FDA Stakeholder Update - August 15, 2019

Dear Colleague, FDA's Stakeholder Engagement Staff works to provide you with up-to-date information that helps to further our commitment in advancing public health and well-being. FDA Announcements

FDA proposes new required health warnings with color images for cigarette packages and advertisements to promote greater public understanding of negative health consequences of smoking FDA issued a proposed rule to require new health warnings on

cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking. The proposed warnings, which feature photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, stand to represent the most significant change to cigarette labels in more than 35 years. When finalized, this rule would fulfill a requirement in the Family Smoking Prevention and Tobacco Control Act and complement additional important work the FDA is undertaking to advance the health of America’s families. [08/15/2019] FDA warns consumers about the dangerous and potentially life threatening side effects of Miracle Mineral Solution FDA is warning consumers not to purchase or drink a product sold online as a medical treatment due to a recent rise in reported health issues. Since 2010, the FDA has warned consumers about the dangers of Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide (CD) Protocol, Water Purification Solution (WPS) and other similar products. Miracle Mineral Solution has not been approved by the FDA for any use, but these products continue to be promoted on social media as a remedy for treating autism, cancer, HIV/AIDS, hepatitis and flu, among other conditions. [08/13/2019]

FDA In Brief FDA takes new steps to improve drug supply chain integrity and patient safety by announcing its intention to begin deactivating outdated drug listing records in its database FDA announced that it will inactivate listing records in its database that have not been recently updated or certified, as required by regulation, or that include an establishment with an expired registration. The agency has found that tens of thousands of drug listing records have not been updated or certified in the past year, and are therefore not in compliance with federal regulations, which can slow down surveillance operations for certain FDA programs. Many of these listings are for products that are no longer being marketed in the United States, but for which the manufacturer never updated the listing.[08/13/2019]

Request for Comment Request for Comment by October 15, 2019 Gastroparesis: Clinical Evaluation of Drugs for Treatment; Draft Guidance for Industry This draft guidance is intended to provide the FDA's current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis. This draft guidance replaces the draft guidance for industry of the same name issued July 23, 2015.

Request for Comment by October 15, 2019: Tobacco Products; Required Warnings for Cigarette Packages and Advertisements FDA is issuing a proposed rule to establish new required cigarette health warnings for cigarette packages and 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 new textual warning statements.  The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965 to require each cigarette package and advertisement to bear one of the new required warnings.  This proposed rule, once finalized, would specify the color graphics that must accompany the new textual warning statements.  FDA is proposing to take this action to promote greater public understanding of the negative health consequences of cigarette smoking. CDER Regulatory Science Impact Story A New Possible Way to Evaluate Bioequivalence of Topical Drugs Demonstrating the bioequivalence of a generic drug product means showing that it can deliver the same amount of the same drug to the site(s) of therapeutic action at the same rate and to the same extent as the brand name product. For many systemically acting drug products, evaluating bioequivalence involves administering the product (e.g., a tablet taken by mouth) and then drawing blood at scheduled times to measure the amount of the drug in the circulation at each point.