White House (OMB) hasn’t held any additional meetings in past 3.5 weeks on the FDA’s Enforcement Discretion Policy for CBD — I think that’s a good sign that the White House and FDA are in the final stage of putting together this policy
The Global Widget meeting is looking very much looking like a courtesy meeting:
FDA Enforcement Discretion = “Legalization” + Regulations
So it will be a definite gamechanger for the Hemp-CBD industry and the CBD sector when the FDA announces this policy
Here are the ramifications of an FDA Enforcement Discretion Policy for CBD Products:
Enforcement Discretion for certain CBD products is de facto national legalization
In essence, the FDA would announce that they will permit national sales of CBD products as long as these products avoid making health claims and follow interim regulations
Practically speaking, this should greenlight national sales and open up banking, as the FDA-related legal risks of interstate commerce are largely erased and the fear of a federal crackdown on these products is removed
A declared FDA policy of formal enforcement discretion would have a number of positive effects on the national CBD industry, chief among them:
The distribution of CBD products would spread across the country in medical offices and retail stores
Financing for CBD businesses would open up
Investment in the CBD industry would increase
Sales of CBD products would increase sharply
It sounds like a strange situation, but the FDA regularly applies the policy of enforcement discretion in situations like the current CBD conundrum, when more time is needed to create final regulations around a product or device before it can legally enter the marketplace, but there is a need or demand for that product/device in the marketplace now — it’s basically a form of conditional legalization — “We will allow you to manufacture, distribute and sell these products as long as you follow these rules (interim regulations) and do not make health claims.”
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