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.