How the FDA Got Her Groove Back (With CBD Warning Letters)

The FDA has changed its approach when enforcing compliance for nicotine and cannabis products. Whereas previously the FDA was practicing enforcement discretion, often limited by the lack of guidance and will, the FDA is slowly solidifying its stance on how it will regulate vaping products, CBD products and pharmaceuticals. As a result, companies in FDA regulated companies are forced to scramble as the consequences of not following regulations leave them exposed to administrative penalties, fines or even criminal prosecutions.  Increase in warning letters When examining the FDA’s most recent enforcement actions, it appears that the FDA targets companies based on how they frame the intended use of their products. The intended use of a product is determined by looking at the product labeling and also the claims and advertising materials accompanying the product. Companies must be cautious when promoting their products to ensure that they do not produce products that are adulterated, misbranded or unsafe.  The FDA has been issuing warning letters much more frequently, particularly as CBD and vaping products become more popular. In 2017, for instance, the FDA only issued five warning letters. However, enforcement in 2019 increased so much that one letter has been issued per month in the last three months. There has been a similar uptick in enforcement trends around the promotion of vaping and cannabis. Effects on nicotine and CBD industries The United States House Committee on Appropriations recently stated that it expects the FDA to identify lawful regulatory pathways for CBD foods and dietary supplements. These pathways would include safety parameters such as labeling requirements and limitations on CBD quantities to protect public health. The committee has also said that the FDA needs to preserve the integrity of its drug development and approval process to ensure drug products are going through validation processes, and have been tested for safety, quality and efficacy. Overall, the committee has significantly pressured the FDA to speed up their regulatory process and develop their stance on vaping and cannabis products. This may be a difficult undertaking, as FDA Chief Information Officer, Dr. Amy Abernethy, has estimated that it may end up taking up to five years to generate a complete regulatory framework for CBD. The dangers of inappropriate promotion Vape Companies Although recent updates in the law suggest that evidence of off-label intended marketing may not be inherently illegal, it can still lead to civil, criminal or administrative penalties. This is where some companies go wrong–they may speak off-label and end up violating FDA mis-branding provisions. This was the case for multiple vaping companies, including Juul, which ended up being penalized for their relationship with social media influencers. Influencers neglected to include mandatory warnings in their posts about nicotine in vape and violated FDA regulations.