Industry's Antioxidant/Cancer Health Claim on Horizon?

WASHINGTON--In a letter received April 20 by Emord & Associates, P.C., the Food and Drug Administration stating that it has to postpone its decision for the antioxidant/cancer health claim under Pearson v. Shalala (Docket No. 91-N-0101). The new deadline is set for tomorrow, May 4.

"I hope that FDA approves the claim that has been submitted to the agency, or at worst with a disclaimer that would allow the claim, such as `while the evidence is supportive, the benefits of antioxidants on cancer are inconclusive,'" said Claudia Lewis-Eng, a regulatory attorney at Emord & Associates. She added that, "I would rather that FDA state that the evidence is 'supportive but not conclusive' than not have Americans know the benefit of antioxidant vitamins, and their benefits for cancer, at all."

In the letter, Christine Lewis, director of FDA's Office of Nutritional Products, Labeling and Dietary Supplements, stated that even though the agency is not ready to come forward with its decision, she expected the response would be more than 60 pages long. One hypothesis the agency is taking so long to reach a decision is that it may be trying to generate more evidence to deny the claim or to fashion a disclaimer that would withstand judicial review while rendering the claim impotent. FDA may have learned its lesson when it did not take the same precautions with the folic acid/neural tube defect health claim. In that matter, the industry challenged FDA's decision with another lawsuit.

Eng said that if FDA does not publish its decision soon, the Pearson plaintiffs would evaluate legal options. One option they would consider is asking for an injunction that would allow the industry to use its claim until FDA has rendered its decision.

As for whether FDA would stick to this latest deadline--its fourth in five months--Eng stated, "I'm giving them the benefit of the doubt." For more information, visit www.emord.com or www.fda.gov.