FDA Announces ANPRM on Flavored Tobacco Restrictions

The U.S. Food & Drug Administration (FDA) is once again asking for input from the public about tobacco, this time about flavored tobacco.

Today, FDA will publish an Advanced Notice of Proposed Rulemaking (ANPRM) seeking comment on potential restrictions regarding flavored tobacco.

An ANPRM seeks comment from the public and industry regarding potential rules from the agency. It also serves as a formal document to show what FDA is thinking regarding specific topics.

The memo includes over two dozen questions regarding the impacts of flavored tobacco—largely centered around its appeal to “youth and young adults.” FDA’s interest covers all flavored tobacco products including combustible products like cigars, little cigars and cigarettes, as well as non-combustible tobacco like e-cigarettes.

In one question, FDA specifically mentions steps it could take, such as added restrictions on flavored tobacco products in the form of marketing and warning labels:

FDA may consider restrictions on the sale and distribution of flavored tobacco products. Possible restrictions could include restrictions on the advertising and promotion of tobacco products with flavors; on access to tobacco products with flavors; and/or on the label, labeling, and/or packaging of tobacco products with flavors. These restrictions could include requirements to bear warnings or disclosure statements. What such restrictions, if any, should FDA consider and why?

In 2014, FDA released the draft of its landmark deeming regulations which went into effect two years later. An earlier, though unpublished draft of those regulations showed FDA planned on placing stricter requirements on flavored tobacco products compared to non-flavored products. Ultimately, the White House Office of Management and Budget (OMB) removed the language regarding flavored tobacco products and the finalized version of the rule included no additional restrictions for flavored tobacco products, though made it clear the agency planned on addressing them at a later date.

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The flavored tobacco ANPRM was originally announced in a blog post last December. Dr. Scott Gottlieb, commissioner of FDA, said the agency would issue multiple ANPRMs in 2018, including one on further restrictions on flavored tobacco and one on exempting premium cigars.

Last week, FDA issued a separate ANPRM regarding potentially limiting the maximum levels of nicotine in cigarettes. In it was some discussion of large cigars, including a question regarding exempting premium cigars.

However, the agency also announced last week that it would issue two additional ANPRMs “shortly”—this one regarding flavored tobacco and a separate one regarding premium cigars, which has yet to be announced.

Comments are open for 90 days, which means they will close on June 19.

Notably different from the maximum nicotine ANPRM is more explicit language regarding the inclusion of data in comments. The first 12 questions of this ANPRM begin “Provide studies or information…” It should be noted that comments are not required to have data or evidence.

The ANPRM can be read here.