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Interpreting FDA’s New Tobacco Deeming Rules

NACS has created an updated memo for members to provide additional clarification on the final rule, which went into effect last month.
September 9, 2016

​ALEXANDRIA, Va. – On August 8, the FDA’s final rule extending the agency’s regulatory authority to products such as e-cigarettes, cigars, hookah (waterpipe) and pipe tobacco, certain dissolvables, and nicotine gels, went into effect. Now that the dust has settled a bit, NACS has drafted an updated memo for members on the tobacco deeming rule.

To read the full memo, click here. Here are the highlights:

The deeming regulations do NOT:

  • Ban flavors
  • Prohibit self-serve on cigars, OTP and vape products
  • Immediately ban 8-8-16 products

However, what is new or changed in the deeming regulations includes:

  • All cigars (premium and domestic), pipe tobacco, e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, electronic pipes, hookah tobacco, dissolvable tobacco products, and nicotine gels are deemed “tobacco products” and now subject to regulation by the FDA.
  • Accessories that do not contain tobacco are not included, such as ashtrays, cigar cutters, humidors or conventional matches and lighters.
  • The minimum purchase age is 18.​ However, if the state or locality has a higher minimum age, such as 19 or 21 years old, then retailers must also follow the more restrictive state or local law.
  • Free samples of all deemed products are banned and includes manufacturers and wholesalers, but “buy two, get one free” promotions are still legal. Coupons for free products are prohibited, but cents- or dollar-off coupons are acceptable. Adult product loyalty awards are permissible.
  • The FDA is requiring a new health warning on the packaging and on advertisements for cigarette tobacco, roll your own tobacco and all of the newly deemed tobacco products such as cigars, pipe tobacco, e-cigarettes, vapor products, dissolvables and nicotine gels. The new caution reads as follows: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." It goes into effect on products manufactured after May 10, 2018.

For more information on FDA regulation of tobacco, visit  www.nacsonline.com/advocacy/Issues/Tobacco/Pages/default.aspx.

Join NACS at 9:05 am on Thursday October 20, at the 2016 NACS Show for the educational session, “The Impact of FDA Deeming Regulations on the C-Store Tobacco and Vapor Business.” The NACS Show is October 18-21 in Atlanta. For more information on the Show, go to www.nacsshow.com.