Welcome to the beta version of Reuters Legal News. As we continue to improve the Reuters legal news experience, please enjoy and provide us with your feedback.

On August 29, 2020, signs can be seen outside the headquarters of the Food and Drug Administration (FDA) in White Oak, Maryland, USA. REUTERS/Andrew Kelly

The names of the companies and law firms shown above are automatically generated based on the text of the article. As we continue to test and develop in the Beta version, we are improving this feature. We welcome feedback, and you can provide feedback using the feedback tab on the right side of the page.

(Reuters)-The Federal Court of Appeals upheld the US Food and Drug Administration's regulations, requiring cigars and pipe tobacco to be approved before they go on the market and imposing royalties on their manufacturers and importers.

A unanimous panel of the Washington Circuit Court of Appeals on Tuesday dismissed three industry organizations, namely, the American Cigar Association, the American Cigar Rights Association, and the Premium Cigar Association. The challenge to the FDA's so-called cigar and pipe tobacco determination rules is the same as that of cigarettes.

Plaintiff's lawyer Steptoe & Johnson's Michael Edney (Michael Edney) did not immediately respond to a request for comment. The FDA declined to comment.

The U.S. Food and Drug Administration passed the presumption rule in 2016, and determined that various tobacco products including cigars and pipe tobacco are subject to its supervision according to the Family Smoking Prevention and Tobacco Control Act of 2009.

Industry groups filed lawsuits in the District of Columbia on various grounds to challenge the rule. Some aspects of the challenge have been successful, such as the DC Circuit overturning arbitrary and capricious warning label requirements last year.

However, on Tuesday, the court upheld the FDA's power to require cigar and pipe tobacco products to undergo pre-market review, or to require manufacturers to provide a "substantial equivalent report" indicating that the product is equivalent to products already on the market before 2007, so "Grandpa." "

The Cigar Group questioned the rule on the grounds that the FDA failed to provide product-specific instructions on how to prepare a substantive equivalent report, which violated the provisions of the Tobacco Control Act, that is, the report must be “as prescribed by the Minister (Ministry of Health and Human Services) ."

Circuit Judge Judith Rogers wrote that there is no need to discuss whether the law requires the FDA to provide instructions, because the agency has stated that it will give the company 18 months to submit a substantial equivalent report. The judge said that this means that even if the FDA is required to provide clarifications, it does not have to do so as part of the rule, but it can do so later, which means that the rule cannot be overturned on this basis.

The judge also rejected the plaintiff's claim that the FDA did not specifically consider the costs and benefits of pre-market review for each industry or product, saying that they did not cite any part of the law that requires this.

Rogers further supports the agency's usage fees charged by manufacturers and importers of cigar and pipe tobacco. The plaintiff questioned these fees on the grounds that the agency did not impose similar fees on other newly identified products such as e-cigarettes.

Rogers said that the Tobacco Control Act specifically authorizes the FDA to charge for cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, and self-rolled tobacco, and insists that it has no right to charge for any other products.

David Tuttle and Justin Walker also joined Rogers.

The case is the American Cigar Association et al. v. FDA et al., Washington Court of Appeals for the Circuit, No. 20-5266.

Plaintiff: Michael Edney of Steptoe & Johnson

For the government: Lindsey Powell of the U.S. Department of Justice

Court overturns FDA regulations on cigar and pipe tobacco labeling

Brendan Pierson covers all areas of product liability litigation and healthcare law. You can contact him at brendan.pierson@thomsonreuters.com.

Subscribe to our daily featured newsletter to receive the latest Reuters legal news and headlines sent to your inbox.

Reuters, the news and media division of Thomson Reuters, is the world's largest multimedia news provider, reaching billions of people around the world every day. Reuters provides business, financial, domestic and international news directly to consumers through desktop terminals, world media organizations, industry events and directly.

Rely on authoritative content, lawyer editing expertise, and industry-defining technology to build the most powerful argument.

The most comprehensive solution to manage all complex and expanding tax and compliance needs.

The industry leader in providing online information for tax, accounting and financial professionals.

Access unparalleled financial data, news, and content with a highly customized workflow experience on desktop, web, and mobile devices.

Browse an unparalleled combination of real-time and historical market data and insights from global resources and experts.

Screen high-risk individuals and entities on a global scale to help discover hidden risks in business relationships and interpersonal relationships.

All quotes are delayed by at least 15 minutes. Please see the complete list of exchanges and delays here.