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Executive Summary

FDA TAKING REGULATORY ACTION AGAINST FISH OIL dietary supplements for making unsubstantiated "drug" claims. FDA Center for Drug Evaluation and Research's Health Fraud Branch notified regional and district directors on March 25 that regulatory letters should be sent to firms marketing fish oil (omega-3 fatty acid) products making therapeutic claims, including cholesterol-lowering. According to FDA, the reg letters will be sent to approximately 100 of the 200 firms currently marketing fish oil products. The regulatory action follows a year long review by the agency. In April 1987, FDA asked its district offices to conduct a survey to identify marketed fish oil products and submit labels, labeling, and advertising for regulatory and medical review. Based on the survey, the agency identified 13 unapproved therapeutic claims being made for the fish oil products, including: arthritis; atherosclerosis; cancer; cholesterol-lowering; diabetes; eczema and psoriasis; blood pressure lowering; immune system effects; migraine; platelet aggregation effects; prostaglandin effects; heart disease effects; and triglyceride-lowering. The letter to the districts notes that the agency reviewed documents submitted by companies as well as published and unpublished studies, and concluded "that these data do not demonstrate the safety or effectiveness of the omega-3 fatty acids for the prevention or treatment of any of the claimed conditions." Warner-Lambert, Squibb and R.P. Scherer, three pharmaceutical firms that also manufacture and market fish oil products in the U.S., said they had not received regulatory letters as of April 15. Warner-Lambert's fish oil product, Promega, does not contain a specific label indication for any of the claims cited by FDA, but is labeled as a "heart health supplement from the sea." In an official statement prepared in anticipation of the regulatory letter, the company said it "believes that the current claim for its Promega brand dietary fish oil supplement is based on solid scientific evidence and accurately reflects the facts." The company also noted that "hundreds of scientific studies exist on the benefits of fish oil and fish in helping to reduce the risk factors associated with heart disease when consumption accompanies a low fat diet and other health habits designed to reduce risk." Labeling for Squibb's product, Proto-chol, describes the fish oil as "a dietary supplement [that's] part of your cholesterol control program." Scherer's fish oil product is not packaged by the company. Scherer supplies the supplement in bulk to other firms for distribution under the firm's MaxEPA tradename. FDA's letter to the districts notes that the agency may have some safety, as well as efficacy, concerns with fish oil products. The letter states that "there may be an element of risk associated with effects on bleeding time and platelet function." FDA included a model of the regulatory letter to be sent to manufacturers in its communication to the districts. The letter informs marketers that "promotional material -- labeling -- distributed with your product states or suggests that (name of product) is useful in the prevention or treatment of (specify) . . . and is [therefore] a drug within the meaning of . . . the FD&C Act. We are unaware of any substantial scientific evidence which documents that this drug is generally recognized as safe and effective for the above referenced disease conditions or any other disease conditions [and] the drug is therefore a new drug . . . in violation of the FD&C Act." The model reg letter requests that recipients respond in 10 days stating the actions to be taken to discontinue marketing of the product. The letter also asks for an estimate of the amount of drug in inventory and in distribution channels, the firm's "intention with respect to disposition of inventories and outside stocks in trade channels," an estimate of the quantity of drug manufactured or received in the past 12 months, and an estimate of the size and frequency of shipments made in the past 12 months.

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