mitigating risk for clients in the emerging CBD sector
FDA Regulatory Counsel has been advising clients on CBD business since 2014. There are currently legal avenues to manufacture and sell CBD products under both federal and state laws. There are also wide-ranging business options along the risk spectrum on which we are well-versed in counseling. In addition, FDARC monitors evolving regulatory priorities and tracks enforcement actions so our clients can make the most informed business decisions.
Our attorneys are comfortable in this space because of our long history of providing legal counsel in emerging industries. Time and experience have taught us that regulators approach new products in familiar ways. Whether dietary supplements, med-tech, aesthetics treatments, wellness therapies, compounding pharmacies or vape products, to name just a few, we have been able to provide practical, actionable legal advice at the intersection of innovation and regulation.
Compliance With Current Applicable Regulations
With passage of the long-awaited Farm Bill, first in 2014 and again with further clarity in 2018, Congress legalized hemp crops by effectively decoupling CBD from federal marijuana drug laws. As a result, 2019 has seen a proliferation of 'non-marijuana' products akin to post-prohibition days in America. In fact, the current state of the market is often described as the Wild West due to the vacuum of standards and practices established for these products by either regulators or industry.
However, FDA already has an ample toolkit of product-agnostic regulations to apply to the CBD industry. For example FDA and FTC have already started enforcing False Advertising, Product Claims, and Product Safety/Quality regulations against CBD stakeholders in the form of Warning Letters to individual companies found to be in violation.
Agency Position on CBD
In addition, the FDA often guides industry by publicizing its current thinking on compliant practices. For new products like CBD, where official regulations have not yet been promulgated, this informal guidance is often the most reliable compliance benchmark industry can use. FDARC continually monitors the Agency's positions as they evolve so our clients can make informed business decisions.
The FDA crowdsources scientific information on innovative products. At a public hearing on May 31, the Agency engaged in a robust dialogue with industry stakeholders in which it both shared and solicited areas of focus and concern. FDARC actively participates in public fora so we can share our insight.
The beginnings of an industry are where the FDA is most open to considering varied paradigms and pathways for regulation. For stakeholders who wish to establish themselves as leaders by working collaboratively with FDA in shaping the dialogue and regulatory standards, FDA Regulatory Counsel is an experienced guide.
The combined machinery above will continue - shaped by politics, consumer events and market trends - until an operational framework of standards and practices eventually emerges. Stakeholders who best plan for these cycles, and mitigate their attendant risks, are invariably best-situated to achieve their business objectives.
FDARC represent clients looking to establish themselves as leaders in shaping CBD dialogue and regulatory standards, as well as those who prefer to focus on maintaining compliant operations while others pave the road. We invite all businesses that participate or invest in this booming industry to learn how we can support your goals through transactional diligence, compliance guidance, and regulatory advocacy.