FDA Stakeholder Update January 2020

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 Announcement FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint Amid the epidemic levels of youth use of e-cigarettes and the popularity of certain products among children, the FDA issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. Under this policy, companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions. “The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes. HHS is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally,” said HHS Secretary Alex Azar. [01/02/2020]

FDA in Brief

FDA continues to advance agency-wide scientific and technical capabilities by holding public meeting on modernization of data strategy The FDA announced it is holding a public meeting on March 27, 2020 at the FDA’s White Oak campus on “Modernizing FDA’s Data Strategy.” The purpose of the public meeting and the request for comments is to discuss possible agency-level approaches to modernizing the FDA’s data strategy, including approaches to data quality, data stewardship, data exchange and data analytics. This meeting is part of the FDA’s efforts to modernize technology used at the agency, as detailed in the  Technology Modernization Action Plan (TMAP), released in September 2019. The TMAP describes steps the FDA is taking to modernize the use of technology, including computer hardware, software, cloud-based solutions and data exchange. The FDA’s data strategy meeting announced today is the next step in these efforts. [1/07/2020] FDA provides additional information about requirements for dual column labeling, serving sizes on Nutrition Facts label The FDA is issuing a final guidance to help manufacturers of packaged foods comply with the FDA’s updated Nutrition Facts labeling regulations. The final guidance addresses serving sizes of foods, including single-serving foods and other foods that can reasonably be consumed at one eating occasion and require dual column labeling. [12/30/2019]

FDA Voices

Innovation in New Drug Approvals of 2019 Advances Patient Care Across a Broad Range of Diseases By: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research New drug therapies for patients suffering from rare diseases are often among the most important approvals. Patients with rare diseases frequently have few or no drugs available to treat their condition — and for them, approvals of so-called “orphan” drugs can mean new hope for an enhanced quality of life, and in some cases, survival. Among others, in 2019 CDER approved new therapies for patients suffering from a wide array of rare and debilitating conditions including cystic fibrosis, systemic sclerosis-associated interstitial lung disease, erythropoietic protoporphyria, neuromyelitis optica spectrum disorder, and Duchenne muscular dystrophy. Many orphan drug approvals can help patients with various forms of cancer, tumors, and blood disorders. In 2019, among others, CDER approved new drug therapies for patients with tenosynovial giant cell tumor, sickle cell disease, diffuse large B-cell lymphoma, mantle cell lymphoma, a type of myelofibrosis, acquired thrombotic thrombocytopenic purpura, beta-thalassemia, and acute hepatic porphyria. [01/07/2020]

Outbreaks Emphasize the Importance of Implementing Produce Safety Standards by: Frank Yiannas, Deputy Commissioner for Food Policy and Response, and Judy McMeekin, Acting Associate Commissioner for Regulatory Affairs Fresh produce plays an important part of an overall healthy diet. While millions of servings of fresh produce are consumed safely every day, recent outbreaks of foodborne illness have once again placed produce safety in the spotlight. We must continue to build upon and implement the science- and risk-based controls envisioned by Congress through the Food Safety Modernization Act (FSMA), including those set forth in the Produce Safety Rule. Last year was the first in which the U.S. Food and Drug Administration and our state regulatory counterparts began conducting routine inspections of large farms for this rule established by FSMA. (In general, we’re not addressing sprouts operations here, which have additional requirements and earlier compliance dates.) Leading up to 2019, the agency has collaborated with the  National Association of State Departments of Agriculture (NASDA) and our state partners to help prepare farmers to comply with the rule. We have also supported states in the development of their own produce safety programs. [01/06/2020]

REQUEST FOR COMMENT Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry by 01/23/2020 This draft guidance describes how we intend to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States without the required FDA approval. As discussed below, FDA has developed a risk-based approach under which the Agency intends to prioritize enforcement and regulatory actions involving certain categories of such products that potentially pose a higher risk to public health. Public Warning-Notification of Recalls Under 21 CFR Part 7, Subpart C by 02/08/2020 The draft guidance, when finalized, establishes official guidance for industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notification of voluntary recalls under Federal regulations. The intent of the draft guidance is to increase and expedite the appropriate and accurate use of public warnings and public notification, to increase public health protection by better informing the public about violative products being recalled. The draft guidance clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification.

Public Meetings and Workshops Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement Date: January 14, 2020 Time: 8:00 am to 5:30 pm Agenda: The committees will discuss new drug application 211802 for oxycodegol, a new molecular entity full mu-opioid receptor agonist, submitted by Nektar Therapeutics, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product. Public Meeting on Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc Date: February 4, 2020 Time: 8:30 am to 5:00 pm Agenda: The purpose of the public meeting is to discuss and obtain scientific data and information on topics related to testing methodologies, terminology, and criteria that can be applied to characterize and measure asbestos and other potentially harmful mineral particles present as contaminants in talc and consumer products manufactured using talc as an ingredient.

CONSUMER UPDATE

Is It a Cold or the Flu? Prevention, Symptoms, Treatments Most viral respiratory infections, like the common cold, usually come and go within a few days, with no lasting effects. But influenza (flu) is a disease that can cause serious health problems and can result in hospitalization or death. You can fight back by adopting healthy habits and by using medicines and vaccines approved by the U.S. Food and Drug Administration to combat and help prevent the flu. If you are generally healthy, here’s how to tell if you have a cold or the flu, and when to seek medical care.