How Will FDA Bring Order to the Wild West of Cannabis Regulations?

By Frederick R. Ball and Carolyn A. Alenci, Duane Morris LLP

The cannabis industry is the next frontier, growing rapidly and becoming one of the highest grossing industries in the country. The problem is, through no fault of its own, it is also the “wild west” of industries in many ways operating without guidance or regulation from the federal agencies that have jurisdiction of its products.

On May 31, 2019, the U.S. Food and Drug Administration (FDA) held a public hearing to allow stakeholders to share their experiences and challenges with cannabis or products containing cannabis-derived compounds. For this hearing, FDA requested information, scientific data, and stakeholders’ views on the safety of CBD-containing and cannabis-derived products. FDA hoped to obtain input on possible strategies that will allow for lawful marketing of CBD-containing and cannabis-derived products in a predictable and efficient manner, while still providing incentives for drug development with CBD and cannabis-derived compounds. Over 100 academic, industry, medical, and consumer stakeholders spoke or gave presentations at the hearing to a packed audience of about 500 attendees. In addition, over 1300 written comments have been posted to the FDA’s public docket FDA-2019-N-1482 for this hearing.

The hearing opened with remarks from Acting Commissioner Dr. Norman Sharpless. As expected, he made no new announcements about FDA’s current thinking about regulating products containing cannabis or cannabis-derived compounds. He did restate the FDA’s current position that CBD and THC cannot lawfully be added to a food or dietary supplement and that FDA does not have a policy of enforcement discretion with respect to these products.

To read the full text of this article written by Duane Morris attorneys Rick Ball and Carolyn Alenci, please visit the Food and Drug Law Institute website

NJ Assembly Delay Vote on Medical Cannabis Expansion – likely due to concern over potential Governor’s veto

NJ Assembly leaders announced they would not be voting on the proposed expansion of medical cannabis licenses earlier today – 6-10-19.

Instead, per NJ.com, legislators are going to attempt to work with Gov. Phil Murphy’s office on a plan that’s more amenable to him and the state Legislature, said Kevin McCardle, a spokesman for Assembly Democrats.

The Governor’s team has previously raised objections to a few provisions in the medical expansion bill, including the creation of the Cannabis Regulatory Commission, which would assume oversight of the industry. Currently, the state Department of Health regulates the medical marijuana program.

We will keep an eye out for any collaborative resolution of the medical licensure issue and report back.

#Duane Morris – Brad A. Molotsky, Esq.

New Jersey Medicinal Marijuana Program Set For Expansion

Just days after the NJ Senate and Assembly close in on expansion of medical use Cannabis, the New Jersey Department of Health (“Department”) published notice of a Request of Applications (“RFA”) for an additional 108 alternative treatment center (“ATC”) permits which authorize holders to cultivate, manufacture, and/or dispense medicinal marijuana. The Public Notice is available here, while the RFA is summarized below and available in full here.

Continue reading New Jersey Medicinal Marijuana Program Set For Expansion

FDA Holds Public Hearing on Cannabis

On Friday, May 31, 2019, the U.S. Food and Drug Administration (FDA) held a public hearing to discuss scientific data and information about products containing cannabis or cannabis-derived compounds. Acting Commissioner Sharpless made no new announcements about FDA’s current thinking about how it will regulate products containing cannabis or cannabis-derived compounds. However, it was clear from the FDA panel’s questions to the various academic, industry, and other stakeholders that FDA is looking for as much data from as many sources as possible. In particular, FDA’s questions focused on age and youth restrictions, dose and route of administration and how they affect the safety of the products, adverse event reporting, and interactions between cannabis/cannabis-derived products and other drugs. In addition, FDA continued to inquire about whether deregulating cannabis and cannabis-derived products would affect the incentive for research on these products.

Industry stakeholders asked for a prompt, expedited, clear, and transparent regulatory framework for products containing cannabis and cannabis-derived products. Specifically, industry sought clear definitions for terms like “full spectrum,” “broad spectrum,” “isolate,” and “THC-free.” Further, industry requested regulations on labeling, testing, good manufacturing practices, and track and trace for products. Many industry stakeholders asked FDA to look to the dietary supplement and food regulations already in place as a guideline for regulations on cannabis.

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Why the Trend of Going Public in Canada May be Ending

Greenlane Holdings, Inc., a U.S. vape distributor, went public on the Nasdaq in April. Greenlane is the first U.S. cannabis company to obtain a Nasdaq listing and may well bode the beginning of the end of the prior trend of U.S. companies going public in Canada, where cannabis is federally legal. The New York Stock Exchange also recently reversed its prior ban on listing U.S. pot companies by allowing the name and symbol change for Kathy Ireland’s company, formerly known as Level Brands, Inc. The company changed its name to cbdMD with the new symbol YCBD, reflecting its change to primarily a CBD company. The NYSE also reversed its own initial delisting decision on India Globalization, now a CBD company as well, back in February. (As we know, cannabidiol, or CBD, derived from the cannabis plant, is believed to contain much of the plant’s medical benefit without the psychoactive “getting high” features of THC).

A number of U.S. cannabis companies decided to go public in Canada in the last few years, mainly under the belief that fundraising would be easier there and the company’s valuation in trading would fare better than if they traded only in the U.S. over the counter markets. Canada’s senior exchange, the Toronto Stock Exchange, had declined to list U.S. companies, so they trade on its lower exchange known as the Canadian Securities Exchange or CSE.

To read the full text of this article written by Duane Morris attorney David Feldman, please visit the Green Entrepreneur website.

NJ Senate and Assembly close in on expansion of medical use Cannabis – Brad A. Molotsky, Esq. – Duane Morris

The New Jersey Senate voted 33-4 yesterday (Thursday) to advance a bill that is intended to increase medical marijuana sales and likely create new business opportunities in the state.

Per Marijuana Business Daily, before the vote, the Senate amended Assembly Bill 10 to allow marijuana workers to become union members.

The Bill will now return to the NJ Assembly for a vote to approve the Senate’s modification.

If the Bill is ultimately signed, the measure will:

– Create a new regulatory commission for medical marijuana.
– Pave the way for the state to issue additional business licenses.
– Allow cannabis home delivery.
– Ease restrictions on the process for recommending medical marijuana.

Currently there are 12 vertically integrated medical cannabis licenses that have been granted in NJ.

We will continue to track this development and report back as it get’s closer to passage in the Assembly. -Brad

USDA Memo Clarifies Key Provisions Regarding Hemp in the 2018 Farm Bill

The Agriculture Improvement Act of 2018 (the “2018 Farm Bill”), signed into law on December 20, 2018, altered the federal government’s treatment of hemp in a number of ways. The 2018 Farm Bill expanded the definition of “hemp” to include, explicitly, derivatives, extracts and cannabinoids, and removed hemp from the definition of federally unlawful marijuana under the Controlled Substances Act (CSA). See 2018 Farm Bill, Pub. L. No. 115-334 §§ 10113, 12619, 132 Stat. 4490. Notably, the 2018 Farm Bill also explicitly permitted the interstate transportation of hemp: “No State or Indian Tribe shall prohibit the transportation or shipment of hemp or hemp products produced in accordance with subtitle G of the Agricultural Marketing Act of 1946 (as added by section 10113).” Id. at § 10114.

Subtitle G, for its part, provides that “[n]othing in this section prohibits the production of hemp in a State or the territory of an Indian tribe—(1) for which a State or Tribal plan is not approved under this section, if the production of hemp is in accordance with section 297C or other Federal laws (including regulations).” Id. at § 10113 (emphasis added). This final clause, “or other Federal laws,” is significant because the Agriculture Act of 2014 (the “2014 Farm Bill”) is also a “federal law,” and to date approximately 40 states have instituted industrial hemp programs pursuant to the 2014 Farm Bill. Under the language of the 2018 Farm Bill, then, states may not interfere with the interstate transportation of hemp produced in accordance with either the 2014 Farm Bill or—once regulations are implemented and state hemp programs are approved—the 2018 Farm Bill.

Notwithstanding the language of the 2018 Farm Bill, the absence of federal regulations implementing the new law and sanctioning state hemp programs revised pursuant to the 2018 Farm Bill has caused significant confusion regarding the true impact of the act.

View the full Alert on the Duane Morris LLP website.

“How to Free CBD from the FDA’s Grasp: Call It GRAS,” The Cannabis Reporter Radio Show with Rick Ball

Duane Morris partner Rick Ball was a guest speaker on The Cannabis Reporter Radio Show, hosted by Snowden Bishop, on May 20, 2019. The episode is titled “How to Free CBD from the FDA’s Grasp: Tell Congress to Call It GRAS,” and can be found on The Cannabis Reporter website.

About the Episode

When Congress legalized agricultural hemp with the passage of the 2018 Farm Bill, it seemed like the hemp industry would finally be out of the woods from a regulatory standpoint. So, it defies logic that the FDA is creating obstacles for hemp CBD producers and that every-day people are still being arrested for possession of hemp biomass and extracts.

Just last week, a 67-year-old great grandmother was arrested at the happiest place on earth when a Disney World employee discovered a bottle of CBD in her purse after a routine inspection at the park entrance. You may recall the truck driver who was arrested in Idaho with a load of freshly harvested hemp on its way from Oregon to a processing plant in Colorado just weeks after the hemp measure was signed into law.

Incidents like that leave most of us scratching our heads, considering that hemp is now legal at the federal level and hemp-derived CBD is a harmless molecule that is naturally produced in our own bodies when we’re young.

Let’s face it, legal hemp seems to be an oxymoron. Minutes after the hemp measure was signed into law, the FDA blindsided the elated industry with its stern warning that only one CBD product has ever been approved for sale in the U.S. and that all other hemp CBD products would remain illegal to sell until they can be approved by the FDA. The only exceptions would apply to the manufacturing and sale of CBD limited to states that had included CBD provisions in their state marijuana policy measures.

To read more about this episode and listen to the interview with Duane Morris attorney Rick Ball, please visit The Cannabis Reporter Radio Show page here.

Big News for the Organic Certification of Hemp

The public’s desire for organic products continues to grow. This is equally true for cannabis and hemp-derived products, especially where they are being used for medicinal purposes. The U.S. Department of Agriculture (USDA) has issued regulations setting out standards setting out specific requirements that must be met for an agricultural product to be labeled “organic”. In order to be able to include the USDA’s organic certified seal on a product’s packaging, a USDA-accredited certifying agency must verify that the product meets USDA’s regulations. This USDA certification provides many benefits, including, for example, premium prices for products. So why haven’t we seen many certifications for hemp products?

Back in 2016, the USDA, in conjunction with the U.S. Drug Enforcement Administration and the U.S. Food and Drug Administration, issued a Statement of Principles on Industrial Hemp concerning the applicability of Federal law to industrial hemp programs after the 2014 Farm Bill, but the ability to gain organic certification for hemp products was unclear. The USDA also issued Instruction: Organic Certification of Industrial Hemp Production (updated in September 2018), which stated that industrial hemp produced in accordance with the 2014 Farm Bill could be certified if it met all of the requirements of USDA’s organic regulations. The problem was that under the 2014 Farm Bill only certain parts of the hemp plant (e.g., the stalk and non-viable seeds) were permitted to seek organic certification. And, actually, some hemp seed products have received USDA organic certification.

Continue reading Big News for the Organic Certification of Hemp