Fiberall cholesterol label claims changes under way in response to FDA "courtesy" letter.

FIBERALL CHOLESTEROL LABELING CLAIMS MODIFICATION under way at Heritage Consumer Products in response to a June 17 "courtesy" letter from FDA. The letter designated as unapproved new drug claims the product's label statements: "Helps lower cholesterol when used as part of a low fat diet" and "...When used as part of a low fat diet, gives your body more of what it needs to lower cholesterol." The agency letter followed a June 10 company notification describing the statements as dietary supplement structure/function claims allowable under the Dietary Supplement Health & Education Act.

"The statements you are making for this product suggest that it is intended to treat, prevent, cure, or mitigate disease, namely hypercholesterolemia," which disqualifies them as structure/function claims, the agency told the company. "These claims suggest that this product is intended for use as a drug," the letter continues. The company is working with FDA to bring the claims in line with agency policy. FDA tentatively designated "Helps to maintain a healthy cholesterol level" as acceptable for supplements and "Lowers cholesterol" as unacceptable in its recent proposal on structure/function claims ("The Tan Sheet" May 4, p. 5).

The letter does not address other current label claims that the product "promotes normal regularity." Heritage is in the process of relaunching Fiberall as a dietary supplement after acquiring the product from Novartis in August 1997.

Heritage is going ahead with TV advertising plans for Fiberall that are scheduled to break in August ("The Tan Sheet" July 6, p. 19). Ads state: "Now there's an easy, great-tasting way to stay regular and, with a low-fat diet, it helps your cholesterol and may even reduce your risk of heart disease."

Formerly marketed as a bulk laxative with psyllium and oat bran, the product has a new formulation with six different fibers derived from fruit, grain and vegetables and 11 essential daily vitamins ("The Tan Sheet" April 20, p. 5). Novartis has been working on its own cholesterol-lowering dietary supplement and recently received a similar advisory letter from FDA for claims for its Choltrol ("The Tan Sheet" April 20 p. 8). However, the company has decided to continue with claims that Choltrol is "clinically proven to lower total blood cholesterol by 10% when added to a low fat diet." The five-fiber powder began test marketing last summer.

The appropriateness of structure/function claims for Citrol that relate to smoking cessation is under review by FDA, the agency told MGA Development Corp. in a June 22 letter. MGA is engaged in a debate with the agency regarding the use of such claims. Citrol is marketed as a "dietary alternative to smoking."

The claims include: "Citrol can help you get over those immediate moments when you want to smoke"; "Use Citrol to reduce your desire to smoke in any smoke-free environment"; "With its tart, citrus taste, Citrol can help you get over those immediate moments when you want to smoke"; and "Citrol -- a pocket-sized oral spray -- can help smokers cope with those immediate moments when they want to smoke, but can't." The claims were the subject of a March 6 courtesy letter from FDA ("The Tan Sheet" April 20, p. 14).

However, the company argued in a March 11 response it "believes the agency is mistaken as a matter of fact and law" and "requests that FDA withdraw the letter immediately." Noting the agency had concluded the statements for Citrol constitute unapproved new drug claims for the "disease" of nicotine addiction, MGA maintains, "the product is not intended to have a physiological impact on addiction, and the statements of nutritional support make no mention of anything other than the taste of Citrol and its potential use in a particular context." In "fact," the letter continues, Citrol labeling states explicitly that the product is nicotine free, that it is not a nicotine replacement drug and that it is not a substitute for an overall smoking cessation program."

What Citrol "offers" is "an option for smokers who feel like having a cigarette but are unable to do so because it is prohibited or simply inconvenient," the company continues. "It does so by providing a quick taste and oral sensation in the dietary ingredient citric acid."

The letter further notes the Wrigley chewing gum company began a series of ads in late 1995 promoting the use of its spearmint gum "when you'd like to smoke but can't." What these ads state is that "by chewing gum, a smoker can distract him or herself from cigarettes," according to MGA. "Citrol makes the same statements with respect to a dietary supplement." The letter was written on the company's behalf by the D.C. firm Patton Boggs.