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FDA's Final Deeming Regulations Move to Next Step

WASHINGTON, D.C. — The Food and Drug Administration (FDA) is moving closer to regulating electronic cigarettes and cigars.

The agency's proposed deeming regulations, which will give the FDA authority over electronic cigarettes, cigars, pipe tobacco and certain dissolvable products that are not smokeless tobacco, are now in the hands of the White House Office of Management and Budget (OMB) for review.

The FDA has not made public the final version of the deeming regulations.

According to the National Association of Tobacco Outlets (NATO), the submission of the final deeming regulations by the FDA to the OMB is the eighth step in the federal government's nine-step regulatory process.  

If the OMB approves the final deeming regulations, the next step requires that the final regulations be published in the Federal Register. Generally, the deeming regulations would be effective 30 days after the date of publication, the association noted. 

When the OMB completes its review of the deeming regulations, NATO will issue a detailed summary of the new regulations, the association said. Generally, the OMB has a period of 90 days to review final federal agency regulations, but can extend the review time by another 30 days.  

The submission to OMB comes 18 months after the FDA released its proposed deeming regulations in April 2014.

The agency already has the authority to regulate tobacco products under the Family Smoking and Tobacco Control Act of 2009, but it must issue deeming regulations to extend its authority to cover additional tobacco products, as CSNews Online previously reported. The agency currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.

The April 2014 proposed deeming regulations called for minimum age and identification restrictions to prevent sales of the products to underage youth; requirements to include health warnings; and prohibition of vending machine sales unless in a facility that never allows minors, such as bars and nightclubs.

Under the proposed rules, manufacturers of newly deemed tobacco products would, among other requirements: 

  • Register with the FDA and report product and ingredient listings; 
  • Only market new tobacco products after FDA review; 
  • Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim, and that marketing the product will benefit public health as a whole; and 
  • Not distribute free samples.
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