Follow-Up FDA Inspections Yield Civil Money Penalties

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Follow-Up FDA Inspections Yield Civil Money Penalties

By Melissa Kress, Convenience Store News - 11/15/2011

SILVER SPRING, Md. -- One week after revealing that it has sent out warning letters for tobacco violations to 1,200 retailers, the Food and Drug Administration's (FDA) follow up inspections have resulted in civil money penalties.

Speaking in a webinar this afternoon, Jessica Zeller, deputy director of the Office of Compliance and Enforcement, Center for Tobacco Products, detailed a retailer's options if they do receive a civil money penalty. The 2009 Family Smoking Prevention and Tobacco Control Act gives the FDA the authority to regulate the manufacturing, marketing and distribution of tobacco products. That, in part, includes the authority to issue civil money penalties, she explained.

The act also sets up two schedules of those fines, including amounts per violation, one for retailers who have an approved training program and one for retailers who do not have an approved training program. However, since the FDA has yet to issue regulations defining an approved training program, all retailers found in violation are issued penalties under the lowest schedule, Zeller said. Those penalties begin with a warning letter than can rise to up to $250 for the first subsequent violation and up to $10,000 for six or more violations, she added.

The FDA is currently in the beginning stages of its inspections of retail establishments that sell tobacco -- with the first locations inspected just about this time last year, according to Zeller. The 1,200 retailers who have received warning letters to date are now subject to follow-up inspections without advance notification, she said. If subsequent violations are found during that inspection, the retail will be levied a civil money penalty.

As Zeller detailed, notice of a civil money penalty will be delivered to the owner of the retail establishment or the appropriate person. The notice will contain a cover letter (informing the retailer of the penalty amount, date of the previous warning letter and when there was a follow-up inspection, and how the retailer can respond in 30 days). The notice will also receive a copy of the FDA complaint describing the alleged violations, she added.

Retailers receiving a civil money penalty have several options: pay the penalty; file an official answer and request a settlement conference; file an official answer and request a hearing before an administrative law judge; request an extension to file an official answer; or do nothing. Retailers must respond within 30 days of receipt of the complaint, Zeller said. If a retailer does not respond the court and administrative law judge can issue a full payment order.

She added that retailers are subject to civil money penalties for a period of four to five years after receiving a warning letter. "Once a retailer receives a warning letter they should expect not to get another warning letter," Zeller said. "Once you get a warning letter you are on notice to comply with the law."