What’s Next at the FDA?
What’s Next at the FDA? The future of CBD.
Dr. Scott Gottlieb’s announcement of his departure from the FDA on March 5, seemed to catch the industry by surprise. None more so then the nascent CBD industry.
With President Trump’s December, 2018, approval of the Farm Bill and Hemp Act legalizing hemp farming, the sale of hemp derived CBD and the removal of hemp from the controlled substance list the stage seemed set for the launch of what the Brightfield Group suggests will become a $22 billion industry within five years. The notable caveat – FDA Commissioner Gottlieb’s concurrent announcement that the new law did not change the FDA’s role in regulating cannabis or cannabis derived compounds. Gottlieb stated “Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.”
This statement served to cast confusion across the world of CBD. The CBD industry is generally begging for regulation so that it can move forward in addressing consumer demand for innovative and cost-effective approaches to basic health issues. Goettlieb promised to accelerate the FDA’s consideration of CBD in finding regulatory pathways to support the industry. Several states have publicly deferred to the FDA to determine the safety and labeling requirements associated with CBD products. The FDA is also under enormous pressure from Congress. A February 15, 2019 bipartisan letter signed by 12 House members wrote “that a series of recent actions by state and local officials in New York City, Maine, and Ohio to crack down on the sale of CBD foods and beverages have “spurred a tremendous amount of confusion among product manufacturers, hemp farmers, and consumers of these products.” These House members “are calling on FDA to swiftly provide guidance on lawful pathways for food products with CBD.”
The implications and opportunities of CBD and hemp are far-reaching. On the production front, a promising and profitable new cash crop for our nation’s farmers. On the consumer front, a potential innovation for consumers looking for alternatives to traditional clinical solutions for general health issues from skin care to aches and pains and even a desperate need for an alternative to pain managing/addictive opioids.
The need for action is now – to protect consumers and the industry. A challenge for the FDA will be remaining neutral and truly evaluating the most effective safeguards for the consumer. The traditional pharmaceutical industry is not an advocate of a possible alternative to pharmacological products that can be grown and harvested on farms across the country. A great deal of clinical research is required before any clinical claims can be made, but the indications from 3000+ years of hemp production support the potential for hemp derived CBD to benefit consumers.
This is the challenge facing the next FDA commissioner – let’s hope he or she hits the ground running, maintains independence and keeps the consumer as the focus in defining CBD regulations.
Cannovia is a branding and product company specializing in commercializing federally-legalized cannabis products like CBD. The objective of Cannovia is to capitalize on the CBD opportunity, but to do so in a consumer-friendly manner. Cannovia will: ensure quality and consistency of CBD ingredients by sourcing through Cannovia Farms; create high-quality brands that are reliable and trusted; and incorporate transparent, educational information in all branding and communication strategies.
Brian Baum / [email protected]