Recently Released Final Rule Extends FDA’s Authority to ALL Tobacco Products

May 11, 2016

FDA Extends Authority to All Tobacco Products

On May 5, 2016, the FDA published a final rule, extending the Agency’s authority to all tobacco products, including, but not limited to, e-cigarettes, cigars, and hookah and pipe tobacco.  This rule, which further implements the Family Smoking Prevention and Control Act of 2009, will allow “the FDA to improve public health and protect future generations from the dangers of tobacco use.”

What is a “tobacco product”?

According to the FDA, “the term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product. This includes, among other products, cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.”  The final rule applies to all products meeting this definition.  Accessories of the newly deemed tobacco products are not subject to the regulations set forth in the Agency’s rule.  Furthermore, the rule also serves to “establish specific restrictions that are appropriate for the protection of the public health for the newly deemed tobacco products.”

Tobacco Use Among Youth

Over the past decade, the rate of traditional cigarette use among youth has significantly declined.  However, the rate of use for other types of tobacco products has continued to increase among this population.  According to the Agency, “a recent survey supported by the FDA and the Centers for Disease Control and Prevention shows current e-cigarette use among high school students has skyrocketed from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) and hookah use has risen significantly. In 2015, 3 million middle and high school students were current e-cigarette users, and data showed high school boys smoked cigars at about the same rate as cigarettes.”  In addition, another study conducted in 2013-2014 [by FDA and the National Institutes of Health (NIH)] shows that, when asked, nearly 80% of current youth tobacco users admitted to using flavored tobacco products within the past 30 days.  Furthermore, these individuals cited the availability of appealing flavors as one of the leading reasons for use.

Prior to last week’s final rule, there were no federal laws prohibiting the sale of e-cigarettes, hookah tobacco, or cigars to children under the age of 18.  With the new regulations in place, that is going to change.  The FDA’s final rule, which goes into effect on August 8, 2016, contains provisions aimed at restricting youth access, including:

  • “Not allowing products to be sold to persons under the age of 18 years (both in person and online).”
  • “Requiring age verification by photo ID.”
  • “Not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility).”
  • “Not allowing the distribution of free samples.”

Additional Contents of Final Rule

While the following list is not all-inclusive, some of the requirements of the final rule include:

  • “Registering manufacturing establishments and providing product listings to the FDA.”
  • “Reporting ingredients, and harmful and potentially harmful constituents.”
  • “Requiring premarket review and authorization of new tobacco products by the FDA.”
  • “Placing health warnings on product packages and advertisements.”
  • “Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.”

Timeline for Compliance

The final rule will take effect on August 8, 2016.  However, in its press release, FDA notes that, under staggered timelines, it “expects that manufacturers will continue selling their products for up to two years while they submit – and an additional year while the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.”

Do you manufacture a “tobacco product” as defined by the FDA?  Assuring you are compliant with FDA’s regulations for these products can be tricky, but that is why we are here to help.  We have a history of working with various tobacco and e-cigarette products; and, using our unique approach that combines scientific knowledge with regulatory expertise, we have been able to help numerous clients get through FDA successfully.  To learn more about our tobacco and e-cigarette services, or for more information on how we can help you obtain FDA compliance and/or approval, contact us today.


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