More Updates to the Deeming Rule Guidance – Free Samples

Today, October 11, 2017, FDA published an updated version of its "Prohibition of Distributing Free Samples of Tobacco Products" guidance, which, sets its restrictions on free samples apart from many of its other rules and requirements by extending the prohibition to components and parts. (note, in many of its recent guidances, FDA has stated an intention not to extend enforcement of certain restrictions or requirements to components or parts).

Unlike other restrictions that the Deeming Rule expanded to include only “covered tobacco products” (i.e., deemed tobacco products made or derived from tobacco) or provisions that FDA intends at this time to enforce only against “finished tobacco products,”  the free sample ban applies to all tobacco products that are subject to FDA’s tobacco product authority, even if they are not made or derived from tobacco.

See Guidance at 5 (emphasis added).

Why is FDA treating this provision differently?

In the guidance, FDA explains that this all-encompassing prohibition will advance its goal of curtailing the use of and access to "tobacco products" by youths. This rationale is based on FDA's determination that

components and parts of some tobacco products, such as the aerosolizing apparatus of ecigarettes, can be the most expensive part of a tobacco product. If minors can obtain the most expensive components or parts of tobacco products as free “samples,” they face less significant barriers to using tobacco products.


FDA further calls back upon its preamble from the ban on free samples of cigarettes to support its conclusion, noting that

[b]y prohibiting the distribution of free samples of tobacco products, FDA . . . eliminated this source of tobacco products for youth by requiring tobacco products to be distributed only through product sales that . . . are subject to minimum purchase age and photographic identification verification requirements.


What is and is not a "free sample"?

FDA clarifies that a consumer must "face a monetary cost in order to receive a tobacco product"--otherwise, the exchange constitutes the distribution of a free sample. In plain English, consumers must provide money in exchange for "tobacco products".

FDA notes that the use of coupons or discounts, which reduce the full price of the "tobacco product" are permitted. This includes "buy one, get one at the time of purchase" promotions. Also permitted are membership/rewards programs offering discounted rates; games or contests in which the prize is the offer of a free tobacco product -- so long as it is redeemed along with a legal "tobacco product" sale; and, business-to-business exchanges of free samples for purely marketing or business-relations purposes.

Of critical importance to each of these items is that the redemption must occur within a legal "tobacco product" sale--meaning the consumer is of legal age and money is exchanged for a "tobacco product". Thus, promotions offering free tobacco products at a later date, or games or contests awarding free "tobacco products" are not allowed unless the redemption requires the consumer to also lawfully purchase a "tobacco product".

For more details please contact Tom Norby or Lindsey Streicher.

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