The United States District Court for the District of Columbia recently issued an order vacating the health warning
requirements for cigars and pipe tobacco set forth in 21 CFR §§ 1143.3 and 1143.5 and remanding the Final Deeming
Rule’s warning requirements for cigars and pipe tobacco back to the Agency. See Order, Cigar Ass’n of Am. v. U.S. Food
& Drug Admin., No. 1:16-cv-01460 (D.D.C. September 11, 2020). Although the requirement has been vacated, cigar and
pipe tobacco firms may choose to voluntarily comply with these health warning provisions. FDA will continue to enforce
the other requirements it was already enforcing for cigars and pipe tobacco under the FD&C Act and its implementing
regulations, such as not selling these products to individuals under 21 years of age or marketing them as modified risk
tobacco products without an FDA order.
The court’s order does not enjoin FDA from enforcing the health warning requirements for other product categories,
including Electronic Nicotine Delivery Systems (ENDS) products, hookah tobacco, and cigarette tobacco and roll-your-
own tobacco products.