Wholesalers & Distributors
Wholesalers and distributors of tobacco products have responsibilities under the Federal Food Drug, and Cosmetic Act (FD&C Act) and its implementing regulations as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). These responsibilities can help protect public health from the dangers of regulated tobacco products.
“Reduced Harm” Claims
Tobacco products cannot be distributed with a product label, labeling, or advertising that contains the descriptors “light,” “low,” or “mild,” or any similar descriptor unless an FDA order is in effect under section 911(g) with respect to such product.
- Guidance for Industry and FDA Staff: Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products
- Draft Guidance for Industry: Modified Risk Tobacco Product Applications
Warning Labels on Smokeless Tobacco Products
The Tobacco Control Act requires that smokeless tobacco packages and advertisements have larger and more visible warnings. These warning labels must rotate regularly in accordance with an FDA approved warning plan. Wholesalers and distributors may not distribute any smokeless tobacco product unless its packaging and advertisements comply with the warning label requirements. Smokeless tobacco includes tobacco products such as moist snuff, chewing tobacco, and snus.
Substantial Equivalence and Exemption from Substantial Equivalence
New tobacco products may not be legally marketed in the U.S. unless FDA has issued an order permitting their marketing.
IF a new tobacco product meets the following criteria:
- It was commercially marketed after Feb. 15, 2007, but before March 22, 2011; and
- A Substantial Equivalence Report was submitted by March 22, 2011
THEN this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to an appropriate predicate product.
A substantially equivalent tobacco product has been found by FDA to either have the same characteristics as a predicate tobacco product; or the new product has different characteristics than the predicate tobacco product but the information submitted demonstrates that the new product does not raise different questions of public health.
A tobacco product that is modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, may be considered for exemption from demonstrating substantial equivalence.