ST PETERSBURG, FL / ACCESSWIRE / February 12, 2020 / President Tump's budget would remove protections for medical marijuana states and block Washington, D.C. from legalizing sales.The reason why the federal Government is opposed to the state to state federally illegal marijuana products is because "There is a significant gap in our understanding of their impact on health," Nora Volkow, Director of NIDA said. Furthermore, "The recent outbreaks of e-cigarette or vaping product use associated lung injury (EVALI), which has been linked to informally-sourced THC-containing vape products, underscores the critical importance of facilitating researcher access to different product sources."
Aligning with President Trump's mandate, MMJ International Holdings the premier medical research company, has filed it's Investigational New Drug (IND) applications with the FDA for it's proprietary formulation of THC & CBD. MMJ International Holdings (MMJ) will be initiating its clinical trials in Multiple Sclerosis (MS) and Huntington's Disease (HD) to prove safety and efficacy for patients.
MMJ has recently accomplished several major milestones, including the DEA's most recent approval for its THC and CBD international shipment to the United States for further development of its plant-derived cannabinoid drug. MMJ was also recently awarded FDA "Orphan Drug Designation" for its Huntington's proprietary drug formulation.
This MMJ Orphan Drug award by the FDA means that MMJ has demonstrated its promise for the diagnosis and/or treatment of rare diseases or conditions. Orphan designation qualifies MMJ International Holdings for various development incentives provided by the Orphan Drug Award, including tax credits for qualified clinical testing.
As stated by MMJ's CEO, Duane Boise, ″MMJ's Orphan Drug award is another milestone that the company has meet as we continue to set industry standards. MMJ has established a leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise″.
The FDA's ‘Assault' on others companies egregious CBD Claims
On March 28, 2019, when teamed with the FTC, the FDA issued warning letters to three CBD product sellers alleging false, unfounded, unsubstantiated and egregious health claims about their products' ability to limit, treat or cure without sufficient evidence or FDA approval and threatening product seizures, injunctions and sales proceeds reimbursement. The new budget would provide additional funding for the FDA to properly monitor more companies.
The FDA regulations clearly states that CBD is not generally recognized as safe and effective for these uses and, therefore, rendered "new drugs" under Section 201(p) of the FDA Act that are barred from being introduced into interstate commerce without prior FDA approval (which is solely provided on the basis of scientific data and information demonstrating that drug is safe and effective);
Furthermore the FDA states that misbranded CBD products under Section 502(f)(1) of the FDA Act for failing to bear adequate "intended use(s) directions" defined as "directions under which a layperson can use a drug safely and for the {intended} purposes" or as "prescription drugs" which "can only be used safely at the direction, and under the supervision, of a licensed practitioner"; and Intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without a licensed practitioner's supervision" and for which it is "impossible to write adequate directions for.
Tim Moynahan chairman of MMJ International Holdings stated, "We continue with the process of scientific drug development and discovery per the FDA protocol guidance, MMJ intellectual property portfolio development and DEA regulatory manufacturing guidelines.
Contact:
Michael Sharpe
561-627-9455
SOURCE: MMJ International Holdings