FDA Warning Letter on Health Claims Rebutted by Ocean Spray
April 1, 2001
FDA Warning Letter on Health Claims Rebutted by Ocean Spray
WASHINGTON--In response to the Food and Drug Administration's (FDA) Jan. 19 letter warning food manufacturers from making "unauthorized health claims," Middleboro, Mass.-based juice manufacturer Ocean Spray sent its own letter to FDA Feb. 9 seeking clarity on the boundaries between health claims on product labeling and company Web sites. In FDA's letter to Ocean Spray, one of the agency's objections included the company Web sites promoting the association of vitamin C with a reduced risk for cancer, heart disease, hemorrhaging and cataracts. FDA found these sort of claims to not fall under the umbrella of structure/function claims, or even authorized health claims, such as fruits and cancer. FDA also stated that wording on Ocean Spray's "Grapefruit Juice and Cancer Care" portion of its site was negligent in that it understated the risks associated with concurrent use of certain drugs and grapefruit juice. For additional information, visit www.fda.gov.
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