WASHINGTON – This week, the U.S. Food and Drug Administration (FDA) moved closer to issuing final regulations related to additional tobacco products.
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), enacted in 2009, provides FDA with authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. The law also allows the FDA to issue regulations deeming other tobacco products that meet the statutory definition of “tobacco product” to also be subject to the Food Drug & Cosmetic Act, commonly referred to as a “deeming” regulation.
In April 2014, the FDA released a proposed “deeming” rule that would prevent minors from purchasing electronic cigarettes and give the FDA authority over e-cigarettes, cigars, pipe tobacco, nicotine gels, hookah and dissolvables. The FDA proposed to include the additional items in several provisions that apply to regulated tobacco products, such as age and identification requirements to restrict sales to youth under 18 and prohibitions on free samples and vending machine sales.
On Monday, the FDA sent its final “deeming” rule to the Office of Management and Budget (OMB) for review. OMB review and approval is generally the last step in the regulatory process before a regulation is published and usually takes between 30 to 90 days. The contents and text of the final rule are not publicly available until it is approved by OMB and published in the Federal Register.