FDA’s Implementation of the Family Smoking Prevention and Tobacco Control Act Picks Up Steam

By Ricardo Carvajal –

June 22 looms large on the calendar for firms subject to the requirements of the Family Smoking Prevention and Tobacco Control Act (“FSPTCA”) and FDA’s final rule curbing promotion and sale of cigarettes and smokeless tobacco to underage consumers.  In anticipation of that date, FDA has issued the following guidance documents:

• Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents – This draft guidance document addresses questions raised by retailers with respect to their obligation under FDA’s final rule to ensure that cigarettes and smokeless tobacco are not sold to underage consumers.  It also addresses questions with respect to the obligation of retailers, distributors, and manufacturers to ensure compliance with advertising, marketing, and promotion restrictions imposed by that rule.  According to the document, FDA intends to exercise enforcement discretion with respect to certain requirements that are the subject of litigation (e.g., the limitation of labeling and advertising to black text on a white background and the restriction on the use of trade names of nontobacco products).  Violation of the final rule’s many other requirements could subject a retailer, distributor, or manufacturer to a range of civil and criminal penalties.  The final rule takes effect on June 22.

• Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products – This guidance document addresses the statutory ban on the use of the cited descriptors in labeling and advertising unless FDA authorizes such use.  Products labeled or advertised as such may not be sold after July 22 unless they were manufactured before June 22 and introduced into domestic commerce before July 22.

• Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products – This guidance document states FDA’s intent to exercise enforcement discretion with respect to the requirement that smokeless tobacco manufacturers, distributors, importers, and retailers have a rotational warning plan that has been approved by FDA, as long as they submit such a plan to the agency by July 22.  However, industry must begin rotating the warnings on June 22.

In addition, FDA has published “Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.  This draft guidance document provides FDA’s interpretation of the phrase “harmful and potentially harmful constituents.”  The FSPTCA requires that FDA publish a list of such constituents within two years of the law’s enactment.  That list will partially guide subsequent submissions by manufacturers of information on constituents in their products.  In that same vein, FDA will announce in the June 15 Federal Register that the Tobacco Product Constituents Subcommittee of the Tobacco Products Scientific Advisory Committee will meet on July 7-8 to "finalize its proposed list of harmful or potentially harmful constituents, the rational for inclusion of each substance, validated methods for measuring the constituents and the ancillary and normalization standards for the identified constituents."