Rapid Therapeutic Science Files with FDA to Register Facility and Products
Dallas, TX – August 4, 2020 – Rapid Therapeutic Science Laboratories, Inc. (OTC: RTSL) an SEC fully-reporting, growth-oriented manufacturing and marketing company focused on employing FDA-approved Metered Dose Inhaler (MDI) technology to deliver aerosolized cannabinoids, such as CBD, CBG, and CBN, announces that it has formally engaged FDA Compliance Solutions, LLC to begin the initial FDA regulatory process of registering their new facilities and ultimately all products. FDA Compliance Solutions, LLC will act as RTSL’s agent through the entire registration process. FDA Compliance Solutions submitted RTSL’s initial filing required by the FDA in May 2020.
This registration process will establish the initial account and fulfill preliminary FDA compliance notification requirements by documenting current domestic manufacturing locations, and product offerings in the secure approved FDA electronic directory database for all products in commercial distribution in the United States. Registration will incorporate presentation of associated product advertising and labeling (exterior packaging, instructions for use, websites, and promotional materials).
Donal R. Schmidt, Jr., CEO states “We look forward to having our facilities and products fully registered. This will ensure our products adhere to the highest standards of safety and efficacy as required by the FDA for any type of medical product being sold in the US or abroad. Except for our cannabinoids, all our consumables and excipients are already listed in Drug Master Files (DMF) with the FDA. This is the first step in ultimately obtaining a fully compliant product in the anticipated regulatory environment related to cannabinoids. By seeking registration in conjunction with our new ISO 13485 manufacturing laboratory facility, we are leading the cannabinoid space in the standards that the rest of the medical world utilizes.”
This effort will lay the introductory groundwork for full implementation of cGMP (current Good Manufacturing Practices) operational control. These regulations have the force of law (Quality System Regulation – 21 CFR 820 – 06/01/97), with the primary intent of ensuring provision of safe, pure, and effective products. Rapid Therapeutics’ goal of delivering quality products, while safeguarding the health of our many consumers remains the highest priority.
About Rapid Therapeutic Science Laboratories, Inc. (OTC: RTSL)
RTSL has developed and perfected a new method of formulating and manufacturing pressurized metered dose inhalers (pMDI or MDI) that contain and properly aerosolize proprietary formulae consisting of one or more cannabinoid compounds, such as CBD, CBG, and/or CBN which may or may not be blended with or without terpenes). The Company’s RxoidTM product line is manufactured in compliance with GMP, on FDA approved equipment. Note that while non-THC cannabinoids such as CBD and CBG are not yet approved by the FDA, under the laws of Texas and of many other states, it is legal to consume, sell and export them to legal jurisdictions.
Properly formulated MDI deliver Active Pharmaceutical Ingredients (API) (drugs, nutraceuticals or bioceuticals) through the pulmonary tract. An MDI is generally the most efficient delivery method for an API other than an IV. In addition, MDI are less expensive than any other route of delivery, based on the net cost per bioactive mg as tested in blood serum levels. MDI are, however, expensive to formulate and difficult to manufacture to deliver cannabinoid compounds to the level required by the FDA and FTC truth in labelling laws. Ideally, a properly formulated, properly manufactured MDI containing cannabinoids will deliver the same dose on its first use as well as its 100th use.
RTSL’s MDI are a safe and technically superior replacement for vape pens because they use no heat, function perfectly without using dangerous ingredients, and deliver a 98% bioavailable dose of CBD and/or CBG or CBN directly to the systemic blood stream. This allows RTSL to address the current U.S. vape market, which is estimated to be $5 billion in annual sales.
RTSL markets its RxoidTM MDI products directly to pharmacies and physicians who treat GAD, PTSD and other stress and anxiety disorders as well as chronic pain and insomnia. RTSL’s MDI products also can be purchased by consumers online, at www.rxoid.com.
We encourage all individuals to do their own research regarding cannabinoids, the use of MDI and our products. RTSL makes no claims about therapeutic benefits of its products. None of our products are intended to diagnose, treat, cure, or prevent any disease. Always consult a physician prior to using any cannabinoid product. If you experience any adverse reaction stop use immediately and seek appropriate medical attention. RTSL’s products are not approved by the FDA or under the Food Drug & Cosmetics Act (FD&C Act).
Visit our corporate website at www.rtslco.com.
This press release may contain forward-looking statements. In particular, when used in the preceding discussion, the words “may,” “could,” “expect,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions are intended to identify forward-looking statements. Any statements made in this news release other than those of historical fact, about an action, event or development, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, which may cause the results of RTSL, its divisions and concepts to be materially different than those expressed or implied in such statements. These risk factors and others are included from time to time in filings made by RTSL with the Securities and Exchange Commission, including, but not limited to, in the “Risk Factors” sections in its Form 10-Ks and Form 10-Qs and in its Form 8-Ks, which we have filed, and file from time to time, with the U.S. Securities and Exchange Commission. These reports are available at www.sec.gov. Other unknown or unpredictable factors also could have material adverse effects on RTSL’s future results and/or could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements. The forward-looking statements included in this press release are made only as of the date hereof. RTSL cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. We undertake no obligation to update publicly any of these forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable laws. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.
Contact: Donal (Don) R. Schmidt, Jr. Chairman and CEO firstname.lastname@example.org
Source: Rapid Therapeutic Science Laboratories, Inc.