Business

Tobacco Company Lawsuit Alleges FDA Overstepping Authority

Published

9 years ago

April 15, 2015

This Tuesday, July 15, 2014 photo shows the tobacco in cigarettes in Philadelphia. A study ties a host of new diseases to smoking, and says an additional 60,000 to 120,000 deaths each year in the United States are probably due to tobacco use. (AP Photo/Matt Rourke)

MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — The nation’s largest tobacco companies are suing the Food and Drug Administration over recent guidelines that they claim overstep the agency’s authority over labeling and packaging for cigarettes and other tobacco products.

Units of R.J. Reynolds Tobacco, Altria Group Inc. and Lorillard Tobacco filed the lawsuit Tuesday in the U.S. District Court for the District of Columbia, claiming the FDA’s guidance infringes on their commercial speech.

The FDA gained authority to regulate tobacco in 2009, including the power to pre-review new tobacco products that are significantly different from older ones already on the market.

Last month the agency issued guidelines intended to help manufacturers determine which new products require FDA review.

But the tobacco makers allege that the FDA is asserting overly-broad authority to approve or deny any labeling change that would make a product “distinct.” Their lawsuit argues that the FDA only has prior-review authority for labels on tobacco products claiming to represent a “modified risk,” or to be less harmful than other tobacco products.

FDA guidelines are considered suggestions and are not legally binding. But the tobacco companies say the FDA document “creates specific legal obligations with clear and draconian consequences for violations.”

The FDA said it does not comment on litigation.

The agency issued a draft version of the guidelines in September 2011 and took comments from industry and the public on the proposal.

In an explanation accompanying the final guidelines issued last month, the FDA said that certain labeling changes effectively create a new product “if consumers are likely to perceive it as ‘new’ by virtue of the different label.” Regulators listed examples such as changing a product’s logo, packaging color or product description.

The U.S. tobacco industry has repeatedly challenged FDA authority in court since Congress passed the Tobacco Control Act of 2009.

In 2011, some of the industry’s largest companies sued the FDA to block an order that would have required cigarette packages to carry large, graphic warning labels illustrating the dangers of smoking. But an appeals court decision ruled that the labels violated the First Amendment’s free speech protections and the government abandoned the plan in 2013.

Tobacco companies rely on their packaging to build brand loyalty and grab consumers. It’s one of few advertising levers left to them after the government curbed their presence in magazines, billboards and TV.

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Google’s New Deal with California Lawmakers and Publishers Will Fund Newsrooms, Explore AI

Gov. Gavin Newsom, California lawmakers and some newspaper publishers last week finalized a $172 million deal with tech giant Google to support local news outlets and artificial intelligence innovation. This deal, the first of its kind in the nation, aims to invest in local journalism statewide over the next five years. However, the initiative is different from a bill proposed by two legislators, news publishers and media employee unions requiring tech giants Google and Meta to split a percentage of ad revenue generated from news stories with publishers and media outlets.

Published

2 weeks ago

October 1, 2024

Oakland Post

iStock

By Bo Tefu, California Black Media

This deal, the first of its kind in the nation, aims to invest in local journalism statewide over the next five years. However, the initiative is different from a bill proposed by two legislators, news publishers and media employee unions requiring tech giants Google and Meta to split a percentage of ad revenue generated from news stories with publishers and media outlets. Under this new deal, Google will commit $55 million over five years into a new fund administered by the University of California, Berkeley to distribute to local newsrooms. In this partnership, the State is expected to provide $70 over five years toward this initiative. Google also has to pay a lump sum of $10 million annually toward existing grant programs that fund local newsrooms.

The State Legislature and the governor will have to approve the state funds each year. Google has agreed to invest an additional $12.5 million each year in an artificial intelligence program. However, labor advocates are concerned about the threat of job losses as a result of AI being used in newsrooms.

Julie Makinen, board chairperson of the California News Publishers Association, acknowledged that the deal is a sign of progress.

“This is a first step toward what we hope will become a comprehensive program to sustain local news in the long term, and we will push to see it grow in future years,” said Makinen.

However, the deal is “not what we had hoped for when set out, but it is a start and it will begin to provide some help to newsrooms across the state,” she said.

Regina Brown Wilson, Executive Director of California Black Media, said the deal is a commendable first step that beats the alternative: litigation, legislation or Google walking from the deal altogether or getting nothing.

“This kind of public-private partnership is unprecedented. California is leading the way by investing in protecting the press and sustaining quality journalism in our state,” said Brown Wilson. “This fund will help news outlets adapt to a changing landscape and provide some relief. This is especially true for ethnic and community media journalists who have strong connections to their communities.”

Although the state partnered with media outlets and publishers to secure the multi-year deal, unions advocating for media workers argued that the news companies and lawmakers were settling for too little.

Sen. Mike McGuire (D-Healdsburg) proposed a bill earlier this year that aimed to hold tech companies accountable for money they made off news articles. But big tech companies pushed back on bills that tried to force them to share profits with media companies.

McGuire continues to back efforts that require tech companies to pay media outlets to help save jobs in the news industry. He argued that this new deal, “lacks sufficient funding for newspapers and local media, and doesn’t fully address the inequities facing the industry.”