Key provisions of the tobacco "deeming" rule extending FDA's regulatory authority to e-cigarettes, cigars, and hookah are set to go into effect in a few days, but anti-smoking groups say the final law misses an important opportunity to make the products less attractive to children and teens.
Starting on Monday, sales of e-cigarettes, cigars, and other previously unregulated tobacco products will be prohibited to anyone under the age of 18, and photo IDs will be required for adults under the age of 27 who purchase the products.
The distribution of free samples of e-cigarettes and other newly regulated tobacco products will also be prohibited, as will sales in vending machines unless the machines are located in establishments that do not allow minors.
Another provision of the law going into effect Aug. 8 will prohibit the introduction of new e-cigarettes, little cigars, cigars, hookahs, and pipe tobacco products without FDA approval.
"If a company wants to put a new product on the market, they have to submit an application to us first," , director of the FDA Center for Tobacco Products, told ڴŮ.
Manufacturers and marketers will also no longer be allowed to make health claims about their products, although descriptors like "lite," "mild," and "low" will be allowed for another year, Zeller said.
"These are provisions that consumers may not be aware of, but they will certainly have an impact on consumer health and the industry."
Missing from the final version of the tobacco-deeming regulations is a provision that would have removed flavored e-cigarettes and flavored versions of the other newly regulated products from the market pending FDA review starting in November.
This provision was removed from an earlier version of the regulations by the Obama administration, angering anti-tobacco groups and other public health advocates who have long argued that fruit- and candy-flavored tobacco products target children and teens. E-cigarettes are of special concern because their use among teens has risen dramatically in recent years.
"We absolutely share the public health concern that flavored e-cigarettes remain quite popular with kids," Zeller said. "But we still need to sort out what the right policy is for regulating flavors in e-cigarettes now that we have completed the monumental task of asserting jurisdiction over these products."
Under the newly enacted regulations, manufacturers of products introduced to the market after mid-February 2007 will be required to submit applications to FDA for review over the next 24 months in order for their products to stay on the market. They will either have to show that their product is virtually identical to those being sold before that date to achieve "substantial equivalence" status or submit a premarket tobacco application.
Thousands of newly regulated products will be required to register with FDA and undergo regulatory review.
of the American Lung Association said it remains to be seen if smaller manufacturers will comply with the regulatory process, as well as determine what FDA will do if they don't: "Frankly, it is not yet clear if these companies are going to follow the law," she told ڴŮ. "Will they register and actually do what is required by FDA, or will they register just to stay on the market for a couple more years?"
Moves now being considered by Congress to restrict the FDA's new authority over e-cigarettes and the other products are adding to the uncertainty about what FDA's role will ultimately be.
Two tobacco riders attached to the 2017 appropriations -- both strongly opposed by the Obama administration -- would greatly weaken FDA's authority to regulate tobacco products.
One would exempt so-called premium cigars from FDA authority, and another would do away with the grandfather clause for e-cigarettes and the other newly regulated tobacco products.
"In effect this would allow every single one of these new products to stay on the market forever without undergoing premarket review," Zeller said. "And these unreviewed products could then serve as the basis for newly introduced products achieving substantial equivalence authorization down the road."