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Who Will Drive Innovation in CBD Products?

Cannabidiol (CBD) has the potential to be big business. Since the descheduling of hemp-derived CBD, large corporations have been exploring how they might capitalize on CBD’s hold on the public’s attention. CVS and Walgreens announced their rollout of CBD products in thousands of stores. The creator of Jelly Belly plans to make CBD jellies. CBD’s potential marketability stretches across diverse industries and target markets. But the regulatory uncertainty around CBD products puts all of these actions in a legal gray area. And although large companies might be willing to test the waters with low risk investments, capital-intensive research and development (R&D) is likely on hold until the FDA or Congress clarifies CBD’s regulatory future. And it is precisely this type of research that is needed to bring products to the market that can offer something more novel than the small-batch CBD products that have been available in some states for years.   The passage of the 2018 Farm Bill removed hemp and its derivatives from the Controlled Substances Act. CBD’s new status allows companies greater flexibility to use CBD in R&D. But the complex web of FDA regulations, combined with the ready availability of locally-made CBD products, may disincentivize companies from delving too deep into CBD’s therapeutic potential. The FDA considers any product with a therapeutic “intended use” a drug. Once a product is classified as a drug, it is subject to the extensive–and expensive–process by which the FDA approves new drugs for the market. Drug companies rely on market exclusivity to recoup the costs of pre-market approval. Companies interested in developing CBD-based therapies are in the unique position...

Telemarketing and the TCPA: Still Stuck in 1991?

“Computerized calls are the scourge of modern civilization.” This 1991 quote by Senator Fritz Hollings is as relatable today as it was nearly thirty years ago. Whether it’s a call congratulating you on winning a vacation to Florida, a voicemail recording in Mandarin, or your trusty cable provider soliciting even more of your money, every consumer appreciates how pervasive these calls are. Do not call registries, attempts to block offending numbers, and apps created to filter out spam calls fail to provide meaningful protection against evasive tricks like spoofing (where the spam-callers use an area code and number similar to your own). A recent analysis estimated that the number of robocalls made per month increased by over a billion in the first half of 2018. A large percentage of these calls are scams (like the recording in Mandarin) or debt collections. But a substantial number are telemarketing calls (like the evening ring from your neighborhood cable service). And consumer groups are worried that recent changes in the law and regulations restricting telemarketing are going to make the situation worse. Congress enacted the Telephone Consumer Protection Act in 1991 to protect consumers from the proliferation of automated telemarketing calls. The TCPA prohibits calls to cellular phones that are placed using an automatic dialing system or a pre-recorded message, without the prior consent of the recipient. The Act authorizes a private right of action and plaintiffs may recover at least $500 in damages for each call made in violation of the statute, and up to treble damages for each “willful or knowing” violation. The TCPA delegates authority to the Federal Communications...