also specify requirements for distinct labeling of any seafood exposed to sulfiting agents.

Consumer awareness and labeling remain the most effective measures to prevent exposure to seafood that could elicit a food sensitivity response. Commercial practices for dual processing or preparation of other foods in facilities or with utensils used for seafood must avoid potential cross-contamination that could result in unanticipated exposures. Requirements to identify seafood or any use of seafood ingredients, as well as certain food additives, have been emphasized by the HACCP mandate (FDA, 2001a) requiring appropriate hazard analysis to identify any potential food sensitivity risks controlled through proper cleaning, product segregation, or product identification in order to prevent a potential hazard.

Adverse Effects Associated with Omega-3 Supplementation

While there is extensive research suggesting health benefits from the consumption of EPA/DHA found in fish oils, there are also data that indicate that overconsumption of fish oils could have adverse consequences. Evidence suggests that EPA and DHA may increase bleeding time, specifically by reducing platelet aggregability, and prolonged bleeding times in humans whose diets were supplemented with fish oil have been observed (e.g., Jensen et al., 1988; Rodgers and Levin, 1990; Harris et al., 1991). After reviewing this literature, FDA concluded that prolonged bleeding is not a significant risk at levels of consumption of up to 3 grams per day of EPA and DHA (Source: http://www.cfsan.fda.gov/~dms/ds-ltr11.html). This conclusion was the basis for FDA’s recommendation, which remains in force, that consumption of EPA and DHA combined should be limited to 3 grams per day, of which 2 might come from supplements.

Other potentially adverse effects of excessive consumption of fish oils include reduced glycemic control among diabetics, increased levels of lowdensity lipoprotein (LDL) cholesterol among diabetics and hyperglycemics, and immunosuppressive effects. FDA determined that limiting consumption of EPA and DHA to 3 grams per day would protect against these effects also.

Since some contaminants that may be found in seafood are lipophilic, including PCBs, DDT and its metabolites, DLCs, and polyaromatic hydrocarbons (PAHs), they may tend to concentrate in the fish oil. It is important to recognize that dietary supplements, including fish oils sold as supplements, are subject to the same regulations regarding adulteration as are conventional foods. A food is considered adulterated if it “bears or contains any poisonous or deleterious substance which may render it injurious to health” or if it “has been prepared, packed, or held under insanitary condi-



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