FDA Increases Fines for Tobacco Retailer Violations

Not only are premium cigar retailers now subject to FDA compliance inspections, they will have to pay higher fines should they be violate the agency’s regulations for retailers.

FDA has announced a 10 percent increase to its previous fine structure, which applies to penalties assessed after August 1, 2016, even if the associated violations occurred as far back as November 2, 2015.

Number of Violations	Previous Amount	Adjusted Amount
1	$0 with a Warning Letter	$0 with a Warning Letter
2 within a 12-month period	$250	$275
3 within a 24-month period	$500	$550
4 within a 24-month period	$2,000	$2,200
5 within a 36-month period	$5,000	$5,501
6 within a 48-month period	$10,000	$11,002

The increase comes by way of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, and as a result the Department of Health and Human Services (HHS) recently issued a new regulation that adjusts, for inflation, the civil money penalty amounts assessed against tobacco retailers who have violated the law.

FDA recently released a list of 55 retailers who violated sales regulations on newly regulated products, which include cigars, electronic cigarettes, vaping products and pipe tobacco. Retailers are prohibited from selling any of these items to persons under 18 years of age, and are required to check the photo ID of anyone under age 27, among other restrictions. The agency has been conducting compliance checks for cigarettes, moist snuff and other tobacco products since the 2009 Family Smoking Prevention and Tobacco Control Act went into effect.