FDA Public Comment Opportunities

Comment periods offered on non-face-to-face sales, premarket review of new tobacco products, brand name provisions and required warnings

Published in Tobacco E-News

By  Linda Abu-Shalback Zid, Senior Editor

ROCKVILLE, Md. -- The U.S. Food and Drug Administration's Center for Tobacco Products (CTP) is offering several opportunities for public comments on its ongoing activities.

Advance Notice of Proposed Rule-Making: Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products.The FDA is issuing this advance notice of proposed rulemaking to obtain information related to the regulation of non-face-to-face sale and distribution of tobacco products and the advertising, promotion, and marketing of tobacco products.

FDA is requesting comments, data, research or other information related to non-face-to-face sale and distribution of tobacco products; the advertising, promotion and marketing of such products; and the advertising of tobacco products via the Internet, email, direct mail, telephone, smart phones and other communication technologies that can be directed to specific recipients. Please click here for more information; the deadline to comment is January 19, 2012.

Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products.This draft guidance is intended to assist persons submitting applications for new tobacco products, and explains among other things:

  • Who may submit a new tobacco product application under section 910 of the FD&C Act (21 U.S.C. 387j);
  • When to submit a new tobacco product application;
  • How to submit a new tobacco product application;
  • What information the Federal Food, Drug, and Cosmetic Act requires you to submit in a new tobacco product application; and
  • What information FDA recommends you submit in a new tobacco product application.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in Agency guidances means that something is suggested or recommended, but not required. Please click here for more information; the deadline is December 27.

Proposed Rule: Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents (Amends Brand Name Provision). The FDA is proposing to amend the Agency's regulations to allow the manufacturer of a cigarette or smokeless tobacco product with a trade or brand name that is also the trade or brand name of a nontobacco product to continue to use the name if the tobacco product was sold in the United States on or before June 22, 2009. FDA further proposes to amend the Agency's regulations to ensure that a manufacturer of a cigarette or smokeless tobacco product may continue to use its trade or brand name even if that name is subsequently registered with the United States Patent and Trademark Office or subsequently used for a nontobacco product. Please click here for more information; the deadline is January 31, 2012.

Guidance for Industry: Required Warnings for Cigarette Packages and Advertisements - Small Entity Compliance Guide.This guidance is intended to help small businesses understand and comply with FDA's regulations regarding the required warnings on cigarette packages and in cigarette advertisements. The rule requires a combined textual statement and graphic image (known as a "required warning") to appear on all cigarette packages and in cigarette advertisements. Parties must be in compliance with this final rule beginning on September 22, 2012. The Food and Drug Administration has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act. Please click here for more information; the deadline is September 22, 2012.