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.
Understanding RSV: Symptoms, Treatment, and Prevention
RSV: a viral respiratory infection affecting children and adults. Learn about symptoms, treatment, and prevention for a healthier future.
RSV, short for Respiratory Syncytial Virus, is a common viral infection that primarily affects the respiratory system, particularly young children. While RSV infections are usually mild, they can pose a greater risk to infants, older adults, and individuals with weakened immune systems. If you or a loved one are facing RSV, it can be overwhelming to know what to do next. That’s why it’s important to know the symptoms, treatment options, and preventative measures available to you. By being informed and taking action, you can give yourself and those around you hope and guidance during this difficult time. So let’s explore what you can do to fight RSV and emerge victorious.
Symptoms and Diagnosis:
RSV presents symptoms resembling a cold, including cough, runny nose, fever, and occasionally, difficulty breathing. Infants may exhibit irritability, decreased appetite, and lethargy. Diagnosing RSV usually involves a medical professional evaluating symptoms, conducting a physical examination, and, if necessary, performing laboratory tests to confirm the presence of the virus.
Treatment and Management:
In most cases, RSV infections can be managed at home with supportive care. This includes ensuring proper hydration, maintaining a comfortable environment, and using over-the-counter medications to alleviate symptoms under a doctor’s guidance. However, for high-risk individuals or severe cases, hospitalization may be required for closer monitoring and specialized treatment, such as oxygen therapy or intravenous fluids.
Prevention is Key:
Preventing the spread of RSV is crucial, especially for vulnerable populations. Practicing good hygiene, such as frequent handwashing, covering coughs and sneezes, and avoiding close contact with infected individuals, can significantly reduce the risk of transmission. Additionally, promoting a clean and sanitized environment, particularly in daycare centers and schools, can help curb the spread of the virus.
While RSV can be concerning, it’s important to remember that most cases resolve on their own with time and supportive care. In fact, the majority of children infected with RSV recover fully without complications. By following preventive measures, seeking medical attention when needed, and staying informed about the latest developments in RSV research and treatment, we can approach this viral infection with hope and confidence.
Respiratory Syncytial Virus (RSV) is a common viral infection that primarily affects young children, causing cold-like symptoms and occasionally resulting in more severe respiratory distress. However, with proper care and attention, RSV can be managed effectively. By understanding the symptoms, seeking medical help when necessary, and adopting preventive measures, we can protect ourselves and our loved ones from the impact of RSV and look forward to brighter days ahead.
You can find more information about RSV, including its treatment and prevention, by visiting the CDC website. https://www.cdc.gov/rsv/index.html
FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors
Today, the U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.
Desmoid tumors are non-cancerous but can be locally aggressive. The tumors may invade into surrounding structures and organs, resulting in pain, issues with being able to move, and decreased quality of life. Although surgical removal has historically been the treatment of choice, there is a high risk that the tumor will return or that other health challenges will occur after removal; therefore, systemic therapies (cancer treatment targeting the entire body) are being increasingly evaluated in clinical trials.
“The FDA continues to address unmet medical need and advance the development of safe and effective therapies for the millions of Americans whose lives are affected by rare tumors,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Desmoid tumors are rare tumors that can lead to severe pain and disability. Today’s approval will offer the first approved treatment option for patients beyond surgery and radiation.”
The effectiveness of Ogsiveo was evaluated in an international, multicenter, randomized, double-blind, placebo-controlled trial in 142 adult patients with progressing desmoid tumors not amenable to surgery. Patients were randomized to receive 150 milligrams (mg) of Ogsiveo or placebo orally, twice daily, until disease progression or unacceptable toxicity. The main efficacy outcome measure was progression-free survival (the length of time after the start of treatment for which a person is alive and their cancer does not grow or spread). Objective response rate (a measure of tumor shrinkage) was an additional efficacy outcome measure.
The pivotal clinical trial demonstrated that Ogsiveo provided clinically meaningful and statistically significant improvement in progression-free survival compared to placebo. Additionally, the objective response rate was also statistically different between the two arms with a response rate of 41% in the Ogsiveo arm and 8% in the placebo arm. The progression-free survival results were also supported by an assessment of patient-reported pain favoring the Ogsiveo arm.
The most common side effects seen in at least 15% of the patients in the trial were diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection and dyspnea.
Ogsiveo was granted Priority Review under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition compared to available therapies. Ogsiveo also received FDA Fast Track and Breakthrough Therapy designations for the indication noted above, as well as Orphan-Drug designation for treatment of desmoid tumor (aggressive fibromatosis). Orphan-drug designation provides incentives to assist and encourage drug development for rare diseases.
The FDA granted the approval of Ogsiveo to SpringWorks Therapeutics Inc.
Salmonella Outbreak: Cantaloupe Recall Investigation
Salmonella outbreak: Cantaloupes recalled. Ongoing investigation. Stay informed for updates on the recall.
In recent weeks, an outbreak of Salmonella linked to cantaloupes has raised concerns across the United States and parts of Canada. The outbreak, which began in early November 2023, has resulted in numerous cases of illness reported from various states. Health authorities, including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), are diligently investigating this outbreak to identify the source of contamination and prevent further illnesses. This blog post aims to provide an overview of the outbreak investigation, affected products and stores, symptoms of Salmonella infection, and recommendations for consumers and businesses.
On November 22, 2023, Crown Jewels Produce, Sofia Produce, and CF Dallas initiated a recall of fresh cantaloupes and related products due to potential Salmonella contamination. As of November 24, CDC reported a total of 99 cases from 32 states, with the latest onset date being November 10, 2023. The investigation is still ongoing, as authorities are working to determine if additional products are linked to the illnesses. The FDA will provide updates on this situation as more information becomes available.
Affected Products and Stores:
The following brands of whole fresh cantaloupes have been recalled:
- Cantaloupes labeled “Malichita” or “Rudy,” with the numbers “4050” and “Product of Mexico/produit du Mexique.”
- These cantaloupes were sold in retail stores located in Arizona, California, Maryland, New Jersey, Tennessee, Illinois, Indiana, Kentucky, Michigan, Ohio, Oklahoma, Wisconsin, Texas, Florida, and Canada. It is important to note that this list may not include all states, as the cantaloupes could have reached consumers through further retail distribution.
Recalled cut cantaloupe and products made from the recalled whole cantaloupes include:
- ALDI’s cantaloupe, cut cantaloupe, and pineapple spears in clamshell packaging with Best-by dates between October 27 and October 31.
- Vinyard’s cantaloupe chunks and cubes, fruit mixes, melon medleys, and fruit cups containing cantaloupe. Most of these products have a “Vinyard” label, and some have a red label with “Fresh” sold between October 30 and November 10 in Oklahoma stores.
- Freshness Guaranteed seasonal blend, melon trio, melon mix, fruit blend, fruit bowl, seasonal fruit tray, fruit mix, and cantaloupe chunks. RaceTrac fruit medley sold in clear square or round plastic containers at select retail stores in Indiana, Michigan, Ohio, Kentucky, North Carolina, Tennessee, Virginia, Illinois, Texas, and Louisiana.
Symptoms of Salmonella Infection:
Salmonella infection typically manifests within 12 to 72 hours after consuming contaminated food and typically lasts for four to seven days. Common symptoms include diarrhea, fever, and abdominal cramps. It is important to note that severe infections are more likely to occur in children younger than five, the elderly, and individuals with weakened immune systems.
Status and Recommendations:
The investigation into the cantaloupe-related Salmonella outbreak is still ongoing. Authorities will continue to provide updates as new information becomes available. In the meantime, the following recommendations are crucial:
- Consumers, restaurants, retailers, and wholesalers should refrain from consuming, selling, or serving recalled cantaloupes or products containing cantaloupe.
- Those who have frozen cantaloupes for later use should check their freezers and discard any recalled fresh or cut cantaloupes.
- If you are unsure whether your cantaloupe is part of the recall, it is best to err on the side of caution and dispose of it.
- Retailers and wholesalers who received recalled whole melons should identify the boxes labeled “Malachita/Z Farms” or “Malichita” or “Rudy” from Crown Jewels Produce and Sofia Produce (TruFresh) and remove them from their inventory.
- It is crucial to follow FDA’s safe handling and cleaning advice, ensuring that any surfaces and containers that may have come in contact with the recalled products are thoroughly cleaned and sanitized to prevent cross-contamination.
- If you suspect you may be experiencing symptoms of a Salmonella infection after consuming recalled cantaloupes, it is essential to seek medical attention promptly.
The outbreak investigation of Salmonella linked to cantaloupes is a matter of concern, and authorities are actively working to protect public health. By staying informed, following the recommendations, and taking necessary precautions, we can collectively mitigate the risks associated with this outbreak. Stay tuned for updates and adhere to the guidance provided by health authorities to ensure the safety of yourself and your loved ones.
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