FDA Stakeholder Update - October 24, 2019

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

FDA Announcements

Statement on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products FDA recognizes that consumers may use various types of unapproved drugs, such as homeopathic drug products, to treat or relieve different diseases and conditions. These products are often marketed as natural alternatives to approved prescription and nonprescription products and are widely available in the marketplace. Homeopathic products, however, are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling. FDA uses a risk-based approach to monitor these products and to evaluate reports of adverse effects. [10/24/2019] Statement on the Agency’s Continued Efforts to Protect Women’s Health and Enhance Safety Information Available to Patients Considering Breast Implants The FDA is taking another significant step in protecting women’s health by helping to ensure patients have complete information about the benefits and risks of breast implants. In a draft guidance issued today, we are providing proposed labeling recommendations to manufacturers of these devices to help ensure women receive and understand information regarding the benefits and risks of breast implants. The draft guidance offers numerous recommendations to help ensure women have access to this information, including that manufacturers incorporate a boxed warning and patient decision checklist in the device’s labeling, update recommendations for patient screening for device rupture and more. [10/23/2019] FDA, FTC Warn Company Marketing Unapproved Cannabidiol Products with Unsubstantiated Claims to Treat Teething and Ear Pain in Infants, Autism, ADHD, Parkinson’s and Alzheimer’s Disease The FDA and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases. [10/22/2019]

FDA In Brief FDA Notifies Eonsmoke  to Remove Nearly 100 Flavored Electronic Nicotine Delivery System Products from the Market for Not Having Required Marketing Authorization, Among Other Violations The FDA issued a warning letter to Eonsmoke LLC (Eonsmoke) of Clifton, New Jersey, notifying the company that nearly 100 flavored electronic nicotine delivery system (ENDS) products do not have the required marketing authorization, and thus cannot be legally sold in the United States, among other violations. Eonsmoke sells ENDS products, such as flavored e-liquids, many of which are compatible with other popular ENDS devices, such as JUUL. [10/24/2019]

DEA National Prescription Drug Take Back

Drug Take Back Day October 26, 2019: The best way to safely dispose of most types of old, expired, or unused medicines

Medicine take back options are the best way to safely dispose of most types of unneeded or expired prescription and over the counter medicines. Before disposing of prescription medicines using a drug take back option, be sure to remove all personal information on the label of pill bottles or medicine packaging. Note that there are a few, select medicines with specific instructions to immediately flush down the toilet only if a drug take back option is not readily available.

Request for Comment

Breast Implants - Certain Labeling Recommendations to Improve Patient Communication: Submit Comments by December 23, 2019 This draft guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. FDA is issuing this draft guidance to help ensure that a patient receives and understands the benefits and risks of these devices. The recommendations are being made based on concerns that some patients are not receiving and/or understanding information regarding the benefits and risks of these devices.

FDA Voices

Expanding Criminal Enforcement Operations Globally to Protect Public Health by: Ned Sharpless, M.D., Acting Commissioner, Melinda K. Plaisier, Associate Commissioner for Regulatory Affairs, and Catherine A. Hermsen, Director, Office of Criminal Investigations The American public relies on the FDA to help ensure the quality and safety of FDA-regulated products available to consumers, many of which are sourced or manufactured overseas. As the volume of globally produced products and suppliers expands daily, the risk of fraudulent, intentionally adulterated, and/or other illegal products shipping into the U.S. also increases. Every day, thousands of illicit products are shipped to the United States from overseas, across the spectrum of things the FDA regulates, including unapproved opioids, counterfeit medicines, fake medical devices, bogus vaccines, imitation cosmetics, adulterated foods and components of illicit vaping products.

Recall and Safety Information

Baby Powder by Johnson & Johnson Recalled for Asbestos On October 18, 2019, the FDA alerted consumers of a voluntary recall by Johnson & Johnson of Johnson’s Baby Powder after FDA testing has found that a sample from one lot of the product contains chrysotile fibers, a type of asbestos. Zantac (ranitidine): Recall - Due to Possible Presence of N-nitrosodimethylamine (NDMA) On October 23, 2019, the FDA issued alerts to inform consumers, pharmacy's, patients and health professionals about the possible presence of a nitrosamine impurity called NDMA. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests from the following manufacturers: Perrigo Company plc Sanofi Dr. Reddy's, Kroger, Walgreens, and others. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Healthcare providers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.