain cancers (a qualified claim initially denied by FDA in May 2001).

New product trends will likely be influenced by and reflect petitions now under review at FDA. Qualified health claim petitions include those for such mainstream ingredients as calcium, green tea, monounsaturated fats, soy protein and lycopene. Less conventional substances not typically touted include chromium picolinate, glucosamine and/or chondroitin sulfate, xangold lutein and omega-3 fatty acids.

Calcium-related claims, for example, are actively under consideration at FDA for a variety of disease-related conditions, including reducing the risk of various cancers, certain kinds of fractures, hypertension, kidney and urinary stones, and menstrual disorders. FDA has similarly advised a petitioner that nine of 12 requested health claims relating the risk reduction of joint problems with the consumption of glucosamine and/or chondroitin would be reviewed by the agency.

Chromium picolinate, once the target of Federal Trade Commission enforcement for advertising claims relating to weight loss, has reappeared in relation to insulin resistance, abnormally elevated blood sugar levels and kidney disease when caused by abnormally high blood sugar levels, among other claims. FDA is now reviewing public comments, and a decision is expected in November 2004.

FDA action is expected by the end of the year on several other pending petitions as well.

Lycopene, a constituent of tomatoes, is the subject of a petition for 30 different proposed health claims relating to risk reduction of various cancers (e.g., “Lycopene may reduce the risk of cancer” and “Lycopene-containing tomato-based foods may reduce the risk of cancer.”) An FDA decision is expected by the end of December 2004.

Omega-3 fatty acids and heart disease (“Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease. Multiple studies have shown that consumption of omega-3 fatty acid-containing foods and dietary supplements reduced the risk of coronary heart disease. Moreover, recent clinical trials have proven to a near conclusive degree its safety and efficacy for use by the general population.”)

Soy protein and the risk of certain cancers (“Soy protein may reduce the risk of certain cancers. Scientific evidence suggests that consumption of soy protein may reduce the risk of certain forms of cancer. However, this evidence is not conclusive.”)

The future of qualified claims is uncertain. Rulemaking that would make permanent the current interim policy is ongoing. A change of administration or philosophy could bring the current interim policy to an end. A pending lawsuit challenging FDA's authority to permit qualified health claims further clouds the future of these claims.

FDA's new-found flexible approach to health claims has, and will continue, to advance marketers' ability to capitalize on the important role foods can play in the management of dietary-related risk factors relating to a wide spectrum of diseases. The times, indeed, are a-changing.

Sidebar 1: Questioning the Future

New products are greatly impacted not only by regulations, but also by factors such socio-demographic and technological changes. On the Tuesday afternoon of October 12, in Scottsdale, Ariz., during Prepared Foods' New Products Conference, John Helferich, VP of R&D/quality services, Masterfoods USA; Leah Evans, senior VP of R&D, Pizza Hut; and Todd Abraham, VP of research, Kraft Foods, will give their view on the top five trends impacting new product development in the next ten years. All these speakers, plus Steven Steinborn (the author of this article), also will participate in a Q&A session following the three industry leaders' presentations.