At Last, Some Good News from the FDA for Vape Shops!

The U.S. Food and Drug Administration will allow vape shops to change coils, assemble kits, and fill atomizers on-site for customers, even if they are not designated as tobacco product manufacturers under the deeming rule.

The federal agency has just released guidance rules that clearly outline what activities are allowed in retail stores in plain English. Since the deeming regulations were published, business owners have repeatedly sought clarification.

The deeming rule was published last May and went into effect on August 8, 2016. According to the FDA, any retail business that “creates or modifies” newly deemed “tobacco products” (which includes all e-cigarettes and vapor products) will be considered a manufacturer and must register as such, list all products sold, submit health documents to the agency, report ingredient lists, and report harmful and potentially harmful constituents (HPHC). Additionally, manufacturers must submit premarket tobacco applications (PMTA) for all products they create or modify.

Many vapor retailers have explained these regulations, including prohibiting basic customer service activities such as changing coils, assembling devices for new vapers, simple repairs, or explaining product functions. The FDA has avoided accurately stating what is allowed in several online seminars, calls, and emails with store owners.

The following activities can be conducted in vape shops without certification as manufacturers:

· “Demonstrating or explaining the use of ENDS products (Electronic Nicotine Delivery Systems) without assembling products”

· “Maintaining ENDS products through cleaning or tightening fixtures (e.g., screws)”

· “Replacing coils in ENDS products with the same coil (e.g., same resistance and wattage)”

· “Assembling components and parts into a final product within ENDS kits”

Furthermore, the FDA stated it would not enforce some activities considered “modifications” of products. According to its announcement, the FDA “does not intend to enforce the five requirements listed above against these vape shops if, in general, all modifications are consistent with the conditions of the FDA’s marketing authorization (MA) or if all modifications are consistent with the specifications provided by the original manufacturer.”

Examples of modifications now allowed by the FDA include:

· “Refilling an open ENDS system, provided that no further modifications to the device or e-liquid are made outside of the FDA marketing authorization (MA) order before, during, and after refilling”

· “Refilling an open ENDS system, provided that no further modifications to the device and e-liquid are inconsistent with the manufacturer’s specifications and no MA order exists”

In other words, as long as no modifications are made to the device beyond what is recommended by the manufacturer (as per marketing orders or instructions), stores will be allowed to assist customers in refilling atomizers.

They specifically explained that replacing coils with any other coils not designed for specific atomizers is prohibited. Therefore, it is not allowed for staff to create for customers. Filling closed system devices is also prohibited.

The publication of the new draft guidelines also opens a simple window for public opinion. All retailers and customers of vape shops can provide specific criticisms or suggestions on how the deeming rule affects vape shop transactions.

The draft guidelines closely follow the FDA’s postponed deadlines related to manufacturers. The deadline for manufacturers to register with the agency was postponed from December 31, 2016, to June 30, 2017. Shortly thereafter, the FDA also postponed the deadline for submitting ingredient lists from February 8 to August 8, 2017.

Finally, the agency announced in this document that it would not require all tobacco products to provide “an accurate statement of the percentage of foreign and domestic tobacco used in the product.” This is indeed a relief.