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FDA Year in Review: A Shifting Regulatory Landscape

The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning-enabled medical devices. FDA continued to take action to lower drug prices by focusing on approvals of competitive biosimilars and generic drugs, and FDA enforcement actions signaled the Agency’s ongoing interest in ensuring GMP compliance overseas.

1. Tobacco: E-Cigarettes Top Public Health, Enforcement Priority

E-cigarettes dominated the headlines throughout 2019. On December 31, 2019, the Trump Administration announced that it would remove most flavors of e-cigarettes from the US market. Two days later, FDA published a modified enforcement policy on flavored pod and cartridge-based e-cigarettes. Under the policy, companies that do not stop the manufacture, distribution and sale of flavored e-cigarettes (other than tobacco and menthol flavors) within 30 days risk FDA enforcement action.

FDA announced a shift in its compliance policy in March 2019 in response to the growing appeal of e-cigarettes to youth. Under the March 2019 policy, FDA put manufacturers and retailers of flavored ENDS on notice that they may be subject to FDA enforcement for selling flavored products without premarket authorization. FDA also tightened the deadline for companies selling non-flavored ENDS products to submit premarket tobacco product applications (PMTAs). The January 2020 policy further tightens the deadline to May 12, 2020 for all ENDS products.

The January 2020 policy is in part a reaction to the outbreak of lung injuries in teens and young adults associated with the use of e-cigarettes and vaping products.

Regulating e-cigarettes and other electronic nicotine delivery systems (ENDS) has been a priority for FDA since assuming authority over these products in 2016. FDA’s primary focus at the time, however, was curbing the use of combustible tobacco products, such as traditional cigarettes. FDA recognized that nicotine—a highly addictive substance—is most harmful when delivered through smoke particles in combustible cigarettes. The agency viewed non-combustible ENDS as a less harmful alternative to traditional cigarettes. Market data in 2018, however, showed an “epidemic-level rise” in youth use of e-cigarettes, and in 2019, the FDA (under then-Commissioner Gottlieb) developed a laser-like enforcement focus on e-cigarettes.

Based on the new policy, we can expect escalated enforcement in 2020 against companies manufacturing and selling unauthorized e-cigarettes. We also may see FDA take a stance on its authority over non-tobacco e-cigarettes, given the open questions regarding the substances causing the reported lung injuries (e.g., tetrahydrocannabinol (THC), vitamin E acetate).

2. Food and Supplements: CBD Was All the Buzz, FDA Stymied by Lack of Data

In 2019, hemp-derived products, including those containing cannabidiol (CBD), moved from the fringe to the mainstream, from state-licensed dispensaries to traditional brick-and-mortar retailers. And yet, the FDA’s position has been clear — it is illegal to sell human food, pet food, dietary supplements and unapproved drugs that contain CBD.

As previously reported, on May 31, 2019, FDA held a public hearing on cannabis and cannabis-derived compounds, and drew a wide audience of participants, with strong views on how the FDA should (or should not) regulate the controversial plant. The hearing focused on the use of CBD in food and dietary supplements, which accounts for a large part of the market growth. (CBD is not prohibited in cosmetics; unlike foods and dietary supplements, cosmetic ingredients do not undergo safety review prior to commercial use.)

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