DEA Fails It's Congressional Mandate To Facilitate FDA Marijuana Clinical Trials & Pharmaceutical Development For Suffering Patients
PROVIDENCE, RI / ACCESSWIRE / May 10, 2022 / Attorneys representing the MMJ biopharma conglomerate, a federal cannabis cultivation license applicant, filed a petition in federal court today, citing that the Drug Enforcement Agency (DEA) is taking too long to issue a determination for its application.
The company is further requesting 'declaratory and injunctive relief' as a result of the DEA's violation of the Administrative Procedures Act (APA) for the DEA's 'unreasonable delay in determining the outcome of its applications for registration for marihuana manufacturing and importing for it pending FDA sanctioned clinical trials.'
Yet this week the U.S. Food and Drug Administration( FDA) issued warning letters to dozens of companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act. This action is the first time the FDA has issued warning letters for products containing delta-8 THC. Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of CBD adverse events experienced by patients who have consumed these products, meanwhile the DEA drags its heals on legitimate scientific research to validate public health and safety.
Delta-8 THC is one of over 140 cannabinoids produced in the Cannabis plant that MMJ Biopharma Labs has studied in the lab. Concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects. Products containing delta-8-THC are available in varying forms, including but not limited to candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges (carts), dabs, shatter, smokable hemp sprayed with delta-8-THC extract, distillate, tinctures, and infused beverages.
Dr. Elio Mariani, CEO of MMJ BioPharma Cultivation stated'In addition to addressing the illegal marketing of delta-8 THC products as unapproved treatments for medical conditions or other therapeutic uses, the FDA officials said in their release that the warning letters also cite violations related to the misbranding of drugs-such as not including adequate directions for use-and the addition of delta-8 in food products. MMJ proceed according to federal law to substantiate our claims by results of eventual FDA approved clinical trials.
Duane Boise, President and Founder of MMJ BioPharma continued that' the DEA has been an impediment to the much needed scientific research to validate efficacy by FDA. Multiple Sclerosis and Huntington's disease clinical trials of the cannabis derivatives of our medicines are on hold. We have completed our manufacturing of our gelatin capsule pill only to be stonewalled by the DEA in our process.'
Tim Moynahan, chairman of MMJ further stated 'MMJ continues its process of scientific drug
development and discovery by FDA protocols for the development processes, developing our intellectual
property portfolio and following the DEA regulatory manufacturing guidelines.
SOURCE: MMJ International Holdings
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