The FDA took a hard stance on e-cigarette regulation under former FDA Commissioner Scott Gottlieb. With his departure and replacement by Norman Sharpless, manufacturers and lawyers are watching closely to see what’s next, with most expecting the agency to continue its crackdown.
Sharpless has shown support for the FDA’s efforts on underage vaping, and “if anything, he will likely defer to the Center for Tobacco Products to continue what they’re doing,” says Azim Chowdhury, a partner in Keller and Heckman’s food and drug law practice. “In their view, we’re dealing with an epidemic of underage users, so I don’t see any letup on enforcement.”
The FDA’s crackdown has already brought significant changes and concerns for the e-cigarette industry:
- The agency issued guidance in March that aims to limit sales of certain flavors of vaping products to stores that are adult only or have adult-only sections.
- In April, Gottlieb blogged that increasing youth use of e-cigarettes could prompt the agency to reconsider its current enforcement discretion, which has granted manufacturers until Aug. 8, 2022, to file premarket tobacco applications (PMTA) for products marketed before Aug. 8, 2016.
- Gottlieb also stated that the FDA might temporarily remove pod-based nicotine products from the market if youth use continues to rise.
Manufacturers’ next moves
With the spotlight expected to stay on the e-cigarette industry, manufacturers should be taking steps now to make sure they aren’t the subject of the FDA’s next enforcement action.
In particular, the March guidance suggests that enforcement could be taken against manufacturers for retailer actions that they have little control over. Both Chowdhury and Eric Heyer, a partner in Thompson Hine’s business litigation and e-cigarette industry practice groups, recommend manufacturers be proactive by setting restrictions with their brick and mortar retailers. These restrictions should ensure products are not seen as targeting youth. It is also important to look into online sales and make sure vendors’ age verification methods for both in-person and online sales are appropriate.
A critical step is reviewing distribution and supply agreements, Heyer says. “The FDA has indicated very forcefully it’s looking for appropriate restrictions that will flow down to the retailer level in terms of not marketing to youth and not having youth access to the products.” He notes that while there are multiple links in the supply chain, he anticipates that FDA will look more favorably upon manufacturers who have contracts with their high-volume distributors that have detailed, flow-down provisions restricting marketing and sales to minors.
Chowdhury advises manufacturers to make sure their products are only made available in adult-only stores, or, if in a convenience store, that the convenience store has created a walled-off section that is adult only.
Manufacturers must also exercise caution with advertising, social media, packaging and labeling. “This means not using cartoon characters or models that appear to be under the age of 25. You want to market your product in a mature way,” Chowdhury says.
While taking these steps, companies should also be preparing for the guidance to become final by working on their PMTA strategy.
Possible legal challenges for FDA
As manufacturers move forward on measures to protect themselves, the FDA’s enforcement efforts and guidance face some legal uncertainty. In particular, there is a good chance litigation will be brought against the guidance, depending on its specifics once finalized, Heyer says.
Chowdhury also believes the agency will face legal challenges once the guidance is finalized, as its enforcement efforts link to its ability to exercise enforcement discretion and modify compliance dates, effectively preventing retailers from selling certain types of products. “It’s not clear Congress intended the FDA to use their ability to change compliance dates in this manner.”
The FDA could also face lawsuits if it moves forward with the threat to temporarily remove pod-based nicotine products from the market, as it would be exclusively taking enforcement action or changing enforcement policy to specifically target pod-based systems, says Heyer. However, “I would be surprised if they would move quickly to something like this.”
It remains to be seen how any potential legal challenges will shake out. In the meantime, manufacturers can and should take a variety of actions to insulate themselves against possible FDA enforcement and ensure they are on firm footing should the spotlight turn to them.
April Hollis is Custom Content Editor, Health Care. She has been with SmartBrief for six years and has covered health care topics since 2006.
For more news, research and commentary delivered straight to your inbox, check out all of SmartBrief's life sciences and technology newsletters, covering pharma, biotech, devices and more.