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Headlines Tagged with FDASuit 446 headlines found


RIVKIN/FOLEY: The Supreme Court's bad call on Affordable Care Act

the precedent upon which the King majority relied for this contextual interpretation, FDA vs. Brown and Williamson Tobacco Corp. (2000)...manufacturers challenged [FDA's] authority to regulate tobacco products as “medical devices” or “drugs.” The court co
Los Angeles Times
added Jun 30, 2015 08:36

WHITE: Symposium: Defining deference down

Last year, in Loving v. IRS, the court invoked Brown & Williamson in holding that the IRS was unreasonable in interpreting its statutory jurisdiction ...Two years earlier, the D.C. Circuit invoked Brown & Williamson’s “major questions” doctrine to strike
added Jun 26, 2015 09:15

Cig Label Fight Shows Growing Pains In New FDA Oversight ($$)

Experts say the agency's move to advance the new requirements in the form of a quick guidance — and the industry's prompt lawsuit — show the regulator and the regulated trying to gauge how far they can push each other in this early phase of federal overs
added Jun 6, 2015 12:14

Tobacco Cos. Drop Suit After FDA Holds Labeling Enforcement ($$)

The FDA announced on Friday that it was suspending enforcement against new products that are identical to a product already on the market aside from label changes or quantity. The interim enforcement policy will stay in effect until 30 days after the FDA
added Jun 4, 2015 14:12

Big Tobacco Fires on New 'Draconian' FDA Rules

Although disguised as "guidance," the FDA rule described in the complaint as the "SE directive" imposes legal obligations that manufacturers must follow or face penalties, including seizure of an entire product line, they continue. "Moreover, b
Courthouse News
added Apr 17, 2015 23:38


An article Wednesday on Page B1 did not provide a precise description of the labels involved in the Big Three tobacco manufacturers' lawsuit against the Food and Drug Administration. The combined lawsuit filed by Altria Group Inc., Lorillard Inc., and Re
Winston-Salem (NC) Journal
added Apr 16, 2015 14:05

U.S. FDA sued for Mandating Pre-Approval of Labeling Changes for Tobacco Products

tobacco companies said that the FDA is already going beyond its authority by issuing the guidelines. And a required FDA-authorized labeling changed will only make a product unique in the market – something like changing its brand name. In the lawsuit fil
Daily Times Gazette
added Apr 16, 2015 10:48

Big Three sue over packaging labels

They want a permanent injunction against the FDA for implementing the guidance it issued March 4. The FDA plans to broaden its power of prior restraint on the companies’ marketing communications, foremost by saying its approval is required for changes to
Winston-Salem (NC) Journal
added Apr 15, 2015 18:24

Tobacco Companies File Suit Against FDA Over Label Regulations

"We disagree that FDA's new requirements that manufacturers must obtain agency authorization before changing certain product labels when the actual physical tobacco product remains exactly the same," said Brian May, an Altria spokesman. "We're asking the
Dow Jones Newswires
added Apr 15, 2015 10:10

Big Tobacco Sues FDA Over Label Guidance ($$)

The companies, which include R.J. Reynolds Tobacco Co. and Lorillard Tobacco Co., say the FDA issued guidance in March that effectively asserts a broad power of prior restraint over their marketing and labels prohibited by the First Amendment and despite
added Apr 15, 2015 08:35
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