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Sarah Blitz

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Sarah Blitz is an associate in the Business Trial Practice Group in the firm's Los Angeles office and leader of the firm’s Cannabis industry team.

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On May 4, 2022, the Food and Drug Administration (FDA) issued warning letters to five companies it asserts are illegally marketing products labeled as containing delta-8 tetrahydrocannabinol (Delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FDCA). Simultaneously, FDA issued a new consumer update “5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC.”  The consumer update and warning letters are a continuation and expansion of FDA’s efforts to warn the public about products that are not approved under the FDCA and to rein in the rapidly expanding market of products containing hemp-derived cannabinoids.  This set of warning letters marks the first time FDA has publicly taken enforcement action against products containing Delta-8 THC, and it will likely not be the last.
Continue Reading Warning! FDA Issues Warning Letters for Products Containing Delta-8 THC

On October 29, 2019, the U.S. Department of Agriculture (USDA) released its long-awaited interim final rule governing the U.S. Domestic Hemp Production Program. USDA has been developing these interim regulations since hemp was federally legalized under the 2018 Farm Bill. These hotly anticipated rules are important not only for hemp producers and hemp-derived product companies, but for cannabis companies interested in diversifying or pivoting into a crop that is legal under federal law.
Continue Reading BREAKING NEWS: USDA Releases Interim Final Hemp Rule

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The long-awaited draft guidance on Clinical Decision Support (CDS) software sets forth FDA’s proposed approach to regulating CDS, including software that incorporates machine learning (ML) technology. Companies developing ML software for life science applications should consider reviewing FDA’s planned approach to inform their regulatory strategies.
Continue Reading New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

*This article was originally posted in Law360 on June 4, 2019.

The much-anticipated public hearing last week at the U.S. Food and Drug Administration on cannabis and cannabis-derived compounds drew a wide audience of participants, with strong views on how the FDA should (or should not) regulate the controversial plant.

In an amazingly short period of time, hemp-derived products, including those containing cannabidiol, have moved from the fringe to the mainstream, from state-licensed dispensaries to traditional brick-and-mortar retailers. And yet, the FDA’s position has been clear — it is illegal to sell human food, pet food, dietary supplements and unapproved drugs that contain CBD.
Continue Reading What We Learned From FDA’s Public Hearing On Cannabis*