FDA Sends OMB Tobacco Regs for Final Review

Will deem whether more products subject to same oversight as cigarettes, RYO, smokeless

NATO FDA OMB deeming regulations tobacco

MINNEAPOLIS -- The U.S. Food & Drug Administration (FDA) Center for Tobacco Products has submitted to the White House Office of Management & Budget (OMB) the final “deeming” regulations on cigars, pipe tobacco, e-cigarettes, hookah tobacco, nicotine gels and dissolvable products, according to NATO News.

As reported in a 21st Century Smoke/CSP Daily News Flash, 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 the tobacco products are under the FDA’s jurisdiction. If the OMB approves the final regulations, then the ninth step requires that the final regulations be published in The Federal Register.

Generally, the regulations would be effective 30 days after the date of publication.

Although the FDA submitted the final set of regulations to the OMB, the final version of the deeming regulations was not made public. 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 deeming regulations were first proposed by the FDA in April 2014. As proposed, the FDA regulations contained two options. Option 1 would regulate all cigars, pipe tobacco, electronic cigarettes, nicotine gels, hookah tobacco and dissolvables, except accessories of a tobacco product. Option 2 would also regulate these six categories of tobacco products, but exempt premium cigars and tobacco product accessories from regulations. Exempt accessories would include such items as lighters, cigar cutters, humidors, cases and hookah accessories.

Under the deeming regulations, the FDA proposed that nine kinds of regulations already applicable to cigarettes, roll-your-own (RYO) tobacco and smokeless tobacco products be extended to the six additional product categories, except premium cigars and accessories under Option 2.

According to NATO News, the nine regulations include the following:

  1. Manufacturers would be required to register each of their tobacco manufacturing facilities with the FDA, and report any harmful and potentially harmful constituents.
  2. Manufacturers would be required to submit a list of the tobacco products they produce and a list of ingredients in each product.
  3. Modified risk descriptors such as “light,” “low” and “mild” could not be used to describe a regulated tobacco product.
  4. Free samples of the deemed tobacco products would not be allowed.
  5. For e-cigarettes and other newer novel tobacco products that were not on the market as of Feb. 15, 2007, manufacturers of these products would need to submit a premarket tobacco application (PMTA) to the FDA within 24 months following the effective date of the final deeming regulations. If a PMTA application is filed with the FDA during this 24-month period, then the manufacturer can continue to market its products unless and until the FDA responds to the application. The PMTA process allows the FDA to authorize the introduction of products into the market where appropriate for the protection of the public health and prevent introduction of products that are detrimental to the public health.
  6. FDA enforcement actions can be taken against manufacturers whose tobacco products are determined to be adulterated or misbranded.
  7. 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.
  8. A new health warning would be required on all deemed tobacco products, plus all cigarette tobacco and roll-your-own tobacco, 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 not be required for cigarettes or smokeless tobacco products because federal law already requires health warnings on these two products. However, this new health warning would be required on advertisements created by retailers for deemed tobacco products, cigarette tobacco and RYO tobacco.
  9. A prohibition on the sale of the deemed tobacco products through vending machines, unless the machine is located in an adult only facility.