The firm advises and represents clients with respect to a wide range of regulatory activities involving dietary supplements comprising vitamins and minerals, herbs, and other substances used to supplement the diet. These representations go back over fifty years to the first major FDA challenges to the industry and have involved all the statutory changes, including the 1994 Dietary Supplement Health and Education Act (DSHEA), which created both opportunities and new issues for our clients. These issues have included the interpretation of the statutory definition of “dietary supplement,” the application of the “new dietary ingredient” criteria, and the continuing issue of the line between permitted “structure or function” claims and impermissible “disease” claims.
In addition, we advise on general labeling issues, GMP compliance, and the distinction between labeling and advertising. Some of our clients are pharmaceutical companies accustomed to complying with FDA requirements, while others are direct-selling marketers and start-up companies requiring significant counseling on FDA requirements, statutory provisions, and the risks involved in the regulatory process.