Is 2021 The Year CBD Becomes A Lawful Dietary Ingredient?

A few months ago, I discussed why hemp-derived cannabidiol (CBD) products should be regulated as dietary supplements despite the fact that the FDA deems the marketing of these products as unlawful. If you recall, this rationale stems from an exclusion clause in the definition of “dietary supplement” under the Food, Drug and Cosmetic Act (FDCA) that generally disallows the use of an FDA-approved “drug” as a dietary supplement (the Drug Exclusion Rule). Because CBD was investigated and approved as a new drug ingredient — Epidiolex — before CBD was marketed as a dietary supplement, the sale and marketing of these products violates the FDCA.

In that article, I also mentioned that Congress shared my views and introduced bipartisan bills, namely H.R. 5587 and H.R. 8179, that proposed to exempt CBD products from the Drug Exclusion Rule so they could be regulated as dietary supplements.

Though these bills died in the 2020 legislative session, Representatives Kurt Schrader (D-OR) and Morgan Griffith (R-VA), along with 18 bipartisan co-sponsors, recently reintroduced H.R. 8179, also known as The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act (the Act).

If enacted in its current form, the Act would legalize the manufacture, sale, and marketing of hemp, hemp-derived cannabidiol, and other hemp extracts (collectively referred to as “Hemp Products”) as dietary supplements under the FDCA.

To be compliant with the FDCA, these Hemp Products would need to meet the existing regulatory framework imposed on dietary supplements. This comprehensive regulatory framework mandates, in part, that these products be safe, as well as properly labeled and marketed.

Because Hemp Products were not sold and marketed in the U.S. as dietary supplements or conventional foods before October 15, 1994, they would be deemed “new dietary ingredients” (NDIs). Pursuant to Section 413 of the FDCA, if a dietary supplement contains an NDI, its manufacturer and distributor must ensure that the NDI is adequately substantiated as being safe — this includes following stringent manufacturing requirements known as “Current Good Manufacturing Practices” (CGMPs) — and must notify the FDA about that ingredient prior to marketing.

To meet this standard, manufacturers and distributors of Hemp Products would have to provide the FDA with information that is the basis on which they have concluded that their Hemp Products are reasonably expected to be safe under the conditions recommended or suggested in the labeling.

If the manufacturers or distributors were to receive a no-objection letter from the FDA, or no response at all, they could lawfully market their Hemp Products after the 75-day notification period is over, assuming there is in fact a history of use or other evidence of safety establishing that the Hemp Products, when used under the conditions recommended or suggested in the labeling, are reasonably expected to be safe.

When it comes to labeling requirements, manufacturers and distributors of Hemp Products would need to ensure their product packaging contains specific labeling elements, such as an identity statement and a supplement facts panel, but also contain no medical claims about the therapeutic values of their products. Inclusion of medical claims would suggest that the Hemp Products’ intended use is that of a drug, and thus, would violate the FDCA and warrant FDA and Federal Trade Commission (FTC) enforcement actions — the FDA and the Federal Trade Commission both regulate the marketing of dietary supplements.

In sum, the enactment of the Act would help alleviate regulatory uncertainties surrounding the legality of Hemp Products, which have hindered market opportunities for hemp farmers and businesses. In addition, the passage of this bipartisan bill would help raise the quality and safety of Hemp Products, and thus, assure consumers that these products are safe.

Industry leaders, such as the U.S. Hemp Roundtable, the U.S. Hemp Authority, and the National Association of State Departments of Agriculture (NASDA), as well as major herbal products associations like the American Herbal Products Association (AHPA), have expressed strong support for the bipartisan bill, which suggest the significant likelihood that CBD and Hemp Products will finally be regulated this year.


Nathalie practices out of Harris Bricken’s Portland office and focuses on the regulatory framework of hemp-derived CBD (“hemp CBD”) products. She is an authority on FDA enforcement, Food, Drug & Cosmetic Act and other laws and regulations surrounding hemp and hemp CBD products. She also advises domestic and international clients on the sale, distribution, marketing, labeling, importation and exportation of these products. Nathalie frequently speaks on these issues and has made national media appearances, including on NPR’s Marketplace. For two consecutive years, Nathalie has been selected as a “Rising Star” by Super Lawyers Magazine, an honor bestowed on only 2.5% of eligible Oregon attorneys.  Nathalie is also a regular contributor to her firm’s Canna Law Blog.

Morning Docket: 02.09.21

* A lawsuit has been filed following the Rose Bowl being played in Texas this year because of COVID-19. They should have a bowl game to resolve the dispute… [Fox News]

* President Trump’s former lawyer Michael Cohen has apologized to Stormy Daniels for putting her through “needless pain.” [Yahoo News]

* A Pennsylvania lawyer, who allegedly helped clients commit insurance fraud, has been disbarred. [Bloomberg Law]

* Robinhood is facing a wrongful death lawsuit filed by the family of a college student who allegedly killed himself after purportedly sustaining trading losses using the platform. [Hill]

* The Justice Department has dropped a lawsuit filed against a former aide to Melania Trump over a tell-all book published about the Trump Administration. That book must be a pager-turner… [Washington Post]


Jordan Rothman is a partner of The Rothman Law Firm, a full-service New York and New Jersey law firm. He is also the founder of Student Debt Diaries, a website discussing how he paid off his student loans. You can reach Jordan through email at jordan@rothmanlawyer.com.

FOMO: Lawyer Edition

The most profitable startup ever was a totally new idea called FOMO, Inc. The idea capitalized on the one thing lawyers have major FOMO for. Do you know what it is? It’s the one thing lawyers need nearly every day (and I’m not talking about coffee, though that’s a great guess). If FOMO, Inc. went public, their IPO would possibly be the highest ever recorded.

Still not sure? For those of you who don’t know, FOMO usually stands for “Fear of Missing Out,” but, in the case of FOMO, Inc., it stood for “Fulfilling Obligatory Midnight Oil.” They sold midnight oil by the gallon, by the barrel. Nearly every person in their target market — lawyers — bought until they could buy no more.

I am joking, of course. Midnight oil is, unfortunately, not something you could buy, or else I would have by now, but the idea behind FOMO, Inc. still rings true: working all night is encouraged and is one of a plethora of bad practices in the legal industry. Why is this the norm?

The way I see it, the biggest contributor to these bad practices is a failure to update. If you think of law as an app, we are running the oldest version, even though the software and hardware around it are improving, like we’re running 1997’s MS Word 97 on the latest present-day laptops. It’s just outdated and inefficient. We must modernize the lens through which we assess the value of legal work.

To do that, I propose a change in attitude and environment.

Attitude

There is an expectation for lawyers to give more and more. Not to produce more, but to give more.

What’s the difference?

The former asks for increased effort, whereas the latter asks for increased output, a matter of quality vs. quantity.

I like to use an acronym to help remind me of this dichotomy. It’s rather appropriately called MORE, which stands for “Midnight Oil is Rarely Expedient.” Thinking of this snaps my mind out of trying to convince myself I should be working harder.

Lawyers do not need to be chained to their desks for as long as possible each day. A classic example can be found in Goodhart’s Law: when a measure becomes a target, it ceases to be a good measure. A certain (high) number of working hours should not be a target. People have gamed what once was an indicator, and, in doing so, sacrificed productivity.

The second attitude is closed-mindedness. The legal institution is so stuck in the rut of tradition that it is has set up camp there, getting comfortable — all the while the technology tow truck strains to pull it out. Technology can embed company policies and automate workflows in such a way that lawyers do not have to spend countless hours on low-value activities.

To expand on that and to bridge us to discuss the work environment, I’ll introduce you to Pournelle’s Iron Law of Bureaucracy, which states that, in any bureaucratic organization there will be two kinds of people:

First, those who are devoted to the goals of the organization, e.g., dedicated classroom teachers in an educational bureaucracy.

Second, those who are dedicated to the organization itself, e.g. administrators in the education system.

The law states that the second group will gain and keep control of the organization, writing the rules and controlling promotions.

I think that law is rife with the second kind of people, people who do not stand for the law itself but the institution that evolved out of it. This dissonance causes a mental block to creativity and innovation.

Environment

That mental block is the same thing that keeps us stuck under the harsh fluorescent lights of the main office, while we idolize the grandiose corner office. If people stood for the goals of the legal bureaucracy, then they would have revised the working environment a thousand times to capitalize on technological and psychological benefits.

Better working environment = better frame of mind = better outcomes.

It’s time to modernize our mindset and question the norm. Change may be inevitable, but directionless change leads to the complication of simple processes without better results.


Olga V. Mack is the CEO of Parley Pro, a next-generation contract management company that has pioneered online negotiation technology. Olga embraces legal innovation and had dedicated her career to improving and shaping the future of law. She is convinced that the legal profession will emerge even stronger, more resilient, and more inclusive than before by embracing technology. Olga is also an award-winning general counsel, operations professional, startup advisor, public speaker, adjunct professor, and entrepreneur. She founded the Women Serve on Boards movement that advocates for women to participate on corporate boards of Fortune 500 companies. She authored Get on Board: Earning Your Ticket to a Corporate Board Seat and Fundamentals of Smart Contract Security. You can follow Olga on Twitter @olgavmack.

Maybe It Wasn’t Such A Great Idea To Fire A Guy Who Knew About The Ponzi Payments You Were (Allegedly) Making

Private-equity firm GPB Capital Holdings says it’s “extremely disappointed” by the reams of criminal and civil charges leveled against the firm, its CEO and two of his associates—one of whose lawyers trumpets his client as “a good man with a spotless record”—from Boston to Birmingham, Ala. The firm promises to present “significant evidence in its favor,” and boy oh boy will it need it, because there sure was enough in the opposite direction to catch the attention of the Justice Department, SEC, FINRA, a whole host of clients, and the powers that be in New York, New Jersey, Massachusetts, Illinois, Georgia, Missouri, South Carolina and Alabama.

It’s Time For Biglaw To Give Black Women The Chance To Shine

(Image via Getty)

If it’s not clear now the impact of Black women attorneys and how we change the world, I don’t know what else we can do. We are the lowest numbers in the legal profession in terms of law firms and partnerships, and yes, the impact when Black women lawyers are supported and actually trusted by leadership and their peers is profound.

Paula Edgar, founding board member of The Black BigLaw Pipeline, Inc. and former president of the Metropolitan Black Bar Association in New York, commenting on the need for Biglaw firms to start focusing on Black women attorneys in their diversity and inclusion efforts.


Staci ZaretskyStaci Zaretsky is a senior editor at Above the Law, where she’s worked since 2011. She’d love to hear from you, so please feel free to email her with any tips, questions, comments, or critiques. You can follow her on Twitter or connect with her on LinkedIn.

New Book Aims To Demystify A.I. For Lawyers

The hype cycle surrounding AI has taken the legal community on a journey. From the early days of never-ending, but also never plausible, promise to the spirited backlash, to the “well, actually you’ve been unwittingly using it all this time!” It seems as though lawyers are more at piece with A.I. these days, at least to the extent they’re told that the legal research software is, fundamentally, “doing AI” behind the scenes.

But to some extent the profession traded the backlash for a lack of imagination. Artificial intelligence can rev up legal research, but it’s capable of a lot more if lawyers just have some faith.

Last week, Kira Systems gurus Noah Waisberg and Dr. Alexander Hudek released AI For Lawyers: How Artificial Intelligence Is Adding Value, Amplifying Expertise, and Transforming Careers (affiliate link) attempting to provide lawyers with a straight-forward guide to the technology and its potential.

From research to analytics to contract review, the book lays out the potential AI can bring to your practice. It’s almost as if the logic of A.I. permeates the very structure of the book, with multiple asides from other authors adding fresh insights or demonstrated use cases in their own personal styles — no survey of a body of data would be complete without tackling it from multiple perspectives and drawing consensus conclusions. A chapter on research penned by the Casetext crew imparts a story from a solo practitioner using their A.I. product to successfully keep a client from a life sentence. Most artificial intelligence stories aren’t nearly as dramatic, but it’s hard to argue with the value of getting over whatever technological hangups you might have when keeping up to date on the latest advancements could have an effect like that.

The book doesn’t shy from the ethical questions surrounding the tech. Dealing with bias and unauthorized practice concerns can be as much a reason keeping attorneys away as being an inveterate luddite and calming those nerves is at least as important in any introductory tome as a convincing use case.

If you’re still frightened by the concept of bringing artificial intelligence into your practice, this is the book for you. And if you’ve already embraced the tech revolution, this book can still offer a useful survey of the opportunities out there for expanding the use of AI in the legal industry.

Even if they aren’t going to take over the profession, the robots are coming and how comfortable you are with them is going to define the practice in the future.


HeadshotJoe Patrice is a senior editor at Above the Law and co-host of Thinking Like A Lawyer. Feel free to email any tips, questions, or comments. Follow him on Twitter if you’re interested in law, politics, and a healthy dose of college sports news. Joe also serves as a Managing Director at RPN Executive Search.

Michigan Attorney Tells Court He Had Nothing To Do With Kraken Suit He Filed

Your Honor, please don’t sanction me because I never read that thing I signed my name to. I was just a conduit for these crazy people to get their case before your court. Also, it was kinda your fault, if you think about it, for not holding an evidentiary hearing. Further affiant sayeth not.

Or words to that effect.

Thus reads the affidavit filed by Michigan attorney Gregory J. Rohl in response to Governor Gretchen Whitmer and Secretary of State Jocelyn Benson’s motion for sanctions in the Michigan Kraken case. See, the counselor was just home fixing Thanksgiving dinner on November 25 when he got a call at 6:30 p.m. from “an associate who asked Rohl if he would assist in litigation involving election fraud in Michigan which was being spearheaded by Sidney Powell and Lin Wood.”

And instead of saying, “Gosh, can we maybe talk about this on Monday so I can have the weekend to read the filing and make comments before I agree to put my name on it,” he said GIDDYUP!

After Rohl “advised that he was not political and did not really care who won,” he was “thereafter forwarded a copy of the already prepared proposed Complaint with over 100 exhibits, the review of which took well over an hour.”

Over an hour, Your Honor! That’s like a whole 36 seconds per exhibit.

And then Rohl had a conference call “prior to fling” [sic] with the plaintiffs which “left him with the distinct impression that if true, there was some form of corruption of electoral processes in Michigan by either internal or external forces in Michigan that should be reviewed by a court of competent jurisdiction.”

So Rohl agreed to “serve as a conduit for the pleadings and essentially ‘hold the fort’ until Sidney Powell’s Pro Hac Vice application was accepted by the Court.” At 11:56 p.m., just four minutes before the deadline, Rohl’s secretary filed the complaint with his name on it as one of two local counsels.

The next day “media attention was significant in pointing out various spelling errors and formatting issues,” which is a nice way of saying that it noticed an affidavit purporting to prove voter fraud in Edison County, Michigan, a place which does not exist. (Probably should have given this “Decleration” [sic] 47 or even 49 seconds review, huh?)

Also, there were typos.

And Sidney Powell never did file for pro hac vice admission. But, you know, po-tay-to, po-tah-to.

Mistakes were made. But the important thing is that he just put his name on this case, he didn’t have anything to do with it. Particularly after “Rohl’s limited involvement was seriously further undermined once Judge [Linda] Parker saw fit to waive oral argument and otherwise not order any evidentiary hearings.” (Does he mean “underline?”) How can a lawyer be presumed to know the strength or weakness of his own case if the court refuses to even air it in open court?

Anyway! Gregory Rohl would be most gratified if the court would acknowledge that he was just acting as a good Samaritan whose “only goal was to secure Court review of the alleged election fraud issues raised in the complaint.” So please don’t take away his license to practice law again for deficiencies in this complaint which he put his name on.

Well … good luck with that one.

King v. Whitmer, Docket [Court Listener]


Elizabeth Dye lives in Baltimore where she writes about law and politics.

This Trademark Fight Is The Granddaddy Of Them All

Who owns the rights to the Rose Bowl and Rose Bowl Game? The Pasadena Tournament of Roses Association claims that it is the rightful owner of the marks and has sued the City of Pasadena for trademark infringement, unfair competition, and breach of contract.

The complaint, filed in the U.S. District Court for the Central District of California on February 4, touches upon both whether the City of Pasadena has created confusion in the marketplace about whether it owns any rights in the Rose Bowl and Rose Bowl Game trademarks as well as whether the Pasadena Tournament of Roses Association needs the City of Pasadena’s consent under a contract to host the famous college football Rose Bowl Game outside of Pasadena, California, if a force majeure event, such as the coronavirus pandemic, occurs. In fact, this year’s Rose Bowl did take place away from Pasadena and was instead hosted in Arlington, Texas.

The Pasadena Tournament of Roses Association owns a federal registration to the Rose Bowl Game trademark and has possessed the registration since 1975. It has also owned registrations for Rose Bowl in connection with clothing, jewelry, playing cards, and balloons for many years. However, the City of Pasadena has owned the trademark registration for the Rose Bowl word mark in connection with promoting sports competitions since 2000.

The Pasadena Tournament of Roses Association takes the position that the City of Pasadena’s registration for Rose Bowl should not play a role in the litigation, referencing the aforementioned contract between the parties where the City of Pasadena allegedly acknowledged the Pasadena Tournament of Roses Association’s ownership of that mark and agreed not to use that mark in connection with advertising or promoting the Rose Bowl Game. The contract was not attached to the complaint, but the Pasadena Tournament of Roses Association did include pertinent parts of the agreement, such as:

The Association agrees that it shall cause the Game to be played on
Game Day at the Rose Bowl Stadium during each Tournament Year,
except in the event of Force Majeure which prevents the Game from
being played at the Rose Bowl Stadium on Game Day despite the use by the Association and the City of their commercially reasonable efforts to remedy such event of Force Majeure; provided, however, if the parties are unable to remedy such event of Force Majeure and the Association elects to cause the Game to be played on a day other than Game Day, then the Association shall cause the Game to be played at the Rose Bowl Stadium on such alternative date; provided, that the Rose Bowl Stadium is in a condition that would permit the Game to be played on such alternate date.

The complaint also states that a trademark agreement between the parties says that the City of Pasadena would not “register the trademark ROSE BOWL, the ROSE LOGO, ROSE BOWL DESIGN […] or other trademarks containing the words ‘Rose Bowl’ […] for the events of the Association.” A separate consent agreement allegedly states that the City of Pasadena agreed “not to use any mark containing the words ROSE BOWL on or in connection with the Association’s Goods and Services.”

Tensions flared between the parties after the New York Times published an article, on January 1, that stated, “the Rose Bowl Game, a jewel so treasured it has been trademarked, has been hijacked, usurped and taken away with the type of roguish disregard for tradition that might otherwise be witnessed in Pasadena only when a protected flax-leaved paperbark tree is chopped down.”

Victor Gordo, the newly elected mayor of the City of Pasadena, added, “the football game belongs to the City of Pasadena and the people of Pasadena.” The Pasadena Tournament of Roses Association disagrees and further claims that its contract with the City of Pasadena has been breached based on the City of Pasadena using the Rose Bowl trademark to advertise and promote the Rose Bowl Game.

Tensions between the parties were enhanced when the City of Pasadena sent a letter to the Pasadena Tournament of Roses Association with the stated position that consent from the City of Pasadena was required in order to host the Rose Bowl Game away from the Rose Bowl Stadium. The Pasadena Tournament of Roses Association says that nothing could be further from the truth, particularly in a force majeure situation, which is currently the situation presented by COVID-19. It will now proceed to litigation with the intent of having a court make a declaration in agreement with its stated position.


Darren Heitner is the founder of Heitner Legal. He is the author of How to Play the Game: What Every Sports Attorney Needs to Know, published by the American Bar Association, and is an adjunct professor at the University of Florida Levin College of Law. You can reach him by email at heitner@gmail.com and follow him on Twitter at @DarrenHeitner.