Join the club if you’re a little confused about what e-cigarette and vaping products are effected by new regulatory restrictions being imposed by the U.S. Food and Drug Administration.
On January 2, 2020, the FDA officially published its final guidance in the Federal Register banning most flavored cartridge-based e-cigarettes, except for tobacco and menthol flavors. Under the new policy, companies that do not cease the manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes — other than tobacco or menthol — within 30 days risk FDA enforcement actions. But it’s not quite so cut and dry, and that’s why we looked a little closer at the 52-page document entitled “Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization.”
Remember, we’re only interpeting this information to the best of our ability. Please use your own best judgement with regards to how you proceed with the operation of your business. The official guidance policy can be found at https://www.fda.gov/media/133880/download.
When does the Final Guidance Policy go into effect?
The FDA guidance policy goes into effect on Thursday, February 6, 2020.
Does that mean products cannot be sold after February 6?
Technically, yes. However, the FDA intends to prioritize enforcement of any Electronic Nicotine Delivery Systems (ENDS) product that is offered for sale after May 12, 2020, and for which the manufacturer has not submitted a premarket application (or after a negative action by FDA on a timely submitted application).” So yes, there’s a February 6 deadline, but it won’t be enforced until May 13 —- use your own judgement as to whether you’re going to clear the shelves or keep on selling until then.
Which electronic nicotine delivery products cannot be sold under the Final Guidance document?
Beginning February 6, 2020, flavored cartridge-based and pod-based electronic nicotine delivery products (other than tobacco-flavored, menthol flavored or non-flavored cartridge-based or pod-based electronic nicotine products) cannot be legally manufactured, distributed or sold unless a specific product has received a Pre-Market Tobacco Authorization (PMTA) approval order from the FDA on or before February 6, 2020.
The FDA’s enforcement priorities are not an outright “ban” on flavored or cartridge-based ENDS. If a manufacturer of a flavored cartridge-based or pod-based electronic nicotine delivery product (other than a tobacco-flavored, menthol flavored or non-flavored cartridge-based or pod-based electronic nicotine product) has submitted a PMTA application which is under review by the FDA, the flavored cartridge-based or pod-based electronic nicotine delivery product still cannot be legally sold on or after February 6, 2020 until the FDA reviews the PMTA application and issues a PMTA approval order.
How do we find out who has submitted a PMTA application?
The FDA does not provide information on PENDING applications. Retailers should obtain information about pending applications from distributors and manufacturers so they can satisfy themselves that an application was filed on time and has not been denied. The FDA publishes a list of APPROVED applications on the agency’s website: tinyurl.com/pmtaapps.
Does the policy apply to tobacco and menthol flavors as well as the fruit/dessert flavors?
At least for now, tobacco and menthol flavors are exempt. The FDA has a twelve-month period from the date that a PMTA application is filed to review the application and decide whether to approve or deny the application. During this review period, the tobacco-flavored or menthol-flavored cartridge-based or pod-based electronic nicotine product that is the subject of the PMTA application can remain on the market. If the PMTA application is denied, then the product would be considered to be illegally on the market and there would most likely not be a sell-through period for the product.
Are pods banned?
It would seem so. Enforcement will focus on Flavored, cartridge-based products, which according to the FDA use: a cartridge or pod (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system.
Are bottled e-liquids banned?
According to the National Association of Convenience Stores: Rather than go for a full flavor ban requiring the removal of all flavored vaping products from the market as anticipated, the FDA has instead narrowed it down to small pod-based systems. Retailers can continue to sell e-liquid flavors used in open vaping systems and flavored disposable, single-use vape products.
Can bottles of nicotine e-liquid continue to be sold?
Yes, bottles of nicotine e-liquids that are intended for use in open system electronic nicotine products can continue to be sold after February 6, 2020. However, a manufacturer will need to file a PMTA application with the FDA on or before May 12, 2020.
Are there any exemptions to the ban?
Actually, there is a loophole. A footnote on page 9 of the FDA policy permits all flavors to continue to be sold in “completely self-contained, disposable products.” Examples of are Puff Bars, blu, Posh and Stig. Juul would also fit into that category, but they have voluntarily ceased manufacture and sale of flavored products.
How about mint flavor?
The guidance says that FDA will enforce against to mint, but not menthol. And that makes for another loophole. According to an opinion piece by the UC San Francisco Center for Tobacco Research Control & Education, because FDA seems to be talking about characterizing flavors not ingredients, there is nothing to keep e-cig companies from simply relabeling mint flavored e-cigs “menthol.” After all, menthol is derived from mint. They could package them in green, just as the cigarette companies did in Canada when menthol cigarettes were banned.
Are retailers that mix their own e-liquids required to file PMTA applications with the FDA?
Yes. A retailer that mixes e-liquids is considered a manufacturer by the FDA and will need to submit a PMTA application for each SKU. If PMTA applications are not submitted by May 12, 2020, then the retailer is subject to enforcement action by the FDA and the products would be considered misbranded by the FDA and on the market illegally.
Can “Grandfathered” products continue to be sold?
Yes. A “grandfathered” product is one that was on the market as of February 15, 2007. Grandfathered tobacco products are regulated by the FDA and do not require a PMTA application to be legally marketed. The FDA maintains a webpage which lists grandfathered tobacco products that the FDA has approved as grandfathered products (www.accessdata.fda.gov/scripts/ctpGnd/).
Are other vape products at risk?
Depends. The FDA intends to prioritize enforcement of all forms of ENDS products (flavored or otherwise) that do not have adequate measures in place to prevent minors’ access to these products. Such programs might include: screening retailers, in advance of establishing or renewing distribution agreements, based on the strength of the retailers’ age verification policies; establishing and publicizing a hotline for anonymous reporting of noncompliant sales; implementing a mystery shopper program; requiring use of technology that tracks age-verification practices; or other mechanisms.
Technically, all vape products are on the market illegally, even the ones the FDA has not singled out in its new policy. That’s because to be legal, a product would’ve had to receive premarket authorization, and no e-cigarette product has yet received such authorization.
If a retailer decides to remove effected products what should they do with the unsold stock?
Retailers should follow their own best practices for storing, handling and disposing of unsold stock that has been adulterated/recalled/banned or otherwise not permitted for sale. In general, products should not be in view of customers and should be packaged, sealed and secured within an area of the store or warehouse that the public cannot access until the products can be returned to the manufacturer.
What kind of actions could the FDA take to enforce the Final Guidance Document?
Actions could include a warning letter, issuing an import alert to refuse admission of tobacco products imported or offered for import into the United States, initiating seizure actions, taking civil court actions, and pursuing criminal prosecutions.
