May 28 - June 3, 2019 Dispensary Compliance Updates
By Brittany Radice
Last week, the FDA held a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis/cannabis-derived compounds. Proponents of FDA regulations to clarify the regulatory environment came with strong recommendations and ultimatums.
The U.S. Hemp Roundtable has been working with lawmakers in recent weeks to draft standalone legislation to regulate CBD if the FDA determines that the task is too complicated for the agency to complete on its own. Senate Majority Leader Mitch McConnell, who led the charge on hemp legalization, previously suggested that further legislative action may be necessary to unlock the full potential of the hemp economy.
Representatives from state regulatory agencies in Virginia, Florida, North Carolina and Pennsylvania also addressed the uncertainty that’s prevalent throughout the industry without updated FDA guidelines. “Without the FDA’s guidance and leadership, individual states may carve out their own regulatory exceptions for CBD,” Joseph Reardon of the North Carolina Department of Agriculture and Consumer Services, said, noting that his state’s hemp industry has greatly expanded in recent years. “We urge the FDA to resolve the statutory issues and properly establish a legal pathway for CBD products to enter the market place.”
The reaction from FDA principal deputy commissioner was a statement of understanding of several themes from the meeting, including a need to “further clarify the regulatory framework to reduce confusion in the market,” to provide that clarification in a timely manner, to collect data on CBD to ensure that the products are safe and to create labeling standards so consumers know what they’re getting.
A group of patients and advocates filed a lawsuit against the Justice Department in a U.S. District Court, alleging that the Schedule I status of cannabis under the Controlled Substances Act poses serious health risks and unfair economic disadvantages. In its opinion, the U.S. Court of Appeals for the Second Circuit stated “[W]e are troubled by the Drug Enforcement Administration’s history of dilatory proceedings. Accordingly, while we concur with the
District Court’s ruling, we do not dismiss the case, but rather hold it in abeyance and retain jurisdiction in this panel to take whatever action might become appropriate if the DEA does not act with adequate dispatch.”
It’s a ruling that sets this case apart from several other attempts to change the federal drug scheduling system through the courts, all of which have so far failed. The plaintiffs in the case, which include young cannabis patients who suffer from rare conditions that they’ve effectively treated with cannabis products, told the court that they were concerned that DEA would “not move quickly enough to afford them adequate relief.” With that in mind, the court said it would “retain jurisdiction of the case in this panel, for the sole purpose of taking whatever action might become appropriate should the DEA not act with adequate dispatch.”