Tag: cannabis

U.S. Representative Demands FDA Hand Over CBD Data
Credit: Anankkml
The chairman of a congressional committee is demanding that the U.S. Food and Drug Administration turn over documents relating to the agency’s decision not to regulate CBD products.
Rep. James Comer, chair of the House Oversight and Accountability Committee, sent a letter to FDA Commissioner Robert Califf on Monday, announcing an investigation into the agency’s decision and criticizing the “insufficient rationale for inaction” on CBD regulations.
The agency said in January that, after years of review since hemp and its derivatives like CBD were legalized under the 2018 Farm Bill, it determined that there is not a regulatory pathway in place to enact rules allowing the non-intoxicating cannabinoid to be marketed as a food item or dietary supplement.
It said that congressional action is required to develop CBD regulations, according to Marijuana Moment.
Prior to that announcement, Comer had pledged to confront FDA over the lack of regulations for cannabidiol in his capacity as Oversight Committee chairman.
“CBD is an increasingly popular product among adults and has seen an uptick in usage in recent years,” the letter to Califf says, adding that the World Health Organization (WHO) has found CBD to be generally safe and well-tolerated.
The chairman listed “documents and information” that he’s asking FDA to provide to the committee by May 1:
All documents, communications, and drafts related to the January 26 announcement titled “FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward.”
All documents and communications relating to the FDA’s assessment of the existing regulatory framework at issue regarding CBD.
All scientific data, reports, and research in the possession of the FDA relating to the safety of CBD products for consumption.
Congressional lawmakers in the U.S. have refiled a pair of bills meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.
April 18, 2023
Hong Kong Makes First CBD Arrest Since Start of Ban
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Customs officers have made Hong Kong’s first arrest over cannabidiol (CBD) products after taking a clubhouse worker into custody when he showed up to collect a parcel from Denmark containing two bottles of the recently banned oil.
Officers found two more used bottles of the same CBD skin oil and four grams of cannabis buds from the man’s locker at the clubhouse of a residence in Yau Ma Tei on Wednesday, according to SCMP.
Combined with the banned CBD product, the haul was worth about HK$5,000 ($637).
The case was the first such arrest and seizure since CBD was added to the Dangerous Drug Ordinance, according to Isaac Tsang Yau-chuen, a senior investigator from the customs airport investigation division.
February 8, 2023
Dolly Parton Denies Any Affiliation With CBD Sales

Credit: Joe Hendrickson
Dolly Parton said in a statement that she does not sell Keto oils or CBD gummies that promise to prevent dementia.
The artist and amusement park owner made the announcement via her social media channels yesterday, after rumors claimed she was endorsing these products (realistic-looking ads were posted online, featuring photos of the singer). However, Snopes fact-checked the claims and reported them to be false and “fictional” — and now the Country music superstar has confirmed it.
“Dolly Parton is not affiliated with, has not endorsed and is not associated with any keto or CBD gummy product,” reads her Instagram statement. “She’s more the cake, cookie, and cornbread type.”
The false ads tried to direct readers to buy products like Supreme CBD Gummies, Jolly Nutrition CBD Gummies, and Proper CBD Gummies, according to Yahoo.
February 5, 2023
U.S. FDA to Seek Congress’ Help in CBD Regulations
“FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward”
The U.S. Food and Drug Administration has concluded that a new regulatory pathway for cannabidiol (CBD) is needed. The regulatory agency states it will seek guidance from the U.S. Congress. The new rules would need to balance individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks, according to a press release.
The FDA is also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.
“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” the release states. “Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”
FDA Principal Deputy Commissioner Janet Woodcock stated that a working group she chaired on the subject of CBD regulations closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency.
“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” she stated. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.
“CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.”
Woodcock said the FDA will continue to take action against CBD and other cannabis-derived products to “protect the public, in coordination with state regulatory partners,” when appropriate.
The U.S. House Oversight Committee plans to grill U.S. Food and Drug Administration Commissioner Robert Califf about why the agency still hasn’t developed CBD regulations.
The FDA has said it is planning to release CBD guidance this year.
January 26, 2023
FDA Issues Final Guidance on Clinical Cannabis Research
Credit: Nocturnal
The U.S. Food and Drug Administration today issued the final guidance on clinical cannabis research. The “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry” guidance provides the agency’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis and cannabis-derived compounds, according to a press release.
FDA considered comments received on the draft guidance, issued in July 2020, as the agency worked to finalize the suggested rules. Changes from the draft to the final guidance include clarifying sources of cannabis for clinical research (including Schedule I sources), adding resources explaining expectations for investigational new drug (IND) applications in various stages of drug development, and providing guidance on quality considerations for INDs.
The final guidance also:

Lists applicable United States Pharmacopeia chapters on quality testing, including the assessment of leachables from packaging and delivery systems.

Identifies relevant International Council for Harmonisation guidelines, FDA guidances, and considerations for devices used in combination with a drug.

Addresses the calculation of delta-9 THC content, which is relevant to determine control status for cannabis and cannabis-derived compounds.
“It is critical FDA continues to support robust scientific research needed to develop new drugs from cannabis,” the release states. “FDA believes the drug development and approval process represents the best way to ensure that safe, effective, and high-quality new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy.”
Earlier this month, The FDA said it is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements.
January 23, 2023
U.S. House Oversight Committee to Grill FDA on CBD

Credit: Dogora Sun
The U.S. House Oversight Committee plans to grill U.S. Food and Drug Administration Commissioner Robert Califf about why the agency still hasn’t developed CBD regulations.
The FDA has said it is planning to release CBD guidance this year.
Rep. James Comer, chair of the Oversight Committee, said during an interview with the U.S. Hemp Roundtable advocacy group that his panel wants to ask Califf about the FDA’s “lack of action” on issues including hemp-derived CBD that fall under the agency’s regulatory jurisdiction, according to MJBiz Daily.
“I want to bring the FDA commissioner in front of the committee, and this is one of the things that we want to talk about,” Comer, a Republican from Kentucky, told the U.S. Hemp Roundtable.
“It’s not just their lack of action with respect to CBD and other types of hemp – it’s their inaction regarding a lot of areas of their jurisdiction.”
Comer said he believes the FDA’s focus on Covid-19 and vaccines might have prevented the agency from addressing other issues.
According to Hemp Today, the FDA has focused on enforcement rather than clarifying what the rules are.
In March, for example, the FDA and Federal Trade Commission sent letters to several CBD companies warning them about making health claims related to Covid-19.
January 23, 2023
California: West Hollywood Apartment Vape Ban to Begin
Credit: Walter Cicchetti
Renters West Hollywood (WeHo), California, will soon be banned from using e-cigarettes inside their apartment. The ordinance also includes the patio or balcony.
A new section of the WeHo municipal code goes into effect Jan. 1 that prohibits smoking in “existing units” in multi-family dwellings, which basically means most apartments and duplex rentals.
The city defines “smoking” as cigarettes, cannabis and tobacco vapes, and other products made from tobacco and/or nicotine, such as heat-not-burn products and hookah, according to media reports.
Those caught breaking the new rule are subject to a fine ranging from $100 to $500. However, violations can not be grounds for eviction or imprisonment.
Using cannabis vapes remains legal if for medical purposes. “The City Council further finds that, in the interest of the public health and welfare, imposing restrictions on smoking or vaping cannabis in the privacy of one’ s residence is not warranted for tenants that consume cannabis for medicinal, therapeutic or recreational purposes,” the council stated. “State law does not allow cannabis smoking in public places and prohibiting cannabis consumption in private units would not leave available safe alternatives.”
December 27, 2022
Global Hemp Market May Reach $18.6 Billion by 2027
Photo: Kaylen Settles
The global hemp market could reach $18.6 billion by 2027 if nations around the world take action to clarify the crop’s legal status and address other key issues, according to an extensive report on the industry from the United Nations Conference on Trade & Development (UNCTAD).
Citing figures from researcher Krungsri Research Intelligence, a part of Bangkok-based Bank of Ayudhya, the report suggests the next five years could see the market value of hemp quadruple from the estimated $4.7 billion recorded in 2020, as reported by Hemp Today.
The UNCTAD report addresses:
Information: More transparency is needed for the hemp industry, including public data about production of hemp across all outputs, country-specific data, and pricing, the report’s authors advise.
“At the international level, there is a clear need to improve availability and accessibility of information. Efforts should be devoted to improving the current state of information about all aspects of this commodity.
“Additional categories need to be included to cover, for instance, hemp seeds, hemp seed oil, hemp seed products, hemp oleoresins and essential oils,” according to the report.
Sustainability: The report also suggests that environmental and social considerations are “core to the success of any hemp-related policy” and therefore should be taken into account in broader legal and regulatory frameworks.
“In order to ensure a sustainable hemp sector globally hemp farming can offer environmental benefits that can be considered in policies aimed at mitigating the effects of climate change and restoring healthy ecosystems,” the report observes.
As hemp cultivation can help to maximize the use of land, it may also contribute to increasing the incomes of farmers and rural communities, especially in developing countries, the report notes.
Industrial strategy: A whole-plant strategy for hemp should be considered in most parts of the world, UNCTAD recommends, noting “this is all the more desirable because of the still relatively small size of hemp markets and the economic constraints inherent in such markets.”
A whole-plant approach can mean business in both primary and secondary markets, and hemp farming could be further monetized by integrating carbon credit schemes on a voluntary basis, the paper also observes.
The 84-page report defines the steps that governments can take to capitalize on hemp for its economic and social potential, gives an overview of industrial hemp by output categories, and shows how those hemp subsector derivatives are reflected in trade statistics.
“Hemp value chains can boost growth in rural areas and contribute to both manufacturing and food-processing industries. However, to fully exploit such potentialities, countries may have to take specific actions,” according to the report, which marks the first time an international intergovernmental body has issued a paper promoting the use of industrial hemp.
The report also addresses the legal issues surrounding hemp. Clarifying the legal status of hemp as a non-intoxicant is the first step governments need to take in order to minimize legal and financial risks for producers, the report observes.
“Cultivation of non-intoxicant C. Sativa L. cultivars should be permitted in all countries even though it may require strict governmental control. Moreover, an approach favoring THC threshold in final products, rather than in the field, should be adopted to incentivize a whole-plant approach and uses,” the report says.
Alternatively, increased THC thresholds for crops “on the field” up to levels scientifically recognized as non-intoxicant could be put in place by lawmakers. “This would allow increasing the pool of varieties useable in hemp production chains, thus de facto increasing the possibility to cultivate cultivars best adapted to specific environmental conditions and characteristics,” according to the report.
Other production constraints imposed by regulatory frameworks also must be identified, and strategies should be developed for regional cooperation to establish viable and sustainable value chains, the report also suggests.
December 11, 2022
Costa Rica Authorizes Country’s First Hemp Farm

Credit: Gian
Costa Rica has for the first time has given an agricultural conglomerate authorization to grow and process hemp under a recently signed resolution from the country’s agriculture ministry.
Ingenio Taboga SA, a farming and food company, said it plans to plant hemp and build a processing factory on a 150-acre site.
Taboga, based in Bebedero de Cañas, Guanacaste, lists products in alcohol-based sanitizers, specialty sugars, natural sweeteners, protein powders and CBD on its website, according to Hemp Today.
“For the Ministry of Agriculture and Livestock, the development of responsible and efficient agricultural activities with significant agro-export potential is extremely important,” said Agriculture Minister Víctor Carvajal, adding that seven hemp more projects are being considered for authorization, with approval expected soon.
Under rules approved by agriculture and health officials in September, hemp farming and production licenses are intended to be inexpensive and widely available in Costa Rica. Individuals and legal entities can be authorized to grow and process hemp, and rules are set for post-harvesting, storing, transporting, product manufacturing, marketing, importing and export of health, food and industrial products.
Costa Rica’s rules set the limit for THC in hemp plants at 1.0 percent. Most countries follow a generally accepted limit of 0.3 percent THC as the dividing line between hemp and marijuana.
Industry advocates in Costa Rica say establishing a robust hemp sector can spark development of agricultural value chains by bringing economic and social opportunities to the country’s rural areas, and contribute to the growth of the pharmaceutical industry.
December 7, 2022
Biden Signs First Federal Standalone Marijuana Bill
President Joe Biden officially signed the first piece of standalone federal cannabis reform Friday. The U.S. president signed a marijuana research bill into law that cleared the House in July and the Senate last month.
The act is aimed at providing federal support to facilitate research of cannabis and its potential health benefits. The law gives the U.S. attorney general 60 days to either approve a given application or request supplemental information from the marijuana research applicant.
The Marijuana and Cannabidiol Research Expansion Act also creates a more efficient pathway for researchers who request larger quantities of cannabis.
The act does three things:
Provides a mechanism for the scientific study of cannabidiol and cannabis for medical purposes;
Arranges a pathway for the FDA to approve the commercial production of drugs containing or derived from cannabis; and
Protects doctors who may now discuss the harms and benefits of using cannabis and cannabis derivatives.
The president remains opposed to federal cannabis legalization, but he campaigned on a number of more modest marijuana reforms, including promoting research, decriminalization and rescheduling cannabis under the Controlled Substances Act (CSA), according to the National Law Review.
Biden also issued a mass pardon for Americans who’ve committed federal marijuana possession cases in October and directed an administrative review into cannabis scheduling. The White House recently listed those actions among the “top accomplishments” for the president.
December 5, 2022