FDA CDC News

National Survey Shows Drop in E-Cigarette Use Among High School Students

Published

11 months ago

November 4, 2023

Daily News Staff

FDA Continues Push to Curb Youth Use with Additional Round of Fines Against Retailers for Illegal E-cigarette Sales

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC), released data from the 2023 National Youth Tobacco Survey (NYTS) on tobacco product use among U.S. youth. The findings, which were collected between March and June 2023, show that 10% of U.S. middle and high school students (2.8 million youth) reported current use of any tobacco product.

Among U.S. high school students, current overall tobacco product use declined during 2022-2023 (16.5% to 12.6%). This decline was primarily attributable to reduced e-cigarette use (14.1% to 10%), which translates to 580,000 fewer high school students who reported current use of e-cigarettes in 2023. Among high school students, declines in current use were also observed during 2022-2023 for cigars and overall combustible tobacco smoking, representing all-time lows.

“It’s encouraging to see this substantial decline in e-cigarette use among high schoolers within the past year, which is a win for public health,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “But we can’t rest on our laurels. There’s more work to be done to build on this progress.”

Although a decrease in e-cigarette use was observed among high school students, among middle school students there was an increase in current overall tobacco product use (4.5% to 6.6%) and multiple tobacco product use (1.5% to 2.5%). However, among middle school students overall, no significant change was observed during 2022-2023 for current use of any individual tobacco product type, including e-cigarettes.

E-cigarettes remained the most commonly used tobacco product among both high school and middle school students for the 10th year in a row. Among youth who reported current e-cigarette use, approximately one-quarter reported using e-cigarettes every day. Disposable e-cigarette products were the most common product type used by youth who reported e-cigarette use. However, the most popular brands included both disposable and cartridge-based products. Among current youth e-cigarette users, the most commonly reported brands were Elf Bar (56.7%), Esco Bars (21.6%), Vuse (20.7%), JUUL (16.5%) and Mr. Fog (13.6%).

Among youth who reported current e-cigarette use, nearly all used flavored products (89.4%), with fruit, candy, mint and menthol being the most commonly used flavors. For the first time in NYTS, the 2023 questionnaire asked about use of flavors that included the word “ice” or “iced” in their name, along with other concept flavor names (i.e., names that imply flavor but do not explicitly indicate any particular flavor, such as “island bash”). Accounting for these products provides a more robust picture of flavored tobacco product use among youth, with the results suggesting that flavored tobacco product use among youth might be higher than previously thought.

“The FDA remains concerned about youth tobacco product use, and we cannot and will not let our guard down on this issue,” King said. “The agency has an array of enforcement tools at our disposal, and we’re committed to using them as appropriate. We will not stand by as bad actors place profit over the health of our nation’s youth.”

After filing 22 civil money penalty (CMPs) actions in September for the largest amounts sought to date, the FDA is announcing a new wave of enforcement actions targeting illegal e-cigarettes with youth appeal. The agency is seeking CMPs for similar amounts against 20 additional retailers for the sale of unauthorized Elf Bar products, the most popular brand among youth according to the 2023 NYTS. The FDA previously issued a warning letter to each of these 20 retailers cautioning them to stop selling unauthorized tobacco products. During follow-up inspections, the FDA observed that the retailers had not stopped selling the unauthorized products, resulting in the CMP actions. In September, the FDA announced civil money penalty actions against more than a dozen retailers for the sale of unauthorized Elf Bar/EB Design e-cigarettes and sent hundreds more warning letters to retailers for selling the same products.

Today’s actions mark yet another step in the agency’s continued actions against manufacturers, distributors, importers and retailers of illegal e-cigarettes with youth appeal. Over the past year, the FDA has issued more than 135 warning letters to manufacturers and distributors of unauthorized e-cigarettes – including several distributors of Elf Bar (Easy Wholesale, LLC, EC Supply, Inc., Safa Goods, LLC). The FDA has also conducted a series of nationwide retailer inspections, issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes, issued import alerts for the detention without physical examination of unauthorized e-cigarettes offered for entry into the U.S. marketplace, filed civil money penalty actions for the largest amounts sought to date against manufacturers of unauthorized e-cigarettes and filed the first injunctions against manufacturers of unauthorized e-cigarettes.

Youth use of tobacco products in any form – including e-cigarettes – is unsafe. Keeping tobacco products out of the hands of youth remains a top priority for the FDA. The FDA’s continued efforts, including the enforcement actions announced today, mark important progress toward achieving that goal.

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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.

Published

4 days ago

September 10, 2024

Hal Machina, Daily News Staff

selective focus photo of three eggs on tray — Photo by Monserrat Soldú on Pexels.com

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

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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News

FDA Approves Game-Changing Nasal Spray for Anaphylaxis Treatment

Published

2 weeks ago

August 30, 2024

Hal Machina

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

https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis?utm_medium=email&utm_source=govdelivery

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health and wellness

Sun Pharmaceutical Announces FDA Approval of LEQSELVI™ for Severe Alopecia Areata

Published

4 weeks ago

August 20, 2024

Hal Machina, Daily News Staff

Sun Pharmaceutical Industries Limited is thrilled to announce that the U.S. Food and Drug Administration (FDA) has approved LEQSELVI™ (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata. This approval is a significant milestone, particularly for the roughly 300,000 Americans living with this challenging condition.

Alopecia areata is an autoimmune disorder marked by significant hair loss, often resulting in severe emotional and psychological distress. The journey to finding effective treatment options has been fraught with challenges, as the condition could be unpredictable and resistant to previous therapies.

Groundbreaking Clinical Trial Results

The FDA’s approval of LEQSELVI™ was supported by robust evidence from two Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, which collectively enrolled 1,220 patients. These studies demonstrated that LEQSELVI™ delivered substantial hair regrowth: at 24 weeks, approximately one-third of the patients achieved 80% or more scalp hair coverage, a significant improvement from an average baseline scalp hair coverage of just 13%.

How LEQSELVI™ Works

LEQSELVI™ is a cutting-edge, twice-daily oral medication that selectively inhibits Janus Kinases (JAK) JAK1 and JAK2. This mechanism targets the immune pathways believed to contribute to the hair loss seen in severe alopecia areata, offering a new hope to those who have had limited success with existing treatments.

Safety and Efficacy

The treatment has been carefully tested for safety across several studies. While the medication is generally well-tolerated, it does carry warnings for serious infections, malignancies, thrombosis, and gastrointestinal perforations, similar to other treatments in its class. Patients and healthcare providers are advised to monitor for symptoms and manage them accordingly.

Support and Accessibility

Understanding the challenges associated with treatment access, Sun Pharma is initiating a comprehensive access program. This initiative will help eligible patients begin and adhere to their treatment, ensuring that LEQSELVI™ reaches those who need it the most. More details about this program are available on the official LEQSELVI™ website.

A Step Forward for the Alopecia Community

The approval of LEQSELVI™ represents a significant advancement for the alopecia community. Abhay Gandhi, CEO North America Business, Sun Pharma, shared his enthusiasm about bringing this innovative treatment to the market, stating it “offers a new and effective solution that will significantly enhance the options for patients and their physicians.”

Moreover, organizations such as the National Alopecia Areata Foundation (NAAF) have welcomed this new treatment option. Nicole Friedland, President and CEO of NAAF, highlighted the importance of this development, underscoring the profound impact alopecia areata can have on individuals’ lives.

Looking Ahead

With the introduction of LEQSELVI™, Sun Pharma continues to cement its position as a leader in dermatological treatments. The company’s commitment to addressing complex medical conditions through innovative solutions is evident in their rapidly expanding dermatology portfolio.

For patients suffering from severe alopecia areata, LEQSELVI™ represents not merely a new treatment option but a new hope—a possibility of regaining not just their hair, but also their confidence and quality of life.

For further details on LEQSELVI™ and patient support initiatives, visit www.LEQSELVI.com.

View the full multimedia release.

Disclaimer:
This content may include forward-looking statements, which are based on current expectations and projections about future events. Readers should not place undue reliance on these statements, as actual results may vary.