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The FDA Continues to Show It Is Not Interested in Regulating Hemp-Derived Products

Last week, the Food and Drug Administration (the “FDA”) maintained its strict and narrow position on the legality of cannabidiol (“CBD”) by rejecting two new dietary ingredient (“NDI”) notifications submitted by Charlotte’s Web and Irwin Naturals. Both companies sought agency clearance to market their full-spectrum hemp extract as “dietary supplements.” In its letters to these

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Colorado’s New Hemp Rules Suggest A Wave of Comprehensive State Regulations May Be on the Way

While the Food and Drug Administration (the FDA) continues to drag its feet in forging a legal path for the manufacture, sale, and distribution of hemp-derived products, state regulators are keeping up with the demands of this evolving market and adopting increasingly more nuanced and more sophisticated regulations for these products. Several states, including Oregon

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2021: The Year Hemp-Derived Foods and Dietary Supplements Become Lawful… Maybe.

It has been well over two years since Congress enacted the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), which legalized the commercial production of hemp and tasked the Food and Drug Administration (the FDA) with the regulation of hemp-derived products intended for human consumption. Nevertheless, the FDA has yet to carve a legitimate

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Is Delta-8 THC a Controlled Substance? Yes. No. Maybe.

As anticipated, Delta-8 tetrahydrocannabinol (“Delta-8 THC”) has become the hottest, most flourishing cannabinoid currently found on the U.S. market. In the past few months, the sales of Delta-8 THC products have exploded, representing the fastest growing segment of hemp-derived products. Yet, despite its growing popularity, the legality of Delta-8 THC, including that of Delta-8 THC

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The FDA Objects to the Sale and Marketing of Nasal, Ophthalmic and Inhalable CBD Products

On December 22, the Food and Drug Administration (the “FDA”) issued new warning letters to five companies that illegally sold and marketed unapproved CBD products, which the companies claimed could prevent, diagnose, mitigate, treat or cure various medical conditions. This latest round of enforcement actions was triggered by specific concerns with the manner in which

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FTC Cracking Down and Issuing Fines for Deceptive Claims by CBD Companies

On December 17, the FTC issued a press release announcing its first law enforcement crackdown on deceptive claims in the growing market for cannabidiol (CBD) products. According to the press release, a number of “companies made unsupported claims that their oils, balms, gummies, coffee, and other goods could treat serious diseases such as cancer and

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A Bipartisan Bill Would Regulate Hemp CBD as a Dietary Supplement

Last week, Oregon Representative Kurt Schrader (D) and Virginia Representative Morgan Griffith (R) introduced The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020 (“H.R. 8179”). If enacted in its current form, H.R. 8179 would legalize the manufacture, sale and marketing of hemp, hemp-derived cannabidiol and other hemp extracts (collectively referred to

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Hemp CBD Labeling Requirements: How to Mitigate Risk

Every week, clients ask us to review their hemp-derived cannabidiol (“Hemp CBD”) products to ensure “full compliance.” Unfortunately, given the patchwork of often conflicting state labeling laws, and the lack of a federal pathway for the sale and marketing of these products, it is virtually impossible for Hemp CBD stakeholders to meet compliance standards. Consequently,

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NIST and FDA May Be the Cannabis Quality Assurance Heroes We Need

Over the years, we’ve pointed out when federal agencies opt to ignore the federal illegality of cannabis. It happens more often than you might think depending on the topic (see, for example, the NLRB). One agency, though, that has surprisingly never lifted a finger against state-legal cannabis–though it is taking a closer look at CBD–is

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The Laws and Regulations on Hemp CBD in All 50 States

The 2018 Farm Bill removed hemp from the Controlled Substances Act did not affect or modify the Federal Food, Drug, and Cosmetic Act (“FDCA”) or the Food and Drug Adminstration’s (“FDA”) ability to promulgate regulations and guidelines that relate to hemp under. The FDA regulates a wide variety of medical and consumer products sold in

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