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
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.
Despite the ambiguous regulations surrounding the promotion of CBD, the FDA issued cannabis operator Curaleaf a warning letter on July 23, 2019. The FDA warned Curaleaf for making unsubstantiated claims in its advertisements, claiming that CBD products were anti-inflammatory, treated pain and anxiety, and addressed psychotic symptoms.
This 2019 warning letter follows a string of letters issued on November 1, 2017 sent to cannabis companies, including Green Roads, GreenHealth and Natural Alchemist. The FDA issued a few of these letters because of false health claims made that CBD had the potential to treat cancer by killing off cancerous cells. Because evidence did not back these medical claims, the FDA deemed that the companies making the false claims were out of compliance.
Dealing with promotional enforcement
Because of changes to the FDA’s enforcement priorities, companies within the nicotine and CBD industries should be prepared to deal with the uptick in promotional enforcement. This means that companies should focus on setting up effective quality systems to ensure that products are meeting accuracy and precision standards and building quality into products by design. This may require additional oversight through audits or Medical Legal Review (MLR) processes. If problems occur, companies should undergo a root cause analysis to test whether a corrective or preventative action is being met. If problems continue to arise, companies should a warning letter response team able to communicate with the FDA.
If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.
I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Play or on Soundcloud.