Department of Health and Human Services November 12, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is proposing to amend its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. The proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany the nine new textual warning statements that will be required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This proposed rule, once finalized, would specify the color graphics that must accompany each of the nine new textual warning statements.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' Dear Health Care Provider (DHCP) Letters are correspondenceusually in the form of a mass mailing from the manufacturer or distributor of a human drug or biologic, or from FDAintended to alert physicians and other health care providers to important new information about a marketed drug or biological product. This draft guidance provides recommendations on when to use a DHCP letter, the types of information to include in a DHCP letter, how to organize that information, and formatting techniques to make the information more accessible. The draft guidance is intended to improve the quality of DHCP letters to make them more effective communication tools for new information about marketed products.