FDA CDC News
FDA Denies Marketing of Two Vuse Solo Menthol E-Cigarette Products
Company Must Stop Marketing Unauthorized Products
Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand. The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2. The company must not market or distribute these products in the U.S. or they risk FDA enforcement action. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.
The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product on the population as a whole. After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. Specifically, evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes.
“The FDA is a data driven agency and science remains the cornerstone of our tobacco product regulatory activities,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “The science has guided – and will always guide – the FDA’s decision making on premarket tobacco product applications, including today’s marketing denial orders.”
Existing evidence, including data from the 2022 National Youth Tobacco Survey (NYTS), shows that non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use. In contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk. Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol-flavored e-cigarette products are likely to promote complete switching or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarettes. NYTS data also found Vuse to be the second most common brand youth e-cigarette users reported “usually” using.
These products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In addition to ensuring that the manufacturer complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers. Retailers should contact R.J. Reynolds Vapor Company with any questions about products in their inventory.
Today’s actions are just one of many the FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency. To date, the agency has received applications for more than 26 million deemed products and has made determinations on 99% of these applications. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S.; this includes the Vuse Solo e-cigarette device and two accompanying tobacco-flavored e-liquid cartridges. The FDA has also denied marketing applications for millions of products that did not meet the requirements in the law, including ten non-tobacco-flavored e-liquid cartridges under the Vuse Solo brand, Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%.
Related Information
- Tobacco Products Marketing Orders
- Premarket Tobacco Product Applications
- Quitting Smoking and Other Tobacco Public Health Resources
- Safety Reporting Portal for Tobacco Products | FDA
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FDA CDC News
Seafood Recall: Important Information on Hannaford Seafood Salads
In early November, the U.S. Food and Drug Administration (FDA) announced a Class II recall concerning Hannaford Seafood Salads, affecting over 1,600 units across five states: Maine, New Hampshire, Vermont, Massachusetts, and New York. The recall, initiated on October 31, was due to a mislabeling incident that poses a significant risk to consumers with soy allergies.
Understanding the Class II Risk Level
The FDA has classified this recall as a Class II risk, indicating that exposure to the affected products may cause “temporary or medically reversible adverse health consequences.” However, the risk of experiencing serious health consequences remains “remote.” Despite this classification, consumers with an allergy or severe sensitivity to soy must take this recall seriously, as they could face life-threatening allergic reactions if they consume the mislabeled salads.
What Happened?
The problem arose when the printer responsible for the salad labels provided Elevation Foods, the manufacturer of the salads, with labels that did not accurately reflect the current product formulation. Instead of the correct labels, the printer mistakenly issued labels meant for an upcoming formulation change. As a result, the affected salads may contain undeclared hydrolyzed soy protein, a known allergen that must be clearly stated on product labels to protect consumer safety.
Product Details
The implicated Hannaford Seafood Salads were distributed between October 25 and 29, and they feature use-by dates of November 13 and 14. Consumers can find these dates printed on the lid of the containers. Following the recall announcement, all affected products were promptly removed from store shelves.
Health Risks Associated with Soy Allergies
For individuals with soy allergies, the immune system mistakenly identifies soy proteins as harmful invaders, leading to a range of symptoms that can vary in severity. Common reactions include stomach issues, coughing, itching, wheezing, vomiting, hives, and difficulty breathing. In severe cases, these reactions can escalate to life-threatening conditions, such as anaphylaxis.
To mitigate risks, those with soy allergies are advised to carry an epinephrine injection (Epi-Pen) to counteract severe allergic reactions swiftly.
What Should Consumers Do?
Customers who purchased Hannaford Seafood Salads before the recall are urged not to consume the products. Instead, they can return them to the store where they made the purchase for a full refund. Elevation Foods has not reported any known cases of illness related to these salads, but consumer safety remains a top priority.
Conclusion
This seafood salad recall serves as a crucial reminder about the importance of accurate labeling, especially when it comes to potential allergens. Consumers should remain vigilant and informed about the products they purchase, particularly if they have food allergies. Stay safe and always check your labels!
Related Links:
https://www.newsweek.com/seafood-salad-recall-update-fda-risk-level-hannaford-1992294
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pets
Urgent Dog Treat Recall: Carolina Prime Pet Issues Warning Due to Salmonella Risk
Dog Treat Recall
In a recent announcement that has concerned dog owners across the Southeastern, Midwestern, and Mid-Atlantic regions of the United States, the FDA has reported a recall of “Hollywood Feed Carolina Made Chicken Chips” dog treats manufactured by Carolina Prime Pet, Inc. of Lenoir, North Carolina. This recall, affecting approximately 400 bags of these popular dog treats, is attributed to the potential risk of Salmonella contamination.
Why Is This Recall Important?
While there have been no reported illnesses linked to the consumption of these chicken chips, the safety of pets—and by extension, their human companions—is paramount. Salmonella, a bacteria that can cause severe gastrointestinal distress in animals and humans alike, can be particularly dangerous for pets, leading to symptoms such as vomiting, diarrhea, and lethargy. For individuals, Salmonella can also result in serious health complications, especially in young children, elderly adults, or those with weakened immune systems.
Details of the Recall
The recall specifically pertains to 16-ounce bags of “Hollywood Feed Carolina Made Chicken Chips” that carry the lot number 20051324L2 and an expiration date of 11/13/25. Consumers can easily identify the affected product by checking the back of the packaging, which features a distinctive purple-and-black design. The recall extends to retail locations across 19 states, including:
- Alabama
- Arkansas
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Michigan
- Mississippi
- Missouri
- North Carolina
- Ohio
- Oklahoma
- Pennsylvania
- South Carolina
- Tennessee
- Texas
For those who purchased the treats online, they were also available on the company’s website at www.hollywoodfeed.com.
What Should Consumers Do?
Carolina Prime Pet, Inc. has advised consumers to check their homes for the affected product. If your dog treats match the recalled lot number and expiration date, it is crucial not to feed them to your pet. Instead, return the products to the place of purchase for a full refund. For those who have questions or need more information, the company encourages contacting their customer service.
Final Thoughts
As pet owners, it is our responsibility to stay informed about the products we give our furry friends. The safety of our pets is essential, and recalls like these serve as a reminder to always check product packaging and stay updated on food safety announcements. If you have any concerns about your pet’s health or have noticed any unusual symptoms after consuming potentially contaminated food, it is advisable to consult with a veterinarian immediately.
Stay alert, stay informed, and together we can ensure the safety and well-being of our beloved pets.
Related links:
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FDA CDC News
Popular Nasal Decongestant Falls Short: FDA Advisers Question Efficacy
FDA questions effectiveness of popular nasal decongestant phenylephrine, raising concerns about congestion relief.
In a surprising turn of events, government experts have cast doubt on the effectiveness of the leading decongestant found in popular over-the-counter medications like Sudafed and Dayquil. A recent review conducted by the Food and Drug Administration (FDA) found that the main drug ingredient, phenylephrine, offers no significant relief from nasal congestion. This revelation raises concerns among millions of Americans who rely on these medications for congestion relief.
Phenylephrine became the primary ingredient in over-the-counter decongestants after pseudoephedrine, an older ingredient, was moved behind pharmacy counters due to its potential for illegal drug processing. However, the FDA’s outside advisers unanimously voted against the efficacy of phenylephrine, prompting a reevaluation of its effectiveness. Despite phenylephrine-based versions dominating the market, accounting for four-fifths of the $2.2 billion oral decongestant market, the FDA’s conclusions suggest a need to reconsider their availability.
The FDA review identified significant flaws in the original studies that supported phenylephrine’s approval. These studies, conducted in the 1960s and 1970s, were deemed inadequate by modern standards. Furthermore, three recent, well-conducted studies by reputable pharmaceutical companies found no discernible difference between phenylephrine medications and placebos in relieving congestion. This raises concerns about the effectiveness of phenylephrine, which has relied on outdated research.
The FDA’s advisory panel’s unanimous vote against phenylephrine’s effectiveness could lead to regulatory action requiring drugmakers like Johnson & Johnson and Bayer to withdraw their phenylephrine-based oral decongestants from store shelves. This move may force consumers to opt for behind-the-counter pseudoephedrine products or phenylephrine-based nasal sprays and drops. However, it would necessitate extensive education efforts by the FDA, pharmacists, and drugstores to inform consumers about alternative options for treating congestion.
The Consumer Healthcare Products Association, representing nonprescription drugmakers, argued that the recent studies have limitations and advocated for continued “easy access” to phenylephrine. However, the FDA review highlighted the shortcomings of the original studies and the lack of modern scientific evidence supporting phenylephrine’s efficacy. Balancing public health concerns and consumer access will be a crucial challenge for regulators moving forward.
The FDA’s recent review has cast doubt on the effectiveness of phenylephrine, the key ingredient in popular nasal decongestants. This finding prompts a reevaluation of treatment options for nasal congestion and calls for further research to provide effective relief for individuals in need.
Check out the article from the Associated Press: https://apnews.com/article/sudafed-decongestants-phenylephrine-pseudoephedrine-fda-0f140bafae9a500c5fba05fe764ecb66
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