A California judge rejected a motion by Odwalla, Inc., and the Coca-Cola Co. to dismiss a lawsuit alleging that the companies relied on false and misleading labeling claims that suggest their products were made with juice instead of sugar.
Bipartisan legislation introduced in the Senate Feb. 15 would drop the current statutory requirement for FDA medical device establishment inspections to be conducted every two years and adopt a system of risk-based scheduling for such inspections.
Continuing its enforcement focus on manufacturers and distributors of dietary supplements, the FDA entered into a consent decree of permanent injunction with a Louisiana-based manufacturer and distributor of products that the agency said included unapproved and misbranded drugs as well as adulterated and misbranded supplements.
Eleven members of the West Virginia House of Delegates introduced a bill, HB 2633, that would require state universities with clinical research programs, at the request of a sponsor or a sponsor-investigator, to conduct Phase 3 clinical research studies for any cancer treatment or technology that has been approved for Phase 3 clinical study by the FDA.
The Electronic Retailing Self-Regulation Program (ERSP), an investigative part of the advertising industry’s self-regulation system, determined Nutraceutical Wellness, LLC, can support some claims for Nutrafol, a hair re-growth supplement, but recommended the marketer modify or discontinue other claims.
The FDA may soon have to consider whether clinical study reports submitted in support of drug marketing applications in the United States should be publicly available, a Feb. 20 JAMA Perspective contends.