The FD&C Act does not include a private right of action — only the Agency can enforce FDA law and regulations. Traditionally, courts have been reluctant to entertain private lawsuits under the Lanham Act and unfair trade practice laws as a back door to enforcing FDA laws. However, a recent court ruling in POM Wonderful v. Coca Cola has changed the Lanham Act landscape, opening the door to private lawsuits for unfair competition related to FDA, particularly related to unfair competition from unapproved products, dietary supplements, compounded products, off-label promotion, and even counterfeiters and diverters. Hear from experts on what POM Wonderful and subsequent cases mean for industry, and how these cases are shaping FDA policy and enforcement actions.

The US market has been flooded with CBD products since the 2018 Farm Act was signed into law on December 20, 2018, but with no federal regulations concerning the manufacturing, marketing, or sale of CBD and CBD-containing products, we look to the only official guidance issued thus far: warning letters and state actions. Marketing CBD products for therapeutic purposes online has been at the core of these warning letters, but what does that mean for CBD products that do not include therapeutic claims? This panel will discuss the most recent warning letters, address enforcement actions at the state level, analyze the potential for increased enforcement in this area, discuss enforcement priorities for products making egregious claims, and brainstorm how CBD manufacturers can remain “compliant” in this uncertain regulatory environment.

This session will feature a round-up of recent court decisions, pending cases, and state and federal enforcement actions that either have or likely will impact the tobacco and nicotine products industry. Topics will include: litigation to postpone or remove the May 12, 2020 premarket application deadline; state and private litigation against ENDS manufacturers; federal and state efforts to ban flavors; and a discussion of recent FDA warning letters.

In litigation challenging FDA actions under the Administrative Procedure Act, courts have long deferred to FDA’s interpretation of its own regulations, which means in practice, the agency almost always prevails. Recently, the Supreme Court revisited this deference doctrine in the case Kisor v. Wilkie. Although the Court did not invalidate the doctrine it did articulate numerous restrictions on judicial deference. These restrictions could affect the outcome of future litigation challenging FDA actions by increasing the situations in which courts may invalidate FDA’s interpretation of its own regulations. The panel will discuss the potential implications of Kisor v. Wilkie.

This panel will take a practical look at issues companies face while importing FDA-regulated commodities into the US. After a short introduction to the import process, panelists will discuss and offer insight on issues including: prior notice, import orders  and the differences between import alerts (IA) and import bulletins (IB), FSMA’s FSVP, third party certification of high-risk foods, suspension of registration, and the differences between importing diverse commodities.

FDA has estimated that it has received more than 800 cell and gene therapy INDs, with 200 more expected yearly by 2020. Companies developing these innovative products face many challenges during product development through approval and commercial marketing. This panel will discuss several critical compliance and enforcement challenges facing cell and gene therapy companies, such as: the status of recent stem cell compliance and enforcement actions and pending litigation and whether FDA poised to take more action at the end of the enforcement discretion period next year to further define 351 vs. 361 products; and compliance challenges during the clinical study phase, including transitioning from clinical to commercial manufacturing. What can companies learn from pending actions against Novartis/Avexis for data manipulation? Are there other compliance concerns?