Connect with us

FDA CDC News

FDA Denies Marketing of Two Vuse Menthol E-Cigarette Products Following Determination They Do Not Meet Public Health Standard

Published

on

Company Must Stop Marketing Unauthorized Products or Risk Enforcement

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. The currently marketed products include the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%. 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. 

“Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.” 

When reviewing premarket tobacco product applications (PMTAs), the agency evaluates, among other things, a tobacco product’s components, ingredients, additives, constituents, design, harmful and potentially harmful constituents and health risks, as well as how the product is manufactured, packaged and labeled. 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.

Existing evidence demonstrates 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 a complete switch or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarettes products. Data from the 2022 National Youth Tobacco Survey found that Vuse was the second most common brand youth e-cigarette users reported “usually” using.

“Today’s decision pertains to the specific application submitted for review by FDA,” said Dr. King. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.” 

Advertisement

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 issuance of these MDOs is just one of the many actions the FDA has taken to ensure any tobacco products that are marketed undergo science-based review and receive marketing authorizations by the FDA. The agency has completed the review of and made determinations on more than 99% of the nearly 6.7 million deemed products for which applications were submitted by a court-ordered Sept. 9, 2020, deadline. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S.

Related Information

Source: FDA

https://stmdailynews.com/category/lifestyle/

FDA CDC News

Food Safety Tips for Game Day

Published

on

/PRNewswire/ — Super Bowl Sunday is coming up and you may be planning a party with friends and family. These parties often involve finger foods, communal dishes, and treats that are left out for long periods of time—which can lead to foodborne illness (also known as food poisoning).  Don’t let foodborne illness ruin the fun. Check out these tips from the U.S. Food and Drug Administration and learn how you can keep your food safe.

Food Safety Tips for Game Day

CLEAN

  • Wash your hands with warm water and soap for at least 20 seconds before and after handling food and after using the bathroom, changing diapers, and handling pets.
  • Wash your cutting boards, dishes, utensils, and counter tops with hot soapy water after preparing each food item.
  • Rinse fresh fruits and vegetables under running tap water, including those with skins and rinds that are not eaten. Scrub firm produce with a clean produce brush.

SEPERATE

  • Separate raw meat, poultry, seafood, and eggs from other foods in your shopping cart, grocery bags, and refrigerator.
  • Use one cutting board for fresh produce and a separate one for raw meat, poultry, and seafood.
  • Never place cooked food on a plate that previously held raw meat, poultry, seafood, or eggs unless the plate has been washed in hot, soapy water.
  • Don’t reuse marinades used on raw foods unless you bring them to a boil first.
  • If baking, make sure that no raw flour is on surfaces that contact other foods.

COOK

  • Use a food thermometer to ensure the safety of meat, poultry, seafood, and egg products. These foods must be cooked to a safe minimum internal temperature to destroy any harmful bacteria.
  • When cooking in a microwave oven, cover food, stir, and rotate for even cooking. If there is no turntable, rotate the dish by hand once or twice during cooking. Always allow standing time, which completes the cooking, before checking the internal temperature with a food thermometer.

CHILL

  • Refrigerate or freeze meat, poultry, eggs, seafood, and other perishables within 2 hours of cooking or purchasing. Refrigerate within 1 hour if the temperature outside is above 90° F.
  • Divide large amounts of leftovers into shallow containers for quicker cooling in the refrigerator.

SERVE

  • Keep cold foods chilled to 40 °F or below and hot foods heated to 140 °F or above.
  • If you’re planning a buffet and aren’t sure how quickly the food will be eaten, keep serving portions small. Prepare a number of small platters and dishes ahead of time and replace the serving dishes with the fresh ones throughout the party.
  • Don’t add new food to an already filled serving dish. Instead, replace nearly empty serving dishes with freshly filled ones.
  • Watch the clock with leftovers. Whether you’re sending “doggie bags” home with guests or are saving them for yourself, leftovers should be refrigerated as soon as guests arrive home and/or within 2 hours!

Learn more at:
http://www.fda.gov/Food/FoodborneIllnessContaminants/BuyStoreServeSafeFood/ucm328131.htm

SOURCE U.S. Food and Drug Administration

Continue Reading

FDA CDC News

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward

Published

on

Statement From:Janet Woodcock, M.D.
Principal Deputy Commissioner – Office of the Commissioner

January 26, 2023

Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter. Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.  

The use of CBD raises various safety concerns, especially with long-term use. Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant. 

A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.

Advertisement

The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive. 

The working group, which I chair, has closely examined studies related to the CBD-based drug Epidiolex, published scientific literatureinformation submitted to a public docket, as well as studies both conducted and commissioned by the agency. Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods. 

CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.

The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate. We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.

Continue Reading

FDA CDC News

Nationwide Artificial Tears Lubricant Eye Drops Recall Due to Possible Contamination

Published

on

Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Dropsdistributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level, due to possible contamination. The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare. To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection.

Risk Statement: Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.

Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottle are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun. The product is packaged in a bottle with a safety seal and are placed in a carton box Ezricare NDC 79503-0101-15, UPC 3 79503 10115 7; Delsam Pharma’s NDC 72570-121-15, UPC -72570-0121-15. It can be identified by the photos below. The product was distributed Nationwide in the USA over the Internet.

Global Pharma Healthcare is notifying the distributors of this product, Aru Pharma Inc. and Delsam Pharma and is requesting that wholesalers, retailers and customers who have the recalled product should stop use.

Consumers with questions regarding this recall can contact the distributors: Aru Pharma/Ezricare, LLC – by phone: 1-518-738-7602 or by e-mail: [email protected] from Monday to Friday, 11am to 4pm EST; or DELSAM Pharma LLC by phone: 1-866-826-1309 or by e-mail: [email protected] from Monday to Friday from 11am to 4pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Advertisement
  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Continue Reading

Subscribe to the SPR Newsletter

DON’T MISS A DINK

Be the first to know when the latest episode of Sleeve's Senior Pickleball Report is released on YouTube and more...

We don’t spam! Read our privacy policy for more info.

Advertisement pet, pets, dog, dogs, supplements, Pawlife, Pawlife Pets, dog health, dog treats, all natural, wellness product, dog supplements, all-natural
Advertisement

Want more stories 👋
News you Can Use, "THIS MOMENT!"

Sign up to receive awesome articles directly to your inbox, every month.

We don’t spam! Read our privacy policy for more info.

Advertisement

The Latest from TNC Network: TNC Network News

Trending

%d bloggers like this: