FDA Stakeholder Update - March 13, 2020

Coronavirus Disease 2019 (COVID-19)  FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic Yesterday, the FDA took two significant actions in the agency’s ongoing and aggressive commitment to address the coronavirus outbreak (COVID19). First, the agency issued enforcement discretion and is not objecting to the New York State Department of Health (NYSDOH) authorizing certain laboratories in New York to begin patient testing after validating their tests and notifying the NYSDOH. Under NYSDOH’s approach, laboratories will provide validation data to NYSDOH within 15 days in lieu of pursuing an Emergency Use Authorization (EUA) with FDA. Second, the FDA authorized the Roche cobas SARS-CoV-2 Test, the third Emergency Use Authorization (EUA) granted for a diagnostic test during the COVID-19 outbreak. “These actions today show our commitment to working around the clock to help expedite the availability of tests. This NYSDOH action shows the FDA’s extreme flexibility and adaptability during times of public health emergencies,” said FDA Commissioner Stephen M. Hahn, M.D. “As a practical matter, what this action means is that labs, authorized by NYSDOH, will not engage with FDA to begin patient testing. Nor will they get an Emergency Use Authorization from the FDA. These labs will interact solely with NYSDOH, which should expedite the availability of patient testing in New York State. This action demonstrates FDA’s responsiveness to the needs of our country during this time.” [03/13/2020] FDA sets up 24/7 hotline to help labs with diagnostic test issues FDA’s 24/7 hotline (1-888-INFO-FDA) is available for labs to call regarding difficulties obtaining supplies for collecting patient samples for COVID-19 testing, including swabs and media needed for transport and conservation of the samples. [03/12/2020] Surgical Mask and Gown Conservation Strategies - Letter to Healthcare Providers The Center for Radiologic Health (CDRH) released a Letter to Health Care Providers on Surgical Mask and Gown Conservation Strategies. The letter is an effort to assist health care organizations and personnel with recommended conservation strategies for various supply levels of surgical masks and gowns during the COVID-19 outbreak. We encourage you to share this information with your colleagues and other organizations and to report potential or actual supply issues. [03/11/2020]   Foreign Inspections Statement from - Stephen M. Hahn M.D, Commissioner, Food and Drug Administration We are providing an update on the status of U.S. Food and Drug Administration inspections outside of the U.S. in response to the COVID-19 outbreak. After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. [03/10/2020] FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19 The FDA and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products.  These products are unapproved drugs that pose significant risks to patient health and violate federal law.  The FDA and FTC are taking this action as part of their response in protecting Americans during the global COVID-19 outbreak. The warning letters are the first to be issued by the FDA for unapproved products intended to prevent or treat “Novel Coronavirus Disease 2019” (COVID-19). [03/09/2020] FDA Announcement FDA Warns Retailers, Manufacturers to Remove Unauthorized E-Cigarette Products from Market The FDA issued 22 warning letters to online and brick-and-mortar e-cigarette product retailers and manufacturers across the country who sell flavored, cartridge-based electronic nicotine delivery system (ENDS) products advising them that selling these products, which lack marketing authorization, is illegal. The warning letters were sent to some establishments with well-known names such as 7-Eleven and Shell and are the first of what will be a series of ongoing actions consistent with the FDA’s recently issued policy of enforcement priorities for e-cigarettes and other deemed products on the market. [03/10/2020] FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity Statement from - Stephen M. Hahn M.D., Commissioner, Food and Drug Administration

Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns. [03/05/2020]

Request for Comment Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds

The FDA is reopening the comment period for the notice that appeared in the Federal Register of April 3, 2019, and extending it indefinitely. The notice announced a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. In addition, it notified the public that FDA was establishing a docket for public comment on this hearing and that the docket would close on July 2, 2019. [03/11/2020]

FDA Seeks Input on Premarket Tobacco Product Applications and Recordkeeping Requirements by April 9, 2020 The FDA is reopening the comment period only for the agency information collection activity associated with proposed rulemaking entitled “Premarket Tobacco Product Applications and Recordkeeping Requirements,” which appeared in the Federal Register of September 25, 2019. FDA is not reopening the comment period associated with any other aspects of the proposed rulemaking. [03/10/2020]