All posts by Justin M. L. Stern

USDA Delays DEA Registration Requirement for Hemp Testing Laboratories

On February 26, 2020, the United States Department of Agriculture (USDA) took a significant step toward allaying industry concerns by announcing that it delaying enforcement of the interim final rule (IFR) requirement that hemp producers only use testing laboratories registered with the Drug Enforcement Administration (DEA).

When the IFR was published in late October of 2019, it faced near-immediate criticism from industry participants and stakeholders who, among other things, voiced concerns that the DEA registration requirement would create a bottleneck given capacity issues. Appearing to respond to those critiques, the USDA explained that its enforcement discretion “will allow additional time to increase DEA registered analytical lab capacity.”

Notwithstanding other applicable provisions of law, the requirement that hemp testing labs be DEA-registered largely foreclosed the potential for a single laboratory facility to test both hemp and marijuana, as the DEA, which is a division of the U.S. Department of Justice, continues to treat marijuana as an illegal, Schedule I controlled substance. While this delay may provide an opportunity for labs that currently test medical and recreational marijuana pursuant to state law to also test hemp for compliance with the 2018 Farm Bill, it is not certain that the DEA registration requirement will not be reinstated. It is also not clear what further requirements states may impose.

Under the USDA’s guidance, hemp testing may be “conducted by labs that are not yet DEA registered until the final rule is published, or Oct. 31, 2021, whichever comes first.” Until that time, labs conducting hemp testing are still subject to the other compliance requirements of the IFR, including those related to methods of testing.

FDA Identifies Medical Devices and Systems Exempt From Premarket Notification Requirements

Before a medical device is brought to market, the FDA requires a premarket submission. For low risk devices, that submission is often via a 510(k), demonstrating that the device is at least as safe and effective as (substantially equivalent to) an already legally marketed device that is not subject to premarket approval.

As of December 30, 2019, certain Class I and Class II medical devices and systems that previously required a 510(k) submission are now, based on certain criteria detailed in the FDA’s rule, exempt from that requirement. The regulatory adjustment will mean that the dozens of medical devices and test systems identified will no longer have to comply with the premarket clearance, subject to certain conditions.

For example, among the impacted items are numerous drug detection systems, such as amphetamine test systems, barbiturate test systems, benzodiazepine test systems, codeine test systems, and methamphetamine test systems, all of which are exempt unless they are intended for any other use than employment, insurance, or federal drug testing programs. The new rule also affects other categories of devices and tests, such as unscented menstrual pads, assisted reproduction accessories and microtools, and breath-alcohol test systems.