New Citizen Petition Filed by CBD Company

New Citizen Petition Filed by CBD Company

On February 21, the Natural Product Association (NPA) filed a citizen petition with the Food and Drug Administration (FDA) on specific cannabidiol (CBD) relief in which it requests enforcement discretion for the premarket approval of CBD products. In its petition, the NPA is asking the FDA to do one of three things: Determine that CBD

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Oregon Hemp: New Rules (Part 3)

The end of 2021 was marked by significant regulatory changes adopted by the Oregon Liquor and Cannabis Commission (the OLCC), including new rules for hemp and cannabinoids. Today I will cover a few of the big changes affecting artificially derived cannabinoids, including CBN and Delta-8 THC. In the big picture, Oregon stakeholders knew new regulations would

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Feds Might Regulate CBD as a Food Ingredient

The CBD Product Safety and Standardization Act (the Act) indicates that the Feds might regulate CBD as a food ingredient, and that it may lead to regulation of other cannabinoids. If the Feds regulate CBD as a food ingredient, it could seriously change the game (in a good way) for hemp CBD companies. On December

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Mailing Hemp Cannabinoid Products in the U.S.

Now that the holiday season is upon us, hemp-derived cannabinoid (Hemp Cannabinoid) companies are getting busy selling and shipping their products to consumers throughout the country. In addition to limiting the sale and distribution of their products to jurisdictions where these products are expressly allowed and regulated, Hemp Cannabinoid companies should also familiarize themselves with

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Hemp-Derived Products: The Law Does Not Stop at Labeling Requirements

I work with many manufacturers and distributors of hemp-derived products and am often surprised by the fact that few understand their general obligations beyond labeling requirements. Every state that authorizes and formally regulates the manufacture, distribution, and sale of these products – Colorado is a good example – imposes stringent manufacturing requirements that squarely align

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The FDA Warns Consumers of the Risks Associated with Delta-8 THC Products

On Tuesday, the Food and Drug Administration (the “FDA”) released its first statement via a consumer update regarding Delta-8 tetrahydrocannabinol (“Delta-8 THC”). The agency decided to provide consumers with key information surrounding the popular cannabinoid following a sharp increase in adverse event reports involving the substance and unauthorized marketing practices directed at minors. If you

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The FDA’s Proposed Kratom Ban is a Mistake

Trust in the U.S. Food and Drug Administration (FDA) declined after its approval of the controversial Alzheimer’s drug aducanumab. Three experts resigned amid allegations that the FDA had caved to industry pressure. Some argue that its credibility has reached a new low. These events should have prompted the FDA to pause, reflect, and work to repair its reputation. Instead, the

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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