KKB has helped food industry clients make health claims for foods since the field first opened up in the US in the late 1980s. For example, working with a client, we helped lead the petition process for one of the first FDA-approved health claims - the claim for phytosterols and reduced risk of heart disease, in 2000. More recently, FDA fully accepted another petition prepared by KKB on phytosterols. The petition urged FDA to accept 2 grams of phytosterols as the recommended daily level and to permit foods containing this amount to be labeled with information indicating that they provide in a single serving the daily level of phytosterols. FDA granted this request in its proposed rule, and also permitted the proposal to be immediately implemented by manufacturers.

KKB has significant experience in counseling clients on how to make health claims that will withstand regulatory scrutiny - by ensuring that the claims meet regulatory and substantiation requirements under FDA law, FTC law, and state law. In addition, we have been extensively involved in defending clients against class action lawsuits that have recently proliferated, and which typically allege that health-related claims (or other claims for foods) are false and misleading. By carefully wording claims to closely follow the supporting scientific data, and also by closely following any FDA-authorized language, litigation risks can be significantly reduced.