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Seth Mailhot

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With an education in chemical engineering and a prior career at the U.S. Food and Drug Administration, Seth brings clients rare regulatory insight on food, medical device and drug matters. As Leader of the firm’s FDA group, Seth handles a broad array of matters involving FDA-regulated products and services including food, medical devices, pharmaceuticals, biotechnology, tobacco, radiation-emitting electronic products and cosmetics.

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On April 19, 2021, the U.S. Postal Service issued a notice regarding the upcoming changes to Publication 52, which is titled “Hazardous, Restricted, and Perishable Mail.”  Postal Service, “Treatment of E-Cigarettes in the Mail,” 86 Fed. Reg. 20,287 (Apr. 19, 2021).  The changes relate to the mailability of electronic nicotine delivery systems (“ENDS”), which were added to the definition of “cigarettes” in the Prevent All Cigarette Trafficking (PACT) Act.  See our previous alert regarding these changes.

On August 20, 2020, the Drug Enforcement Administration (“DEA”) published an Interim Final Rule on industrial hemp and hemp derivatives (the “Interim Rule”), which immediately went into effect, to conform DEA regulations with the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”).

As we previously discussed, the 2018 Farm Bill effectively removed industrial hemp from the definition of “marijuana” in the Controlled Substances Act (CSA). Additionally, tetrahydrocannabinols contained in industrial hemp, such as Cannabidiol (commonly known as CBD), were also removed from the purview of the CSA.

The U.S. Food and Drug Administration (FDA) issued a press release on the evening of Monday, November 25 concerning its recent enforcement actions and a regulatory decision concerning products that contain cannabidiol (CBD).  The Warning Letters follow FDA’s trend of focusing its CBD product enforcement on unapproved drug claims.  The regulatory decision stated in the press release concerns FDA’s decision that CBD is not generally recognized as safe (GRAS) for use as a food additive.

The fifteen (15) Warning Letters, each dated November 22, 2019, were issued to companies for marketing various CBD products. The products identified in the Warning Letters spanned conventional foods, dietary supplements and animal products.  FDA made specific mention in several Warning Letters about statements regarding the use of CBD products in infants and children.

Beginning this summer, the Food and Drug Administration (FDA) through its Office of Criminal Investigations, launched a criminal probe to investigate the vaping-related lung illnesses that have affected over five hundred people across the United States. The Centers for Disease Control and Prevention (CDC) has a parallel investigation tracking the incidences of the illness. Both the FDA and CDC are working with state and local health officials to investigate the increasing number of cases nationwide.

On Wednesday, April 3, 2019, the U.S. Food and Drug Administration (FDA) announced plans to hold a meeting to discuss its regulatory approach to products that contain cannabis and cannabis-derived compounds, including cannabidiol (CBD). The public hearing, which is scheduled to be held on May 31, 2019, is intended to obtain scientific data and information…