health and wellness
FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers
The U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers.
First Injunction Actions Relating to Tobacco Products
The U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers. These cases represent the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
Each of these defendants failed to submit premarket applications for their e-cigarettes and have continued to illegally manufacture, sell, and distribute their products, despite previous warning from the FDA that they were in violation of the law. The injunctions would require the companies and named individuals to stop manufacturing, selling, and distributing their e-cigarettes. The injunctions would also require the defendants to obtain marketing authorization from the FDA before marketing such products, as required by law.
“Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.”
DOJ institutes judicial enforcement actions under the FD&C Act in court. Therefore, the injunctions were filed by DOJ on behalf of the FDA against the following defendants in their respective U.S. District Courts:
- Morin Enterprises Inc. doing business as E-Cig Crib in the District of Minnesota
- Soul Vapor LLC in the Southern District of West Virginia
- Super Vape’z LLC in the Western District of Washington
- Vapor Craft LLC in the Middle District of Georgia
- Lucky’s Convenience & Tobacco LLC doing business as Lucky’s Vape & Smoke Shop in the District of Kansas
- Seditious Vapours LLC doing business as Butt Out in the District of Arizona
The FDA had previously warned each of the defendant companies that they were in violation of the FD&C Act’s premarket review requirements for new tobacco products by manufacturing, selling, and distributing new tobacco products without first obtaining marketing authorization from the FDA. However, the defendants continued to manufacture, sell, and distribute unauthorized e-cigarettes to consumers. The FDA’s prior warnings noted that further violations could lead to enforcement action, including injunction.
Defendants have the opportunity to agree to consent decrees of a permanent injunction, which prevent them from directly or indirectly manufacturing, selling or distributing any new tobacco products unless and until certain prerequisites are met. These prerequisites include that the tobacco products receive FDA marketing authorization, that the agency inspect the defendants’ facilities to determine compliance, and that the FDA notify defendants in writing that they appear to be in compliance with the law. For those defendants who do not agree to consent decrees, the government can request the relevant courts to enter injunctions preventing those defendants from directly or indirectly manufacturing, selling or distributing any unauthorized tobacco products.
“These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with FDA to stop the distribution of illegal, unauthorized tobacco products.”
When companies are manufacturing and distributing unauthorized tobacco products, the FDA will typically first issue a warning letter in an attempt to achieve voluntary compliance with the law. If continuing violations are documented by the FDA, the agency may request that DOJ pursue a judicial enforcement action, such as an injunction or seizure. The FDA also has administrative civil money penalty authority for violations of the FD&C Act relating to tobacco products.
Between January 2021 through Sept. 9, 2022, the FDA issued nearly 300 warning letters, to firms that collectively have more than 17 million e-cigarettes listed with the agency, for failure to submit a timely premarket application. After receiving warning letters, a majority of these companies have complied and removed their products from the market.
These actions are part of a comprehensive approach to enforcing the law. For example, earlier this month, the FDA issued a warning letter to EVO Brands LLC and PVG2 LLC, doing business as Puff Bar, which is one of the most popular brands among U.S. youth, for receiving and delivering e-cigarettes in the U.S. without a marketing authorization order. All e-cigarettes on the market without the statutorily required premarket authorization are marketed unlawfully and risk FDA enforcement action. It is illegal to sell or distribute e-cigarettes that the FDA has not authorized, and those who engage in such conduct are at risk of FDA enforcement, such as a seizure, injunction, or civil money penalty.
The FDA encourages retailers to discuss new tobacco products in their inventory with their suppliers, to determine whether such products have the required marketing authorization. The FDA provides the names of authorized e-cigarettes on the FDA’s Tobacco Product Marketing Orders page. The FDA encourages the public to submit potential violations to us through our online form.
Related Information
- Tobacco Products Marketing Orders
- Premarket Tobacco Product Applications
- Report Potential Tobacco Product Violation
- Safety Reporting Portal for Tobacco Products
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(Family Features) In the U.S., 1 in 3 adults is at risk for a newly recognized syndrome that comes from a combination of heart disease, kidney disease, type 2 diabetes and excess body weight. This cluster of conditions, called cardiovascular-kidney-metabolic (CKM) syndrome, is an example of how problems in one part of your body can affect other parts.
To avoid CKM syndrome, health experts suggest paying close attention to four of the American Heart Association’s Life’s Essential 8 – blood pressure, lipids, body weight and blood sugar level – which are core health factors that impact your metabolic health.
Good metabolic health means your body uses energy well and keeps these factors in a normal range. However, when numbers are off in one area, it can affect others, raising your risk for heart disease, stroke, kidney disease and diabetes.
Consider these tips from the American Heart Association to help keep your core health factors under control.
Blood Pressure
High blood pressure, also known as hypertension, happens when the force of your blood pushing against the walls of your blood vessels is too high. High blood pressure is a leading cause of heart disease, stroke and kidney disease.
Because high blood pressure doesn’t have symptoms, the only way to know you have it is to get your blood pressure checked. Healthy blood pressure is below 120/80. If your blood pressure is 130/80 or higher, talk to your doctor about checking your other core health factors.
Lifestyle changes can help reduce high blood pressure. One example is a Dietary Approaches to Stop Hypertension (DASH) eating pattern that’s low in fat and rich in fruits, vegetables, whole grains and low-fat dairy products. Losing 10 pounds and reducing alcohol consumption can also reduce blood pressure.
Cholesterol
Cholesterol is a waxy substance your liver makes then circulates in the blood where your body uses it to build cells and make vitamins and hormones. You may also get cholesterol from eating animal products. If there’s too much cholesterol circulating, your risk of type 2 diabetes, heart disease and stroke may increase.
For optimal CKM health, your LDL cholesterol should be below 100 and triglycerides below 150. Triglycerides are the most common type of fat in the body. If your triglyceride level is 135 or higher, talk to your doctor about decreasing your risk.
Losing body weight and increasing physical activity decrease triglyceride levels. In addition, DASH and Mediterranean (plant-based, high-fiber, low-fat) eating patterns support healthy LDL and triglyceride levels.
Body Weight
Healthy weight may be determined by body mass index (BMI), a number that represents your weight in relation to your height. Extra body fat can mean a higher risk for many health problems, including heart disease, stroke, high blood pressure, high cholesterol and diabetes.
CKM syndrome starts when BMI is 25 or higher and waist circumference is 88 centimeters or higher for women and 102 centimeters or higher for men. Aim for a BMI between 18.5-25.
To lose weight and keep it off, start by setting realistic goals. Understand how much and why you eat, manage portion sizes, make smart snack substitutions and be physically active.
Blood Sugar
High blood sugar can slowly damage the kidneys. In fact, diabetes is the leading cause of kidney disease, and it increases the risk of heart attack and stroke.
Blood sugar is measured in two ways: a fasting blood glucose test (short term blood sugar) and an A1C test (long term blood sugar control). A normal fasting blood glucose level is 70-99 and a normal A1C level is below 5.7%. Fasting blood glucose above 125 and A1C of 6.5% or higher means you have diabetes.
Habits that help you avoid high blood pressure, weight gain and high cholesterol also keep your blood sugar in check. These are especially important if you have a family history of diabetes.
Learn more about CKM syndrome and how to manage your risk at heart.org/CKMhealth.
Photos courtesy of Shutterstock
SOURCE:
American Heart Association
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The two organizations will partner to foster healthy habits in young children and their families by offering free resources and videos and “Sesamatized” spaces
NEW YORK /PRNewswire/ — Today, Sesame Workshop, the global impact nonprofit behind Sesame Street, and NewYork-Presbyterian announced a partnership to improve health outcomes for young children by supporting their physical and emotional well-being through joyful learning moments engaging parents, caregivers, and community providers. Sesame Workshop is collaborating with NewYork-Presbyterian’s physicians and community partners on a social impact and mass media campaign featuring videos, educational materials, and “Sesamatized” physical spaces, to promote children’s health.
The partnership is launching with a six-part video series titled “Ask a Doctor,” featuring Sesame Street Muppets and NewYork-Presbyterian physicians. The videos are designed to educate and empower parents and caregivers on how to help young children stay healthy. They will cover topics including how to develop healthy sleep habits, deal with food allergies, and prepare for wellness visits. The series can be found on Sesame Workshop’s YouTube channel and will be available on NewYork-Presbyterian’s internal patient entertainment system.
“We are delighted to partner with NewYork-Presbyterian in our shared commitment to equity and health justice,” said Jeanette Betancourt, Ed.D., Senior Vice President of U.S. Social Impact at Sesame Workshop. “Our collaboration allows us to combine our expertise in healthcare, child development, and family and community engagement to make an impactful difference in the lives of those who need it most. In fostering healthy practices, especially in the early years, in ways that incorporate the perspectives and needs of parents and caregivers along with their community support networks, we are all working together to pave the way for a healthier, more equitable future.”
“We are thrilled to work with Sesame Workshop to empower parents and caregivers with important health information and meet families where they are,” said Dr. Deepa Kumaraiah, Senior Vice President and Chief Medical Officer of NewYork-Presbyterian. “Through fun learning moments that support the health and well-being of young people in our communities, we can help reduce health disparities and work toward health justice.”
A key focus of the partnership is a collaboration between Sesame Workshop and NewYork-Presbyterian’s neighboring community partners. Sesame Workshop will create educational materials with input from the children and caregivers in the communities NewYork-Presbyterian serves. Among the resources that will be available are bilingual Muppet videos, storybooks, parent guides, and activity books. “Sesamatized” physical spaces including décor featuring Sesame Street Muppets will open in the second half of 2025. The materials will be available where children and their families are, including community centers and NewYork-Presbyterian’s hospitals and clinics.
Additionally, two videos, featuring Elmo, Gabrielle, and other Sesame Street friends, that celebrate everyone of all hair and fur types complement NewYork-Presbyterian’s Dalio Center for Health Justice’s Crown Hair Care program, an initiative to provide inclusive hair care kits for pediatric and obstetric patients with curly, coiled, or tightly textured hair. These are also featured on NewYork-Presbyterian’s patient entertainment system.
About Sesame Workshop
Sesame Workshop is the global impact nonprofit behind Sesame Street and so much more. For over 50 years, we have worked at the intersection of education, media, and research, creating joyful experiences that enrich minds and expand hearts, all in service of empowering each generation to build a better world. Our beloved characters, iconic shows, outreach in communities, and more bring playful early learning to families in more than 150 countries and advance our mission to help children everywhere grow smarter, stronger, and kinder. Learn more at www.sesame.org and follow Sesame Workshop on Instagram, TikTok, Facebook, and X.
About NewYork-Presbyterian
NewYork-Presbyterian is one of the nation’s most comprehensive, integrated academic healthcare systems, encompassing 10 hospitals across the Greater New York area, nearly 200 primary and specialty care clinics and medical groups, and an array of telemedicine services.
A leader in medical education, NewYork-Presbyterian Hospital is affiliated with two renowned medical schools, Weill Cornell Medicine and Columbia University Vagelos College of Physicians and Surgeons. This collaboration means patients have access to the country’s leading physicians, the full range of medical specialties, latest innovations in care, and research that is developing cures and saving lives.
Founded 250 years ago, NewYork-Presbyterian Hospital has a long legacy of medical breakthroughs and innovation, from the invention of the Pap test to pioneering the groundbreaking heart valve replacement procedure called TAVR.
NewYork-Presbyterian’s 50,000 employees and affiliated physicians are dedicated to providing the highest quality, most compassionate care to New Yorkers and patients from across the country and around the world.
For more information, visit www.nyp.org and find us on Facebook, Instagram, YouTube, LinkedIn, and Pinterest.
SOURCE NewYork-Presbyterian
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(Family Features) Staying up to date on recommended vaccines is important during pregnancy. This is especially true during the winter months when more people tend to get sick from flu, COVID-19 and RSV. These viruses can be especially dangerous for pregnant people and babies.
Vaccines are an important part of routine pregnancy care, both for you and your baby. Getting vaccinated against flu and COVID-19 can cut your risk of hospitalization by about half.
Now is the time to get vaccinated if you haven’t already. Flu vaccines help protect you from getting the flu and getting seriously ill, so it’s a good idea to schedule an appointment now. The latest COVID-19 vaccines are important too because they lower your risk of serious illness. An RSV vaccine may also be recommended for when you are 32-36 weeks pregnant. Be sure to talk to your doctor.
“Right now, we are seeing a concerning increase in cases of respiratory diseases, such as the flu, COVID-19 and RSV,” said Adm. Rachel Levin, MD, assistant secretary for health at the U.S. Department of Health and Human Services. “I encourage all pregnant people to take preventive action to protect their health and the health of their baby. The best and safest way to do this is to get vaccinated. Getting vaccinated is easy and is usually covered by insurance.”
Help Protect Your Baby
When you get flu, COVID-19 and RSV vaccines, you’re helping protect your baby by passing your immunity on to them. Getting vaccinated against flu, COVID-19 and RSV during pregnancy can protect your baby during the first 6 months of life. These viruses can be very harmful to newborns. In fact, RSV is the leading cause of hospitalization in infants
Talk to Your Doctor About Timing
Millions of people in the U.S. have already gotten vaccinated against flu, COVID-19 and RSV this season. If you haven’t gotten your vaccines yet, be sure to talk with your doctor. They can help you choose the right vaccines and determine the best timing to help protect you and your baby.
Get the Facts
Getting vaccinated can give you peace of mind, ensuring you have done everything you can to protect yourself and your baby from serious respiratory illness. Information can give you power and comfort, especially when you’re pregnant.
Go to cdc.gov/RiskLessDoMore to learn more about flu, COVID-19 and RSV vaccines, or go to vaccines.gov to get started today.
Photo courtesy of Shutterstock
SOURCE:
U.S. Department of Health and Human Services
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