FDA Publishes Annual Guidance AgendaDecember 8, 2010
By Ricardo Carvajal –
As required by its Good Guidance Practices regulation, FDA published its annual guidance document agenda and request for comment on “possible topics for future guidance document development or revisions of existing [guidance documents].”
Among the food-related topics that caught our eye are new dietary ingredient notifications, use of dietary guidance statements, calorie declaration (think FOP labeling), menu labeling, and effect of the use emerging technologies on the safety and regulatory status of ingredients and food contact substances (think nanotechnology). It appears that the agency also intends to address the safety of nanoscale materials in cosmetics.
On the tobacco side, FDA is considering addressing rotational warning plans for smokeless tobacco, use of descriptors such as “light,” restrictions on distribution of cigarettes and smokeless tobacco to minors, “harmful and potentially harmful constituents,” and issues of interest to retailers such as training programs and civil money penalties.
As swimmers in the social media pool, we also note with interest that CDER will (hopefully) address the promotion of prescription drug products using social media tools.