FDA faces lawsuits from cigar manufacturers on new regulations

The legal challenges to Food and Drug Administration regulations on tobacco products now include two from cigar companies.

A subsidiary of Altria Group Inc., John Middleton Co. LLC, sued the agency May 26 for attempting to ban its “Black & Mild” brand name for cigars and pipe tobacco because mild is in the name.


Altria bought John Middleton for $2.9 billion in 2007. The complaint said the ban violates the company’s First Amendment’s protection of trademarks and brand names, and Fifth Amendment’s prohibition on taking private property for public use without compensation.

In June 2010, the FDA ban went into effect regarding the use of “light, “ “mild, “ “medium” and “low-tar” with cigarettes. Since then, manufacturers have used colors to distinguish brand styles.

The FDA has said any use of mild in connection with tobacco manufacturers may mislead consumers into thinking that one product is healthier than others.

In a separate lawsuit, Global Premium Cigars LLC of Miami sued the FDA on Wednesday over how the rules affect trademarked and copyrighted artwork on its cigar boxes. The rules require labels that could comprise up to 30 percent of the box.

Global also complains about being subjected to the Feb. 15, 2007, predicate date for having a tobacco product in the marketplace.

There have been at least four lawsuits filed against the FDA’s new regulations, which are projected to go into effect Aug. 8. The other two have been filed by vaporizer companies.

Products introduced into the marketplace after the predicate date — including almost every electronic cigarette — would have to retroactively go through stiffer regulatory requirements to prove they don’t cause public harm. That includes providing more detail on liquid nicotine ingredients and manufacturing details.

Analysts have said it could cost millions of dollars for each product to go through the heightened regulatory requirements. The FDA estimates it would cost about $500,000.

John Middleton said the FDA wants to ban the Black & Mild brand name “on the bare supposition that the word mild impermissibly communicates to consumers that (its) products are safer than other cigars and pipe tobacco.”

The company wants the federal court to set aside the final rule “as arbitrary and capricious, not in accordance with law, and in excess of FDA’s authority, all in violation of the Administrative Procedure Act.” It wants the court to order a permanent injunction against the FDA on enforcing the new rules on the brand name.

Global also wants a federal court to set aside the final rule and issue a preliminary injunction.

The FDA predicate date puts the agency at odds with U.S. House Republicans, which could directly affect its funding to implement the new regulations.

The U.S. House agriculture appropriations bill for 2016-17 contains language that would only permit funding for FDA substantial equivalent restrictions with a start date 21 months after the effective date of the final FDA regulatory rule.

rcraver@wsjournal.com (336) 727-7376 @rcraverWSJ

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