Learning About Letters

FDA Center for Tobacco Products offers additional clarification on warning letters through webinar

Linda Abu-Shalback Zid, Senior Editor

ROCKVILLE, Md.-- The FDA Center for Tobacco Products (CTP) held a webinar last week to help retailers understand what is contained in its warning letters, as well as what retailers should do if they receive one.

"FDA's main goal is to protect the public health, but the Center for Tobacco Products has an added goal to reduce tobacco use by young people," Tara Goldman, of the Office of Compliance and Enforcement, said. "And as a retailer, you are paramount in helping us achieve this goal."

The FDA currently has contracts with 38 states, as well as the District of Columbia, to perform FDA retail compliance inspections to verify that retailers check photo IDs of anyone under age 27 who attempts to purchase cigarettes, smokeless tobacco or loose cigarette tobacco; that the retailer only sells those products to those age 18 or older; that the products are only sold in a direct face-to-face exchange, except when self-service displays or vending machines are allowed; that retailers do not give away free samples of cigarettes; and that retailers do not sell "loosies" or cigarettes in packages containing fewer than 20 cigarettes.

Goldman addressed some commonly occurring questions, including some centered around checking the ID of regular customers. "The law does not include an exception for family members or customers you may know. Therefore, if you do not request the ID of everyone under 27 who purchases cigarettes, smokeless tobacco or loose cigarette tobacco, you will be breaking the law."

When a vending machine or self-service display is present, retailers should not allow minors to be present or permitted in the facility or location at any time. "This means no minors ever, not even accompanied by an adult," Goldman clarified, adding that there are "no exceptions" even for infants or small children.

Goldman said that in most situations, retailers will not know they are being inspected, although in situations where, for example, inspectors would like to check something behind the counter, they might identify themselves.

If retailers are found to be compliant, the information will be posted on a searchable database on the FDA's website.

If violations are observed, they will receive a warning letter that "puts the retailer on notice," according to Goldman. Components of the letter include the date the warning letter was issued, as well as the date of the inspection; the address of the retail establishment where the inspection occurred; a reference number that the retailer should use when communicating with the FDA; a list of specific violations; additional details, such as the brand of cigarettes sold; a directive for the retailer to correct the violations; a reminder that the list is not exhaustive, and although the inspector might not have seen all violations, the retailer is responsible for complying with all requirements; and the request for a response within 15 days.

Goldman explained that responding to the letter opens up the discussion, which is its own benefit. Also, if a retailer has subsequent violations and it is seen that they were responsive in the past to a warning letter and took due diligence, it could play into any civil money penalty amount issued.

Upcoming FDA CTP Webinars include:

October 18, 2011 -- Cigarettes and Smokeless Tobacco Warning Plan Requirements

November 1, 2011 -- Draft Guidance for Industry Applications for Premarket Review of New Tobacco Products

November 15, 2011 – Topic to be Determined

For more information, or to participate in the webinars, please click here.