A few big names in the tobacco industry have sued the US Food and Drug Administration on Tuesday over recent guidelines about mandating pre-approval of labelling changes in tobacco products.
Companies including RJ Reynolds, Lorillard Tobacco and Altria Group's Philip Morris USA have filed the lawsuit in the US District Court for the District of Columbia alleging that the guidelines infringe on their free speech.
A few smokeless tobacco companies, including US Smokeless Tobacco and American Snuff have also joined the bigger companies in suing the FDA.
The FDA has been given the authority for regulating tobacco in 2009. Last month, the agency issued guidelines to help manufacturers determine which new products require FDA review under the 2009 Tobacco Control Act.
Accompanying the guidelines was an explanation that said 'certain labeling changes effectively create a new product "if consumers are likely to perceive it as 'new' by virtue of the different label",' as cited in Trib Live. Few examples were also cited such as changing a product's logo, packaging colour or product description.
However, the companies say the FDA is going beyond its scope of authority which is limited to labelling of products that claim to reduce tobacco-related harm or other circumstances addressed by formal rulemaking.
While FDA guidelines are considered to be suggestions and are not legally binding, the lawsuit alleges that the FDA document "creates specific legal obligations with clear and draconian consequences for violations."
The lawsuit adds that the guidelines violate First Amendment protections for commercial speech by blocking certain labelling statements until they receive FDA approval and accused FDA of depriving stakeholders of the chance to weigh in on the directive by issuing it as guidance and not through formal rulemaking.
Few parts of the guidance were also challenged where companies have to seek FDA's approval for changing product quantity, such as putting more cigarettes in a pack.
Image: FDA had released its guidance about tobacco labelling in March. Photo: courtesy of Mister GC / Freedigitalphotos.net.
