By Justin M.L. Stern and Frederick R. Ball
For consumers, the widespread availability of products containing cannabidiol (CBD) is old news. But for those in the cannabis industry—and in particular, those monitoring applicable regulatory developments—the state of CBD remains largely in flux and continues to be marred by uncertainty.
Under the 2018 Farm Bill, the U.S. Food and Drug Administration (FDA) retained its regulatory authority over products derived from hemp, including CBD incorporated into products it traditionally regulates, such as food, dietary supplements, and cosmetics. Unfortunately for the industry, FDA has yet to propose or issue formal regulations concerning the manufacture, distribution, or sale of such products. At the same time, FDA has issued numerous warning letters to producers and retailers incorporating CBD into products operating in the complex gray area between state and federal law. Nevertheless, recent events occurring across all three federal branches of government may reflect an impetus for change in FDA’s approach to CBD products.
To read the full article, please visit the FDLI website.
Duane Morris partner Frederick Ball will be moderating the Food and Drug Law Institute’s webinar, “The USDA Hemp Interim Final Rule: Status, Remaining Issues, and Next Steps,” on January 21, 2020.
To register for the event, visit the Food and Drug Law Institute website.
When the United States Department of Agriculture released the interim final rule for the hemp program in October 2019, many stakeholders—including businesses and state agencies—were caught off guard by certain testing-related requirements contained in the rule. Because hemp is now legal under the 2018 Farm Bill if it contains no more than 0.3 percent THC concentration, testing for THC levels is critical. However, significant questions and issues with the testing requirements must be clarified.
On November 20, 2019, Senators Ron Wyden and Jeff Merkley, both from the state of Oregon, submitted a letter to the secretary of the USDA, in which they flagged—“in no particular order”—five controversial testing-related requirements and requested modifications to those requirements. Below, we have summarized the senators’ concerns and proposed solutions to three particularly controversial testing-related requirements in the interim final rule.
View the full Alert on the Duane Morris LLP website.
Duane Morris Partner Frederick Ball is quoted in the Agri-Pulse article “Regulatory Uncertainty Hangs Over Production of Industrial Hemp.”
Nearly a year after the 2018 farm bill legalized industrial hemp production, the business community continues to seek answers to questions about testing and marketing of products derived from the crop, the commercial potential of which has sparked interest throughout the country. […]
Rick Ball, a lawyer with Duane Morris in Boston, said on the sidelines of the FDLI meeting that he has “no clue” when FDA might take action.
Ball said regulatory confusion is stoked in some cases by different rules in different states. In Massachusetts, for example, farmers were left holding their hemp after the state followed FDA and said CBD cannot be used in foods or dietary supplements or marketed with health claims.
“They lost a huge market for their product,” Ball said. […]
To read the full article, visit the Agri-Pulse website (subscription required).
On August 26, 2019, the Drug Enforcement Agency (DEA) issued a press release announcing “it is moving forward to facilitate and expand scientific and medical research for marijuana in the United States.” This announcement comes in the midst of a growing demand for marijuana for medical and scientific research. Several years ago, in an August 11, 2016, press release, DEA first announced its intention to “expand… the number of DEA-registered marijuana manufacturers” because “only one entity was authorized to produce marijuana to supply researchers in the United States: the University of Mississippi.” Since that announcement, 33 entities have applied to DEA for a marijuana manufacturer registration. However, the approval process was stalled during Attorney General Jeff Sessions’ term in office, and to date no new applications have been approved. Meanwhile, the number of entities registered by DEA to conduct research on marijuana, marijuana extracts or marijuana derivatives has jumped from 384 in January 2017 to 542 in January 2019. Thus, while demand for marijuana for research purposes has increased sharply, the number of suppliers has remained stagnant.
View the full Alert on the Duane Morris LLP website.
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.
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.