WATKINS REMOVES CHOLESTATIN CHOLESTEROL ABSORPTION CLAIMS

WATKINS REMOVES CHOLESTATIN CHOLESTEROL ABSORPTION CLAIMS following receipt of a June warning letter from FDA. In the letter, the agency noted that a product profile sheet for Cholestatin 190 mg tablets "states that Cholestatin blocks the body's absorption of cholesterol," a claim FDA said is unsupported by scientific evidence. In response, Watkins told the agency that it revised its product profile sheet "immediately to remove any references to Cholestatin's use as a means to reduce cholesterol absorption or for any other medically associated uses and position [the product] strictly as a nutritional supplement as a source for phytosterols." The warning letter states that the product profile sheet "discusses medical and scientific investigations relating to the amount of dietary cholesterol absorbed by the body, leading to a definite risk factor in the development of atherosclerosis." In reply, Watkins promised the agency that it would "discontinue the distribution of or reference to the noted scientific studies relating to plant phytosterols and the absorption of cholesterol." Watkins' amended product profile sheet for Cholestatin now reads: "Watkins offers this 'nature's wonder' in a highly purified, well-balanced blend of vegetable phytosterols containing absolutely no preservatives, sugar or salt." Product "benefits" listed on the profile sheet state that Cholestatin contains "the three phytosterols that are of the greatest nutritional importance in vegetables." Watkins also assured FDA that it would revise its catalog and other sales literature that "represents or suggests that Cholestatin is useful for inhibiting the absorption of dietary cholesterol," according to the warning letter. Watkins also agreed to correct certain good manufacturing practices deficiencies cited by FDA involving its Watkins Cough Syrup and other over-the-counter medications. The violations were observed during April 8 and 12 inspections of Watkins' Winona, Minn. facility. For example, the firm told FDA that it is in the process of adopting the U.S. Pharmacopeia's methodology for identification testing for Watkins' Supercold and Supercold Plus tablets. The agency observed in the warning letter that the Supercold products had not undergone identity testing with a certificate of analysis. In response to an FDA complaint that packaging equipment used for "1.5 grain aspirin tablets" was not adequately cleaned "in that two Supercold tablets were found under the machine," Watkins said that it plans to re-train its personnel to ensure that adequate cleaning is undertaken. The firm added that it is revising its procedures "to insure that no unapproved production records are given to manufacturing" after FDA noticed that "batch production records" for products including Watkins Cough Syrup "were not checked for accuracy, dated and signed." Watkins added that it is "implementing checks and balances to insure that" the modified procedures are being followed.