Tag: business (page 1 of 40)

FDA Sends Warning Letters to CBD Product Brands with GW Pharmaceuticals Links

Warning letters have been sent to four cannabidiol (CBD) product brands as the FDA makes good on their promises from a month ago.

The brands that received these warning letters are:

The letters take issue with a number of different violations and give each company 15 days to respond. Happy Halloween.

In each letter, the FDA spells out how they take issue with stating treatment for any type of illness or condition. Whether it is bipolar disorder, cancer, autism, or anything in between.

“Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.”

Additionally, the FDA took issue in many complains regarding the fact that there were no “adequate directions for use.”

“A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.”

Three of the four letters contain reference to GW Pharmaceuticals and their clinical trials for Sativex and Epidolex with the letter to the Stanley Brothers going into the most detail:

“The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex[1] Under FDA’s regulations [21 CFR § 312.2], unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the Act. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act, but you may present FDA with any evidence that has bearing on this issue. . FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect.”

The links to the GW Pharmaceuticals references are:

The letters came from three different parties with two from Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV, one from Maridalia Torres-Irizarry Director San Juan District Program Division Director OHAFO IV East, and one from Darla R. Bracy, District Director Office of Human and Animal Food Division 5 West.

These are some of the clearest indications of desire for control of labeling from the federal government as CBD products begin to hit shelves and get quickly pulled from them as well.

These letters also come just one day after GW Pharmaceuticals made a significant announcement. From GW Pharmaceuticals and Its U.S. Subsidiary Greenwich Biosciences Completes Rolling New Drug Application Submission to U.S. Food and Drug Administration for Epidiolex® (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome:

“The submission of the Epidiolex NDA is an important milestone for patients with LGS and Dravet syndrome in that a potential new treatment option is within sight for these very difficult to treat and devastating conditions,” stated Justin Gover, CEO of GW Pharmaceuticals. “On behalf of all those patients, clinicians and GW employees who have supported the Epidiolex program, we are pleased to submit this promising therapy for FDA review and we look forward to working with the FDA throughout the review process. This regulatory submission is a demonstration of GW’s commitment to developing innovative cannabinoid-based treatments that have the potential to address significant unmet medical needs.”

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Jeff Sessions and the Uncertain Future of Cannabis

The man who is President Tump’s front-runner for Attorney General, Jefferson Beauregard Sessions, today saw Democrats delay the committee vote for his nomination. Many different groups and organizations oppose Sessions for a number of reasons, all of which reveal some very threatening trends. This has left many Americans on edge, especially members of the nascent cannabis industry.

Jeff Sessions has been quoted as sayinggood people don’t smoke marijuana.” While everything uttered by politicians needs to be taken with a grain of salt, it is no surprise people who live and love cannabis felt pretty uneasy. Sessions has made public statements that the comments were taken out of context, but his history of negative remarks is less than consoling.

The reason Sessions is so threatening for this industry and community is that the position he is vying for currently holds together the rocky relationship between federal and state cannabis laws. Memos from past Attorney Generals allowed for states to implement their own laws, provided they were compliant based on reasonable standards, like reduced youth exposure and other public safety measures.

Despite Jeff Sessions denigrating cannabis users, there are those in cannabis that are not so worried about his nomination. Cannabis is at an all time high in terms of social popularity, with major positive influence from veteran support organizations, medical practitioners, and families of sick children who have miraculous responses to certain cannabinoids.

Federal law has not been supportive of cannabis, and the DEA has made no acknowledgement of the streams of scientific evidence showing the medical benefits of cannabis. If Sessions were to be approved, and he upheld his federal jurisdiction when it came to cannabis, there would be problems. States would be more apprehensive to allow for legal business, and supply would dwindle. Entire local economies could shut down if raids on cultivators began again.

Still, the majority of states allow for legal cannabis in some form, and the new administration knows how cumbersome a states’ rights battle would be with half of the nation. Combine that with overwhelming public support for medical cannabis, and over half of Americans now comfortable with responsible adult use laws, and you have a social juggernaut that would not go quietly.

But the social power of cannabis is now rivaled by the power of the industry, at least in economic terms. Recreational cannabis sales are sky high, and tax revenues have been exceeding expectations wherever sales are made legal. Additionally, the cannabis industry now employees hundreds of thousands, (if not millions) of people.

The reporting on cannabis employment is somewhat flawed due to the proliferation of the black market, but cannabis laws will inevitably change that. Licensed business paying taxes have employees who pay taxes, and the government loves nothing more than people paying them money.

It may all come crashing down if Sessions is eventually nominated. Democrats in Congress are certainly not making it easy, as Sessions’ hate toward cannabis is far outweighed by his many disparaging remarks of racism.  But even if Sessions becomes the Attorney General, there is so much going for cannabis right now, that you should feel confident in the integrity of your state’s cannabis laws.

For the most up to date info on Cannabis Reports, follow us on Twitter, and like us on our Facebook page.

Nevada Shuts Down Cannabis Database After Massive Data Exposure

Data security continues to be a major issue for the cannabis industry, after a medical cannabis database in Nevada accidentally exposed the personal information of thousands of cannabis business applicants. The breach was caused by a bug that did not properly secure the eight-page documents filed for nearly 12,000 individuals.

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Applicants were required to electronically submit their information, including full names, complete addresses and contact information, Social Security Numbers, citizenship status, race, gender, and a state-approved photo ID. That is more than enough information for an individual with malicious intent to cause some serious damage in the way of identify theft.

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As of December 29th, online access to the database portal was completely revoked, and the unprotected web address was eliminated. Nevada state law requires the government to notify all applicants of the leak in the coming days. Early in December, the portal had been shutdown temporarily when technical staff noticed an issue. Access was re-established a week later. The database of business applicants contains only a portion of the data hosted by Nevada’s Medical Marijuana Program, which gathers patient information as well.

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Data vulnerability has plagued many industries that inherently require the storage of sensitive information. The majority of US states have passed some sort of cannabis law, but so far no data security standards have been established. A number of consumer websites in the cannabis space have also come under fire for their lack of security after it was discovered that amateur computer programmers were able to access user information datasets.

Nevada has come a long way when it comes to cannabis laws.

Nevada has come a long way when it comes to cannabis laws.

Security researchers are confident that the data breach in Nevada  was a technological accident, although that does not lessen the impact of exposing the sheer volume of personal records. Nevada voters recently approved the adult use of cannabis, which will require the Medical Marijuana Program to create a new database for recreational cannabis business applicants.

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For the most up to date info on Cannabis Reports, follow us on Twitter, and like us on our Facebook page.

 

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