One More Week to Go: FDA’s New Tobacco Rules Go Into Effect on August 8, 2016

Retailers, manufactures and retailer/manufacturers of tobacco products should take note that compliance with the U.S. Food and Drug Administration (FDA) new tobacco rules is rapidly approaching.  Certain provisions of the final rule become effective Monday, August 8, 2016.  

On May 10, 2016, the FDA issued its final rule expanding the FDA’s definition of “tobacco products” to include  e-cigarettes and vape pens, cigars, hookah, pipe tobacco, and nicotine gels, making these products subject to the premarket requirements of the FD&C Act, among other requirements. The rule sets forth new obligations and timelines for retailers and manufacturers.

Below is a summary of the most pertinent requirements that go into effect in the coming week as per FDA’s new tobacco laws:

Retailers: Beginning August 8, 2016, tobacco retailers will be prohibited from selling to persons under 18 — this primarily affects only Michigan and Pennsylvania, as all other 48 states already ban sales of e-cigarettes to people under 18.  Moreover, retailers will be required to check IDs for everyone under age 27 and will not be permitted to give away free  samples.

Manufacturers: Beginning August 8, 2016, tobacco manufactures will be subject to the premarket review requirements of the FD&C Act.   Tobacco products on the market as of this date will be permitted to remain on the market temporarily while the manufacturer works toward achieving compliance with the tobacco application requirements.  Manufacturers will have additional time to submit a tobacco product application to the FDA depending on the type of application:   1) substantial equivalence applications must be submitted by February 8, 2018; and 2)premarket tobacco applications for new products must be submitted by August 8, 2018.  However, any new tobacco products introduced into market after August 8, 2016, will not be covered by this additional compliance period and will be subject to enforcement if marketed without authorization.

Retailer/Manufacturer: Retail establishments engaged in the manufacturing, preparation, compounding, and/or processing of a tobacco product will be subject to the same rules as other more traditional manufacturers.  Thus, retailers that roll their own cigars, and vape shops that mix up custom e-juice flavors must document all tobacco products in their inventory by August 8, 2016, or they will be prohibited from lawfully offering those tobacco products for sale any more.

Of greatest importance to manufacturers and retailer/manufacturers is the need to accurately document all tobacco products you have on the market as of August 8, 2016, which you will be able to lawfully continue selling during the additional compliance period while a tobacco product application is in process.    Thus, tobacco manufacturers and retailer/manufacturers must establish reliable methods for demonstrating that a tobacco product was commercially marketed in the United States as of as of August 8, 2016.  If a facility cannot adequately prove that the product was on the market as of  this date, the product will be considered an unapproved new tobacco product whose sale is unlawful, and will be subject to enforcement action by the FDA.

If you are a retailer, manufacturer or both it is imperative that you take all necessary steps to comply with the August 8, 2016 deadline.  To speak with an attorney who can assist with the compliance requirements, including establishing proper inventory records, submission of premarket tobacco applications (PMTA), substantial equivalence applications or reports, substantial equivalence exemptions, review of labels and warning requirements, or other regulatory issue relating the manufacturing, selling and importing of tobacco  contact Rafael A. Gaitan, Esq., at 786.440.8115 or via e-mail at [email protected].