FDA

U.S. District Court for the Eastern District of New York Crediting the CBD company’s forthrightness, a federal judge in New York federal judge has dismissed a lawsuit against Massachusetts-based Curaleaf from investors who argued the company misled them about legality of its CBD products. The investors sued when Curaleaf’s share price fell in 2019 after
A bipartisan bill that was introduced in the U.S. House of Representatives Thursday could push legal CBD through Congress, providing consumer access and protection while clearing the supply chain bottleneck. The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021 is sponsored by Representatives Kurt Schrader, a Democrat from Oregon, and Morgan
U.S. drug regulators have withdrawn their proposal to regulate over-the-counter CBD, handing the industry another setback after years of delay from the Food and Drug Administration. The proposal in question appears to be on pause because of the changing administration. The delay was widely anticipated but still frustrating for CBD operators awaiting the rules. The
Federal food and drug officials said Friday that they plan to fill in current CBD research gaps with “real world data” — but industry advocates are frustrated that regulators haven’t done enough to clear up the rules, which has caused supply-chain bottlenecks while leaving consumers to navigate an increasing field of unregulated products. An update
U.S. health officials are asking for research about how hemp-derived cannabinoids and other plant-derived treatments affect chronic pain. The Agency for Healthcare Research and Quality, part of the U.S. Department of Health and Human Services, opened a four-week call for submission Wednesday. They’re conducting a systematic review on pain to “produce evidence to make health
Federal food and drug regulators this week highlighted the challenges they’re facing in regulating CBD and other cannabis-derived products, emphasizing the knowledge gaps that still exist due to a continued lack of data regarding the science of CBD and other cannabinoids. Kaveeta Vasisht, director of the FDA’s Office of Women’s Health and associate commissioner for
The hemp and CBD industry will be watching closely this week to find out whether federal regulators seem inclined to require warning labels for pregnant or nursing women on CBD products, or to mandate gender-specific dosing levels. That’s because the U.S. Food and Drug Administration’s Office of Women’s Health will be leading discussions about “CBD
Federal health authorities want to discuss gender differences in the effects of CBD and other cannabinoids. The U.S. Food and Drug Administration’s Office of Women’s Health announced a Nov. 19 “multidisciplinary scientific conference” for medical professionals and members of the public to talk about how genders might be affected differently by cannabinoids. The agency says
The biggest question mark for the global CBD industry right now is not how to market the cannabinoid and what it can do. Instead, the biggest question mark is whether the hemp and marijuana industries will be allowed to show customers what CBD can do. Ongoing legal questions about the cannabis extract – which is
Two scientists will lead a third-party consumer research study on the effects of regular CBD use on humans, particularly focused on liver safety. Dr. Keith Aqua, a Miami-based medical doctor, and Dr. Jeff Lombardo, a Buffalo, New York-based pharmacist who specializes in toxicology, are the co-principal investigators for a national clinical trial measuring the potential
Over-the-counter CBD isn’t legal and continues to worry federal drug regulators as more people take it and give it to animals, a lawyer for the U.S. Food and Drug Administration said Friday. Randall Gnatt, senior counsel at the FDA, told the nation’s veterinarians that the FDA thinks there are “data gaps and safety concerns” about
Hemp advocates have been sending their own recommendations to the U.S. Food and Drug Administration to try to direct the agency’s enforcement discretion policy for CBD products. The latest hemp group weighing in is the National Industrial Hemp Council, which filed comments with the agency this week emphasizing the importance of establishing basic safety standards
United Kingdom-based GW Pharmaceuticals posted marginal revenue growth in the second quarter over the previous quarter, citing challenges stemming from the COVID-19 pandemic. GW reported revenue of $121.3 million for the quarter ended June 30 – about the same as the previous period. GW’s quarterly net loss rose slightly to $8.8 million. By product, Epidiolex sales of
Federal food and drug officials submitted a CBD enforcement policy document for approval on Wednesday, Hemp Industry Daily has learned, meaning that long-awaited industry guidance on CBD is nearing. The U.S. Food and Drug Administration submitted its Cannabidiol Enforcement Policy Draft Guidance for Industry to the White House Office of Management and Budget. With approval
Federal food and drug officials dropped draft guidance for clinical research related to developing cannabis and cannabis-derived drug products on Tuesday. The U.S. Food and Drug Administration’s seven-page draft guidance, titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry,” focuses on pharmaceutical quality and chemistry, manufacturing and controls. The guidance doesn’t establish
Hemp industry legal experts said newly released guidelines on cannabis-based drug development that the U.S. Food and Drug Administration dropped on Tuesday will not necessarily affect any future regulations on CBD products and that it’s still unclear whether the recommendations will be turned into rules. Jonathan Havens “A guidance document doesn’t mean that they’re necessarily
Corporate leaders in the CBD industry are increasingly coming from the consumer packaged goods universe, lending their experience and asking the hard questions to whip the nascent hemp industry into shape and navigate the enormous growth that entrepreneurs foresee in the market. Deanie Elsner joined Charlotte’s Web as CEO last year, bringing with her more
Officials from the National Credit Union Administration have outlined additional information on serving legal hemp businesses. A letter issued this week points out that hemp-related businesses have also been affected by the COVID-19 pandemic and that it is “important that credit unions stay current with the federal, state and Native American tribal laws and regulations