To me, it looks like we are going to know nothing new, outside of the horrible news we already know, today. To quote a friend, “they are worms”.
Bottom line, NOTHING has been approved, but them cigarettes are still out there though!
They have banned millions of private sector, small business products while delaying the decision on the larger, Big Tobacco owned Juul. Let’s think about that for a second.
Let’s add more job loss, more business loss, more stress, and more death to an already struggling society. But hey, the kids are safe because Mom and Dad can’t control them.
Perhaps the title of this press announcement should have been, “FDA Makes Significant Progress in destroying lives, jobs, and killing people.”
Press announcement from the FDA:
As of today, the agency has taken action on applications for over 6 million ENDS products, including refusing to file (RTF) one company’s applications for approximately 4.5 million products because required contents were missing as well as issuing 132 MDOs for more than 946,000 flavored ENDS products, including flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.
We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review. For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard. Our continued review also includes a smaller number of pending applications that are being reviewed under the “substantial equivalence” standard, for cigars, pipes and hookah tobacco and for which we’ve granted marketing orders covering over 350 products.
All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion. The FDA is committed to completing the review of the remaining products as quickly as possible to provide regulatory certainty and will continue to keep the public informed of our progress. In the meantime, products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities. If such products are not removed from the market, the agency intends to follow its usual enforcement practices in these circumstances and will issue a warning letter before initiating enforcement action (such as civil money penalties, seizure, or injunction) and afford the recipient an opportunity to respond. Since January 2021, we have issued a total of 170 warning letters to firms that collectively have listed more than 17 million ENDS with the FDA and that had not submitted premarket applications for these products. Among those warning letters, and in an effort to take action on products with a likelihood of youth use or initiation, the FDA issued a warning letter in July to a single company that did not submit an application and has more than 15 million products listed with the FDA.
Read the full article HERE.
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