pad

FDA Sued for Refusing Labels on Antioxidants/Cancer

FDA Sued For Refusing Labels That Tout Antioxidants' Possible Anticancer Action

NEW YORK Jul 18 (Reuters Health) - A group of dietary supplement firms has sued the US Food and Drug Administration and three agency officials over whether anticancer claims for antioxidant vitamins may be presented on product labeling.

The plaintiffs seek to have the Court "enjoin FDA's decision [not to permit a claim of reduced cancer risk] and allow the claim with a concise and accurate disclaimer," according to a news release issued by the Washington-based law firm Emord and Associates.

The plaintiffs also want the Court to reprimand the FDA and its officials for violating the First and Fifth Amendments and their oaths of office, and compel them to evaluate health claims made in a previous suit that were upheld by a US Court of Appeals, the release said.

The lawsuit was filed on Monday in US District Court in the District of Columbia by Jonathan Emord on behalf of Wellness Lifestyles, Durk Pearson and Sandy Shaw, Dr. Julian M. Whitaker of Pure Encapsulations, and the American Preventive Medical Association.

A representative of the FDA cited to Reuters Health a policy not to comment on ongoing litigation.

Several years ago, Jonathan Emord filed a suit against the FDA on behalf of Durk Pearson, claiming that the agency had ignored court directions that it should evaluate the use of disclaimers on labels instead of disallowing mention of potential health benefits of certain natural agents.

"In 1999, the US Court of Appeals held FDA's suppression of the very claim that is in issue here unconstitutional, and ordered FDA to evaluate disclaimers as a less restrictive alternative to outright suppression," Emord told Reuters Health on Wednesday.

More than 2 years later, "the FDA issued its decision on remand, refusing to evaluate the [anticancer] claim in accordance with the Court's decision, and refusing to evaluate disclaimers for the claim," the attorney said. "And once again the FDA denied the claim outright."

The FDA and the officials cited in the suit have 60 days after service of process to file their answer to the lawsuit.

Remember we are NOT Doctors and have NO medical training.

This site is like an Encylopedia - there are many pages, many links on many topics.

Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.