Earlier this month, five U.S. senators, led by Senate Majority Whip Dick Durbin (D-Ill.), issued warning letters to 22 major retailers and distributors for the sale of allegedly unauthorized vape products. Other senators involved in the issuing of the letters include Bernie Sanders (I-Vt.), Sherrod Brown (D-Ohio), Richard Blumenthal (D-Ct.) and Ron Wyden (D-Ore.).
The senators wrote, “Companies distributing or selling any such unauthorized products are subject to enforcement penalties by the Food and Drug Administration (FDA), which may include a civil monetary penalty or no-tobacco-sale order. To date, FDA has issued more than 440 warning letters and 88 civil monetary penalties to retailers for the sale of illegal e-cigarettes and vaping products. Retailers and distributors engaged in the sale or distribution of such unauthorized products risk liability.”
Staying in Compliance
Some industry experts are concerned that FDA regulations with regards to e-cigarette products remain unclear. Therefore, it is more important than ever that retailers stay up to date with compliance protocol.
“Retailers can check the FDA’s online Center for Tobacco Products to check if they are carrying any products that have been the subject of an FDA enforcement action,” said Anna Ready Blom, director of government relations for the National Association of Convenience Stores (NACS). “They should also ask that their suppliers provide evidence of compliance for their products. However, compliance can be difficult because the FDA’s list of marketing denial orders does not specify what products are covered and indicates that some products from at least 18 manufacturers may be sold while undergoing further administrative or court processes.”
David Spross, executive director for the National Association of Tobacco Outlets (NATO), added that retailers should track the FDA’s marketing granted order (MGO) and marketing denial order (MDO) decisions through the agency’s website and press releases.
“Retailers should stay informed of FDA enforcement actions, which can provide some insight to the vapor products that are current FDA enforcement priorities,” said Spross.
The lack of clarity from the FDA regarding the authorization processes of vape products can lead to confusion from retailers, which is why operators should remain vigilant and informed.
“Currently, there is a lack of clarity and information from the FDA regarding the premarket tobacco product application (PMTA) process. Specifically, it is difficult to identify products covered by timely-filed, still-pending PMTAs,” added Spross. “These PMTAs may be pending because FDA has not yet completed its review (even though many of these applications have been before the agency for over three years), or because FDA or a court has stayed a negative determination.”
NACS’ Ready Blom mirrored Spross’ thoughts, noting that the lack of clarity on products that cannot be sold poses real challenges for retailers who might want to continue to be responsible about what products they sell, and how they sell them.
According to Spross, the FDA needs to communicate its enforcement policies better or provide an accurate and updated list of products awaiting PMTA decisions.
“Despite the diligence of responsible retailers, including requesting documentation of timely-filed PMTAs, it is often impossible to differentiate between products that blatantly flout the law — for example, those for which no PMTA was filed at all or a PMTA was filed after the applicable deadline for on-market products — and those that are the subject of PMTAs that were timely filed but are still waiting for FDA’s review process or completion of an appeal.”
Where We Stand
As of today, there are only 23 vapor products that have been approved with MGOs and a number of products still under review.
“While the FDA has stated there are only 23 vapor products that have received MGOs, FDA’s enforcement policies appear not to have focused on vapor products that are covered by timely-filed still-pending PMTAs,” noted Spross. “Therefore, retailers should check with their suppliers to obtain proof of a timely-filed pending PMTA application.”
Ready Blom stated that the FDA needs to supply retailers with updated information explaining how they can treat products that do not have final order decided, stating that it is “unclear what is the universe of products under a type of review such that they may continue to be sold.”
This uncertain space between a product with a pending PMTA and a product with a final MGO is where retailers are seeing confusion.
“Retailers should keep their federal elected officials informed of the confusion and frustration with the FDA and let them know that FDA needs to urgently complete reviews of pending applications, authorize products that meet adult consumer demand, tell the retail community that products with timely-filed pending PMTAs are not an enforcement priority, provide a list of those products and take much more aggressive action against the companies that are ignoring FDA regulation altogether,” added Spross.
Spross said that there are five steps that the FDA needs to take going forward:
- Be more transparent about its requirements for authorization of a new tobacco product
- Review applications in a fair, timely and transparent manner
- Be guided by science in its application reviews
- Clearly articulate its enforcement priorities (including publishing an accurate and up-to-date list of products covered by timely-filed, still-pending applications)
- Effectively and consistently enforce against products and entities that make no attempt to comply with the legal and regulatory requirements, including by blocking imports of such products into the U.S.
Listed below are the companies that received letters from the senators, accompanied by links to their respective letters.
- 7-Eleven
- Circle K Stores, Inc.
- Casey’s General Stores, Inc.
- Murphy USA Inc.
- EG America
- GPM Investments
- bp America
- Chevron/ExtraMile Convenience Stores
- Wawa Inc.
- QuikTrip Corp.
- Kwik Trip, Inc.
- Sheetz, Inc.
- Pilot Co.
- Love’s Travel Stops & Country Stores, Inc.
- RaceTrac, Inc.
- Royal Farms
- Amcon Distributing Co.
- Atlantic Dominion Distributors
- Core-Mark
- McLane Company, Inc.
- Imperial Trading Co.
- H.T. Hackney