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Focus on Regulation

Tag Archives: consent decree

FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good Manufacturing Practice (cGMP) requirements and for failing to include required labeling.  Under the 24-page decree, a federal court enjoined the defendants,

Emerging EPA CWA Regulations to Address Potential Hazardous Substances Releases

On February 16, 2016, the U.S. District Court for the Southern District of New York approved a Consent Decree between environmental plaintiff groups and the U.S. Environmental Protection Agency that likely will result in comprehensive new requirements affecting companies that handle, store, transport or process hazardous substances. Envtl. Justice Health All. for Chem. Reform. v.

FTC Obtains Multi-Million Dollar Settlement Against Marketer of Fitness Gear

The Federal Trade Commission (FTC) has obtained a $25 million settlement against the marketers of the Ab Circle Pro, an abdominal exercise device, for alleged deceptive advertising.  According to the Commission, the defendants, including Fitness Brands, Inc. and Fitness Brands International, Inc., falsely promised that a three-minute workout with the Ab Circle Pro was the

FTC Requires Two “Gold-Standard” Studies in Sketchers Consent Decree

For the second time in eight months, the Federal Trade Commission (FTC) has obtained a multi-million dollar settlement as the price paid for alleged deceptive advertising of footwear promoted to help customers lose weight and strengthen muscles. The FTC announced its $40 million settlement with Sketchers earlier this week. According to the FTC, Sketchers incorrectly