Shortly before the September 30, 2017 establishment registration and product listing deadline for domestic establishments manufacturing newly-regulated tobacco products as of August 8, 2016, FDA revised its Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments guidance to, among other things, provide a new compliance policy for product listing labeling submissions. Under this compliance policy, if certain conditions are met, FDA will not require separate labeling copies for all variations of a particular tobacco product. Using e-liquids as an example, FDA says it recognizes that product listing for particular tobacco products may result in copious labeling submissions, given the commonly seen variations in package size, nicotine strength, propylene glycol (PG)/ vegetable glycerin (VG) ratio and flavors for such products.
To address this burden on industry, FDA states that it does not intend to enforce the requirements that owners and operators submit labeling for each individual listed tobacco product if the registrant submits representative labeling information for a line of products. In a newly-added “Appendix A” to the revised guidance, FDA provides examples of how tobacco establishment registrants can accomplish this by submitting a “package label plan.” A package label plan should include a “model/generic product label” that shows the representative formatting, fonts, colors, background text, and images as they appear on the actual product label. In addition, the model label would include placeholder text for labeling variations such as package size, nicotine strength, PG/VG ratio, and flavor. A firm should also submit as part of the package label plan a “product variation index” listing all variations for a specific product.
In determining whether a registrant’s submitted information falls within this compliance policy, FDA states that it would consider whether the tobacco products’ labeling is essentially identical (e.g., the same formatting, fonts, colors, background text, and images) and whether the variations are limited to package size, nicotine strength, PG/VG ratio, and flavor. Upon reviewing the package label plan, if FDA determines that it needs additional labeling submissions, it would notify the firm and request this information. Of course, the labeling must comply with all other applicable labeling requirements under the Food, Drug, and Cosmetic Act. Given the last-minute timing of FDA’s new compliance policy, companies that are first engaging in manufacturing after August 8, 2016 (i.e., the ones that must immediately register and list) may be able to benefit most from this new compliance policy. We encourage all companies, however, to consider preparing a package label plan to the extent it may be used to support and streamline other, later submissions, including any tobacco product premarketing applications.