FDA Finalizes Rule Extending Oversight to All Tobacco Products

WASHINGTON — Today, the U.S. Food and Drug Administration (FDA) finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.

This rule helps implement the Family Smoking Prevention and Tobacco Control Act of 2009; steps include restricting the sale of these tobacco products to minors nationwide.

Before today, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18. Today’s rule changes that with provisions aimed at restricting youth access, which go into effect in 90 days, 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.

Today’s rule also requires manufacturers of all newly regulated products to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007.

The tobacco product review process gives the agency the ability to evaluate factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

Under staggered timelines, the FDA 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.

Today’s actions will subject all manufacturers, importers and retailers of newly regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.

These requirements 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.

Watch for details in CSP Daily News.

CSP Daily News <glindenberg@e.cspnet.com>

4 comments ↓

#1 Eli on 05.05.16 at 10:36 AM

Where can I see the regs?

#2 Lou on 05.05.16 at 1:34 PM

https://www.federalregister.gov/public-inspection

as requested

#3 OTP Kid on 05.06.16 at 3:52 PM

Bye-bye flavored cigars and blunt wraps!

#4 Eli on 05.10.16 at 11:10 PM

Whoa 499 pages. Is this like Obamacare documents?

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