FDA CDC News
FDA Warns Firms for Selling Illegal E-cigarettes That Look Like Toys, Food, and Cartoon Characters
U.S. Food and Drug Administration issued warning letters to five firms for the unauthorized marketing of 15 different e-cigarette products. Each e-cigarette product is packaged to look like toys, food, or cartoon characters and is likely to promote use by youth. None of the manufacturers submitted a premarket application for any of the unauthorized products.
Companies Must Stop Marketing Unauthorized Products or Risk Enforcement
Today, the U.S. Food and Drug Administration issued warning letters to five firms for the unauthorized marketing of 15 different e-cigarette products. Each e-cigarette product is packaged to look like toys, food, or cartoon characters and is likely to promote use by youth. None of the manufacturers submitted a premarket application for any of the unauthorized products.
The unauthorized products described in the warning letters include e-cigarettes that:
- Are designed to look like toys and youth-appealing electronics like glow sticks, Nintendo Game Boy, and walkie-talkies;
- Feature youth-appealing characters from TV shows, movies, and video game characters, including “The Simpsons,” “Family Guy,” “Squid Game,” “Rick and Morty,” “Minions,” and “Baby Bus;” or
- Imitate foods like popsicles.
“The designs of these products are an utterly flagrant attempt to target kids,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “It’s a hard sell to suggest that adults using e-cigarettes with the goal of quitting smoking need a cartoon character emblazoned across the front of the product in order to do so successfully.”
The FDA issued warning letters to:
- Wizman Limited doing business as Wizvapor
- Shenzhen Fumot Technology Co., Ltd. doing business as R and M Vapes
- Shenzhen Quawins Technology Co., Ltd.
- Ruthless Vapor
- Moti Global
The warning letters notify the recipients that e-cigarettes without a marketing authorization order are adulterated and misbranded, and that selling or distributing these products to consumers in the U.S. is prohibited under the Federal Food, Drug, and Cosmetic (FD&C) Act. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. In addition, products that appear to be misbranded or adulterated that are offered for import into the U.S. are at risk of being detained or refused admission. Retailers and distributors should communicate with their suppliers to discuss possible options for the unauthorized products in their inventory.
“The FDA is committed to keeping tobacco products out of the hands of our nation’s youth,” said Dr. King. “The agency will continue to hold companies accountable for illegally selling e-cigarettes, particularly those that shamelessly target youth.”
Today’s warning letters mark another step in the FDA’s continued efforts to remove illegally marketed tobacco products from the market. Through Oct. 28, the FDA has issued more than 440 warning letters to firms marketing illegal e-cigarettes containing tobacco-derived nicotine, and more than 60 warning letters to firms marketing illegal products containing non-tobacco nicotine. On Oct. 18, the U.S. Department of Justice (DOJ), on behalf of the FDA, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers who failed to submit premarket applications for their e-cigarette products and continued to illegally manufacture, sell, and distribute their products, despite previous warnings from the FDA that they were in violation of the law.
Related Information
- Warning Letters
- CTP Compliance and Enforcement
- Results from the Annual National Youth Tobacco Survey
Source: FDA
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Lifestyle
Mac and Cheese Recall: Potential Spoilage Concerns Affect Products at Major Retailers
Mac and Cheese Recall
In a recent announcement by the Food and Drug Administration (FDA), two types of macaroni and cheese products sold at major retailers have been recalled due to concerns over potential spoilage. The recall affects Reser’s American Classics Macaroni & Cheese and Reser’s American Classics Macaroni & Cheese White Cheddar, as part of a broader recall of Reser’s Fine Foods deli salads and refrigerated items.
Scope of the Recall
The affected macaroni and cheese varieties were distributed across five states: California, Illinois, Minnesota, North Dakota, and South Dakota. The specific “use by” dates for the recalled products are as follows:
- Reser’s American Classics Macaroni & Cheese: Use by dates of September 14 and September 16, 2024.
- Reser’s American Classics Macaroni & Cheese White Cheddar: Use by date of September 11, 2024.
In addition to the macaroni and cheese products, the recall includes a variety of other items such as potato salad, scalloped potatoes, pasta salad, corn, egg salad, spinach dip, gravy, and various desserts.
Cause of the Recall
According to the FDA, the potential spoilage was linked to “temperature abuse” during transportation, specifically due to a malfunctioning refrigeration unit on a trailer. A representative from Reser’s Fine Foods confirmed to FOX Business that the issue was isolated to a single truckload of product delivered to only one distributor location.
“The recall was initiated on July 29, 2024, and no affected products ever made it to the store shelves,” the representative stated. They further reassured consumers that any items purchased from stores are safe to consume.
Retailer Responses
Major retailers, including Safeway, Stop & Shop, and Walmart, which stock Reser’s macaroni and cheese products, have stated that their stores were not impacted by the recall. However, Target, another retailer selling the products, did not provide a comment when contacted by FOX Business.
Consumer Safety First
The FDA and Reser’s Fine Foods have stressed the importance of consumer safety in this situation. While the affected products have not reached store shelves, customers who may have purchased any items from the recalled batch are encouraged to check the packaging for the specified “use by” dates.
As always, consumers are advised to be vigilant about food safety and to report any concerns to their local health department or the FDA. For those who may have questions or require further information regarding this recall, contacting Reser’s Fine Foods directly or checking the FDA’s website can provide additional clarity.
In conclusion, while the recent recall raises concerns over food safety, companies and regulatory agencies are working diligently to ensure that consumers remain informed and protected. As the situation develops, staying updated through reliable sources is essential for maintaining food safety standards in your household.
Read the story on Fox Business.com: https://www.foxbusiness.com/lifestyle/mac-cheese-sold-major-retailers-recalled-potential-spoiling
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FDA CDC News
Important Recall Alert: Milo’s Poultry Farms and Tony’s Fresh Market Eggs Potentially Contaminated with Salmonella
Milo’s Poultry Farms, LLC has recalled eggs under the “Milo’s Poultry Farms” and “Tony’s Fresh Market” labels in Wisconsin, Illinois, and Michigan due to Salmonella contamination, advising consumers to discard or return products.
As of September 6, 2024, Milo’s Poultry Farms, LLC, headquartered in Bonduel, Wisconsin, has issued a voluntary recall of all its egg products due to possible contamination with Salmonella. This recall applies to both “Milo’s Poultry Farms” and “Tony’s Fresh Market” branded eggs, spanning across various retail stores and foodservice distributors in Wisconsin, Illinois, and Michigan.
What You Need to Know
Salmonella is a bacteria that can cause serious and occasionally fatal infections, particularly in young children, the elderly, and individuals with weakened immune systems. Healthy individuals infected with Salmonella often experience fever, diarrhea (potentially bloody), nausea, vomiting, and abdominal pain. In severe cases, the infection can result in the bacteria entering the bloodstream and causing more critical conditions such as infected aneurysms, endocarditis, and arthritis.
Scope of the Recall
The recall encompasses:
- All carton sizes and types of eggs under the “Milo’s Poultry Farms” label, across all expiration dates.
- All carton sizes of “Tony’s Fresh Market” branded eggs, applicable to all expiration dates.
- All cases of eggs intended for retail foodservice distribution, regardless of expiration dates.
Reason for the Recall
The recall was triggered after environmental samples collected by the FDA tested positive for Salmonella. Further investigations through whole genome sequencing linked these samples to an ongoing outbreak of Salmonella, prompting immediate action by Milo’s Poultry Farms.
Consumer Safety Measures
Milo’s Poultry Farms, LLC has temporarily halted production and distribution of the affected products to conduct necessary testing and sanitization processes at their facilities.
What Should Consumers Do?
Customers who have purchased any of the recalled eggs are strongly advised not to consume them. These products should be discarded immediately or returned to the place of purchase for a full refund.
Consumers with additional questions or concerns can reach out directly to Milo’s Poultry Farms, LLC at (715) 758-6709 for further guidance and support.
Stay Informed
Salmonella is an ongoing risk in uncooked poultry and eggs. Consumers are reminded to cook eggs thoroughly before consumption to kill bacteria and prevent illness. Stay updated with food recall alerts and safety guidelines to ensure the health and safety of you and your family.
Remember, food safety is paramount. Keep abreast of the latest FDA warnings and manufacturer recalls to safely navigate any potential health risks associated with contaminated products.
About the FDA
The Food and Drug Administration (FDA) is a U.S. federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The FDA also regulates the nation’s food supply to safeguard against contamination and prevent foodborne illnesses. One of its key functions is monitoring and managing food recalls when potential risks are identified, ensuring that hazardous foods are quickly and effectively removed from the market. The FDA issues alerts to inform the public about foodborne illness outbreaks, working collaboratively with manufacturers to recall affected products and maintain the safety and integrity of the food supply chain.
Follow FDA
- Follow@US_FDA on X
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- Recent Recalled Product Photos on FDA’s Flickr Photostream
Read the FDA release here: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/milos-poultry-farms-llc-recalls-eggs-because-possible-health-risk
Source: FDA
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STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.
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News
FDA Approves Game-Changing Nasal Spray for Anaphylaxis Treatment
In a landmark decision on August 9, 2024, the U.S. Food and Drug Administration (FDA) approved the first-ever nasal spray, neffy, for the emergency treatment of severe allergic reactions, including anaphylaxis, in individuals weighing at least 30 kilograms (approximately 66 pounds). This approval marks a significant breakthrough in the management of life-threatening allergic reactions, offering a non-injectable form of epinephrine that could transform how patients handle emergency situations.
Breaking Away from Injections: The Significance of Neffy
Traditionally, the treatment of anaphylaxis—a rapid and severe allergic reaction—has relied solely on injectable forms of epinephrine. This method, while effective, poses a challenge for many, particularly children who might fear needles, potentially delaying life-saving intervention. Neffy emerges as an innovative solution, providing epinephrine in a nasal spray form. As highlighted by Dr. Kelly Stone, MD, PhD, of the FDA’s Center for Drug Evaluation and Research, the development of neffy addresses an urgent need by removing the barrier of injection-associated anxiety and facilitating quicker, more accessible treatment.
The Science Behind Neffy
The approval of neffy was based on extensive clinical research involving 175 healthy adults. These studies explored the absorption and effect of neffy compared to traditional injectable epinephrine forms, focusing on indicators such as epinephrine concentration in the blood and the consequent physiological responses like changes in blood pressure and heart rate. The results confirmed that neffy delivers comparable epinephrine levels and physiological effects necessary for treating anaphylaxis effectively. Further research in children over 66 pounds mirrored these findings, showcasing neffy’s efficacy across different age groups.
How Neffy Works
Neffy is administered as a single dose via a nasal spray into one nostril. In cases where symptoms do not improve or worsen, a second dose may be applied using a new unit. It’s imperative for users to seek immediate medical attention after administering neffy to ensure comprehensive care and monitoring.
Considerations and Side Effects
While neffy stands as a revolutionary step forward, it comes with necessary precautions. Individuals with certain nasal conditions, such as nasal polyps or a history of nasal surgeries, may experience altered absorption rates. In such cases, traditional injectable products might be recommended. Users must also be cautious about potential side effects, which can include throat irritation, headache, nasal discomfort, and dizziness among others.
A Forward Leap in Allergy Management
With the introduction of neffy, patients and caregivers now have a less invasive option at their disposal. This development not only expands the tools available for combating severe allergic reactions but also significantly lowers the threshold for timely, effective intervention. The FDA’s fast-track designation of neffy underscores its potential impact, promising a new era of empowerment for those living with severe allergies.
In conclusion, the FDA’s approval of neffy represents a major advance in allergy care, highlighting ongoing innovation in medical treatments and patient care options. As neffy becomes available, it is poised to become a crucial asset in allergy management, enhancing safety and comfort for patients across the United States.
Source: FDA
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.
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