FDA takes significant steps to protect Americans from dangers of tobacco through new regulation
Thursday, May 05, 2016
Posted by: Natalia Gromov
Today, the U.S. Food and Drug Administration finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including 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); and
· 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 February 15, 2007. The tobacco product review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.
Today’s actions will subject all manufacturers, importers and/or 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; and
· Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.
Please see the following link to the FDA News Release: FDA takes significant steps to protect Americans from dangers of tobacco through new regulation. For additional information, including supporting documents, please see the link: Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah