7 Insights About the FDA Draft Guidance

LAKEVILLE, Minn.— With the issuance of a draft guidance on tobacco policy in March, the U.S. Food and Drug Administration (FDA) has unleashed a cascade of uncertainty and confusion as to what it both intends to do and has the actual power to do, raising concerns among retailers and the potential for litigation from any number of stakeholders.

The proposed policies focus on flavors in vaping products and cigars, suggesting measures such as restricting the sale of flavored products, “stores within stores” that only adults can enter, and altogether barring flavored cigar sales other than tobacco.

To help retailers wade through the newly unsettled terrain, NATO, a Lakeville, Minn.-based tobacco-retailing group, held a webinar recently to lay out its understanding of the draft policy and what it means for the industry.

Here are several insights ...

The draft guidance that the FDA issued March 13 is not a proposed regulation, according to Tom Briant, executive director of NATO. It is a set of enhancements to its current polices on how it will administer and enforce tobacco regulations in the United States. Its development and implementation differs from an official rulemaking process—where true regulation emerges—in that guidance changes can occur within a matter of months, while formal rulemaking can take years.

While not specifically banning sales of e-cigarettes flavors (excluding menthol, mint and wintergreen) or any flavor of cigar except tobacco-flavored, the policies, if developed into a formal guidance, prioritize FDA enforcement measures, Briant said. The agency would prioritize retail locations with actions that could include inspections, warning letters and bans on selling tobacco.

While the draft guidance talks about allowing flavored-tobacco sales in a section of a store where minors aren’t allowed, the concept of "a store within a store" is vague and unclear, Briant said. When asked if behind-the-counter placement qualified—because no one is allowed behind where the tobacco products are—Briant said the FDA was unclear, but he sees potential in that argument. However, he said the agency could mean a physical walk-in space potentially involving an employee at the entrance checking IDs.

The draft guidance also cuts off any pathway for new product approval for any flavor of cigar other than tobacco. Briant said revised new-product application policies specifically eradicated any opportunity for such products to enter the process. The FDA stands on shaky footing with its justifications, Briant said, noting that no data proves the type of gateway progression from flavored e-cigarette use to flavored cigar use to cigarettes.

Briant named several areas where the industry could have standing to contest the FDA’s actions. One involved a stipulation in the Family Smoking Prevention and Tobacco Control Act of 2009 that forbade the agency from favoring one kind of retail channel over another with regard to tobacco sales.

Another argument centered around manufacturers’ need for the time originally provided to prepare their new-product applications. Cutting short that time was detrimental to those manufacturers. The draft guidance policies put new-product application deadlines for flavored e-cigarettes a year earlier than what it set in 2017.

A third position has to do with the agency’s use of the guidance-development process when it should be using the more formal, federal rulemaking path to achieve its goals.

When asked if the popular Swisher Sweet cigars and cigarillos were actual flavors, Briant said he did not think so, and that “Sweet” in that respect, came from a decades-old trade name and not necessarily a flavor ingredient.

Other flavored-cigar products exempt from the process would be those on the market before Feb. 15, 2007, which are “grandfathered in” and permitted for sale in the United States.

While NATO is asking for an extension of the public comment period on the agency’s draft guidance, which ends April 15, the tobacco-retailing association still appealed to members to submit comments to the FDA. Their voices are important, Briant said.