Omega-3 supplements using the QHCs the FDA is allowing under enforcement discretion must comply with these criteria CFSAN stated in its letter to GOED:

Level of the ingredients must be sufficiently high and in an appropriate form;
Minimum amount per serving of 0.8 g EPA and DHA (combined total) for a conventional food or dietary supplement;
Not provide more than 5 g/day of EPA and DHA combined when used according to labeling to ensure that consumption of high-potency EPA and DHA supplements based on the presence of QHCs in product labeling does not increase potential for adverse effects;
Meet the "extra lean" criterion for cholesterol (95 mg of cholesterol per reference amount customarily consumed [RACC]); Meet the disqualifying nutrient level for fat per 50 g for foods with a small RACC (30 g or less or 2 tablespoons or less;
Food products must meet 10% minimum content requirement for Daily Value for vitamin A, vitamin C, iron, calcium, protein, or dietary fiber per RACC; 10% minimum nutrient content requirement does not apply to supplements.

FDA Holds Line On Omega-3 Claims, But Gives Enforcement Discretion For More

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