FDA Roundup: November 29, 2022

SILVER SPRING, Md., Nov. 29, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA issued two guidance documents about food allergen labeling requirements to help the food industry meet the requirements to list any major food allergen on the labels of FDA-regulated foods. Food labels are a powerful tool to help protect consumers with food allergies. Consumers can avoid ingredients they may be allergic or sensitive to in a food by looking for specific allergen labeling and reading the ingredient list. Comments about the draft guidance should be submitted within 60 days of publication of the notice in the Federal Register announcing the availability of the draft guidance (before Jan. 30, 2023).
  
  
• Today, the FDA issued draft guidance entitled, "Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs." The draft guidance is intended for animal drug sponsors interested in pursuing approval of new heartworm prevention products for dogs. Preventing heartworm disease is important because treatment for heartworm disease can cause significant adverse effects in dogs and is expensive for pet owners. The FDA is seeking public comment on the draft guidance for 60 days from the date of publication in the Federal Register (until Jan. 30, 2023).
  
  
• On Monday, Nov. 28, the FDA extended the comment period for the proposed rule entitled Food Labeling: Nutrient Content Claims; Definition of Term "Healthy" that appeared in the Federal Register on Sep. 29, 2022. The new deadline for comments is Feb. 16, 2023. The FDA is extending the comment period by 50 days in response to a request from stakeholders to allow additional time for interested persons to develop and submit comments.
  
  
• On Wednesday, Nov. 23, the FDA issued a Safety Alert advising consumers not to eat, restaurants and food retailers not to sell, and to dispose of Dai One Food Co. frozen half shell oysters with a harvest date of 2/6/2022 from Designated Area No. II from the Republic of Korea (ROK).
  
  
• The FDA and the National Institute of Standards and Technology are collaborating on a project to develop and harmonize methods to standardize the description of the temperature sensitivity and stability of monoclonal antibodies (mAbs) and other large molecules used for vaccines and therapeutics. When new mAbs and other large biomolecules for drugs and vaccines are developed, they often must be stored in very cold temperatures to ensure their quality and efficacy. This puts a large burden on the supply chain to maintain these freezing temperatures. Testing to reduce cold storage requirements takes time and there is often not enough information about these biomolecules to predict their temperature sensitivity. This effort aims to help product developers and the FDA understand molecule stability at different temperatures. This could help simplify test design and reduce testing to more quickly reduce the burden on cold storage supply chains, and help facilitate the distribution of mAbs and other biomolecules during public health emergencies. This project was funded by the Office of Counterterrorism and Emerging Threats OCET Advanced Manufacturing Program, in the FDA Office of the Chief Scientist.
  
  
• Each month, the FDA Grand Rounds lecture series highlights a key public health challenge and how the FDA is applying science and innovation to its regulatory activities. The agency invites you to attend the next presentation on Dec. 8, 2022, from 12 to 1 p.m. ET, on the topic, "Wastewater Surveillance for SARS-CoV-2 Variants: a pandemic response project leveraging FDA's GenomeTrakr network." With funding from the American Rescue Plan Act, FDA scientists leveraged an existing laboratory network normally tasked for foodborne pathogen surveillance to start sequencing SARS-CoV-2 from regional wastewater treatment plants across the U.S. New laboratory and analysis methods, public database structures, and FDA dashboard summarizing data collected were developed for this project.
  
  
• 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 302 molecular tests and sample collection devices, 85 antibody and other immune response tests, 55 antigen tests, and 1 diagnostic breath test. There are 79 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 23 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 for molecular OTC at-home tests.
• The FDA has authorized 39 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1164 revisions to EUA authorizations 

 Additional Resources: 

• FDA Newsroom

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Media Contact: FDA Office of Media Affairs, 301-796-4540 

Consumer Inquiries: 888-INFO-FDA 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 

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SOURCE U.S. Food and Drug Administration