tions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health” (21 USC 342(a)(1) & (4)).

Fish-oil supplements are regulated by FDA under the provisions of the Dietary Supplement Health and Education Act (DSHEA). This law provides that no FDA safety notification is needed for dietary supplement ingredients that were already on the US market prior to October 15, 2004. Fish oils are “grandfathered” under this provision, and thus there are no standards of identity for commercial fish-oil dietary supplements. Further, there is no provision under any law or regulation that requires a firm to disclose to FDA or consumers the information they have about the safety or purported benefits of their fish-oil products.

FDA is, however, empowered to remove from the market any fish-oil supplement that is not of adequate purity to ensure consumer safety under normal conditions of use. Since FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law.

Fish-oil products, as opposed to fish themselves, can be processed to remove undesirable constituents. An industry trade association, the Council for Responsible Nutrition, established voluntary standards for its members in October of 2002. These standards limit concentrations of contaminants in fish-oil products as follows:

  • DLCs: ≤2 pg TEQ/g

  • PCBs: ≤0.09 µg/g

  • Heavy metals (lead, cadmium, mercury, arsenic): all <1 µg/g

Data submitted to FDA by the National Fish Meal and Oil Association on pesticide and PCB analysis in fish oil, conducted under Title 21, Code of Federal Regulations, Parts 109 and 509 “Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed,” indicated that multiple samples of menhaden and fish oil (refined and crude) did not contain detectable levels of a panel of pesticides, PCBs, and dioxins (Source: http://www.fda.gov/ohrms/dockets/dailys/02/Jul02/070202/99p-5332_sup0003_01_vol1.pdf).

Summary of Evidence

In summary, while certain hazards associated with specific species (e.g., scombroid poisoning) and lack of compliance with food safety guidelines (e.g., eating raw molluscan shellfish) persist, reviews of reported seafoodborne illnesses indicate that more acute seafood safety hazards are not



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