Latest news with #U.S.FoodandDrugAdministration
CNBC
7 hours ago
- Health
- CNBC
Whoop says FDA is 'overstepping its authority' with warning about blood pressure feature
The U.S. Food and Drug Administration on Tuesday published a warning letter addressed to the wrist wearable company Whoop, alleging it is marketing a new blood pressure feature without proper approvals. The letter centers around Whoop's Blood Pressure Insights (BPI) feature, which the company introduced alongside its latest hardware launch in May. Whoop said its BPI feature uses blood pressure information to offer performance and wellness insights that inform consumers and improve athletic performance. But the FDA said Tuesday that Whoop's BPI feature is intended to diagnose, cure, treat or prevent disease — a key distinction that would reclassify the wellness tracker as a "medical device" that has to undergo a rigorous testing and approval processes. "Providing blood pressure estimation is not a low-risk function," the FDA said in the letter. "An erroneously low or high blood pressure reading can have significant consequences for the user." A Whoop spokesperson said the company's system offers only a single daily estimated range and midpoint, which distinguishes it from medical blood pressure devices used for diagnosis or management of high blood pressure. Whoop users who purchase the $359 "Whoop Life" subscription tier can use the BPI feature to get daily insights about their blood pressure, including estimated systolic and diastolic ranges, according to the company. Whoop also requires users to log three traditional cuff-readings to act as a baseline in order to unlock the BPI feature. Additionally, the spokesperson said the BPI data is not unlike other wellness metrics that the company deals with. Just as heart rate variability and respiratory rate can have medical uses, the spokesperson said, they are permitted in a wellness context too. "We believe the agency is overstepping its authority in this case by attempting to regulate a non-medical wellness feature as a medical device," the Whoop spokesperson said. High blood pressure, also called hypertension, is the number one risk factor for heart attacks, strokes and other types of cardiovascular disease, according to Dr. Ian Kronish, an internist and co-director of Columbia University's Hypertension Center. Kronish told CNBC that wearables like Whoop are a big emerging topic of conversation among hypertension experts, in part because there's "concern that these devices are not yet proven to be accurate." If patients don't get accurate blood pressure readings, they can't make informed decisions about the care they need. At the same time, Kronish said wearables like Whoop present a "big opportunity" for patients to take more control over their health, and that many professionals are excited to work with these tools. Understandably, it can be confusing for consumers to navigate. Kronish encouraged patients to talk with their doctor about how they should use wearables like Whoop. "It's really great to hear that the FDA is getting more involved around informing consumers," Kronish said. Whoop is not the only wearable manufacturer that's exploring blood pressure monitoring. Omron and Garmin both offer medical blood pressure monitoring with on-demand readings that fall under FDA regulation. Samsung also offers blood-pressure-reading technology, but it is not available in the U.S. market. Apple has also been teasing a blood pressure sensor for its watches, but has not been able to deliver. In 2024, the tech giant received FDA approval for its sleep apnea detection feature. Whoop has previously received FDA clearance for its ECG feature, which is used to record and analyze a heart's electrical activity to detect potential irregularities in rhythm. But when it comes to blood pressure, Whoop believes the FDA's perspective is antiquated. "We do not believe blood pressure should be considered any more or less sensitive than other physiological metrics like heart rate and respiratory rate," a spokesperson said. "It appears that the FDA's concerns may stem from outdated assumptions about blood pressure being strictly a clinical domain and inherently associated with a medical diagnosis." The FDA said Whoop could be subject to regulatory actions like seizure, injunction, and civil money penalties if it fails to address the violations that the agency identified in its letter. Whoop has 15 business days to respond with steps the company has taken to address the violations, as well as how it will prevent similar issues from happening again. "Even accounting for BPI's disclaimers, they do not change this conclusion, because they are insufficient to outweigh the fact that the product is, by design, intended to provide a blood pressure estimation that is inherently associated with the diagnosis of a disease or condition," the FDA said.
NBC News
10 hours ago
- Health
- NBC News
YoCrunch yogurts recalled over potential choking risk from plastic pieces
Popular YoCrunch yogurt products are being voluntarily recalled following consumer reports of plastic pieces in the dome topper that could potentially cause choking, parent company Danone U.S. announced Tuesday. The company, based in White Plains, New York, issued the recall on Friday for "all flavors and sizes of YoCrunch® products currently inmarket," according to the release, and is being conducted with the U.S. Food and Drug Administration. "The plastic pieces are transparent, may have sharp edges, and could present a risk to consumers because some pieces are between 7 and 25 mm in length," the statement read. Only the separately packaged topper is affected and not the yogurt itself, the release stated. Customers who purchased the affected products are advised not to consume them and may contact the company regarding refunds. "The company is working swiftly with retail partners to remove the impacted product from shelves, while it works to address the issue and bring back the YoCrunch® products so many people enjoy," the company said.
Yahoo
11 hours ago
- Health
- Yahoo
This Popular Cheese Product Is Being Recalled For a Very Serious Reason—Here's What to Know
This Popular Cheese Product Is Being Recalled For a Very Serious Reason—Here's What to Know originally appeared on Parade. Food recalls are never a fun experience. As consumers, we're forced to check our labels carefully, and if we have the recalled item in our possession, we either return it for a refund or discard it completely. But not every food safety issue starts as a full-fledged recall. This week, for example, the U.S. Food and Drug Administration (FDA) announced a recall of a select batch of Boar's Head deli products—though the agency has yet to classify the severity. 😋😋SIGN UP to get delicious recipes, handy kitchen hacks & more in our daily Pop Kitchen newsletter🍳🍔 According to the official notice, 65 cases, roughly amounting to 780 packages (each carrying 12 8-ounce packages) of Boar's Head Smoked Gouda cheese were distributed despite having a mislabeling issue. The recalled cheese products were produced by the Alpine Slicing and Cheese Conversion Company out of Wisconsin, and distributed to stores in the state of Florida. For those out of the loop with recalls, a mislabeling issue can mean a number of things. At worst, it involves the omission of a major allergen or ingredient from the label—posing serious health risks for people with food allergies or dietary restrictions. At best, it's a less serious error, like a mislabeled flavor or an inaccurate photo on the packaging, which doesn't pose a danger but still warrants a recall to uphold consumer transparency and company standards. While the severity of the recall is still being determined, and no further information about the mislabeling has been provided, it's reassuring that the issue is limited to one state. The recalled cheese was sold in 8-ounce packages and found in most major store refrigerators. It does not affect Boar's Head Smoked Gouda sliced at the deli counter, and no other products have been you think you have a package of Boar's Head Smoked Gouda Cheese at home, check for UPC 0 42421-50006 6, code 03 SEP 25 F, and 'Distributed by Brunckhorst Co., NY, NY 11206." While the recall has not yet been officially classified, the FDA advises consumers not to eat the product out of an abundance of caution—either throw it away or return it to the place of purchase for a full refund. Otherwise, as the issue progresses and more information becomes available, we'll report back to keep things up to date. The last thing anyone wants is to kick off the summer with a foodborne illness—or worse, for someone with an allergy to have a serious reaction to something that could've been Popular Cheese Product Is Being Recalled For a Very Serious Reason—Here's What to Know first appeared on Parade on Jul 14, 2025 This story was originally reported by Parade on Jul 14, 2025, where it first appeared.
Yahoo
11 hours ago
- Business
- Yahoo
Popular yogurt recalled; could contain sharp plastic pieces: FDA
(WJW) – A popular yogurt company is recalling more than a dozen varieties of yogurt due to the potential presence of plastic pieces, which could have sharp edges and cause choking, according to the U.S. Food and Drug Administration. Bread sold at Walmart and Kroger recalled The recall alert states that Danone U.S. is voluntarily recalling all flavors and sizes of YoCrunch products currently inmarket and sold at retail stores nationwide. According to the alert, consumers have reported the presence of plastic pieces in the toppers. Officials say the issue is isolated to the separately packaged topper and does not impact the separately packaged yogurt. KFC offers free buckets of chicken in 'comeback' 'The plastic pieces are transparent, may have sharp edges, and could present a risk to consumers because some pieces are between 7 and 25 mm in length,' reads the alert. 'The company is working swiftly with retail partners to remove the impacted product from shelves, while it works to address the issue and bring back the YoCrunch® products so many people enjoy.' Impacted product names and code dates are below (provided by the FDA): Product LOT #/EXP DATE YOCRUNCH STRAW W/GRANOLA 6OZ(UPC 46675000105) 2025.07.07, 2025.07.12, 2025.07.26, 2025.08.03, 2025.08.08, 2025.08.19,2025.08.22, 2025.08.30, 2025.09.04 YOCRUNCH VANILLA W/M&M 6OZ(UPC 46675000792) 2025.07.11, 2025.07.14, 2025.07.25, 2025.08.07, 2025.08.11, 2025.08.22, 2025.08.26, 2025.09.03 YOCRUNCH VANILLA W/OREO 6OZ (UPC 46675000808) 2025.07.11, 2025.07.14, 2025.07.24, 2025.07.25 2025.08.06, 2025.08.11, 2025.08.21, 2025.08.26, 2025.09.03 YOCRUNCH STRAW W/M&M 6OZ (UPC 46675000839) 2025.07.12, 2025.07.25, 2025.08.07, 2025.08.22, 2025.09.04 YOCRUNCH VANILLA W/SNICKERS 6OZ (UPC 46675001126) 2025.07.10, 2025.07.24, 2025.08.06, 2025.08.21 YOCRUNCH VANILLA W/TWIX CANDY 6OZ (UPC 46675001133) 2025.07.24, 2025.08.07, 2025.08.21 YOCRUNCH STRAW W/M&M MULTI 4X4OZ (UPC 46675013129) 2025.07.08, 2025.07.12, 2025.07.13, 2025.07.17, 2025.07.18, 2025.07.26, 2025.07.27, 2025.08.02, 2025.08.03, 2025.08.09, 2025.08.11, 2025.08.12, 2025.08.13, 2025.08.15, 2025.08.16, 2025.08.23, 2025.08.24, 2025.08.29, 2025.08.30, 2025.08.31 YOCRUNCH VAN W/COOKIE DOUGH 4X4OZ (UPC 46675013150) 2025.07.17, 2025.08.01, 2025.08.13, 2025.08.29 YOCRUNCH VANI W/SNICKER PCS 4X4OZ (UPC 46675013266) 2025.07.17, 2025.08.01, 2025.08.13, 2025.09.01 YOCRUNCH VANI W/TWIX CANDY 4X4OZ (UPC 46675013273) 2025.07.17, 2025.08.01, 2025.08.14, 2025.08.29 YOCRUNCH VANILLA OREO 4X4OZ(UPC 46675013501) 2025.07.13, 2025.07.14, 2025.07.20, 2025.07.21, 2025.07.24, 2025.07.25, 2025.07.26, 2025.07.31, 2025.08.01, 2025.08.02, 2025.08.08, 2025.08.09, 2025.08.10, 2025.08.11, 2025.08.15, 2025.08.16, 2025.08.23, 2025.08.24, 2025.08.25, 2025.08.30, 2025.08.31 YOCRUNCH VANILLA M&M 4X4OZ (UPC 46675013518) 2025.07.07, 2025.07.09, 2025.07.14, 2025.07.15, 2025.07.16, 2025.07.17, 2025.07.22, 2025.07.23, 2025.07.26, 2025.07.27, 2025.07.28, 2025.08.02, 2025.08.03, 2025.08.05, 2025.08.06, 2025.08.07, 2025.08.10, 2025.08.13, 2025.08.14, 2025.08.16, 2025.08.17,2025.08.18, 2025.08.19, 2025.08.20, 2025.08.21, 2025.08.22, 2025.08.26, 2025.08.27, 2025.08.28, 2025.08.29, 2025.09.01, 2025.09.02, 2025.09.03, 2025.09.04 YOCRUNCH VAN OREO & M&M FR PK 8X6OZ(UPC 46675014003) 2025.07.12, 2025.07.13, 2025.07.14, 2025.07.15, 2025.07.16, 2025.07.20, 2025.07.21, 2025.07.22, 2025.07.23, 2025.07.24, 2025.07.25, 2025.07.28, 2025.08.02, 2025.08.03, 2025.08.04, 2025.08.05, 2025.08.06, 2025.08.07, 2025.08.10, 2025.08.11, 2025.08.12, 2025.08.13, 2025.08.14, 2025.08.17,2025.08.18, 2025.08.19, 2025.08.20, 2025.08.21, 2025.08.22, 2025.08.23, 2025.08.25, 2025.08.26, 2025.08.27, 2025.08.28, 2025.08.29, 2025.09.02 YOCRUNCH STR/RAS GRNLA FR PK 8X6OZ (UPC 46675014010) 2025.07.26, 2025.08.23, 2025.08.30 YOCRUNCH STRW W/M&M&OREO FR PK 8X6OZ (UPC 46675026136) 2025.07.22, 2025.08.03, 2025.08.19, 2025.08.29 YOCRUNCH VAN W/SNIC&TWIX FR PK 8X6OZ (UPC 46675026143) 2025.07.14, 2025.07.28, 2025.08.11, 2025.08.26 YOCRUNCH VAN OREO/VAN M&M 18X6OZ CLB (UPC 46675027010) 2025.07.11, 2025.07.19, 2025.07.20,2025.07.26, 2025.07.27, 2025.07.28, 2025.07.31, 2025.08.01, 2025.08.02, 2025.08.08, 2025.08.09, 2025.08.16, 2025.08.17, 2025.08.23, 2025.08.24, 2025.08.25, 2025.08.30, 2025.08.31 Consumers who have purchased the affected products are advised not to consume them. 'Danone U.S., the makers of YoCrunch, takes every consumer experience seriously and is initiating this voluntary recall in line with its commitment to product quality and consumer safety,' reads the recall alert. For information on refunds, contact the YoCrunch Consumer Care Line at 1-877-344-4886. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
12 hours ago
- Health
- Yahoo
Popular yogurt recalled nationwide due to possible plastic pieces
Danone U.S., the maker of YoCrunch, is recalling the yogurt product due to the potential presence of plastic pieces in the packaging's dome topper, according to federal health officials. In an alert, the U.S. Food and Drug Administration said the plastic pieces, which were discovered after reported consumer complaints, could potentially cause a choking response if eaten. "The plastic pieces are transparent, may have sharp edges, and could present a risk to consumers because some pieces are between 7 and 25 mm in length," the FDA noted. "The issue is isolated only to the separately packaged topper and does not impact the separately packaged yogurt." This recall applies to all flavors and sizes of YoCrunch products currently in market at retail stores nationwide, including those with toppers containing granola, cookie dough, Oreo, M&M, Snickers and Twix pieces. A full list of impacted product names and code dates is on the FDA's website. "The company is working swiftly with retail partners to remove the impacted product from shelves," the FDA said. For information on refunds, consumers can contact the YoCrunch consumer care line at 1-877-344-4886. Sen. Lindsey Graham says "a turning point regarding Russia's invasion of Ukraine is coming" Trump pushes senators to make $9.4 trillion in spending cuts Watch: Waltz makes case to be U.N. ambassador after Trump administration ousting
