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Today, the U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of upper respiratory infection. This test is the first at-home over-the-counter (OTC) test for COVID-19 to be granted marketing authorization using a traditional premarket review pathway and the first ever at-home test authorized using a traditional premarket review pathway for any respiratory illness.
“Today’s authorization is the first at-home COVID-19 test granted marketing authorization outside of emergency use authorities, representing a new era of consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities. This is part of the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing.”
The Cue COVID-19 Molecular Test consists of a single-use Cue COVID-19 test cartridge, a single-use Cue sample wand (nasal swab), and the Cue cartridge reader (sold separately). The test also uses the Cue Health app, which displays results when the test is complete. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the app in about 20 minutes. In a study reviewed by the FDA, this test correctly identified 98.7% of negative and 92.9% of positive samples in individuals with signs and symptoms of upper respiratory infection.
As with all rapid tests, there is a risk of false positive and false negative results. Individuals who test positive for SARS-CoV-2 should take appropriate precautions to avoid spreading the virus and should seek follow-up care with their physician or healthcare provider as additional testing may be necessary. Negative results should be confirmed by a lab-based molecular test if necessary for patient management. Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 or another respiratory infection and should seek follow up care with their healthcare provider.
Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
The FDA granted the marketing authorization to Cue Health Inc.
###
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.
I can't believe it's been 10 days already since starting this diet. Time flies when you're having fun, right? This has certainly been an educational experience.
Today I had some BBQ pork rib fun, featuring Curley's BBQ Sauce. It's a brand I had never tried before, not even during my BBQ Sauce Challenge done back in 2019, Curley's wasn't available in my neck of the woods at that time.
I picked up a bottle of Curley's during my last grocery shop. While I prefer to make my own BBQ sauce, I do always have a store-bought bottled version in my pantry for times when I don't have any of my stuff on hand and am not in the mood for making some. But my old favorite bottled sauces have wheat ingredients in them.
Not all bottled barbecue sauces are gluten-free, many of them contain wheat. Check for ingredients on the label such as Modified Food Starch (a wheat-based thickener) and Worcestershire Sauce (which may use a barley malt vinegar base). Basically, if the bottle does not state "Gluten Free," it isn't.
A Kansas City-style barbecue sauce, Curley's has been around since 1955 and made a name for itself with its hickory smoke-flavored sauce. Sweet and tangy like its Hickory cousin, the Mesquite version uses the same award-winning recipe, but swaps out the smoke flavor. Costing around $3.50 for a 20-ounce bottle at the mainstream grocery store, it's worthy of a repeat buy and being gluten-free, now has a reserved spot in my pantry.
Here's the Day 10 Menu:
Overall, a good diet day, staying gluten-free, but mostly through abstention, with the only gluten-free product I consumed being Curley's Mesquite Barbecue Sauce. I enjoyed the sauce when having a couple of ribs for an afternoon snack. I would have had more of the sauce when enjoying more of those ribs during dinner, but I wanted to keep that carb count in check. And yes, my ribs are quite good, with or without sauce.
I'm feeling good with this diet and look forward to Day 11. Stay tuned for another restaurant review!
$pend Wisely My Friends...
~ Mike
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If you appreciate the article you just read and want to support more great content on BachelorontheCheap.com, you can help keep this site going with a one-time or monthly donation. Thank you so much for your support! ~ Mike
WASHINGTON – J.T.M. Provisions Company, a Harrison, Ohio establishment, is recalling approximately 22,530 pounds of frozen, ready-to-eat beef chili with beans products that may be contaminated with extraneous materials, specifically white plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The frozen, ready-to-eat beef chili with beans items were produced on February 27, 2023. The following products are subject to recall [view labels]:
The products subject to recall bear establishment number “EST. 1917” inside the USDA mark of inspection on the case. These products were purchased by USDA Foods for the National School Lunch Program (NSLP). These items were shipped to distributors in California, Massachusetts, New York, Pennsylvania, New Jersey, and Wisconsin.
The problem was discovered after the company received a customer complaint about semi-rigid white plastic material found in the frozen, ready-to-eat beef chili with beans and notified FSIS.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
FSIS is concerned that some product may be in school freezers or refrigerators. School nutrition professionals who have purchased these products are urged not to prepare or consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.
Consumers and members of the media with questions about the recall can contact Matt Montgomery, CFO, J.T.M. Provisions Company at 513-367-4900 or [email protected].
Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or live chat via Ask USDA from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday. Consumers can also browse food safety messages at Ask USDA or send a question via email to [email protected]. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.
Thank goodness Ranch dressing is gluten-free! It's my go-to dressing and it's SO versatile! Not only does it add great flavor to a salad, and can be used as a chip or veggie dip, but it's also good on baked potatoes, excellent as a featured ingredient in crack chicken, or in powder form, as a coating for fried chicken or pork chops (pre-GF diet days).
Before starting this diet, I took some products for granted, not giving a thought to if a bottled dressing or sauce had any wheat ingredients in it. Cooking up some fried rice? Grab the soy or teriyaki. Having a salad? Reach for the Blue Cheese. Grilling up a steak? Hit it with some Worcestershire. Smoking up some ribs? Slap some BBQ sauce on them. A lot of my standard go-to bottled dressings and sauces have wheat ingredients in them, all of the above except the Ranch, included. Those bottled dressings and sauces are no longer on my regular grocery shopping list.
Early on in starting this diet, as I was going through the assortment of bottled stuff I have in my pantry and fridge, I was saying out loud when reading labels, "Oh shit!"... So many products have wheat ingredients in them that you kind of ignorantly assume, don't. When I discovered my favorite blue cheese dressing had a wheat ingredient listed, I started to fear the worst... I slowly reached for the Ranch bottle...
Phew! I was pleased to learn Tuscan Valley Ranch Dressing is gluten-free. Life without Ranch dressing? NO! Available at Aldi, it's every bit as tasty as Hidden Valley Ranch and WAY cheaper! Compare the Tuscan Valley price of $1.89 for a 16-ounce bottle, to the Hidden Valley Ranch price for a 16-ounce bottle of around $3.98 at the mainstream grocery store. That's a difference of $2.09! You can buy twice as much dressing at Aldi and still save $0.20 over buying a single bottle of Hidden Valley at the mainstream grocery store, with no sacrifice in taste, texture, or quality.
Day 9 on the diet was another eat-at-home day, which was low on protein count (I like to have at least 100 grams a day). I did enjoy four gluten-free products, including the Ranch dressing, which before this diet, I didn't notice that it was GF "safe."
Here's a quick rundown of those GF products of the day:
The Day 9 Menu:
The calorie count was good, I'm trying to stay at around 1,600 per day. The protein count was low, as previously mentioned, I try to get over 100 grams a day to benefit the exercise routine and weight loss. The carb count is too high, I'd rather be at no more than 60 grams per day, but that's tough to do, especially if you want some variety in the daily diet. Having options in tastes, textures, nutritional balance, and even convenience are all critical elements to maintaining a smarter and long-term effective diet. And as convenient and tasty as hot dogs and brats are, I'm going to have to eliminate them as a regular in the diet, swapping them out for leaner proteins. I need to 'treat' them, as an occasional treat, not a regular weekend or quick meal menu item. I also need more veggies & fruits, I didn't get enough on the day with just the potato and avocado.
I used to think I was a pretty good food label reader, but my focus was always on protein and carb counts, and sodium levels. My eyes have been opened in looking for wheat ingredients. Going gluten-free has been educational and there's a lot more information to absorb!
$pend Wisely My Friends...
~ Mike
Related: A Bachelor on the Cheap Challenge: Going Gluten-Free For Good
Enjoy this post?
If you appreciate the article you just read and want to support more great content on BachelorontheCheap.com, you can help keep this site going with a one-time or monthly donation. Thank you so much for your support! ~ Mike
My body doesn't like gluten. Whenever I consume regular bread, pasta, cookies, crackers, and the like, my body complains.
So in getting serious about going gluten-free for good after tinkering with the diet off-and-on for the last couple of years, I recently promised to maintain an online diary of my daily menu, including new gluten-free products I sample, as well as restaurant reviews and their gluten-free offerings. It's the Bachelor on the Cheap Gluten-Free Challenge, 2023.
The Day 8 menu was highlighted with dinner at Bubba's 33, catching up with friends from my working days with Public Storage. None of us work for Public Storage anymore, but the bonds we created there are strong, lasting, and meaningful.
Bubba's 33 is a "go-to" place for my friends and me, the food is always good, the atmosphere is comfortable, and the prices are reasonable. My typical order before going on this Gluten-Free diet would have been pizza, wings, or a burger, but on this occasion, I had to venture outside of what used to be my comfort zone. Bubba's menu doesn't have specific GF choices or alternatives to traditional bread or pasta, so this was one of those dining-out occasions where you just have to order smart, ignoring the temptations feeding the eyes. I went with the salmon dinner, a 5-ounce filet seasoned with chili and topped with sweet honey lime sauce. Served over garden rice I also ordered some broccoli for a side. The dinner has an 8-ounce salmon filet option as well. In addition to the dinner, I ordered a Chorizo Queso appetizer. It's a group favorite of melted cheese, scratch-made chorizo, pico de gallo, jalapeno sauce, fresh tortilla (corn) chips, and a side of salsa.
The Chorizo Queso wasn't put together as nicely as it typically is, the presentation was a bit sloppy and the flavors didn't seem as robust as usual, but it was still enjoyable. The salmon dinner was excellent. The fish was cooked perfectly, flaky, and moist and those chili, honey, and lime flavors really sang! The garden rice was pleasant with nice red bell pepper notes and the broccoli was delightfully seasoned, vibrantly green, and tender-crisp. I was very pleased with my dinner choice, it was quite satisfying. Other GF-friendly dinners to consider were two steak options and a grilled chicken dish. I've never had a bad meal at Bubba's 33 and the restaurant continues to be repeat visit-worthy, a go-to place for my friends and me.
Here's the rest of the menu for the day, I consumed a little over 1600 calories, had a decent protein intake of 106 grams, and enjoyed two GF products earlier in the day, Cassava Chips and Cheddar Cheese Rice Snacks.
Of note, after a week of the Bachelor on the Cheap Gluten-Free Challenge, 2023, I'm pleased to report that eliminating wheat products while monitoring calorie, protein, and carb intake, along with exercise has resulted in a three-pound weight loss. The most important thing, I feel better, with reduced bloating, and reduced joint pain.
Stay tuned for Week 2! Coming up, Gluten-Free breakfast options.
The Bubba's 33 visited for dinner is located at 412 S Towne East Mall Dr, Wichita, KS 67207. The food was good, the orders were delivered to the table in a timely fashion and Ean provided polite and attentive service.
$pend Wisely My Friends...
~ Mike
Enjoy this post?
If you appreciate the article you just read and want to support more great content on BachelorontheCheap.com, you can help keep this site going with a one-time or monthly donation. Thank you so much for your support! ~ Mike
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It's been a week now... No regular bread, no cake, no muffins, no waffles, no breaded and fried, no crackers or the like... And it hasn't been all that tough to do.
The Day 7 menu was light, with less than 1,000 calories, but still provided an ample amount of protein. The highlight of the day was a "potato" chip snack, featuring Simply Nature Grain Free Cassava Chips with Sea Salt.
If you're not familiar with cassava, it's a root vegetable, a tuber not unlike a potato or yam, and very popular in South America. You can do all sorts of things with cassava, there's mashed, french fried, and chips, you can make bread and cake with cassava flour, and tapioca pudding is made from the cassava root.
I've never had Cassava Chips before, I sampled them today for lunch with an onion & sour cream dip. They're lighter-colored chips with a very dense crunch. They're also thicker cut chips, with some elongated shapes and they had a nice amount of sea salt in the bite. Given the robust sea salt flavor, I was a bit surprised in reading the label that they only have 90mg of sodium per serving, just 4% of the recommended daily intake. That's almost unheard of in a chip snack. Despite the pleasant sea salt flavor note, however, these chips definitely need a dip. The chips can handle a dip well too, it's a VERY sturdy chip, almost too sturdy in texture.
Costing me $2.99 for a 6-ounce bag at Aldi, I'm giving Simply Nature Cassava Chips with Sea Salt 3 out of 5 Bachelor on the Cheap Stars. They taste OK, but the chips are too dense for my liking and a bit bland, needing a dip to be enjoyable. They are not worthy of a repeat buy, I'll pass on these next time I'm looking for another gluten-free chip or cracker option.
Here's the Day 7 menu:
I started out light, which kind of set the tone for the rest of the day, eating lighter than usual during normal meal times and eating heavier at snack time. With less than 1,000 calories consumed, an overall good week, and smarter eating choices, I'm looking forward to weighing in tomorrow morning.
After seven days of removing wheat products from my diet and replacing them selectively with Gluten-Free products, I'm not feeling the joint pain nearly as much, and that bloated feeling has been greatly reduced. I'm looking forward to weighing in tomorrow morning.
$pend Wisely My Friends...
~ Mike
Related: A Bachelor on the Cheap Challenge: Going Gluten-Free For Good
Enjoy this post?
If you appreciate the article you just read and want to support more great content on BachelorontheCheap.com, you can help keep this site going with a one-time or monthly donation. Thank you so much for your support! ~ Mike
WASHINGTON – DEKA Trading Corp., the importer of record located in Miami, Fla., is recalling approximately 13,771 pounds of imported ready-to-eat pork rind products. The products were imported from Guatemala, a country ineligible to export meat products to the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The following products are subject to recall, regardless of the product date [view labels]:
The products subject to recall do not bear an establishment number nor a USDA mark of inspection. These items were shipped to wholesale and retail locations in Georgia, New Jersey, New York, Rhode Island, and Virginia.
The problem was discovered during routine FSIS surveillance activities. Guatemala is not eligible to import meat products into the United States.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.
FSIS is concerned that some product may be in consumers’ pantries. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers and members of the media with questions about the recall can contact Alejandro Mencos, President, DEKA Trading Corp. at 305-716-8375 or [email protected].
Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or live chat via Ask USDA from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday. Consumers can also browse food safety messages at Ask USDA or send a question via email to [email protected]. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.
WASHINGTON – E.N.A. Meat Packing Inc, the importer of record located in Paterson, N.J., is recalling approximately 39,947 pounds of frozen, raw lamb products that were imported without the benefit of import reinspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The frozen, raw lamb items were produced on Feb. 22 through March 13, 2023. The following products are subject to recall [view labels]:
The products subject to recall do not bear the USDA mark of inspection. Each carton bears the Chile establishment number 12-01. These items were shipped to a Texas state-inspected facility for further processing.
The problem was discovered during routine FSIS monitoring when a shipment of frozen, raw lamb carcasses and bone in lamb leg products imported from Chile was identified that was not presented for FSIS import reinspection.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.
FSIS is concerned that some product may be in consumers’ freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers and members of the media with questions about the recall can contact Edibey Kucukkarca, CEO, ENA Meatpacking Corp., at (973) 742-4790 or [email protected].
Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or live chat via Ask USDA from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday. Consumers can also browse food safety messages at Ask USDA or send a question via email to [email protected] For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.