FDA Roundup: January 13, 2023

FDA News Release

• For Immediate Release: January 13, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA released a fact sheet and constituent update to remind produce stakeholders of the upcoming end of the intended enforcement discretion period for the harvest and post-harvest agricultural water requirements in the Produce Safety Rule for covered produce other than sprouts. For large covered farms, this period will end on January 26, 2023. As has been done with other FSMA rules, the FDA plans to take an educational posture for these harvest and post-harvest requirements as farms begin implementing those requirements. During the first year after the end of the intended enforcement discretion period, FDA will work closely with state and industry partners during this time to advance training, technical assistance, educational visits, and on-farm readiness reviews to prepare both farmers and state regulators for implementing these provisions.  FDA continues to intend to exercise enforcement discretion for the pre-harvest agricultural water requirements for covered produce other than sprouts while the FDA continues rulemaking. 
• On Thursday, the FDA signed a Mutual Recognition Agreement between the United States and Switzerland, allowing the FDA and Swissmedic to share each other's GMP inspectional findings, which will reduce unnecessary costs and duplicative efforts.
• On Thursday, the FDA published a new informational video about the new category of over-the-counter (OTC) hearing aids, prescription hearing aids, and how they are different from personal sound amplification products. You can also visit FDA’s Consumer Update for more information here.
• On Thursday, as part of Closer to Zero the FDA announced two meetings as part of our work to identify the scientific research base for action levels for contaminants in foods eaten by babies and young children. The FDA announced Bridging the Biological and Communication Sciences on Nutrients and Environmental Contaminants in Foods to Support Child Development, a two-day virtual workshop scheduled for February 9-10, 2023. The agency also shared that the first meeting of the NASEM Committee on the Role of Seafood Consumption in Child Growth and Development will be webcast on January 19, 2023.
• On Wednesday, the FDA approved Airsupra (albuterol and budesonide) inhalation aerosol for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in patients with asthma 18 years of age and older. Airsupra is a combination of albuterol (a beta-2 adrenergic agonist) and budesonide (a corticosteroid). It is the first combination of an inhaled corticosteroid (ICS) and a short-acting beta-agonist to be approved in the U.S. Additionally, Airsupra is the first product containing an ICS to be approved in the U.S. as a reliever treatment (rather than as a controller) for asthma. The treatment works to relax the muscles and reduce inflammation in the lung airways to reduce the risk of severe asthma attacks. The most common side effects of Airsupra are headache, oral candidiasis, cough, and difficulty speaking. See full prescribing information for additional information on risks associated with Airsupra.
• On Wednesday, the FDA approved DectoGard, the first generic doramectin topical solution for treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, horn files, and mange mites in cattle. DectoGard is an antiparasitic drug that contains the same active ingredient (doramectin) in the same concentration and dosage form as the approved brand name drug product, Dectomax, which was first approved for use in cattle on September 16, 1997.
• On Tuesday, the FDA published a Consumer Update and video reminding consumers that as of January 1, 2023, sesame is required to be labeled as an allergen on packaged foods, including dietary supplements. It’s important to note, food products already on their way to or on store shelves before 2023 don’t have to be removed from the market. So, people should proceed with caution and contact the manufacturer or distributor on the food product's label for information if they need to know more about the use of sesame in a food product.
• COVID-19 testing updates: 
  • As of today, 443 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 antigen tests, and one diagnostic breath test. There are 79 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
  • The FDA has authorized 43 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1203 revisions to EUA authorizations.