FDA Warning Letter to Retailers: What You need to Know

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FDA Tobacco Retailer Warning Labels

In case you’ve been living under a rock for the last year or two, the U.S. Food and Drug Administration (FDA) now regulates all tobacco products, including cigars, hookah tobacco, and e-cigarettes. While the regulation of tobacco products often is viewed as an issue for manufacturers, it’s still very much an issue impacting tobacco retailers and violating these new and at times confusing new rules can have damaging and costly consequences. A quick visit to the FDA’s Tobacco Retailer Warning Letters page [click here] shows that this is a major issue, as there are 20 pages worth of tobacco retailers who have received a warning letter since June 22, 2017, alone.

What exactly is a warning letter and how do they come about? The FDA carries out undercover buy inspections, unbeknown to the retailer. These undercover operations involve a minor and inspector being in a store and attempting to purchase a regulated tobacco product. These minors are of course trained and the results of these operation are sent to the FDA for review. If there is no violation, great, then the inspection results are posted on the FDA’s website and the tobacco retailer has nothing to worry about–until the next inspection. Let’s say there is a violation and the trained minor is able to purchase a regulated tobacco product. Then what follows can get complicated and costly.

When a potential violation has been made, a notice of Compliance Check Inspection (CCI) is sent within one week of inspection to the retailer, informing them that there was a potential violation for sale to a minor. The FDA then reviews evidence and confirms that a violation occurred. If this is the offending tobacco retailers’ first violation then a warning letter is sent to the the retailer informing them of the violation(s). The results are also posted to the FDA’s inspection website [click here to view] and the retailer is subject to re-inspection. The FDA will issue a Warning letter, which is sent to the retailer to achieve a prompt, but voluntary compliance. Traditional brick and mortar and online retailers can be the recipient of a Warning Letter. Of course, the result of not complying can be monetary penalties and the inability to sell tobacco products at all which for a tobacco retailer can be damaging beyond recovery.

A Warning Letter will typically include:

  • References to relevant laws and regulations
  • The date the store was inspected, and if a violating sale was made, the approximate time
  • The particular violation(s) inspectors observed and an explanation of the evidence used to support the violation(s)
  • A statement directing the retailer to correct the violation(s)
  • Notice that enforcement action may come without further notice if violations are observed in the future
  • A request to submit a written response within 15 working days of receiving a Warning Letter

So, you’ve received a Warning Letter from the FDA. What now? The retailer should review the letter carefully to see what charges are listed. It may seem like a no-brainer, but the retailer should work quickly to fix the violation(s) and make sure they are in compliance with the laws and regulations. After this, the retailer should respond in writing to the FDA within 15 working days by mail or email. In the response to the FDA’s Warning Letter, the retailer should include:

  • An explanation of the steps taken to correct the violation(s) and what will be done to prevent future violation (such as retraining employees or removing problematic items)
  • Current contact information, including an email address and telephone number

Since Warning Letters are often times sent after a retailer allows a minor to purchase a regulated tobacco product, they are encouraged to download the “FDA Age Calculator” app which will help retailers comply with federal age restrictions for selling tobacco products. Questions about warning letters can be directed to the Center for Tobacco Products at (877) CTP-1373, and by email CTP-Compliance-WL-Correspondence@fda.hhs.gov or CTPCompliance@fda.hhs.gov.