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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health and wellness
Get Proactive with Your Eye Health

Eye Health
(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.
- 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.
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Understanding Hypertrophic Cardiomyopathy

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

- 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.
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- There are many helpful ways patients can try to manage their weight.
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