The Final Steps for the FDA ‘Deeming’ Regulations

Only OMB review, publication in the Federal Register remain

MINNEAPOLIS -- On October 19th of this year, the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products submitted to the Office of Management and Budget (OMB) the final deeming regulations on cigars, pipe tobacco, and e-cigarettes.

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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 to deem whether certain tobacco products are under the FDA’s jurisdiction. Step Eight involves the OMB reviewing the financial impact of the FDA’s final regulations. If the OMB approves the final deeming regulations, then Step Nine requires that the final regulations be published in the Federal Register. Generally, the OMB has 90 days to review the regulations and then the regulations would be effective 30 days after the date of publication in the Federal Register. 

Although the FDA submitted the final set of deeming regulations to the OMB, the final version of the deeming regulations was not made public. By way of background, in April of 2014, the FDA proposed two deeming regulatory options. Option 1 would extend the agency’s regulatory authority to all other categories of tobacco products including cigars. Option 2 would extend the FDA’s regulatory authority to all of categories of tobacco products, except premium cigars and accessories of a tobacco product. At this time, it is not known which option the FDA included in its final rule submitted to the OMB.

Under the deeming regulations, the FDA proposed that regulations already applicable to cigarettes, roll-your-own tobacco and smokeless tobacco products be extended to the six additional product categories, except to premium cigars and accessories under Option 2.  These regulations include the following:

  1. Manufacturers would be required to submit a list of the tobacco products they produce and a list of ingredients in each product.
  2. Modified risk descriptors such as “light,” “low,” and “mild” could not be used to describe a regulated tobacco product.
  3. Free samples of the deemed tobacco products would not be allowed.
  4. For newer tobacco products that were not on the market as of February 15, 2007, manufacturers of these products would need to submit either a substantially equivalent (SE) or premarket tobacco application (PMTA) to the FDA within 24 months following the effective date of the final deeming regulations. A SE application can be filed if the newer product is virtually identical to a tobacco product on the market as of February 15, 2007. A PMTA application is filed with the FDA if the new product is different from other products on the market as of February 15, 2007. This means that most cigars and pipe tobaccos would need to have a PMTA application filed because the blends have changed since 2007.
  5. The minimum age to purchase deemed tobacco products would be 18 years old and retailers would be required to verify through photographic identification the legal minimum age of a customer who is younger than 27 years old. 
  6. A new health warning would be required on all deemed tobacco products and in all advertisements for these tobacco products. This warning would read: “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.” This new health warning would be required on advertisements created by retailers for deemed tobacco products.

The deeming regulations are only the first set of regulations that would govern cigars, pipe tobacco, and e-cigarettes. With the FDA sponsoring half a billion dollars in research studies on all kinds of tobacco products, the agency intends to use the results of the scientific studies to draft additional regulations in the future.

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