ALEXANDRIA, Va. – NACS and the Society of Independent Gasoline Marketers of America (SIGMA) this week jointly submitted formal comments on the FDA’s draft guidance regarding the sale of flavored – other than mint, menthol and tobacco – electronic cigarettes. Hundreds of retailers also have submitted comments to the agency.
In comments addressed to Dr. Norman Sharpless, acting commissioner of the FDA, NACS and SIGMA said they share the FDA’s concern over the increased use of e-cigarettes by underage consumers; however, the groups pointed out that the draft guidance doesn’t address that concern but instead favors some retail outlets over others “in a way that is not consistent with the reality of the marketplace.”
In its draft guidance, the FDA proposes to focus its enforcement efforts in stores that allow minors to enter (such as convenience stores), essentially banning those stores from selling most flavored e-cigarettes. Simultaneously, FDA intends to allow stores that are adult-only (such as vape shops and tobacco shops) to continue selling the products. With its proposed action, FDA has not provided data that supports this type of distinction between adult-only and stores where minors can enter. In fact, the draft guidance cites data showing that more teens acquire e-cigarettes from vape shops (14.8%) than from convenience stores (8.4%).
If implemented as written, the FDA’s draft guidance “will push underage consumers to retail outlets with the worst track record of compliance with age restrictions. The result will be more overall sales of [e-cigarettes) to minors rather than less,” NACS and SIGMA pointed out. An American Journal of Health Promotion study indicates that each vape shop/tobacco store is 100 times more likely to sell e-cigarettes to a minor than the average convenience store.
While the Tobacco Control Act gives the FDA the authority to regulate tobacco products, it also imposes limits on that authority. For example, the Tobacco Control Acts states that the FDA cannot “prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets.”
The associations added that the current draft guidance is an attempt to impose a regulation on an industry, which mandates a more extensive rulemaking process than the FDA has used in this situation. For one, the FDA has not performed an economic cost-benefit analysis as part of this rulemaking process as required by law, and the draft guidance is inconsistent with the current administration’s regulatory agenda and directives.
The comments note that tobacco sales are vital to the convenience industry’s economic viability, since tobacco products were nearly 38% of an average store’s in-store sales in 2018. Because those products are highly regulated, the associations have devoted extensive time and resources to ensuring that c-store operators are equipped to comply with all tobacco regulations. NACS and SIGMA agree with the FDA that efforts must be made to prevent underage customers from accessing tobacco products but maintain that the agency should focus on underage users’ access to the products themselves. Stores should keep them behind a sales counter that is solely accessible by adult employees.
Finally, the comments noted that the draft guidance uses confusing language and high-level recommendations that don’t specify how retailers can comply. Plus, the FDA has said it will begin enforcing the updated policy in 30 days after it is finalized, which is not sufficient time for businesses to respond appropriately.
This week, 46 members of the U.S. House of Representatives sent a bipartisan letter to the FDA addressing some of the same concerns. The letter, which was led by Congressman Trey Hollingsworth of Indiana, underlines that the proposed restrictions pick winners and losers in the marketplace by allowing certain channels of trade to sell these products and prohibiting other channels like the convenience store and grocery channels.
"We should want a marketplace where in all players are competing under equal rules and that advances the stated, pressing public policy need of keeping e-cigarettes out of the hands of minors. That mission is advanced by having a set of guidelines that enables and ensures compliance by all retailers, not one that fundamentally excludes one set of retailers who have proven capable of compliance with laws forbidding the sale of products to minors,” the letter stated.
Additionally, the letter raises concerns with the FDA’s process in implementing the draft guidance. While the agency accepted public comments on the draft guidance from March 13 – April 30, 2019, it did not go through a notice and comment rulemaking, which it is required to do under the Tobacco Control Act when regulating the sell and distribution of tobacco products.
The members concluded by applauding the age verification efforts of the convenience store industry.
“The convenience stores and grocery stores that have for decades demonstrated consistent compliance deserve the data underpinning a decision that would bar their sale of these products to legal adults and a process wherein the industry could provide input about the guidance’s impact on equality in the marketplace,” the letter states.