WASHINGTON — The U.S. Food and Drug Administration (FDA) appears to be making an end run around its normal, lengthy rule-making process by putting language in its newly issued draft guidance about age-restricted access for stores that sell certain flavored e-cigarettes and flavored cigars, according to a lawyer formerly with the FDA’s Center for Tobacco Products (CTP).
Saying this isn’t the first time the FDA has tried to “regulate by guidance,” Jonathan Havens, chair of the food and beverage group for Saul Ewing Arnstein & Lehr, Washington, D.C., told CSP Daily News that the agency’s newly released draft guidance, when finalized, would be nonbinding, but it could have the same effect as regulations by prioritizing how the FDA would initiate enforcement action.
Those protocols surfaced in recent weeks when the FDA filed complaints seeking a 30-day ban on selling tobacco products at two stores for what it claims were repeated tobacco sales to underage operatives. Prior to those public announcements, the agency said it issued 1,300 warning letters to retailers for similar alleged violations.
On a practical level, the biggest difference between a guidance and a regulation is time. The guidance-making time frame could be a few months, while the more formal regulation-setting process—known as “notice-and-comment rulemaking,” according to Havens—is a multistep endeavor involving advance notice of proposed rulemaking (ANPRM); a proposed rule; a final rule and public comment; and FDA consideration and response to the same along the way. FDA notice-and-comment rulemaking has been known to take years.
“While FDA guidance is technically nonbinding, the agency has been known to try to regulate by guidance,” said Havens, who began his career at the CTP and now counsels clients on a broad range of federal and state regulatory, compliance and enforcement matters.
To restrict the sale of certain products, the FDA would have to go through formal rulemaking, he said.
The public has until April 12 to submit comments on the draft guidance, after which the FDA will review those comments to help it develop a final document, according to the International Premium Cigar and Pipe Retailers association (IPCPR), Washington, D.C. While the FDA gave no time frame on how long it would take to unveil that final document, IPCPR officials say policy changes could become effective 30 days after that version comes out.
The other key aspect of the draft guidance document is the moving up of the deadline for manufacturers of flavored e-cigarettes (other than tobacco, mint and menthol flavors) to submit premarket tobacco product applications (PMTAs); the deadline is now Aug. 8, 2021. In July 2017, the FDA pushed existing application deadlines for all vaping products to Aug. 8, 2022.
Havens said that because the FDA originally pushed back the deadline under an enforcement policy, it’s probably on strong legal footing to move the deadline back up; however, he questioned whether the FDA will be logistically ready to substantively review e-cigarette PMTA submissions by 2021.
Whether the FDA can impose what could be perceived as new regulatory requirements using a guidance policy is a question that could receive legal challenge, he said.
“You could argue there is unequal treatment between online vs. brick-and-mortar, if stores have to create an age-restricted area and online only has to do third-party verification,” Havens said. And while the FDA may try, he said, it “can’t prohibit the sale [of tobacco products] for any one category of retailer.”
Whether the FDA’s new guidance policy will ultimately have its intended effect, Havens’ biggest advice to retailers is to continue to focus on a “robust” age-verification program. “For the FDA, the low-hanging fruit are stores that have already received warning letters for violative sales of flavored products,” Havens said.