Medical Marijuana, Inc Subsidiary HempMeds Brasil Sponsors Autism Event At Rice University In Houston

 CALIFORNIA: Medical Marijuana, Inc., the first-ever publicly traded cannabis company in the United States that launched the world’s first-ever cannabis-derived nutraceutical products, brands and supply chain, announced today that its subsidiary HempMeds Brasil, in partnership with the Consulate General of Brazil in Houston, sponsored “Autism Together We Are Stronger” at Rice University on February 22.

“We see events like this one as prime opportunities to educate people on what cannabidiol, or CBD, is and its potential benefits,” said HempMeds® Brasil Vice President Caroline Heinz. “CBD can be legally imported in Brazil and is even subsidized by the Brazilian government for many indications including autism. We want to do everything we can to help bring awareness to current research that is being conducted on how CBD can be used by people around the world.”

In addition to sponsoring the event, HempMeds® Brasil shared the event stage with two researchers who the Company has worked with frequently in the past, Dr. Alysson Muotri, Professor at the School of Medicine, University of California in San Diego, and Dr. Abram Topczewski, Neuropediatrician and Enuresis Clinic Director at the Albert Einstein Hospital.

“Education is the most important thing when it comes to helping the world become more accepting of cannabis and its compounds,” said Medical Marijuana, Inc. CEO Dr. Stuart Titus. “We’re proud to be able to sponsor events like these and work with such prestigious doctors such as Dr. Muotri and Dr. Topczewski to help further medical research around the world.”

FDA, FTC Warn Company Marketing Unapproved Cannabidiol Products With Unsubstantiated Claims

FDA is also working quickly to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD

DISTRICT OF COLUMBIA: The U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases.

“Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance. We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children,” said Acting FDA Commissioner Ned Sharpless, M.D. “We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements. As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority. We appreciate the FTC joining us on these and other actions to protect consumers from fraudulent CBD products.”

As described in the warning letter issued to Rooted Apothecary, the company used product webpages, through its online store and social media websites, to make unfounded claims about its CBD products, and some of the products were also unlawfully marketed as dietary supplements. The agency has determined that CBD products cannot be marketed as dietary supplements.

Examples of the unsupported claims made by the company include:

  • “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
  • “No matter what age, ear aches are a terrible, no good way to live each day! Our main priority was safety, effectiveness . . . as we formulated this for the entire family including our precious little ones. When the pain is bad, this roller goes to work for soothing pain, inflammation, and to battle against the bacterial/viral critters to blame.”
  • “Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive and safe option for children.”
  • “CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson’s and Alzheimer’s disease.”
  • “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”

Additionally, under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. The FTC is concerned that one or more of the efficacy claims cited may not be substantiated by competent and reliable scientific evidence. These products are also misbranded under the Federal Food, Drug, and Cosmetic (FD&C) Act, because the products’ labels and product information fail to include adequate directions for use. Drugs in the United States must contain directions explaining how a consumer can use a drug safely for its intended purpose. Under the law, there is an exemption for this labeling requirement for prescription drugs that have FDA-approved applications in effect. However, none of Rooted Apothecary’s products are FDA-approved.

The FDA and FTC have requested responses from Rooted Apothecary within 15 working days stating how the company will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or administrative cease and desist order, and an order also may require that a company pay back money to consumers.

The FDA continues to be concerned about the proliferation of products claiming to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the agency. The FDA approval process ensures that drugs on the market are safe and effective for their intended therapeutic uses. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas and topical lotions and creams. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.

The FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products while maintaining the FDA’s rigorous public health standards.

“The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products. We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence.”

Unlike drugs approved by the FDA, the manufacturing process of unapproved CBD products has not been subject to FDA review as part of the drug approval process. Further, there has been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage is, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. Consumers may put off getting important medical care, such as proper diagnosis, treatment and supportive care due to unsubstantiated claims associated with CBD products. For that reason, it’s important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options.

The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

Study: CBD-Dominant Cannabis Oil Safe And Effective In Autistic Patients

ISRAEL: The administration of plant-derived cannabis extracts is effective and well-tolerated in patients diagnosed with autism spectrum disorders (ASD), according to data published in the journal Scientific Reports.

Israeli investigators assessed the safety and efficacy of the daily administration of CBD-enriched cannabis oil (consisting of 30 percent CBD and 1.5 percent THC) in a cohort of 188 patients with ASD. Of those patients who continued treatment for six months and provided feedback to researchers, over 90 percent reported some level of symptomatic improvement — including reductions in restlessness, seizures, and rage attacks. Approximately one-third of respondents reported a reduction in their intake of other medications.

Authors concluded: “Cannabis as a treatment for autism spectrum disorders patients appears to be well-tolerated, safe and seemingly effective option to relieve symptoms, mainly: seizures, tics, depression, restlessness and rage attacks. … [W]e believe that double blind placebo-controlled trials are crucial for a better understanding of the cannabis effect on ASD patients.”

The results are consistent with those of a prior Israeli study which concluded that the daily administration of CBD-dominant extracts was associated with “overall improvement in behavior, anxiety, and communication” in autism patients.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Real life experience of medical cannabis treatment in autism: Analysis of safety and efficacy,” appears in Scientific Reports.

 

New Study: Children With Autism See Improvement After Treatment With Tikun Olam High-CBD, Low-THC Medical Cannabis

NEW YORK: Children with Autism Spectrum Disorder (ASD) see a “significant” improvement in symptoms and less reliance on other medications after treatment with Tikun Olam’s Avidekel™ medical cannabis, as confirmed by a new study published in Scientific Reports.

The two-year study, “Real Life Experience Of Medical Cannabis Treatment In Autism: Analysis Of Safety And Efficacy,” followed 188 children (average age: 13) diagnosed with ASD. The patients were treated with Tikun Olam’s high-CBD, low-THC medical cannabis strains, which have been specifically cultivated and shown to provide symptom relief for ASD and related conditions with minimal psychoactive effect.

At the study’s outset, the most common patient symptoms were restlessness (90.4%), rage attacks (79.8%), and agitation (78.7%). After six months of daily cannabis treatment at Tikun Olam clinics in Israel, 80.1% of patients reported improvement of their symptoms, with 30.1% reporting “significant” improvement. Other key findings include:

  • Of 27 patients who had epilepsy, 24 reported improved or disappearance of symptoms;
  • 34% of patients decreased other medications; and
  • 20% of patients stopped using antipsychotic medication.

“Autism is a leading condition of concern worldwide, so this study couldn’t have come at a better time,” says Dr. Annabelle Manalo, PhD, Tikun Olam’s Science Director. “The data shows that autism patients can improve their overall quality of life utilizing a high CBD strain, and most importantly, that young users can safely and effectively benefit from medical cannabis.”

“With this study, cannabis is shown to be an effective choice for parents looking for the safest and most neuroprotective treatment.”

Side effects to cannabis treatment were minimal, with the most common at six months reported as restlessness (6.6%), sleepiness (3.2%), psychoactive effect (3.2%).

Study: CBD-Rich Cannabis Mitigates Symptoms In Children With Autism Spectrum Disorder

ISRAEL: The daily administration of CBD-dominant cannabis extracts is associated with improved outcomes in adolescents with autism spectrum disorder (ASD) and severe behavioral problems, according to clinical data published in the Journal of Autism and Developmental Disorders.

Israeli researchers assessed the efficacy of whole-plant cannabis extracts in a cohort of children with ASD. Participants were administered extracts containing a 20 to 1 ratio of CBD to THC for periods of 7 to 13 months.

Patients demonstrated “overall improvement in behavior, anxiety, and communication” following daily cannabis dosing. Just over half of the participants either reduced or ceased taking prescription medications during the trial period.

Authors concluded: “Following the cannabis treatment, behavioral outbreaks were much improved or very much improved in 61% of patients. … [T]he results of the current study render worthwhile further exploration of this treatment avenue in controlled studies.”


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Cannabidiol-rich cannabis in children with autism spectrum disorder and severe behavioral problems – A retrospective feasibility study,” appears the Journal of Autism and Developmental Disorders.

 

Study: CBD Therapy Improves Autistic Symptoms

ISRAEL: The adjunctive use of high CBD oral extracts is associated with improvements in symptom management in children with autism-related behavioral issues, according to clinical data published online ahead of print in the journal Neurology.

Israeli researchers assessed the use of oral extracts containing a 20 to 1 ratio of CBD to THC in 60 adolescents with autism spectrum disorder.

Following treatment, behavioral outbreaks were “much improved or very much improved in 61 percent of patients.” Nearly half of all patients reported improvement in anxiety and in their communication skills, while 29 percent reported a decrease in disruptive behaviors.

Authors concluded, “This preliminary study supports the feasibility of CBD-based medical cannabis as a promising treatment option for refractory behavioral problems in children with ASD.”


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Cannabis-based medical cannabis in children with autism – A retrospective feasibility study,” appears in Neurology.

Austin City Council To Consider Resolution Regarding Medical Marijuana

TEXAS:  This week the Austin City Council will consider a resolution supporting medical marijuana in Texas.

Two council members are sponsoring the resolution, and an Austin mother says she’ll be watching this item closely.

Shaded from the hot Texas sun, 9-year-old Lance enjoys a popsicle with his twin sister. The peaceful scene doesn’t show his struggle to speak or his problems with sleeping and aggression.

Lance is autistic.

Lance’s mother, Thalia Michelle, believes medical cannabis could help her son. “It could help with his hyperactivity, cognition, focus [and] even speech,” she said. “This isn’t just about smoking for nausea and pain anymore.”