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FDA Publishes Revised Ingredient Listing Guidance for Tobacco Products

Last week on the 13th of April, the US Food and Drug Administration (FDA), released a revised ingredient listing guidance for tobacco products which exempts non-consumable product hardware, components and parts.

Diane Caruana

April 20, 2018

The vaping industry has been asking the FDA to exempt the devices from the Tobacco Control Act Section 904(a)(1) for years. Finally, just under a month from the reporting deadline for large manufacturers of deemed tobacco products, the FDA published a revised Guidance for Industry: Listing of Ingredients in Tobacco Products.

The Guidance states that the FDA will now only enforce the ingredient listing for the tobacco product components or parts that are made of or derived from tobacco, or contain ingredients that can be burned, aerosolized or consumed during use.

Subsequently, the ingredient listing deadlines for the above components, remains unchanged, with large manufacturers having till the 8th of next May, and smaller businesses having till the 8th of November 2018. Additionally, vaping businesses must bear in mind that product components and parts are still subject to FDA’s premarket authorization requirements.

A positive step forward

This revised guidance is another good news for the vaping industry, despite the fact that many businesses have already spent considerable time and money to be compliant.

This revised guidance is another good news for the vaping industry, despite the fact that many businesses have already spent considerable time and money to be compliant. The infamous deeming rule has rocked the vaping world and led to the demise of several small well meaning vaping businesses. Many of these ventures were set up by ex-smokers who managed to quit with the help of e-cigarettes and were therefore motivated to share the products that helped them quit with the rest of the world.

Last August, the FDA announced a major shakeup to the agency’s policy on e-cigarettes which includes the de-nicotinization of cigarettes, and a PMTA deadline delay. Following that announcement, the FDA had issued a guidance titled Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule, in order to formalize and explain this deadline extension.

Parts and Components subject to ingredient listing

Below is a list of Components and Parts that are still subject to ingredient listing :

“The revised guidance provides examples of “consumable” components and parts that still require ingredient listing including, but not limited to:

Cigar filler;
Cigar binder;
Cigar wrapper;
Pipe tobacco;
Waterpipe tobacco;
E-liquids;
Cigarette tobacco;
Cigarette paper;
Smokeless tobacco;
Roll-your-own (RYO) tobacco;
RYO rolling paper;
RYO tube; and
Cigarette filter that contains any ingredient that burns, aerosolizes, or is ingested during use (e.g., cigarette filter with menthol because the menthol will aerosolize during cigarette smoking).

Products exempt from ingredients listing

Ingredients of tobacco product components and parts that are not made or derived from tobacco or consumed during use, e.g., pipes, hookah apparatus, vapor devices, etc., need not be submitted to FDA. Examples of components or parts for which FDA does not intend to enforce the ingredient listing submission requirement at this time include, but are not limited to:

Electrical components including, but not limited to, batteries, charging systems, circuit boards, wiring, and connectors;
System software;
Digital display, lights, and buttons to adjust settings;
Connection adapters;
Cartomizers;
Coils;
Wicks;
Tanks;
Mouthpieces;
Pipes;
Waterpipes;
Hoses;
Bowls;
Charcoal; and
Cigarette filter that does not contain any ingredient that is burned, aerosolized, or ingested during tobacco use.”