FDA CDC News
FDA Clears First Over-the-Counter Antigen Test for COVID-19
FDA clears 1st OTC antigen test for COVID-19 by ACON Labs. Safe, accurate, and indicated for children. Expanding access to at-home testing. #COVID19 #FDA
The U.S. Food and Drug Administration (FDA) has taken a significant step in expanding access to COVID-19 testing by clearing the marketing of the first over-the-counter (OTC) antigen test. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, previously authorized for emergency use, has now undergone a traditional FDA premarket review pathway and is the second home COVID-19 test to receive such clearance. Notably, it is also the first test indicated for use in children under 18. This development aligns with the FDA’s commitment to advancing at-home testing options for various medical conditions, thus enhancing patient access to testing.
Advancing Access to At-Home Testing:
Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, highlighted the significance of this achievement, stating, “This marks the latest step forward in our efforts to help test developers provide Americans with continued options for safe and effective COVID tests that can be performed entirely at home.” The FDA’s proactive collaboration with test developers seeking to market their products beyond emergency use authorization underscores their commitment to expanding patient access to testing and supporting the development of at-home tests for various medical conditions.
Flowflex COVID-19 Antigen Home Test:
The Flowflex COVID-19 Antigen Home Test is an OTC test designed for symptomatic individuals within six days of symptom onset. It is cleared for use by individuals aged 14 years or older testing themselves or adults testing individuals aged two years or older. In an FDA-reviewed study, this test demonstrated impressive accuracy, correctly identifying 89.8% of positive and 99.3% of negative samples in individuals displaying signs and symptoms of upper respiratory infection.
Testing Guidelines:
Similar to antigen tests authorized for emergency use, the Flowflex COVID-19 Antigen Home Test should be used at least twice over a three-day period, with a minimum of 48 hours between tests. This means that if a symptomatic individual initially receives a negative test result, they should be re-tested once between 48 and 72 hours after the first test using an antigen test for COVID-19 or follow up with a molecular COVID-19 test.
510(k) Premarket Review Pathway:
The FDA reviewed the ACON Flowflex COVID-19 Antigen Home Test through the 510(k) premarket review pathway. The 510(k) is a submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This detailed review process ensures the safety and effectiveness of the test and provides confidence to consumers who choose to utilize it.
The FDA’s clearance of the Flowflex COVID-19 Antigen Home Test as the first over-the-counter antigen test for COVID-19 represents a significant milestone in expanding access to testing. This advancement allows individuals, including children, to conveniently and accurately test for COVID-19 from the comfort of their homes. With the ongoing commitment of organizations like the FDA and test developers, we can continue to develop and enhance at-home testing options, ultimately helping to control the spread of COVID-19 and improve public health.
About the FDA:
The FDA, as an agency within the U.S. Department of Health and Human Services, plays a vital role in assuring the safety, effectiveness, and security of various healthcare products and regulating industries that impact public health. From drugs and vaccines to medical devices and food safety, the FDA is dedicated to protecting and promoting the well-being of the American public.
Source: FDA
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FDA CDC News
Seafood Recall: Important Information on Hannaford Seafood Salads
In early November, the U.S. Food and Drug Administration (FDA) announced a Class II recall concerning Hannaford Seafood Salads, affecting over 1,600 units across five states: Maine, New Hampshire, Vermont, Massachusetts, and New York. The recall, initiated on October 31, was due to a mislabeling incident that poses a significant risk to consumers with soy allergies.
Understanding the Class II Risk Level
The FDA has classified this recall as a Class II risk, indicating that exposure to the affected products may cause “temporary or medically reversible adverse health consequences.” However, the risk of experiencing serious health consequences remains “remote.” Despite this classification, consumers with an allergy or severe sensitivity to soy must take this recall seriously, as they could face life-threatening allergic reactions if they consume the mislabeled salads.
What Happened?
The problem arose when the printer responsible for the salad labels provided Elevation Foods, the manufacturer of the salads, with labels that did not accurately reflect the current product formulation. Instead of the correct labels, the printer mistakenly issued labels meant for an upcoming formulation change. As a result, the affected salads may contain undeclared hydrolyzed soy protein, a known allergen that must be clearly stated on product labels to protect consumer safety.
Product Details
The implicated Hannaford Seafood Salads were distributed between October 25 and 29, and they feature use-by dates of November 13 and 14. Consumers can find these dates printed on the lid of the containers. Following the recall announcement, all affected products were promptly removed from store shelves.
Health Risks Associated with Soy Allergies
For individuals with soy allergies, the immune system mistakenly identifies soy proteins as harmful invaders, leading to a range of symptoms that can vary in severity. Common reactions include stomach issues, coughing, itching, wheezing, vomiting, hives, and difficulty breathing. In severe cases, these reactions can escalate to life-threatening conditions, such as anaphylaxis.
To mitigate risks, those with soy allergies are advised to carry an epinephrine injection (Epi-Pen) to counteract severe allergic reactions swiftly.
What Should Consumers Do?
Customers who purchased Hannaford Seafood Salads before the recall are urged not to consume the products. Instead, they can return them to the store where they made the purchase for a full refund. Elevation Foods has not reported any known cases of illness related to these salads, but consumer safety remains a top priority.
Conclusion
This seafood salad recall serves as a crucial reminder about the importance of accurate labeling, especially when it comes to potential allergens. Consumers should remain vigilant and informed about the products they purchase, particularly if they have food allergies. Stay safe and always check your labels!
Related Links:
https://www.newsweek.com/seafood-salad-recall-update-fda-risk-level-hannaford-1992294
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pets
Urgent Dog Treat Recall: Carolina Prime Pet Issues Warning Due to Salmonella Risk
Dog Treat Recall
In a recent announcement that has concerned dog owners across the Southeastern, Midwestern, and Mid-Atlantic regions of the United States, the FDA has reported a recall of “Hollywood Feed Carolina Made Chicken Chips” dog treats manufactured by Carolina Prime Pet, Inc. of Lenoir, North Carolina. This recall, affecting approximately 400 bags of these popular dog treats, is attributed to the potential risk of Salmonella contamination.
Why Is This Recall Important?
While there have been no reported illnesses linked to the consumption of these chicken chips, the safety of pets—and by extension, their human companions—is paramount. Salmonella, a bacteria that can cause severe gastrointestinal distress in animals and humans alike, can be particularly dangerous for pets, leading to symptoms such as vomiting, diarrhea, and lethargy. For individuals, Salmonella can also result in serious health complications, especially in young children, elderly adults, or those with weakened immune systems.
Details of the Recall
The recall specifically pertains to 16-ounce bags of “Hollywood Feed Carolina Made Chicken Chips” that carry the lot number 20051324L2 and an expiration date of 11/13/25. Consumers can easily identify the affected product by checking the back of the packaging, which features a distinctive purple-and-black design. The recall extends to retail locations across 19 states, including:
- Alabama
- Arkansas
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Michigan
- Mississippi
- Missouri
- North Carolina
- Ohio
- Oklahoma
- Pennsylvania
- South Carolina
- Tennessee
- Texas
For those who purchased the treats online, they were also available on the company’s website at www.hollywoodfeed.com.
What Should Consumers Do?
Carolina Prime Pet, Inc. has advised consumers to check their homes for the affected product. If your dog treats match the recalled lot number and expiration date, it is crucial not to feed them to your pet. Instead, return the products to the place of purchase for a full refund. For those who have questions or need more information, the company encourages contacting their customer service.
Final Thoughts
As pet owners, it is our responsibility to stay informed about the products we give our furry friends. The safety of our pets is essential, and recalls like these serve as a reminder to always check product packaging and stay updated on food safety announcements. If you have any concerns about your pet’s health or have noticed any unusual symptoms after consuming potentially contaminated food, it is advisable to consult with a veterinarian immediately.
Stay alert, stay informed, and together we can ensure the safety and well-being of our beloved pets.
Related links:
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FDA CDC News
Popular Nasal Decongestant Falls Short: FDA Advisers Question Efficacy
FDA questions effectiveness of popular nasal decongestant phenylephrine, raising concerns about congestion relief.
In a surprising turn of events, government experts have cast doubt on the effectiveness of the leading decongestant found in popular over-the-counter medications like Sudafed and Dayquil. A recent review conducted by the Food and Drug Administration (FDA) found that the main drug ingredient, phenylephrine, offers no significant relief from nasal congestion. This revelation raises concerns among millions of Americans who rely on these medications for congestion relief.
Phenylephrine became the primary ingredient in over-the-counter decongestants after pseudoephedrine, an older ingredient, was moved behind pharmacy counters due to its potential for illegal drug processing. However, the FDA’s outside advisers unanimously voted against the efficacy of phenylephrine, prompting a reevaluation of its effectiveness. Despite phenylephrine-based versions dominating the market, accounting for four-fifths of the $2.2 billion oral decongestant market, the FDA’s conclusions suggest a need to reconsider their availability.
The FDA review identified significant flaws in the original studies that supported phenylephrine’s approval. These studies, conducted in the 1960s and 1970s, were deemed inadequate by modern standards. Furthermore, three recent, well-conducted studies by reputable pharmaceutical companies found no discernible difference between phenylephrine medications and placebos in relieving congestion. This raises concerns about the effectiveness of phenylephrine, which has relied on outdated research.
The FDA’s advisory panel’s unanimous vote against phenylephrine’s effectiveness could lead to regulatory action requiring drugmakers like Johnson & Johnson and Bayer to withdraw their phenylephrine-based oral decongestants from store shelves. This move may force consumers to opt for behind-the-counter pseudoephedrine products or phenylephrine-based nasal sprays and drops. However, it would necessitate extensive education efforts by the FDA, pharmacists, and drugstores to inform consumers about alternative options for treating congestion.
The Consumer Healthcare Products Association, representing nonprescription drugmakers, argued that the recent studies have limitations and advocated for continued “easy access” to phenylephrine. However, the FDA review highlighted the shortcomings of the original studies and the lack of modern scientific evidence supporting phenylephrine’s efficacy. Balancing public health concerns and consumer access will be a crucial challenge for regulators moving forward.
The FDA’s recent review has cast doubt on the effectiveness of phenylephrine, the key ingredient in popular nasal decongestants. This finding prompts a reevaluation of treatment options for nasal congestion and calls for further research to provide effective relief for individuals in need.
Check out the article from the Associated Press: https://apnews.com/article/sudafed-decongestants-phenylephrine-pseudoephedrine-fda-0f140bafae9a500c5fba05fe764ecb66
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