NATO Responds to FDA’s Proposed Training Program

The National Association of Tobacco Outlets (NATO) has responded to the FDA’s proposed guidance on tobacco retail training programs.

Under the FDA law, retailers are not required to train employees on how to prevent the sale of regulated tobacco products to minors. However, if tobacco products are sold to a minor, the retailer will be subject to a lower fine if it has an approved training program with elements required by the FDA.

NATO opposes two of the FDA retail training program requirements. First, the FDA believes retailers should teach store employees about the health effects and economic costs of tobacco use including the number of approximate deaths due to tobacco use and the dollar amount of health care costs and lost productivity attributable to tobacco. NATO noted the FDA law does not require such elements in a training program and these specific claims don’t have any relevance to training store personnel in methods to prevent the sale of tobacco products to minors.

Second, the FDA proposes that retailers conduct internal compliance checks, reward employees who pass an internal compliance check with a “cash bonus or time off,” and include an employee’s pass or fail history from compliance checks in making decisions about annual compensation, job promotion, or job termination. NATO has objected to these proposed requirements as well since smaller, independent retailers may not have the financial resources to establish such a  program and the idea of a cash bonus or time off is outside the scope of the FDA’s jurisdiction and the scope of the FDA law itself, NATO noted.

“Rather than including specific examples of the health and economic effects of tobacco use as an element of a training program, NATO supports the We Card training system which includes a ‘health message’ with appropriate footnoted sources,” NATO said in its letter to the FDA. “Moreover, retail employees as a whole are generally aware of the health effects of tobacco use since the curriculum in elementary, middle and high schools usually contain lessons on tobacco use. This general knowledge should be sufficient to help employees understand why the Act was passed into law and that they have a responsibility to comply with the provisions of the law.”

Meanwhile the FDA has issued a draft guidance titled “Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers,” which is a proposed set of rules the FDA would follow if a retailer violates the FDA law and includes the level of fines for the sale of tobacco to a minor.

The FDA law sets a lower level of fines if a retailer has an approved employee training program that includes the elements the FDA will finalize in the near future.

The fines for a retailer who has an approved training program and sells tobacco products to a minor are: (1) first violation a warning letter; (2) second violation in 12 months a $250 fine; (3) third violation in 24 months a $500 fine; (4) fourth violation in 24 months a $2,000 fine; (5) fifth violation in 36 months a $5,000 fine; and (6) sixth or subsequent violation in 48 months a $10,000 fine.

Repeated violations at any particular tobacco retailer could result in a “no-tobacco-sales” order, prohibiting the sale of tobacco products at that location. The FDA’s draft guidance provides explanations of the factors involved in assessing fines and no-tobacco-sales orders. To enforce the prohibition of sales to minors, the FDA plans to conduct retail compliance checks and contracting with states to carry out the operations.

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