IRVINE, CA / ACCESSWIRE / September 14, 2021 / Award-winning e-liquid and cannabinoid-infused products maker Savage Enterprises ("Savage") (www.SavageEnterprises.com), announced Savage's Premarket Tobacco Product Applications ("PMTA's") for the Company's best-selling e-liquids remain among the applications submitted to the U.S. Food and Drug Administration ("FDA") that have not received Marketing Denial Orders. Savage's PMTA's cost well into 7 figures and are among the most comprehensive PMTA's in the entire industry. We remain fully committed to regulatory compliance and youth access prevention. Under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA must approve PMTA's for "newly deemed tobacco products," including electronic nicotine delivery systems ("ENDS") such as e-cigarettes and e-liquids derived from tobacco, in order for the products to remain on the market. According to the FDA:
"A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. In order to reach such a decision and to authorize marketing, FDA considers, among other things:
- Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers;
- Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available;
- Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available; and
- The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product."
So far, the FDA has issued 168 Marketing Denial Orders for more than 992,000 flavored ENDS products. Savage Enterprises is proud to announce that we have already passed the FDA's filing review phase, and has entered the "Substantive Review" phase.
Savage Enterprises CEO, Chris Wheeler, states: "It's with a heavy heart that I am giving this quote. Some of my best friends are companies that have received MDOs, people that I call family. There are store owners that I watched build a small business of one store into a business of three or four stores. They put kids through college, bought houses, had new kids, took care of their parents, and did a lot of good. The best thing is providing people an alternative from tobacco that currently kills 480,000 people a year.
"I am, however, happy to report that our PMTA currently has not received an MDO on any SKUs. We are continuing to make big updates to FDA about our PMTA & provide what we believe to be the top 5% of PMTAs received. While I am happy that there may be a chance for marketing orders, there has to be more than one company approved. My hope is that an open vapor product gets approved to lead the way for other open vapor products. Our consultants, lawyers, internal employees feel that Savage Enterprises has a chance at being that company. Thanks to all our customers & consumers for using our products over the years, and we hope to continue to provide these products for years to come."
We will notify everyone involved with Savage on our PMTA status as we receive updates.
Contact: Brittany Warner
[email protected]
SOURCE: Savage Enterprises