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FDA Issues Guidance Report on Tobacco Regulations

WASHINGTON, D.C. -- Cigarette retailers, manufacturers and wholesalers have received the FDA's Center for Tobacco Products' draft guidance for compliance with its Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, which was published March 19, 2010.

The 35-page document is meant to assist the industry to better understand how the FDA will interpret and implement the final rule of the regulations, which are meant to reduce access to cigarettes and smokeless tobacco by persons under age 18 and reduce the appeal of such products to persons under age 18, through restrictions on marketing, labeling and advertising. The regulations take effect on June 22, 2010.

The document, which doesn't establish legally enforceable responsibilities, covers FDA's thinking on requirements concerning the sale of cigarettes and smokeless tobacco; advertising, which includes requirements for product labels, labeling, and advertising; who is subject to the regulation; what products are subject to the regulation; prohibition on the sale and distribution of tobacco products to persons younger than 18 years of age.

Among the documents highlights and recommendations:

-- Manufacturer who supply cigarettes to a retailer known to open cigarette packages and sell individual cigarettes are subject to regulatory action for assisting in that violation if it continues to supply cigarettes to that retailer.
-- Retailers and manufacturers must remove self-service displays from the point of sale.
-- A retailer who distributes free samples of smokeless tobacco at the request of a manufacturer or distributor violates the regulation if the store does not meet the definition of a "qualified adult-only facility."
-- At retail sites, manufacturers cannot sell or distribute non-tobacco items, such as T-shirts or hats, or services that bear the brand name, logo, symbol, motto, selling message, recognizable color or pattern of colors, or any other mark of product identification for any brand of cigarettes or smokeless tobacco.
-- Manufacturers cannot offer any gifts or items in exchange for the purchase of its cigarettes or smokeless tobacco.
-- Retailers must verify that any person buying cigarettes or smokeless tobacco is at least 18 years old or older by means of photo ID containing the bearer's date of birth and check ID for everyone under the age of 27;
-- Store operators must sell cigarettes or smokeless tobacco only in a direct, face-to-face exchange with the customer, without the help of any electronic or mechanical device, with the exception of retailers using a vending machine or self-service display in a facility where no one younger than 18 years of age is present or permitted to enter at any time.
-- The FDA does not require retailers to train or educate employees about their responsibilities under the tobacco regulations, but because employers are responsible for their employees' actions, the FDA recommends they develop educational or training materials to require employees to check proof of age and know the regulations prohibits sales to anyone younger than 18, plus teach them how to check proof of age of anyone under 27.

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