FTC News Release
August 9, 1994
Schering Corporation, a major national pharmaceutical manufacturer, has agreed to settle Federal Trade Commission charges that it made false and unsubstantiated claims that its product, Fibre Trim, is a high-fiber product, and unsubstantiated claims that Fibre Trim is an effective weight-loss product. The proposed settlement would prohibit Schering from making any representation about the weight-loss benefits, nutrient content, or nutrient-related health benefits of any food, food supplement, or drug without competent and reliable scientific evidence to substantiate the claim.
Schering, based in Kenilworth, NJ, is a subsidiary of Schering-Plough Corporation and manufactures pharmaceuticals, over-the-counter medicines, and vision-care and animal-health products. Schering spent more than $30 million to advertise and promote Fibre Trim in magazines, newspapers, television, radio, direct-mail correspondence, and in-store displays between 1985 and 1991. Fibre Trim became the top-selling diet product in its category within a few months of its nationwide introduction, and achieved $48.5 million in sales that year (1986).
The Commission issued an administrative complaint in September 1989 alleging that Schering’s advertisements and promotional materials represented that:
- Fibre Trim is an effective appetite suppressant, weight-loss, weight-control, or weight-maintenance product;
- Fibre Trim provides the health benefits associated with a fiber-rich diet or a high intake of dietary fiber from food;
- the recommended dosage of Fibre Trim provides 2.35 grams of dietary fiber per serving or about seven grams of dietary fiber per day;
- Fibre Trim is a high-fiber supplement; and
- the recommended daily dosage of Fibre Trim provides most of a person’s daily requirements of dietary fiber.
The complaint alleged that Schering did not have a reasonable basis for these representations, and that the latter three representations were false.
In September 1991, Administrative Law Judge Lewis F. Parker upheld the first three allegations, holding that Schering’s weight-loss, health-benefit, and fiber-content claims were deceptive. Judge Parker further ruled that Schering’s claim that Fibre Trim is a high-fiber supplement was false for the dosage recommended for weight-maintenance, but true for the higher dosage recommended for weight-loss. The ALJ’s decision was appealed to the Commission, but the consent agreement announced today for public comment would settle the charges and end the litigation.
The proposed consent agreement would prohibit Schering from claiming that any food, food supplement, or drug product provides any appetite-suppressant, weight-loss, weight-control, or weight-maintenance benefit, unless the claims are substantiated by competent and reliable scientific evidence. For certain appetite or weight-related claims, the settlement specifies that the required scientific evidence must include at least two adequate and well-controlled, double-blinded clinical studies. The consent agreement would further prohibit Schering from making unsubstantiated claims regarding the amount of, or health benefit associated with, fiber or any other nutrient or dietary constituent provided by any food, food supplement, or drug product.
The proposed consent agreement also would prohibit Schering from, among other things, misrepresenting the amount of fiber or any other nutrient or dietary constituent in Fibre Trim or any other food, food supplement, or drug product in the future. Schering also would be prohibited from misrepresenting that such products are high, rich, excellent, or superior sources of fiber or any other nutrient or dietary constituent.
In addition, the proposed order would require Schering — when making a fiber-content claim for any food, food supplement, or drug — to disclose clearly and in close proximity to that claim the number of grams of dietary fiber contained per serving.
The proposed order would permit representations permitted in labeling by certain standards or regulations promulgated by the US Food and Drug Administration.
Finally, the order contains various reporting requirements to assist the FTC in monitoring Schering’s compliance with its provisions.
The Commission vote to approve the proposed consent agreement for public comment was 5-0.
Related Documents
- FTC File No. 862-3080. FTC Docket No. D-9232. Decision, 118 FTC 1030.
Related News Release
This page was posted on August 27, 2006.
