The Court of Appeals for the D.C. Circuit, considered the most influential court of appeals on regulatory matters, essentially rejected FDA's high-handed approach to denying health claims deemed lacking "significant scientific agreement." It faulted the agency for failing to define "significant scientific agreement" and for refusing even to consider allowing manufacturers to make some label claims as long as they're mitigated by an FDA-approved disclaimer statement.
After months of speculation, water in plastic bottles from Atlanta, GA-based The Coca-Cola Co. is the real thing in the U.S. The pale blue-tinted polyethylene terephthalate bottles provide a distinctive appearance for Dasani, which the company expects to launch nationwide this spring.
The Food & Drug Administration capped its regulatory efforts to make two-piece gelatin OTC capsules harder to tamper with by requiring manufacturers to seal capsules and to use at least one "tamper-evident" packaging feature.
New software helps SmithKline Beecham comply with FDA GMPs for creating and disseminating packaging specifications. Software permits validation of packaging spec dissemination process, virtually eliminating exposure to compliance violations. Part one of two.
Responding to a petition by soy protein maker Protein Technologies Intl., the Food and Drug Administration has proposed new health claims linking soy protein with a reduction in coronary heart disease.