FDA Roundup: November 4, 2022

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Nov 04, 2022, 15:24 ET

SILVER SPRING, Md., Nov. 4, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

On Thursday, the FDA issued a safety communication warning parents, caregivers, and health care providers not to use infant head shaping pillows intended to change an infant's head shape and/or symmetry or claim to prevent or treat any medical condition. The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows. These infant head shaping pillows are unapproved medical devices that may create an unsafe sleep environment. The safety communication provides important information about unapproved infant head shaping pillows, including:

Background on the potential risk of death or injury in infants.
Recommendations for parents, caregivers, and health care providers.
FDA actions to increase awareness of this safety concern.
Instructions for reporting problems to the FDA and the manufacturer.

On Tuesday, the FDA issued revised food safety standards for state regulatory programs that oversee food facilities that manufacture, process, pack, or hold foods. These regulatory program standards, known as the Manufactured Food Regulatory Program Standards (MFRPS), were first issued by the agency in May 2007. The 2022 changes include updates to defined terms, new job aides, as well as updates to the current standards.

On Tuesday, the FDA issued a warning letter jointly with the Federal Trade Commission to Alternative Health Distribution LLC d/b/a CannaAid for selling unapproved and misbranded products for use in treating or preventing COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.

The FDA continues to warn consumers not to purchase or use products marketed with variations of the names "Artri" or "Ortiga" due to potentially dangerous hidden active drug ingredients not listed on the product label. FDA analysis revealed these products contain hidden drug ingredients, including diclofenac, an NSAID, and dexamethasone, a corticosteroid. The FDA urges consumers taking these products to immediately talk to their health care professional to safely stop using them because suddenly stopping these drugs may be dangerous.

In April 2022, the FDA notified consumers that the agency received adverse event reports, including of liver toxicity and death, associated with the use of Artri King and similarly named products.
In support of public safety, and because some of these products may still be available on the market, FDA issued warning letters on October 28, 2022, to Amazon, Walmart, and Latin Foods Market for distributing various "Artri" and/or "Ortiga" unapproved and misbranded drug products. Walmart and Latin Foods Market already issued voluntary recalls for these products.

COVID-19 testing updates:

As of today, 435 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, 51 antigen tests, and 1 diagnostic breath test. There are 77 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 for molecular OTC at-home tests.
The FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1150 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.

SOURCE U.S. Food and Drug Administration