Juice manufacturer Ocean Spray is asking FDA for guidance on the types of product health benefit statements suitable for company Web sites.

The firm said it is seeking clarity on the boundaries between health claims on product labeling and scientific information on company-operated sites.

Ocean Spray's Feb. 9 letter comes in response to FDA's Jan. 19 warning letter objecting to "unauthorized health claims" on the Lakeville-Middleboro, Mass.-based firm's Web sites.

In the warning letter, FDA says it reviewed the company's "Internet labeling" for Ocean Spray juice products, noting that product container labels direct consumers to www.oceanspray.com and www.oceanspraygrapefruit.com.

Several of the claims FDA objects to include references to cancer, such as, "Vitamin C...associated with a reduced risk of chronic diseases such as cancer, cardiovascular disease and cataracts."

Other claims cited by FDA include: "Flavonoids... reduce intravascular blood clotting...stroke prevention"; vitamin C "helps prevent hemorrhaging" and "helps prevent viral infections such as the common cold"; and "Drinking one glass of grapefruit juice every day reduced the risk of stroke by 25%."

FDA also asserts the Internet sites contain claims indicating the products "are intended to treat, cure or mitigate disease" and are beyond the scope of structure/function claims or authorized health claims.

Such claims, FDA says, include: "In cancer prone mice, resveratrol appeared to inhibit lesion development and reduce skin tumor occurrence"; "May help the body fight cancer"; and "Research shows grapefruit juice slows breast cancer growth." Other challenged claims pertain to potential cholesterol-lowering effects and "anti-inflammatory, anti-allergic" properties.

Furthermore, statements made on the "Grapefruit Juice and Cancer Care" section of the site "pose a serious safety threat as they not only overstate any possible benefit associated with grapefruit juice consumption but also understate the very real risks associated with concomitant use of certain drugs and grapefruit juice," FDA opines.

The site's statement that grapefruit juice "enhances the absorption and effects of some medications" implies that such an effect may be beneficial, the agency says.

"The consumer would need to find a subsequent unnumbered footnote to receive a partial list of medications that may be affected by grapefruit juice and to receive a mild admonition to consult with a physician or pharmacist before taking the listed drugs," FDA contends. "This presentation not only trivializes a serious risk, but also is likely to promote concomitant use of grapefruit juice and affected medications."

FDA further contends the site promotes grapefruit juice for mitigation of diseases and conditions, such as high cholesterol, for which drugs commonly are prescribed that adversely interact with grapefruit juice.

The letter requests Ocean Spray "take prompt action to correct these violations" or face enforcement, such as seizure and injunction.

Ocean Spray said it removed from its Web site all the elements cited by FDA as of Feb. 9, noting it had withdrawn the statements regarding grapefruit juice's interaction with drugs prior to that time.

The company noted it believes the site would not have been targeted for FDA enforcement had its URL address not been listed on product labeling, thereby raising the question of whether companies should include Web addresses on labeling. Ocean Spray said it has no plans to remove its URL from labeling at this time and, pending feedback from FDA, has no immediate plans to add new information to its site.

The company said its Web site is not intended to constitute labeling. Rather, Web content is more akin to advertising, Ocean Spray said, adding that the material was accurate and substantiated. Citations and footnotes were provided for studies referred to on the site, and whether those studies were clinical trials or basic laboratory research was clearly specified, Ocean Spray asserted.

FDA, through the warning letter, has trod upon an area that interferes with free speech rights, blurring the lines between labeling and advertising, the Grocery Manufacturers of America asserted.

FDA said the Ocean Spray Web content was brought to its attention by a physician and the agency had "serious public health concerns" about the statements.

Ocean Spray Request For Web Site Content Guidance Follows FDA Warning

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