Higher Law: Hundreds of Thoughts About CBD | Where Recreational (Legislative) Moves Are Fizzling | 'Lobby Days' Next Week in DC
We're looking at the hundreds of comments the FDA's received on CBD regulations—some highlights. Plus: cannabis headlines that caught our eye. Thanks for reading!
May 16, 2019 at 04:00 PM
8 minute read
Welcome back to Higher Law, our weekly briefing on all things cannabis. I'm Cheryl Miller, reporting for Law.com from Sacramento.
If a summer wedding is in your future, you may want to stock up on some CBD oil. According to an email I received this week, that's the "healthy wedding swag" most sought by millennials. A few thoughts. First, I didn't know wedding swag bags were a thing. Second, the "poll" that led to this finding was conducted by a supplement company. Third, let's hope an FDA official is not on that wedding's guest list.
This week, we sifted through hundreds of comments to see what lawyers and others are advising the FDA to do about CBD-infused products. Plus, are Target and Walmart joining the CBD-craze? And scroll down to see who got the work.
Thanks again for reading Higher Law. If you've got a story idea or feedback, drop me a line at [email protected]. Or you can call at 916-448-2935. Follow me on Twitter @capitalaccounts.
What New Comments Say About CBD Regs
The U.S. Food and Drug Administration asked the public last month for its thoughts on how the agency should regulate CBD-infused products in anticipation of a May 31 hearing on the topic. The comments have poured in—558 were submitted as of Thursday morning.
Most of the commenters are individual consumers who ardently support any effort to make CBD products more readily available. Here are snippets from some of those comments.
>> Rodman Law Group, Denver, Colorado
"The Rodman Law Group receives countless inquiries from individuals and corporations from across the country who wish to participate in the emerging CBD industry, specifically with respect to how to properly label, package, and market popular CBD products like tinctures, gelcaps, balms, lotions, and vaporizers," David Rodman, the firm's managing partner, wrote. "And while certain states (like Colorado) have provided some guidance in these areas, the FDA has taken the position that most, if not all, of these products are unlawful under the Act."
The firm makes four suggestions to the FDA: Announce a policy akin to the Cole Memo and leave alone companies complying with CBD-allowing states; allow the sale of low-dose CBD dietary supplements and / or food additives; create an over-the-counter monograph, or rulebook, for CBD and some of its most common uses; urge Congress to enact a fix.
"The status quo is untenable," Rodman wrote. "Billions of dollars-worth of CBD is currently being sold in the U.S., much if not most of which is unlawful under the [Food, Drug, and Cosmetic] Act. This market inertia is unlikely to cause the CBD industry to voluntarily comply with the Act, and widespread disregard of the law is not good for anyone—industry participants, consumers, regulators, and society at large."
>> Center for Medicine In the Public Interest
"The absence—to date—of advanced regulatory thinking relative to CBD has resulted in a maelstrom of false claims and shoddy quality standards," Center president Peter Pitts, a former FDA associate commissioner, wrote. "Nature abhors a vacuum."
Pitts advocates for CBD production and dosing standards as well as studies of the compound's effectiveness and the effects of long-term use.
"It's time for the proponents of CBD—including many highly vocal patients, physicians, pharmacists, manufacturers and distributors—to become part of the solution," Pitts wrote."If you're not at the table, you're on the menu."
>> The National Organization for the Reform of Marijuana Laws, or NORML
"This retail market is far too large to remain unregulated, and this lack of regulation is leading to a variety of problems," NORML deputy director Paul Armentano wrote. "NORML is aware of numerous instances where local law enforcement has seized CBD products from shelves, only to refuse to file criminal charges later. In other instances, regulators have called for removing certain CBD products from retailers because of ongoing questions regarding their legal status."
NORML asks for "clear guidance" from the FDA on CBD's legality, as well as testing and labeling standards, and regulations for extraction and manufacturing.
"For years, producers of these products have navigated in a grey area of the law — manufacturing products of variable and sometimes questionable quality and safety," Armentano wrote. "Now it is time for the FDA to craft benchmark safety and quality standards for hemp-derived CBD products in order to increase consumer satisfaction and confidence as this nascent industry transitions and matures into a legal marketplace."
Meanwhile….
Steve Schain, senior counsel at Hoban Law Group, wrote in The Legal Intelligencer that the FDA is "locked and loaded" to go after CBD product manufacturers for misbranding or making false or unsubstantiated health claims. Schain raises four questions in considering what moves the agency may make next. You can check out his thoughts here.
>> A great-grandma did not find Disney World to be the happiest place on earth after she was arrested at security checkpoint in the Magic Kingdom last month when park officers found CBD oil in her purse. Hester Jordan Burkhalter of North Carolina said her doctor prescribed the oil to treat her arthritis. Prosecutors later dropped Hashish possession charges that had been filed against her. Burkhalter has threatened to sue the amusement park and the Orange County sheriff's department.
>> More reading at The New York Times: Can CBD Really Do All That?
Who Got the Work
Vicente Sederberg served as regulatory counsel to Québec, Canada-based Neptune Wellness Solutions' $18 million deal to acquire North Carolina hemp company SugarLeaf Labs. Osler, Hoskin & Harcourt is Neptune's legal counsel in the acquisition. Fluet, Huber & Hoang is acting as legal advisor to SugarLeaf.
In the Weeds…
>> A little CBD with your cotton balls and cat food? Walmart and Target are among the major retailers reportedly meeting—quietly—with manufacturers of CBD-infused drinks, gummy bears and topical creams. "We are flying around the country, talking to all the big guys at their headquarters," said Christian Graversen, brand manager of California-based CBDfx. Target and Walmart reps say the retailers have no immediate plans to carry CBD products. [New York Post]
>> If New Jersey is going to have recreational marijuana, it'll probably be up to state voters. State Senate President Stephen Sweeney conceded Wednesday that "the votes aren't there" to pass a recreational measure in the Legislature this year. The issue will likely go before voters in 2020, he said. In the meantime, lawmakers will work on bills to expand the state's medical marijuana program and to expunge convictions for minor cannabis-related crimes. [New Jersey Law Journal]
>> The recreational movement is fizzling in New York, too. Gov. Andrew Cuomo appeared to dash hopes for a standalone legalization bill emerging this year when he told reporters that "if legislators are suggesting that I need to twist arms [for votes], that's a bad sign because arm-twisting doesn't work." Lawmakers last week introduced a bill to expand the state's medical marijuana operations. [Leafly]
>> The new adult-use bill in Illinois may ban home-grows. Bill sponsors say they'll probably drop a provision allowing residents to keep up to five non-medical marijuana plants in their homes. The change is aimed at law enforcement agencies who say the language would make it more difficult to find illegal grows. [Chicago Tribune]
>> Small-scale businesses say Massachusetts' marijuana rules favor corporate pot. Protestors at the state Capitol said local restrictions and lack of access to delivery permits are hurting microbusinesses and co-ops, who don't have the same ins with policymakers. Attorney Blake Mensing, who represents smaller marijuana firms, suggested the state steer a portion of tax revenues to cities that approve applications from co-ops and microbusinesses. [Boston Globe]
Your Calendar: What's Next
May 19 - The International Cannabis Bar Association and Corsearch will host a reception following the International Trademark Association convention in Boston.
May 21-23 - The National Cannabis Industry Association holds its ninth annual cannabis industry lobby days in Washington, D.C.
May 23 - The International Cannabis Farmers Alliance hosts a legislative action dayin Sacramento, California.
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Who Got The Work
Michael G. Bongiorno, Andrew Scott Dulberg and Elizabeth E. Driscoll from Wilmer Cutler Pickering Hale and Dorr have stepped in to represent Symbotic Inc., an A.I.-enabled technology platform that focuses on increasing supply chain efficiency, and other defendants in a pending shareholder derivative lawsuit. The case, filed Oct. 2 in Massachusetts District Court by the Brown Law Firm on behalf of Stephen Austen, accuses certain officers and directors of misleading investors in regard to Symbotic's potential for margin growth by failing to disclose that the company was not equipped to timely deploy its systems or manage expenses through project delays. The case, assigned to U.S. District Judge Nathaniel M. Gorton, is 1:24-cv-12522, Austen v. Cohen et al.
Who Got The Work
Edmund Polubinski and Marie Killmond of Davis Polk & Wardwell have entered appearances for data platform software development company MongoDB and other defendants in a pending shareholder derivative lawsuit. The action, filed Oct. 7 in New York Southern District Court by the Brown Law Firm, accuses the company's directors and/or officers of falsely expressing confidence in the company’s restructuring of its sales incentive plan and downplaying the severity of decreases in its upfront commitments. The case is 1:24-cv-07594, Roy v. Ittycheria et al.
Who Got The Work
Amy O. Bruchs and Kurt F. Ellison of Michael Best & Friedrich have entered appearances for Epic Systems Corp. in a pending employment discrimination lawsuit. The suit was filed Sept. 7 in Wisconsin Western District Court by Levine Eisberner LLC and Siri & Glimstad on behalf of a project manager who claims that he was wrongfully terminated after applying for a religious exemption to the defendant's COVID-19 vaccine mandate. The case, assigned to U.S. Magistrate Judge Anita Marie Boor, is 3:24-cv-00630, Secker, Nathan v. Epic Systems Corporation.
Who Got The Work
David X. Sullivan, Thomas J. Finn and Gregory A. Hall from McCarter & English have entered appearances for Sunrun Installation Services in a pending civil rights lawsuit. The complaint was filed Sept. 4 in Connecticut District Court by attorney Robert M. Berke on behalf of former employee George Edward Steins, who was arrested and charged with employing an unregistered home improvement salesperson. The complaint alleges that had Sunrun informed the Connecticut Department of Consumer Protection that the plaintiff's employment had ended in 2017 and that he no longer held Sunrun's home improvement contractor license, he would not have been hit with charges, which were dismissed in May 2024. The case, assigned to U.S. District Judge Jeffrey A. Meyer, is 3:24-cv-01423, Steins v. Sunrun, Inc. et al.
Who Got The Work
Greenberg Traurig shareholder Joshua L. Raskin has entered an appearance for boohoo.com UK Ltd. in a pending patent infringement lawsuit. The suit, filed Sept. 3 in Texas Eastern District Court by Rozier Hardt McDonough on behalf of Alto Dynamics, asserts five patents related to an online shopping platform. The case, assigned to U.S. District Judge Rodney Gilstrap, is 2:24-cv-00719, Alto Dynamics, LLC v. boohoo.com UK Limited.
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