FDA Releases Final Deeming Rule Regulating All Tobacco Products

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The FDA released its final deeming rule this morning in a long-awaited 499-page document outlining the tobacco and nicotine products over which it now has regulation authority, and detailing the requirements associated with the sale of these products. Restricting youth access to tobacco products was one of the underlying motivations behind the FDA's decision to pass these regulations. As such, there is now a minimum age requirement of 18 for the purchase of all tobacco products, and age must be verified by photo ID. In 2009, the Family Smoking Prevention and Tobacco Control Act provided the FDA with authority to regulate  the manufacture, distribution, and marketing of tobacco products including cigarettes, smokeless tobacco, roll-your-own tobacco and any other product the FDA deemed subject to the law. In April 2014, the FDA proposed extending their authority to additional products. The agency's new "deeming" rules, finalized May 5, 2016, extend FDA authority to cover all tobacco products including:
  • FDAelectronic nicotine delivery systems (e.g. e-cigarettes, vape pens, e-hookah, advanced refillable personal vaporizers, electronic pipes)
  • all cigars (including little cigars, cigarillos, and premium cigars)
  • hookah (waterpipe) tobacco
  • pipe tobacco
  • nicotine gels
  • dissolvables
  • novel and future tobacco products.The FDA also restricts sales from vending machines to adult-only facilities and requires health warnings product packages and advertisements (including warnings for nicotine)

The effective dates for the new regulations vary. The minimum age/ID requirement, along with the restriction on vending machines, will be enforced 90 days from publication of the rule ( August 8, 2016). However, the health warning requirements do not have to be fully implemented until May of 2018.

Another major policy change outlined in the document is the prohibition of distributing free samples of tobacco products.

All newly regulated products are subject to federal public health standards, and manufacturers must receive marketing authorization from the FDA, unless their products were on the market before February 15, 2007. This tobacco product review process allows the FDA to evaluate the ingredients, product design and health risks, and youth appeal of tobacco products such as e-cigarettes and cigars, before allowing them to be marketed. This review process can take one of three pathways: substantial equivalence, exemption from substantial equivalence, or pre-market tobacco application.

The FDA also has prohibited the sale of modified risk tobacco products, such as tobacco products described as "light", "low", or "mild", unless the FDA has first evaluated and approved this marketing. However, the FDA Deeming Rule does not establish any specific restrictions on flavors of newly regulated tobacco products at this time.

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