Neville Bilimoria Quoted on FDA Rules in Cannabis Era

Duane Morris partner Neville M. Bilimoria is quoted in the Law360 article, “CBD Rules In Limbo As FDA Grapples With New Cannabis Era.”

Hemp may have been legalized less than a year ago, but CBD derived from it is already on its way to becoming a multibillion-dollar industry. However, sales of everything from CBD gummies to lattes are occurring in a legal gray area as the U.S. Food and Drug Administration struggles with regulating the largely unstudied ingredient. […]

“This is a watershed year for the FDA and its coming to grips with the increasing demand from the consumer public over marijuana, cannabis, CBD, hemp. It’s trying to catch up to what the consumers are touting as being therapeutic uses for CBD and THC,” Mr. Bilimoria said. “It’s basically saying, ‘Wait, everybody slow down. We’re the FDA. We rely on science before we can approve any uses and regulate any uses of cannabis or CBD.'” […]

Mr. Bilimoria said he can’t blame the FDA for “taking it slow,” but said doing so is frustrating when CBD is already all over store shelves. […]

To read the full article, visit the Law360 website (subscription required).

“Cannabis 205” Webinar Replay Available

A video replay of the webinar “Cannabis 205: What Big Global Companies Should Know About Entering the Cannabis Space” is available to view.

Michigan Court Issues Preliminary Injunction Prohibiting State’s Emergency Ban of Flavored Nicotine Products From Taking Effect

By Joe Pangaro and Jessica Linse

On September 18, 2019, Michigan became one of the first states to impose a ban on flavored e-cigarettes. The Michigan Department of Health and Human Services (“MDHHS”) issued emergency regulations that stated, in part, that a retailer shall not “[s]ell, offer for sale, give, transport, or otherwise distribute, nor possess with intent to sell, give, or otherwise distribute a flavored nicotine vapor product.” The ban went into effect immediately upon the release of the emergency regulations and was supposed to last for six months.

Shortly thereafter a local vape shop owner filed suit in state court against MDHHS, Governor Gretchen Whitmer, and the State of Michigan seeking a preliminary injunction to prevent the emergency rules from going into effect.  See Marc Slis, et al. v. State of Michigan et at., Nos. 19-000152-MZ, 19-000154-MZ (Mich. Ct. Cl., Oct. 15, 2019). At the preliminary injunction hearing, one plaintiff testified the emergency rules forced him to “shutter[] his business and that his customers have been obtaining their flavored vaping products from Wisconsin.”  Id. at 7. Another presented evidence that the emergency rules “ban plaintiff from using its tradename and branding.” Id. The court found both harms constituted “irreparable harm” necessary for preliminary injunction.

The court also found the Plaintiffs established a likelihood of success on the merits of their claims, because the MDHHS rules were procedurally invalid under Michigan law. Id. at 8.  Specifically, an agency must comply with standard procedures for the promulgation of new rules except in “emergency” situations, and the Court did not find there was a “genuine emergency” that warranted circumventing the standard rule-making process with respect to flavored nicotine vaping. “The plaintiffs have convinced the Court that defendants’ proffered reasons for the emergency declaration have fallen short.  It is not enough under [Michigan law] for DHHS to merely identify a problem.”  Id. at 10.

The court also considered the potential harm to the public that would result from allowing the ban to be enacted. After recognizing “compelling interests on both sides of the issue,” the court cited witnesses for the Plaintiffs that testified about their improved health after switching from traditional tobacco products to e-cigarettes. “Thus, plaintiffs have presented evidence that at least some segment of the population will be harmed by the vaping ban.” Id. at 14. Ultimately, after carefully weighing all factors pertinent to granting a preliminary injunction, the court concluded the Plaintiffs carried their burden, and issued a preliminary injunction preventing Michigan’s emergency rules from going into effect.

The Michigan ban of flavored e-cigarettes is significant because many other states around the country have since enacted similar bans, either through emergency regulation or executive order. These states include Rhode Island, Oregon, New York, Washington, Missouri and Montana, and the city of Los Angeles.  Each of these bans may face similar challenges in the near future, and this court’s decision to block the emergency rules, which is in line with another recent ruling by a District Court in Indiana, indicate that such challenges may be successful.

Duane Morris Named One of America’s Top Trusted Corporate Law Firms

Duane Morris has been named one of America’s Top Trusted Corporate Law Firms by Forbes.

The publication writes:

More than 13 million attorneys practice at more than 400,000 law firms in the U.S., according to the American Bar Association, and those firms are becoming increasingly specialized. … Many firms have been expanding into new areas of law necessitated by the emergence of technologies such as blockchain and of state laws legalizing cannabis use. …

[Duane Morris] has a growing and strong focus on the legal cannabis industry, partnering with the American Trade Association of Cannabis and Hemp and representing cannabis companies in one of the first public cannabis industry mergers, a $640 million deal.

For more information, visit the Forbes website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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