American cigarette manufacturers have filed a lawsuit against the FDA.
The largest US tobacco companies filed a lawsuit in the US District Court for the District of Columbia against the Federal Office of the Food and Drug Administration (FDA).
The largest US tobacco companies filed a lawsuit in the US District Court for the District of Columbia against the Federal Office of the Food and Drug Administration (FDA). According to Altria, Reynolds and Lorillard, the regulator violated their right to freedom of expression, requiring companies to negotiate with it any small changes that they want to make in the design of a previously approved to the sale cigarette packs.
The claims of the US largest tobacco companies, the manufacturers of such a famous cigarette brands as: Marlboro, Camel and Newport, are related with the additions to the law about "The Control of tobacco products" (2009), introduced in March. According to that, FDA received the authority to regulate tobacco products. In the new additions to the law, cigarette manufacturers are encouraged to coordinate with FDA any changes in the appearance of all cigarette packs.
For example, if the manufacturer wants to change the color of a cigarette pack, logo, or to print the word "premium class", primarily it must obtain the approval from the FDA. Also, the resolution is needed, in the case, if the manufacturer wants to change the number of cigarettes in a pack. Until March, US companies were forced to receive the permission from the FDA only for a new product, brand of cigarettes, or the cigarette package design release.
According to Altria Group, Reynolds American and Lorillard company, the Act of 2009 does not give to FDA the right to request from companies the prior approval for all changes in cigarette packs, but only for new products and for tobacco products which are positioned as less harmful to human health (menthol, with reduced nicotine content, etc.).
But if the FDA requires approval even on tobacco products that have been already endorsed for sale, then, the regulator violates provided by the The First Amendment to the US Constitution, which guarantees to American companies, the freedom of speech in advertising, said the plaintiffs. (The First Amendment protects the advertising that is not false, not misleading, and does not endorse illegal or harmful activities.)
According to Altria, Reynolds and Lorillard, they should be allowed, at their request, to change the color and the appearance of those cigarettes, which are already on sale. "We do not agree with the new requirements of FDA, under which manufacturers are required to obtain permission before changing the appearance of products, while the tobacco product itself inside the pack does not change - said in connection with the filing of the claim the Altria's Group spokesman, Brian May. - We ask the court to resolve this dispute. " This claim does not apply to placing on the pack of warnings about the dangers of smoking, the companies do not require their removal.
Companies insist that the new FDA requirements entail significant financial and legal costs. In addition, according to the plaintiffs, if the FDA wants to coordinate the pack design with manufacturers, so it can't be made through the unilaterally decree or resolution, this is necessary to do through the standard procedure of adoption of the rules and regulations, with the mandatory participation of the companies in the discussion. However, this is not a quick process and the lawsuit can last for many months.