On May 10th the Food and Drug Administration (FDA) published a final rule expanding regulation to a range of products that meet the statutory definition of a “tobacco product,” including e-cigarettes, gels, and e-vapor among others. As a result, manufacturers of electronic nicotine delivery systems (ENDS) and e-liquids are scrambling to understand the potential impact on their businesses. Fortunately, the final rule becomes effective on August 8th, giving manufacturers time to comply with the immediate provisions of the final rule and plan for future effective dates. Manufacturers should be very proactive about entering the current market. The final rule’s effective date provides manufacturers three months to add tobacco products to the market without needing prior authorization from the FDA. Tobacco products on the market before August 8th will have staggered compliance dates giving manufacturers 24 months to submit an FDA premarket tobacco application (PMTA). This gives manufacturers of newly regulated tobacco products more time to comply with these new regulations, compared to a manufacturer attempting to bring a product to market after August 8th.
Manufacturers should also confirm that their products are not being sold to minors. This should include checking retailers and online vendors for standard operating procedures to verify age, and extends to eliminating the sale of tobacco products in vending machines. Both of these regulations become effective on August 8th.
Small businesses should determine whether or not they qualify as a small-scale tobacco product manufacturer. Manufacturers employing 150 or fewer full-time equivalent employees and with annual revenue of $5 million or less qualify. Small-scale tobacco product manufacturers receive additional time to submit Substantial Equivalence (SE) extension requests, allowing sponsors extra time to respond to SE deficiency letters, tobacco health document submissions, and Ingredient listing submissions. Small businesses can also receive additional assistance with marketing applications.
The FDA final rule notes that at least some flavored combusted products are likely to be “grandfathered” and therefore would remain on the market regardless of the compliance periods provided in the final rule. Grandfathered products are tobacco products that were on the market prior to February 15, 2007. Additionally, the FDA notes that at least one ENDS product has been identified that may have been on the market prior to February 15, 2007. This could allow manufacturers to submit a SE application or SE Exemption Request, which has a different regulatory burden than the PMTA. Manufacturers should determine if their products would qualify under one of these clauses stated in the final rule.
This advice is only part of understanding the new FDA final rule on tobacco products. ProPharma Group recognizes tobacco manufacturers of ENDS and e-liquids are new to FDA regulation and we are committed to assisting your company through the complicated and constantly changing FDA landscape. ProPharma Group can help guide you through the intricacies of FDA tobacco and e-cigarette regulations. Contact us today to learn how.
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