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Executive Summary

STERLING WILL PAY FTC $375,000 TO SETTLE MIDOL COMPLAINT charging the company with making "unsubstantiated therapeutic performance claims" in ads for the OTC menstrual pain relief brand. The Federal Trade Commission said June 12 that the ads violated a 1985 ruling that bars such claims unless a company has a "reasonable basis" for substantiation. The agreement was reached in March but was not announced until after the FTC complaint was filed in D.C. federal court on June 8. The commission announced that Sterling has agreed to pay$375,000 in civil penalties to settle the charges under a consent decree agreement, which does not constitute an admission of wrongdoing. The company said it believes its Midol claims were "adequately supported" but chose not to litigate the matter. None of the ads that were the basis of the FTC complaint is now running. The complaint stems from certain ads that ran from March 1985 to January 1986 and again in April 1988 for Original Formula Midol and Maximum Strength Midol for Cramps as well as Spanish-language ads that ran in the spring of 1986 for Maximum Strength Midol PMS and again in November 1988 for Original Midol Multi-Symptom Formula and Maximum Strength Midol Multi-Symptom Formula. The first series of TV and print ads were cited by the FTC for making unsubstantiated therapeutic performance claims, "directly or by implication," that one active ingredient in the formulation at the time, cinnamedrine HCl, "helps relieve muscle contractions fast and is a muscle relaxant for menstrual cramps." Cinnamedrine was categorized by FDA as a Category III smooth muscle relaxant in the OTC Menstrual Products Tentative Final Monograph published in November 1988. The ingredient is no longer in the Midol formulation. The complaint also takes Sterling to task for Maximum Strength Midol PMS ads that ran in the spring of 1986, claiming that the product provides "total" or "complete relief" from all symptoms of premenstrual syndrome. Finally, FTC said that ads that ran in November 1988 for Midol regular and maximum strength Multi-Symptom Formula made unsubstantiated claims that the products have a combination of ingredients "that relieves menstrual bloating or water weight gain." The 1985 order, which set a two-tiered system for substantiating OTC analgesic superiority claims, settled a longstanding "established superiority" ad claims case from the mid-1970s that involved not only Midol, but also Sterling ads for its analgesics Bayer Aspirin, Bayer Children's Aspirin, Vanquish and Cope. That ruling actually was made in 1983 ("The Pink Sheet" July 16, 1983, p. 7), but did not go into effect until March 25, 1985, when the Supreme Court denied Sterling's writ of certiorari. The Sterling order modified an earlier ruling, made in 1981, that all superiority claims for American Home Products' Anacin/Arthritis Pain Formula had to be substantiated by two double-blind, placebo-controlled clinical trials. The Sterling decision set up a two-tiered system that required two or more adequate and well-controlled clinical trials only for claims that one product has "established" superior effectiveness over competing products. That two-tiered system is still the standard for FTC cases and most recently was cited in a Sept. 28, 1989 complaint involving Schering's weight-loss product Fibre Trim.

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