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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.

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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. 

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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. 

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Get Proactive with Your Eye Health

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Eye Health

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(Family Features) Glaucoma, one of the leading causes of permanent blindness, often does its damage silently – with no noticeable symptoms – as vision is lost. Glaucoma affects an estimated 3 million Americans, but most people don’t know they have the condition until it’s revealed in an eye exam. Once vision is lost, it cannot be recovered. If left untreated, glaucoma can cause blindness. That’s why when it comes to detecting and treating glaucoma, the earlier, the better. What is Glaucoma? Glaucoma is an eye disease caused by increased pressure in the eye, which can damage the optic nerve and reduce vision, sometimes making objects look blurry or dark. Early on, most people don’t notice what’s happening, but as glaucoma progresses, you may notice some loss of peripheral vision. By this point, the disease has progressed significantly toward blindness, and treatment options may be limited. Diagnosing Glaucoma Regular eye exams, including specific glaucoma tests, are important for the early detection and diagnosis of glaucoma. If diagnosed early, an eye doctor can recommend treatment to manage glaucoma and help prevent vision loss. “Many patients are surprised to learn glaucoma often presents with no initial symptoms,” said Oluwatosin U. Smith, MD, glaucoma specialist and ophthalmologist at Glaucoma Associates of Texas. “That’s why routine, comprehensive eye exams are so vital. These screenings allow us to detect glaucoma in its earliest stages, often before any vision loss occurs. Early diagnosis and treatment are the cornerstone of effective glaucoma management and it empowers us to take proactive steps to protect your vision.” To check for glaucoma, your eye doctor tests your eye pressure, peripheral vision and overall eye health. The painless screening is the only way to accurately diagnose the condition and determine appropriate treatment. Traditional Glaucoma Treatment For decades, prescription eye drops have been the most common treatment to help lower eye pressure and slow the progression of the disease. Although prescription eye drops are commonly prescribed and generally effective at lowering eye pressure, they can cause challenges and unwanted side effects, including redness, irritation, burning, stinging or difficulty putting them in the eye. In addition, patients may find it difficult to remember to take their eye drops every day, and missing doses – even by accident – can put vision at risk by allowing eye pressure to rise unchecked. When prescription eye drops are unsuccessful at controlling eye pressure or managing glaucoma, an eye doctor may change treatment by prescribing additional prescription eye drops, which can make the challenges and inconveniences associated with prescription eye drops worse. 17370 detail image embed1 Modern Glaucoma Management Takes a Proactive Approach Modern glaucoma management is evolving with a shift from reactive – that is, take prescription eye drops and “watch and wait” until glaucoma progresses before exploring alternative treatment – to proactive management. Taking a proactive approach to glaucoma treatment means choosing a minimally invasive procedure earlier in the treatment journey to help slow the progression of glaucoma and minimize vision loss while reducing the challenges of daily prescription eye drops. “The shift toward a more proactive approach represents a significant advancement in how we manage glaucoma,” Smith said. “Traditionally, we waited for vision loss before a procedural intervention. However, with modern minimally invasive procedures, we can now proactively lower eye pressure and protect the optic nerve much earlier. This approach helps us preserve our patients’ vision and quality of life for longer. I encourage anyone with a glaucoma diagnosis, or those with risk factors, to discuss proactive options with their ophthalmologist.”
  • Procedural pharmaceuticals, or drug delivery systems, may include tiny, FDA-approved implants that deliver medication continuously to help lower eye pressure and protect vision.
  • Micro-invasive, or minimally invasive, glaucoma surgery involves less-invasive procedures, devices (such as stents) and techniques with faster recovery times than traditional surgeries.
  • Laser treatment commonly involves a laser being aimed through a special lens onto the drainage system of the eye, triggering a natural change that helps fluid drain from the eye to lower pressure.
These treatments may be used in combination with prescription eye drops or on their own. If you or a loved one has been diagnosed with glaucoma, visit livingwithglaucoma.com to learn more and help manage the condition.   Photos courtesy of Shutterstock   collect?v=1&tid=UA 482330 7&cid=1955551e 1975 5e52 0cdb 8516071094cd&sc=start&t=pageview&dl=http%3A%2F%2Ftrack.familyfeatures SOURCE: Glaukos

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Understanding Hypertrophic Cardiomyopathy

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Hypertrophic Cardiomyopathy (Family Features) Hypertrophic cardiomyopathy, also called HCM, is the leading cause of sudden cardiac death in young athletes, sometimes with no warning signs. It is characterized by the thickening and stiffening of the heart walls, which can impede the heart’s ability to pump blood efficiently since the chambers cannot fill up. In addition, HCM is the most common inherited heart disease, affecting 1 in 500 people in the U.S., according to the American Heart Association. Because HCM runs in families, first-degree relatives – including parents, siblings and children – should be screened if a family member has been diagnosed. Consider this information to get a better understanding of this life-altering genetic condition’s symptoms and diagnosis, which can make a crucial difference in managing the disease effectively. Recognizing the Signs and Symptoms The symptoms and severity of HCM can vary widely among individuals. While some people may experience no symptoms at all, common symptoms include fatigue, fainting, shortness of breath, dizziness, chest pain and irregular heartbeats, especially during physical activity. Research shows Black male athletes in high-intensity sports like football and basketball may be at higher risk. The Importance of Family History in Diagnosis Because HCM is a genetic condition, family history is a critical component in its diagnosis. If someone in your family has been diagnosed with HCM, heart failure or cardiac arrest, children, siblings and parents should be screened for HCM. Genetic testing and echocardiograms are commonly used to catch HCM early. These tests assess the thickness of the heart muscle and observe blood flow, which can indicate the presence of the disease. There are two main types of HCM – obstructive and nonobstructive – and treatment options vary depending on the type and severity of symptoms. If HCM runs in your family, don’t wait. Talk to your doctor about screening options and encourage your loved ones to do the same. Early detection can be lifesaving. To learn more about HCM, visit heart.org/HCMStudentAthlete.   Photo courtesy of Shutterstock   collect?v=1&tid=UA 482330 7&cid=1955551e 1975 5e52 0cdb 8516071094cd&sc=start&t=pageview&dl=http%3A%2F%2Ftrack.familyfeatures SOURCE: American Heart Association

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Lifestyle

Beyond the Scale: Understanding the facts about obesity for Hispanic Americans

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obesity (Family Features) Obesity is a lifelong health problem that affects more than 42% of American adults and impacts some ethnic and racial groups more than others. According to the U.S. Centers for Disease Control and Prevention, nearly half (47%) of Hispanic American adults live with obesity, making it one of the most serious health risks for Hispanics. Obesity has been linked to serious conditions including diabetes, heart disease, cancer and digestive health issues, including gastroesophageal reflux disease and liver disease. Many patients do not make the connection between their weight and the impact on these other health conditions. They are unaware these conditions can be prevented and, in most cases, treated successfully by weight management. “As a gastroenterologist, patients often come to my office for serious health issues such as liver disease, which they don’t realize is caused by obesity,” said Dr. Andres Acosta, an obesity doctor and gastroenterologist at the Mayo Clinic. “They often don’t know these issues can be prevented or reversed by staying at a healthy weight. This is very important for Hispanic American adults who have higher rates of obesity and liver disease than other ethnicities. Maintaining a healthy weight is an important way to prevent or reverse many conditions before they become severe.” While some weight-loss programs, services and treatments are covered by insurance plans, many others are not, and without access to affordable, effective treatments, maintaining a healthy weight can be difficult. There is an urgent need for expanded access to treatment and care, including screening and treatment of obesity from a diverse range of health care providers. This should include coverage of prescription drugs for long-term weight management, behavioral counseling and other prevention and treatment options. People can act by advocating for changes in state-level policies to expand Medicaid coverage for obesity treatment and care by reaching out to their elected officials. In addition to advocating for policy changes, consider these important obesity facts:
  • Poor lifestyle choices alone do not lead to obesity.
  • Certain health conditions caused by obesity can be reversed by losing weight.
  • Obesity treatments are available from a variety of health care providers.
  • You have the power to advocate for and impact the future of obesity treatment.
  • There are many helpful ways patients can try to manage their weight.
To learn more about obesity and how to advocate for expanded access to treatment and care in your state, download the Obesity Coverage State Advocacy Toolkit at patient.gastro.org/obesity-learn-the-facts-beyond-the-scale-for-hispanic-americans to take action today.   Photo courtesy of Shutterstock   collect?v=1&tid=UA 482330 7&cid=1955551e 1975 5e52 0cdb 8516071094cd&sc=start&t=pageview&dl=http%3A%2F%2Ftrack.familyfeatures SOURCE: American Gastroenterological Association

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