Recently enacted Pennsylvania Senate Bill 773 (SB773) introduces several amendments intended to expand opportunities and increase competition among existing cannabis licensees in Pennsylvania. The bill seeks to support independent licensees in the state and is a response to the consolidation among licensees that many states have seen as state-legal marijuana operators struggle under the weight of federal prohibition and competition from the unregulated marketplace.
This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory bills would create a mechanism for states to bar the sale of products that are not FDA-authorized or subject to a pending premarket application. Like state cigarette directories implemented in connection with the tobacco Master Settlement Agreement, these directories would specify which vapor products are permitted to be sold in the state.
We recently discussed the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products’ (CTP) strategic plan intended to guide CTP’s activity for the next five years. On the same day, CTP released its annual regulation and policy guidance agenda, which “outlines rules and guidance documents that are in development or planned for development.” Below, we discuss CTP’s current priorities for new regulations. CTP’s policy agenda is important because it identifies the areas CTP views as most in need of regulation or guidance, and the key actions it plans to take in those areas.
The U.S. Department of Health and Human Services (HHS) has drawn criticism for heavily redacting a recommendation letter to the U.S. Drug Enforcement Administration (DEA) concerning the rescheduling of cannabis. HHS said the redactions were justified under Exemption 5 of the Freedom of Information Act (FOIA), which protects inter-agency or intra-agency memorandums or letters that would not be available by law to a party other than an agency in litigation with the agency. As Stephen C. Piepgrass, Agustin E. Rodriguez, Jean Smith-Gonnell, and Cole White noted in a recent article published by Law360, this has sparked debates about the balance between necessary secrecy and the public’s right to government information. Legal challenges to these redactions are expected. The deliberative process privilege, which safeguards deliberative discussions within government corridors, is often invoked in the context of FOIA.
In December, the U.S. Food and Drug Administration (FDA) issued warning letters to online retailers for reportedly selling unauthorized e-cigarette products. Consistent with the Center for Tobacco Products’ (CTP) recent focus, the letters target unauthorized products, which FDA states are particularly appealing to youth — including Lost Mary, Funky Republic/Funky Lands, and Elf Bar/EB Design. These warning letters follow FDA’s recent issuance of civil money penalty complaints against 25 brick-and-mortar retailers for failing to comply with prior warning letters. Those civil money penalty complaints, which we previously discussed here, continued the agency’s approach of seeking the maximum penalty approved by law.
Despite the federal ban on the sale, use, and possession of cannabis in the U.S., in October, Georgia became the first U.S. state to allow pharmacies to sell low-dose tetrahydrocannabinol (THC) products. Pursuant to statutes passed by the Georgia General Assembly in 2019, certain Georgia pharmacies approved by the Georgia Board of Pharmacy, are permitted to sell low-dose THC products containing up to 5% THC, the intoxicating component found in the cannabis plant. The 5% cap is far lower than the allowable THC levels in most states.
The principle of open government is foundational to a healthy democracy, and the availability of government records upon request from the public is one of its chief cornerstones. In the U.S., the primary mechanism by which the public gains access to government records is the Freedom of Information Act (FOIA).[1] FOIA serves as a pivotal tool for ensuring governmental transparency by allowing the public to make requests to governmental entities to access specific government records.
The cannabis space is young in Virginia, but valuable lessons from the past could provide an edge to those paying close attention.
On October 30, Virginia’s hemp industry suffered an early defeat in its effort to overturn Virginia SB 903, a law that imposed stricter limitations on hemp products than what is currently required under federal law.
Recently, NJOY LLC filed a complaint in the U.S. District Court for the Central District of California against more than 30 foreign and domestic defendants that manufacture, market, distribute, and sell tobacco products in an (indirect) effort to force them to comply with federal and state laws. R.J. Reynolds Tobacco Company and R.J. Reynolds Vapor Company (collectively, RJR) also recently filed a complaint with the U.S. International Trade Commission (ITC) against more than 25 foreign and domestic manufacturers, distributors, and retailers (collectively, the respondents) that seeks to prevent the import and resale of certain tobacco products. These lawsuits serve as two examples of how industry is trying to take independent legal action to target allegedly noncompliant actors and force them to comply with applicable law.