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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

Published

1 year ago

November 10, 2023

Rod Washington

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.

https://www.fda.gov/news-events/press-announcements/fda-clears-first-covid-19-home-antigen-test?utm_medium=email&utm_source=govdelivery

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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Author

Rod Washington

Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art. View all posts

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Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.

health and wellness

A Bold Move Towards a Healthier Future: FDA’s Proposed Nicotine Regulation

On January 15, 2025, the FDA proposed regulating nicotine levels in cigarettes to minimize addiction, aiming to prevent millions from smoking. This significant public health initiative promotes fewer smoking-related diseases and economic benefits.

Published

10 hours ago

January 27, 2025

Charles Elliot

close up photo of cigarette ashes. nicotine — Photo by Basil MK on Pexels.com

On January 15, 2025, the U.S. Food and Drug Administration (FDA) made headlines with a groundbreaking proposal that could revolutionize the landscape of tobacco products. The agency announced a plan to limit the nicotine content in cigarettes and certain combusted tobacco products to levels that will make them minimally or nonaddictive. This significant step is geared towards preventing future generations from falling victim to the perils of tobacco addiction and smoking-related diseases.

A Bold Move Towards a Healthier Future: FDA’s Proposed Nicotine Regulation

A Step Long in the Making

The journey to this proposal began in 2018 when the FDA first expressed intentions to regulate nicotine levels in tobacco products. Now, as we stand on the brink of potentially transformative change, it’s clear that the FDA’s vision is not only ambitious but also rooted in a wealth of scientific evidence. The proposed nicotine cap, set at a mere 0.7 milligrams per gram of tobacco, is poised to dismantle the addictive potential of cigarettes, thus reducing the likelihood of new smokers picking up the habit.

Saving Lives and Reducing Costs

The impact of this regulation could be enormous. According to the FDA’s research, by the year 2100, this new nicotine standard has the potential to prevent around 48 million young people from starting to smoke. Additionally, it could encourage over 12.9 million current smokers to quit within the first year of the regulation’s enactment—numbers that elevate to an astonishing 19.5 million after five years. Ultimately, the FDA estimates that over the coming decades, we could see 1.8 million lives saved, climbing even higher to 4.3 million by the end of the century.

The financial implications are just as compelling. With an estimated annual benefit of over $1.1 trillion—not to mention the reduction in healthcare costs, lost productivity, and the avoidance of tobacco-related diseases—the proposal is not only a public health victory but also an economic one.

A Public Health Perspective

Cigarettes remain the deadliest consumer product in history, accounting for nearly half a million preventable deaths each year in the U.S. alone. The FDA Commissioner Robert M. Califf, M.D., expressed a clear commitment to making significant progress in combating this public health crisis. “Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products,” he stated.

The focus on addiction prevention and smoking cessation aligns with a broader goal: to create a healthier society where smoking-related diseases are no longer a pervasive threat. The proposed rule does not impose a ban on tobacco products but instead aims to create a safer environment by altering the products themselves. This is a crucial distinction as it allows for a path that encourages adult smokers to transition to less harmful alternatives without criminalizing their existing choices.

Why Public Engagement Matters

With the proposal open for public comment from January 16 to September 15, 2025, the FDA is keen on gathering input from diverse stakeholders, ensuring that a myriad of perspectives is considered. This effort to foster public dialogue is essential as it demonstrates a collaborative approach to policymaking, inviting the voices of health advocates, smokers wishing to quit, and the general public into the conversation.

The FDA is also reaching out to its Tobacco Products Scientific Advisory Committee to explore further implications of this proposal, underlining the importance of scientific scrutiny in shaping effective tobacco regulations.

Looking Ahead

As we await the final decision on this transformative proposal, the message is clear: reducing nicotine levels in combusted tobacco products could redefine smoking norms in America. The FDA’s intent to prioritize public health and encourage cessation underscores a commitment to safeguarding future generations.

While no tobacco product is completely safe and the best choice for individual health is to avoid all forms of tobacco, the proposed regulations represent a critical stride towards mitigating the risks associated with smoking. With collective efforts and robust community engagement, a healthier future is not only possible, but within reach.

Join the Conversation

Are you interested in contributing to this historic movement? The FDA encourages public input, and your voice matters! Take part in this important conversation in shaping the future of tobacco regulation. Together, we can help create a society where smoking-related deaths are significantly reduced, and a healthier lifestyle becomes the norm.

Stay engaged, stay informed, and let’s pave the way for a smoke-free future!

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News

FDA Issues Class I Recall for Costco’s Kirkland Signature Smoked Salmon

Published

2 days ago

January 25, 2025

Rod Washington

In a significant health alert, the U.S. Food and Drug Administration (FDA) has upgraded the recall of Costco’s Kirkland Signature Smoked Salmon to a Class I designation, indicating a serious health risk. This recall follows the discovery of Listeria monocytogenes during routine laboratory testing.

Originally announced in late October, the recall involved 111 cases of smoked salmon packaged in twin 12-ounce units, with a UPC number of 0 96619 25697 6 and a lot number of 8512801270. The affected products have a best-by date of November 13, 2024, and were distributed between October 9 and October 13, 2024, specifically to Costco locations in Florida.

Listeria monocytogenes is known to cause listeriosis, a severe infection that can result in serious health complications or even death, especially among vulnerable populations such as pregnant individuals, the elderly, and those with weakened immune systems. Although no illnesses have been reported in connection with this product, consumers are advised to check their freezers for these recalled items.

FDA Issues Class I Recall for Costco’s Kirkland Signature Smoked Salmon

Costco is urging customers who purchased this product to return it for a full refund.

For your safety, the FDA reminds consumers that Listeria can be found in a variety of foods, particularly raw or smoked seafood, unpasteurized dairy products, and deli meats. If you suspect you may have consumed contaminated food, please consult with a healthcare professional.

Stay safe and informed by regularly checking for updates on food recalls from reliable sources.

Related links:

The FDA Issued a Class I Recall on Costco’s Kirkland Signature Smoked Salmon https://www.foodandwine.com/costco-kirkland-signature-smoked-salmon-class-i-recall-listeria-monocytogenes-8780336

https://www.fda.gov/food/foodborne-pathogens/listeria-listeriosis

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Food and Beverage

Cinnamon, spice and ‘everything nice’ – why lead-tainted cinnamon products have turned up on shelves, and what questions consumers should ask

A Consumer Reports investigation revealed alarming lead levels in ground cinnamon, prompting concerns over safety, especially for children and pregnant women.

Published

1 month ago

December 22, 2024

The Conversation

It’s important to buy cinnamon from reputable dealers. Anjelika Gretskaia/Moment via Getty Images

Katarzyna Kordas, University at Buffalo

Spices bring up feelings of comfort, cultural belonging and holidays. They can make our homes smell amazing and our food taste delicious. They can satisfy our cravings, expand our culinary horizons and help us eat things that we might normally dislike. Spices have health-enhancing properties and, in medicine, have been used to heal people since the ancient times.

Recently, however, spices have been getting a bad rep.

In September 2024, Consumer Reports, a nonprofit organization created to inform consumers about products sold in the U.S., investigated more than three dozen ground cinnamon products and found that 1 in 3 contained lead levels above 1 part per million, enough to trigger a recall in New York, one U.S. state that has published guidelines for heavy metals in spices.

The Food and Drug Administration issued three alerts throughout 2024, warning consumers about lead in certain brands of cinnamon products. Such notices rightfully put consumers on alert and have people wondering if the spice products they buy are safe – or not. https://www.youtube.com/embed/QxAwznMht8M?wmode=transparent&start=0 A Consumer Reports investigation of more than three dozen ground cinnamon products found that 1 in 3 contain lead levels above 1 part per million.

As an environmental epidemiologist with training in nutritional sciences, I have investigated the relationship between nutritional status, diets and heavy metal exposures in children.

There are several things consumers should be thinking about when it comes to lead – and other heavy metals – in cinnamon.

Why is lead found in cinnamon?

Most people are familiar with cinnamon in two forms – sticks and ground spice. Both come from the dried inner bark of the cinnamon tree, which is harvested after a few years of cultivation. For the U.S. market, cinnamon is largely imported from Indonesia, Vietnam, Sri Lanka, India and China.

One way that lead could accumulate in cinnamon tree bark is when trees are cultivated in contaminated soil. Lead can also be introduced in cinnamon products during processing, such as grinding.

When ground cinnamon is prepared, some producers may add lead compounds intentionally to enhance the weight or color of the product and, thus, fetch a higher sale price. This is known as “food adulteration,” and products with known or suspected adulteration are refused entry into the U.S.

However, in the fall of 2023, approximately 600 cases of elevated blood lead levels in the U.S., defined as levels equal to or above 3.5 micrograms per deciliter – mostly among children – were linked to the consumption of certain brands of cinnamon apple sauce. The levels of lead in cinnamon used to manufacture those products ranged from 2,270 to 5,110 parts per million, indicating food adulteration. The manufacturing plant was investigated by the FDA.

Horizontal photo of cinnamon trees, with trunks in foreground. — Cinnamon trees in Zanzibar, Tanzania. Zanzibar is known the world over as the ‘spice islands.’ Dong Jianghui/Xinhua via Getty Images

More broadly, spices purchased from vendors in the U.S. have lower lead levels than those sold abroad.

There is some evidence that cinnamon sticks have lower lead levels than ground spice. Lead levels in ground cinnamon sold in the U.S. and analyzed by Consumer Reports ranged from 0.02 to 3.52 parts per million. These levels were at least 1,500 times lower than in the adulterated cinnamon.

There are no federal guidelines for lead or other heavy metals in spices. New York state has proposed even stricter guidelines than its current level of 1 part per million, which would allow the New York Department of Agriculture and Markets to remove products from commerce if lead levels exceed 0.21 parts per million.

What does it mean that ‘the dose makes the poison’?

The current FDA guideline on daily intake of lead from diets overall is to limit lead intake to 2.2 micrograms per day for children. For women of reproductive age, this value is 8.8 micrograms.

The lead dose we are exposed to from foods depends on the level of lead in the food and how much of that food we eat. Higher doses mean more potential harm. The frequency with which we consume foods – meaning daily versus occasionally – also matters.

For spices like cinnamon, the amount and frequency of consumption depends on cultural traditions and personal preference. For many, cinnamon is a seasonal spice; others use it year-round in savory dishes or sauces.

Cinnamon is beloved in baked goods. Take a cinnamon roll recipe calling for 1.5 tablespoons (slightly less than 12 grams) of the spice. If a recipe yields 12 rolls, each will have around 1 gram of cinnamon. In the Consumer Reports investigation, some cinnamon products were classified as “okay to use” or “best to use.”

The highest value of lead in cinnamon products in the “okay to use” category was 0.87 parts per million, and in the “best to use” category, it was 0.15 parts per million. A child would have to consume 2.5 or more rolls made with the “okay to use” cinnamon to exceed the FDA guideline on limiting lead intake from foods to 2.2 micrograms per day, assuming that no other food contained lead. To exceed this guideline with “best to use” cinnamon, a child would have to eat 15 or more rolls.

Stick cinnamon and cinnamon powder on rustic wooden table. — Research suggests that ground cinnamon contains higher lead levels than cinnamon sticks. Helen Camacaro/Moment via Getty Images

Can cinnamon contribute to elevated blood lead levels?

Because of lead’s effects on development in early life, the greatest concern is for exposure in young children and pregnant women. Lead is absorbed in the small intestine, where it can latch onto cellular receptors that evolved to carry iron and other metals.

The impact of a contaminated spice on a person’s blood lead level depends on the dose of exposure and the proportion of lead available for intestinal absorption. For several spices, the proportion of available lead was 49%, which means that about half of the lead that is ingested will be absorbed.

Lead absorption is higher after a fast of three hours or more, and skipping breakfast may contribute to higher blood lead levels in children.

People who have nutritional deficiencies, such as iron deficiency, also tend to absorb more lead and have higher blood lead levels. This is because our bodies compensate for the deficiency by producing more receptors to capture iron from foods. Lead takes advantage of the additional receptors to enter the body. Young children and pregnant women are at higher risk for developing iron deficiency, so there is good reason for vigilance about lead in the foods they consume.

Studies show that among children with lead poisoning in the U.S., contaminated spices were one of several sources of lead exposure. Studies that estimate blood lead levels from statistical models suggest that consuming 5 micrograms of lead or more from spices daily could substantially contribute to elevated blood lead levels.

For occasional or seasonal consumption, or lower levels of contamination, more research is needed to understand how lead in spices would affect lead levels in the blood.

For people who have other sources of lead in their homes, jobs or hobbies, additional lead from foods or spices may matter more because it adds to the cumulative dose from multiple exposure sources.

How to test for elevated blood lead levels

The Centers for Disease Control and Prevention recommends that children at risk for lead exposure get a blood lead test at 1 and 2 years of age. Older children can also get tested. Finger-prick screening tests are often available in pediatric offices, but results may need to be confirmed in venous blood if the screening result was elevated.

Adults in the U.S. are not routinely tested for lead exposure, but concerned couples who plan on having children should talk to their health care providers.