Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco: Guidance for Industry | Guideline Explorer

Description

Note: 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.

Scope & Applicability

Product Classes

2

Pipe Tobacco

FDA currently not enforcing warning requirements for this product.; Tobacco product class subject to user fees and health warnings; Warning requirements currently enjoined by court order.; Specific tobacco product category mentioned in court stays

Cigars

Newly deemed products include cigars.; Warning requirements currently enjoined by court order.; Specific tobacco product category mentioned in court stays

Stakeholders

2

Vape Shops

Retail establishments that may be subject to manufacturing requirements

Tobacco product manufacturer

Entity required to submit cigarette plans

Regulatory Context

Attributes

1

Required warning statement

Textual warning statement required on packaging and advertisements.

Related CFR Sections (2)

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