A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

No Carolina / New York

FDA Warns Firm with Over 15 Million Products Listed with FDA to Remove Unauthorized E-Cigarette Products from Market

“Today, the FDA issued a warning letter to a company with over 15 million tobacco products listed with the FDA, including many flavored e-liquids, for illegally marketing electronic nicotine delivery system (ENDS) products without authorization. This action demonstrates the agency’s ongoing commitment toward ensuring that marketed tobacco products are in compliance with the law to better protect youth and public health.

“The warning letter is the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. The FDA wants all tobacco product manufacturers and retailers to know that we continue to watch the marketplace very closely and will hold companies accountable for breaking the law. 

“The FDA will continue to prioritize enforcement against companies that market ENDS without the required authorization and that haven’t submitted a premarket application to the agency – especially those products with a likelihood of youth use or initiation.”

Additional Information:

  • Today, the U.S. Food and Drug Administration issued a warning letter to Visible Vapors LLC—a company based in Pennsylvania that manufactures and operates a website selling electronic nicotine delivery system (ENDS) products, including e-cigarettes and e-liquids—advising them that marketing these new tobacco products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S. The firm did not submit any premarket tobacco product applications (PMTAs) by the Sept. 9, 2020, deadline.
  • Per court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-cigarettes and e-liquids—were required to be submitted to the FDA by Sept. 9, 2020. 
  • While the warning letter issued today cites specific products as examples, including Visible Vapors Irish Potato 100mL and Visible Vapors Peanutbutter Banana Bacon Maple (The King) 100mL, the company has more than 15 million products listed with the FDA, and must ensure all of its products comply with federal rules and regulations, which include the premarket review requirement. 
  • In line with the agency’s enforcement priorities, after Sept. 9, 2020, the FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a product application.
  • From January through June 2021, the FDA issued a total of 131 warning letters to firms selling or distributing more than 1,470,000 unauthorized ENDS and that did not submit premarket applications for such products by the Sept. 9 deadline.

Additional Resources:

 

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Dr. Michael Newman, Indaptus’ Founder, Chief Scientific Officer, and lead author, commented, “The new data are consistent with our preclinical animal tumor model studies and provide evidence for our hypothesis that patented Decoy bacteria can activate a wide range of innate and adaptive human immune cells involved in fighting tumors.  This aligns with what we’ve observed in our ongoing Phase 1 clinical trial of Decoy20 – broad immune activation, as evidenced by transiently increased levels of many key cytokines and chemokines following single dose administration. These findings bolster our confidence in Decoy20's potential as a multifaceted immunotherapy.”
To further understand the impact of platforms like TikTok on nutrition trends, MyFitnessPal partnered with Dublin City University on a research and experimental study that examined diet and nutrition content on TikTok. The study analyzed over 67,000 videos using Artificial Intelligence to compare them against public health and nutrition guidelines
Leveraging the power of Apple Vision Pro to seamlessly blend digital content with the physical world Osso Health brings the operating experience to life via detailed, clinically accurate workflows of common procedures.
“We are excited to present the first look at the safety and clinical activity of ELVN-001, which we believe supports the potential for ELVN-001 to address the limitations of the available active-site TKIs,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “Across a wide dose range, ELVN-001 demonstrated activity in a heavily pre-treated patient population that includes post-asciminib patients, with a preliminary safety profile consistent with its highly selective design. Not only did all evaluable patients have improved or stable BCR::ABL1 transcript levels, but, importantly, 89% of all patients enrolled remain on study. We believe the initial data demonstrate the potential clinical utility of ELVN-001 for all types of patients, including those that are earlier in the treatment paradigm.”
The partnership is with Health-HavenRx ™, an online pharmacy platform. This partnership enables a new, convenient channel for patients to access POGO Automatic by using their health insurance on Intuity Medical’s e-commerce website at www.GoodtoPogo.com.

By using this website you agree to accept Medical Device News Magazine Privacy Policy