FDA has issued an enforcement discretion letter that authorizes qualified health claims (QHC) that relate consuming eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) omega-3 fatty acids in food and dietary supplements to reducing the risk of hypertension and coronary heart disease (CHD). The QHC derives from a health claim petition submitted by Global Organization for EPA and DHA Omega-3s. FDA determined that the overall evidence did not meet the “significant scientific agreement” standard required for an unqualified health claim, but did meet the “credible evidence” standard for a QHC.
The QHC authorized are:
1. Consuming EPA and DHA combined may help lower blood pressure in the general population and reduce the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
2. Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
3a. Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
3b. Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by reducing the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
4. Research shows that consuming EPA and DHA combined may be beneficial for moderating blood pressure, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA Dietary supplements need not declare the amount of EPA and DHA per serving in the claim if it is declared in the “Supplement Facts” in accordance with 21 C.F.R. § 101.36.
Dietary supplements need not declare the amount of EPA and DHA per serving in the claim if it is declared in the “Supplement Facts” in accordance with 21 C.F.R. § 101.36.
FDA intends to consider exercising its enforcement discretion for the above QHC when all the following enforcement discretion factors (as applicable) are met.
- Dietary supplements bearing the QHC may not provide more than 5 g/day of EPA and DHA combined when used according to their labeling.
- 8 g EPA and DHA (combined total) is the minimum amount per serving for a conventional food or dietary supplement to bear a QHC.
- Conventional foods must meet all “low saturated fat” criteria in 21 C.F.R. § 62(c)(3). In contrast, dietary supplements must meet the “equal to or less than 1 g of saturated fat per RACC” criterion in 21 C.F.R. § 101.62 (c)(2), but not the “no more than 15 percent of calories from saturated fat” criterion.
- Dietary supplements, except those in liquid form, must meet the “low cholesterol” criterion of no more than 20 mg per RACC (21 C.F.R. § 101.62 (d)(2)).
- Individual conventional foods must not exceed the disqualifying levels of 13 g of total fat, 4 g of saturated fat, 60 mg of cholesterol, or 480 mg of sodium per RACC, per labeled serving size, and per 50 g if the RACC is 30 g or less or 2 tablespoons or less (21 C.F.R. § 14(a)(4)). The same is true for dietary supplements, except that 30 g or less or two tablespoons or less cholesterol per RACC is substituted for the50 g criterion.
- A conventional food may not bear the QHC unless it contains, prior to any nutrient addition, at least 10% of the Daily Value for vitamin A, vitamin C, iron, calcium, protein, or dietary fiber per RACC (21 C.F.R. § 101.14(e)(6)). However, the 10% minimum nutrient content requirement does not apply to dietary supplements.
In addition to these new QHC, since 2004 FDA has exercised enforcement discretion for the QHC, “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease ….” under similar circumstances.
