Warning Statements for Products Containing or Manufactured With Chlorofluorocarbons and Other Ozone-Depleting Substances

The Food and Drug Administration (FDA) is issuing interim regulations governing warning statements for products containing or manufactured with chlorofluorocarbons (CFC's) and other ozone-depleting substances. The amendments prescribe specific warning statements and additional labeling statements for physicians and patients. These additional statements direct patients to consult their physicians before discontinuing use of a prescription medical product because of concerns about the product's effect on the environment and public health. The interim rule also provides warning statements for over-the- counter (OTC) drug and device products and directs patients to consult their physicians, health professional, or suppliers with questions about the products. In addition, the interim rule revises certain regulations concerning foods, cosmetics, and animal foods in a self- pressurized container with a CFC propellant in order to be consistent with current statutory requirements. FDA is issuing these regulations as an interim rule with opportunity for public comment.