Cannabis and the Often Overlooked Drug Exclusion Rule

Earlier this week, several major news outlets (CNN, Fox Business, and Bloomberg) reported that Coca-Cola is considering making a move into “cannabis drinks” — as evidenced by supposed talks with Aurora Cannabis, Inc., a Canadian owned and operated company that sells a variety of cannabis products including several strains of dried cannabis as well as several oils.  The company finally issued a statement, in response to many media inquiries:  “We have no interest in marijuana or cannabis. Along with many others in the beverage industry, we are closely watching the growth of non-psychoactive CBD as an ingredient in functional wellness beverages around the world.  The space is evolving quickly. No decisions have been made at this time.”

Caution might well be warranted with respect to products for sale in the United States, because of the often-overlooked drug exclusion rule at FDA.  Coca-Cola has sophisticated FDA counsel, and I am sure they are on top of this issue.  But others watching legal and real-world developments relating to sale of cannabis may not be aware of the rule, which presents a significant legal impediment to the sale of CBD in any form other than approved new drugs (even if no medical claims are made).

Many people don’t know about the drug exclusion rule . . .

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I <3 Intended Use (and why some new technologies may fall within FDA jurisdiction)

Cross-posted on Stanford’s Law and Biosciences Blog

A few news stories over the past week or so—one in the Wall Street Journal about “neurotech,” one in Geek Gadget about “neuroscience wearables,” one in the Washington Post about baby monitors for measuring an infant’s vital signs, and one in Gizmodo about “vaginal wellness products” marketed on Etsy—reminded me how much I enjoy questions of intended use.  As I wrote last week, intended use is a critical concept in FDA law, in part because a product’s intended use is crucial to determining whether it meets the law’s definition of drug or device within the FDA’s jurisdiction.  And, for whatever reason, I have an unabashed and—as far as I can tell—limitless love for thinking through questions about whether, and how, products fall with the definition of a drug or device.

As for the reported neurotech, neuro-wearable, baby monitor, and vaginal wellness products, it seems to me that many of these products may fall within the Federal Food, Drug, and Cosmetic Act’s (FDCA) definitions of drugs or devices.  Why is that?

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