Savage Enterprises Notified by FDA That Savage’s PMTAs Have Entered the Substantive Review Phase
IRVINE, Calif. - July 6, 2021 - ( Newswire.com )
Award-winning e-liquid and cannabinoid-infused products maker Savage Enterprises (“Savage”) ( www.SavageEnterprises.com ) is pleased to announce that the U.S. Food & Drug Administration (“FDA”) wrote a letter to Savage dated July 1, 2021, informing Savage that the FDA has completed a preliminary review of Savage’s Premarket Tobacco Products Applications (“PMTAs”) and has determined that these applications meet the filing requirements for a new tobacco product seeking a marketing order under section 910(b) of the Federal Food, Drug and Cosmetic Act. As a result, the applications for the new tobacco products are filed, effective as of July 1, 2021. The decision to file these PMTAs does not mean that the FDA evaluated the adequacy of the data submitted or issued an authorization order. Rather, it represents a decision by the Center for Tobacco Products that the applications are sufficiently complete to enter the substantive review phase. The FDA’s filing review is only a preliminary evaluation of the applications and not indicative of deficiencies that may be identified during a substantive review.
Savage began the work related to submitting its PMTAs in 2016, and submitted its PMTAs for its Vape 100 e-liquid lines on Sept. 8, 2020. This year, through a third-party lab, Savage completed its stability (shelf life) testing and expects to soon have the results of its Harmful and Potentially Harmful Constituents (“HPHC”) testing from its third-party testing lab. Savage is currently in the process of selecting an organization to lead its behavioral testing efforts.
Matt Winters, CFO of Savage Enterprises, commented, “We are very pleased with the current review of our PMTAs. It is our expectation that the process will continue and that our products will be evaluated according to FDA guidelines. As we move further along this process, we expect to engage with the FDA more closely, and we are excited by the chance to work with the FDA while we continue to make our high-quality e-liquid products. Our quality and compliance team members are very pleased with our progress and we hope to have more good news as time goes on as we proceed through each phase of the process.”
If Savage’s PMTAs are eventually approved, Savage will be able to legally market and sell its e-liquid, which could be big news for Savage: according to Grand View Research, “The U.S. e-cigarette & vape market size was valued at $6.09 billion in 2020. It is expected to expand at a compound annual growth rate of 27.3% from 2021 to 2028.”
Christopher G. Wheeler, President and CEO of Savage Enterprises, commented, “I am excited to see our PMTAs progress to the next stage. We are working diligently to meet all of the FDA’s requests and requirements for the FDA’s acceptance of our PMTAs. All of our meetings with the FDA have been positive and we hope to see our products become one of the first to have a market authorization from the FDA. With a rapidly growing industry like ours, it is so important to have testing, manufacturing and everything in between be that of the highest caliber, and we’re happy to be walking the walk here.”
Lead outside consultant Matthew Salter of Vape Rescue LLC commented, “It’s no surprise that Savage’s application has entered the substantiative review phase. We drew from many different resources both inside and outside of the industry to make the application as robust and complete as possible. With the stability testing coming back clean and strong, and our expectation of the same positive results for HPHC testing, we are confident that Savage will be among the few to cross the finish line.”
The update on Savage’s PMTAs follows Savage’s press release that it has signed a letter of intent to merge with publicly traded Acquired Sales Corp. (OTCQX: AQSP ) for aggregate merger consideration of $44 million, consisting of $15,840,000 in cash plus 8,691,358 shares of AQSP’s unregistered common stock. Closing of the transaction is subject to a number of conditions, including but not limited to completion of an acceptable due diligence investigation and audit of Savage, Premier Greens and MKRC, completion of a capital raise of at least $30 million by AQSP, execution of definitive acquisition documents, receipt of a tax opinion on the Savage merger, obtaining all necessary approvals, and the completion of all necessary securities filings.
About Savage Enterprises
Based in Irvine, California, Savage Enterprises was founded in 2014 by co-owners Christopher G. Wheeler and Matt Winters with the vision of bringing innovation to the counter-culture space. Savage has been committed to improving the community it serves by providing superior, consumer-centered and cost-effective products that are third-party lab tested with quality assurance, consistency, and traceability. Savage’s goal is to create the benchmark for quality and assurance in the industry. Under its Delta Effex brand ( www.DeltaEffex.com ), Savage sells delta-10-THC cartridges, disposables and tinctures, delta-8-THC-infused shots, cartridges, concentrates, disposables, edibles, delta-8-THC-infused hemp flower, pods and tinctures. Under Savage CBD ( www.SavageCBD.com ), Savage sells CBD cartridges, disposables, edibles, tinctures, topicals, vape juice and CBD for pets. Under its Vape 100 brand, Savage produces nicotine-infused e-liquids. Under its Zen Panda brand, Savage sells various kratom and kava-based products. Savage also sells disposable nicotine vapes. The team at Savage is currently developing at least three other products in the supplement arena, as well as innovative apparatuses for marijuana consumption.
Savage Enterprises has a 50% membership interest in LftdXSvg, which plans to sell hemp-derived products containing THCV. Savage Enterprises also owns 46% of MKRC, 51% of RJMC Brands, LLC, 6% of AAA, LLC, and 33% of Remediez. For more information about Savage Enterprises, please visit www.SavageEnterprises.com.
About Acquired Sales Corp.
Acquired Sales Corp. (OTCQX ticker symbol AQSP ) is focused upon investing in rapidly growing companies that make hemp-derived, cannabinoid-infused products such beverages, lotions, oils, dabs, saucy dmnds, flower, cartridges, disposable vapes, hemp cigarettes, tinctures, bath bombs, balms, body washes, and gummies. In February 2020, AQSP acquired 100% of Warrender Enterprise Inc. d/b/a Lifted Made (formerly d/b/a Lifted Liquids) ( www.LiftedMade.com ), now located in Kenosha, Wisconsin. Lifted Made’s Urb Finest Flowers brand of hemp-derived delta-8-THC and CBD products is rapidly growing and is nationally recognized. Lifted Made has a 50% membership interest in SmplyLifted LLC, which sells tobacco-free nicotine pouches under the brand name FR3SH ( www.GETFR3SH.com ), and a 50% membership interest in LftdXSvg LLC, which plans to sell hemp-derived products containing THCV. AQSP also owns 4.99% of CBD-infused beverage and products maker Ablis Holding Company ( www.AblisBev.com ), and of craft distillers Bendistillery Inc. d/b/a Crater Lake Spirits ( www.CraterLakeSpirits.com ) and Bend Spirits, Inc. ( www.Bendistillery.com ), all located in Bend, Oregon. Please read AQSP’s filings with the U.S. SEC which fully describe AQSP’s business and the Risk Factors associated therewith. Learn more by subscribing to AQSP’s newsletters at www.LiftedMade.com and www.AcquiredSalesCorp.com.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this document are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such information includes the growth and profitability strategies, and future products and plans of Savage Enterprises, Premier Greens LLC, MKRC LLC, SmplyLifted LLC, LftdXSvg LLC, Lifted Made and Acquired Sales Corp. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors which may cause or contribute to the actual results of these companies’ operations or the performance or achievements of these companies differing materially from those expressed or implied by the forward-looking statements. These companies undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Actual results, performance or achievements could differ materially from those anticipated in such forward-looking statements as a result of certain other factors, including the risk factors set forth in Acquired Sales Corp.’s filings with the Securities and Exchange Commission.
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