US: FDA Retains Disputed Grandfather Date

Source from:  Tobacco Reporter 05/06/2016

Today, the U.S. Food and Drug Administration finalized its rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco.

This rule helps implement the Family Smoking Prevention and Tobacco Control Act of 2009.

"Today's announcement is an important step in the fight for a tobacco-free generation—it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions," said HHS Secretary Sylvia Burwell.

The new rules include provisions aimed at restricting youth access to e-cigarettes, hookah tobacco and cigars, which will go into effect in 90 days.  The new rules include:

A ban on sales to persons under the age of 18 (both in person and online)
Requiring age verification by photo ID
A ban on the sale of covered tobacco products in vending machines (unless in an adult-only facility)
A ban on 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.

The new rules 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.
FDA's document with the rules is available here: deeming regs final. Enditem