For years, tobacco companies have been distributing free samples of their products, particularly targeting young people in an effort to attract new customers. In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) which, among other things, restricts the distribution of “free samples of cigarettes, smokeless tobacco, or other tobacco products.” 

Despite clear language defining “tobacco products” in a way that includes cigars and little cigars, the U.S. Food and Drug Administration (FDA) recently released Draft Guidance for Industry, which says the law will not be applied to certain tobacco products including cigars, little cigars, or pipe tobacco. This Guidance goes against the plain language of the Tobacco Control Act and creates a dangerous loophole in the restrictions on sampling. 

The good news is that the FDA is requesting public comments on the Guidance document. To make sure your comments are considered, you must submit your comments by Monday, May 23.

To join others who are submitting comments on this important issue, visit the FDA’s comments page. (Note that submitting comments to the FDA is not considered lobbying by the federal government or by the California Tobacco Control Program.)

Here is some sample language for the comments field, but we encourage you to modify it to reflect your own thoughts and experience.

I am writing to ask the FDA to amend its “Draft Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents” to ensure that the law is applied to all tobacco products, not just to cigarettes and smokeless tobacco. (FDA Docket No. FDA-2010-D-0277).

Studies have shown that tobacco companies target young people—particularly those in college—by distributing free samples of tobacco products to get them hooked on tobacco at a young age. (www.tobaccofreekids.org/research/factsheets/pdf/0135.pdf).  

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) created a regulation that bans the distribution of “free samples of cigarettes, smokeless tobacco, or other tobacco products” with a limited exception for smokeless tobacco samples. 21 C.F.R. section 1140.16(d)(1) (emphasis added).  This regulation is designed to protect young people from being enticed by ALL types of free tobacco samples.

Cigars, little cigars, and pipe tobacco meet the definition of “other tobacco product” provided in the regulation, and therefore sampling of those products is illegal under the Tobacco Control Act. However, the FDA’s Draft Guidance for Industry says “the regulations do not apply to cigars, little cigars or pipe tobacco” (page 3). This is clearly incorrect as to the regulation restricting free tobacco samples.

Because the language of the regulation banning free samples plainly applies to “other tobacco products,” including cigars, little cigars or pipe tobacco, the Draft Guidance for Industry should accurately reflect the language and intent of the regulation and make it clear that offering free samples of such products is illegal.

Additional Resources:

For more information about commenting on federal regulations, see our fact sheet Getting Your Voice Heard: Commenting on Federal Regulations. This publication explains the legal process for creating regulations, including how and when the public can provide input on proposed new rules.

For more information on sampling and what actions communities can take to further restrict free tobacco giveaways, see our fact sheet on Sampling: How does the FDA law affect local ordinances in California? or the Model Tobacco Sampling Ordinance.

If you have any questions for PHLP about this issue, please submit your question to one of our staff attorneys at www.phlpnet.org/tobaccoquestions.