Month: January 2019

Study: CBD May Help Treat Alcohol Use Disorder

Study: CBD May Help Treat Alcohol Use Disorder

Posted by | Jan 31, 2019 | |

Cannabidiol shows promise as a potential treatment option for alcohol use disorder, according to a new study published by the journal Alcoholism: Clinical and Experimental Research, and epublished by the U.S. National Institute of Health.

“There is substantial interest in the therapeutic potential of cannabidiol (CBD), a non-psychoactive cannabinoid found in plants of the genus Cannabis”, begins the abstract of the study. “The goal of the current systematic review was to characterize the existing literature on this topic and to evaluate the credibility of CBD as a candidate pharmacotherapy for alcohol use disorder (AUD).”

Using a comprehensive search strategy, “303 unique potential articles were identified and 12 ultimately met criteria for inclusion (8 using rodent models, 3 using healthy adult volunteers, and 1 using cell culture).” In both rodent and cell culture models, “CBD was found to exert a neuroprotective effect against adverse alcohol consequences on the hippocampus.” In rodent models, “CBD was found to attenuate alcohol-induced hepatotoxicity, specifically, alcohol-induced steatosis.”

Finally, “findings from preclinical rodent models also indicate that CBD attenuates cue-elicited and stress-elicited alcohol-seeking, alcohol self-administration, withdrawal-induced convulsions, and impulsive discounting of delayed rewards.”

In human studies, “CBD was well tolerated and did not interact with the subjective effects of alcohol. ” Researchers state that “Collectively, given its favorable effects on alcohol-related harms and addiction phenotypes in preclinical models, CBD appears to have promise as a candidate AUD pharmacotherapy. This is further bolstered by the absence of abuse liability and its general tolerability.”

The study concludes by stating that “Human preclinical and clinical studies are needed to determine whether these positive effects in model systems substantively translate into clinically-relevant outcomes.”

More information on this study can be found by clicking here.

The post Study: CBD May Help Treat Alcohol Use Disorder appeared first on TheJointBlog.

Read More
Senators Push for Updates to FDA Regulation of CBD Food Products and Dietary Supplements

Senators Push for Updates to FDA Regulation of CBD Food Products and Dietary Supplements

Posted by | Jan 31, 2019 | |

With the passage of the 2018 Farm Bill and the proliferation of food products containing CBD, we’ve been writing extensively about how the United States Food and Drug Administration (FDA) and in particular, the United States Food, Drug, and Cosmetic Act (FDCA) apply to the interstate sale of CBD products. Unfortunately, however, we have little guidance from the FDA regarding how hemp-CBD products such as foods, beverages, dietary supplements and cosmetics should comply with basic FDA requirements, including labeling rules.

What we do know is that the FDA has consistently taken the position that that CBD is excluded from the definition of “dietary supplement” under the Federal Food, Drug & Cosmetic Act (“FDCA”) because CBD is an active ingredient in FDA-approved drugs and was the subject of substantial clinical investigations before it was marketed as a dietary supplement. Therefore, the FDA maintains, as stated by Commissioner Scott Gottlieb, that:

[It is] unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.”

On January 15, 2019, in light of the FDA’s current position on hemp-derived CBD and the recent passage of the 2018 Farm Bill, Senators Ron Wyden (D-OR) and Jeff Merkely (D-OR) sent a letter to FDA Commissioner Gottlieb urging the Commissioner to update federal regulations governing the use of certain hemp-derived ingredients in food, beverages, and dietary supplements. The Senators began their letter by stating,

As authors of the Hemp Farming Act, which removed the outdated restrictions on the production and marketing of industrial hemp, we urge the U.S. Food and Drug Administration (FDA) to immediately update federal regulations governing the use of certain hemp-derived ingredients in food, beverages or dietary supplements.”

The Senators go on to note that the Act removed from the federal list of controlled substances the hemp plant, and “derivatives of cannabis, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol (THC) concentration of less than 0.3 percent on a dry weight basis. Under this definition, Congress legalized the production and sale of industrial hemp and hemp derivatives, including hemp-derived cannabidiol (CBD).”

Because of the removal of hemp-derived CBD from the list of controlled substances, as well as growing interest from the public in CBD products, the Senators argue that the FDA’s regulations are outdated, and urge the agency to “immediately begin updating regulations for hemp-derived CBD and other hemp-derived cannabinoids, and [to] give U.S. producers more flexibility in the production, consumption, and sale of hemp products.” The Senators also requested a response from the FDA to the following questions within thirty days:

  1. What steps are the agency advancing to clarify to the public the authority the agency has in the production and marketing of hemp, specifically Cannabis sativa L. and its derivatives?
  2. What lawful pathways are currently available for those who seek approval to introduce Cannabis sativa L. and its derivatives as a food, beverages or dietary supplement, including into interstate commerce?
  3. Are there circumstances in which Cannabis sativa L. and its derivatives may be permitted as a food, beverages or dietary supplement by the agency?
  4. Will the agency consider issuing a regulation, or pursuing a process, that would allow Cannabis sativa L. and its derivatives in food, beverages or dietary supplements that cross state lines?

Given the ongoing government shutdown that has left the FDA short on staff, we will be waiting to see if they are able to respond to the Senators’ questions within the requested thirty days. There is no doubt that thorough responses to these questions would provide the hemp-CBD industry with some much needed clarity regarding the FDA’s position on the sale of these products.

Read More
Report: Federal Marijuana Legalization Would Create $86 Billion in New Tax Revenue by 2025

Report: Federal Marijuana Legalization Would Create $86 Billion in New Tax Revenue by 2025

Posted by | Jan 30, 2019 | |

New Frontier Data, which claims to be “the authority in data analytics and business intelligence on the global cannabis industry”, today announced new economic data detailing the potential impact of federal cannabis legalization in the United States.

The federal legalization of medical and adult-use cannabis would create $86 billion in additional U.S. tax revenue between 2019 and 2025 and a $56 billion annual U.S. cannabis market by 2025, states the report. The New Frontier Data State of the Cannabis Union 2019 is now available for free download at the following link: https://newfrontierdata.com/SOTCU.

These findings, as well as comments by Congressman Earl Blumenauer (D-Ore.) and Congressman Lou Correa (D-Calif.) and insights from the world’s first cannabis testing lab Steep Hill and Top 10 U.S. tax firm CohnReznick, were presented during a briefing hosted by New Frontier Data in collaboration with The Liaison Group, a federal advocacy group working with federal lawmakers towards a safe and thriving cannabis economy.

Currently, 33 U.S. states have enacted legal state cannabis programs. Another 14 have approved CBD use, while support among other U.S. states continues to grow.

“Cannabis legalization and decriminalization has not only occurred in nearly 60% of the United States; it is now being explored or adopted in over 60 nations around the world. Our data shows full federal legalization, specifically in the U.S., will drive material gains across key economic sectors, including federal revenue generation, national job creation, and reduced government healthcare spending and crime rates,” said Giadha Aguirre de Carcer, Founder and CEO of New Frontier Data. “Our ultimate goal is to provide U.S. Congress objective and comprehensive intelligence on the potential socio-economic impact of federal cannabis legalization as its members enter into this delicate debate.”

“A changing political tide for advancing cannabis policy is progressing through Congress. More and more Members in both chambers and on both sides of the aisle are recognizing and acknowledging the country’s will for a regulated cannabis marketplace – and that a majority of Americans clearly support respecting states and protecting patients,” added Saphira Galoob, Principal and CEO of The Liaison Group.

New Frontier Data announced the following projections and updated findings:

  • There are an estimated 272 million cannabis consumers globally, equivalent to 4% of the world‘s population
  • These consumers collectively spend approximately $356 billion each year on cannabis across legal and illicit markets
  • In the United States, over 24 million, or 9.9% of adults age 18+ consume cannabis regularly, and 115 million (48.2%) report consuming it in their lifetimes
  • In states where cannabis is currently legal, medical and adult use sales are forecast to grow from $12.9 billion in 2019 to $26.3 billion in 2025
  • Federal legalization would create $86 billion in U.S. tax revenue between 2019 and 2025 on $253 billion in sales over that period
  • Government pain medication spending drops 11% in U.S. medical cannabis markets vs. non-legal markets
  • There were 2.4 million U.S. medical marijuana patients in 2018, up 71% from 2014
  • The U.S. hemp market is projected to grow to $5.7 billion annually by 2020
  • Legal cannabis supported 259,000 plant-touching jobs in 2018

The post Report: Federal Marijuana Legalization Would Create $86 Billion in New Tax Revenue by 2025 appeared first on TheJointBlog.

Read More