The new health claim wording is, like others of its ilk, highly equivocal in nature. Each of the five approved health claims includes the phrase “FDA has concluded that the evidence is inconsistent and inconclusive,” which is a standard boilerplate inclusion for qualified health claims.
Successful multiyear effort
The approval, which was announced yesterday, is the culmination of a process that extended for more than five years. The Global Organization for EPA and DHA Omega-3s (GOED) first submitted a petition for the claims in 2014.
The health claim petition was based in part on a meta analysis of 70 studies on omega-3s and blood pressure that GOED had commissioned and that was published in early 2014 in the American Journal of Hypertension.
“From a clinical and public health perspective, provision of EPA+DHA may lower BP and ultimately reduce the risk of associated chronic diseases,” the authors of that study concluded.
Qualified health claims are often seen as double edged swords. Their highly equivocal nature and generally complex verbiage has made them difficult to use in marketing campaigns and thus they rarely appear on packaging. But the official recognition of these effects is still a welcome step forward, said omega-3s expert William S. Harris, PhD of the Sanford School of Medicine at the University of South Dakota.
“At least the FDA is willing to acknowledge that there is something there,” Harris told NutraIngredients-USA.
Harris is also president and CEO of the firm OmegaQuant, which offers blood tests to measure the Omega-3 Index, which is a measure of omega-3 fatty acids in red blood cells. Harris was a co developer of the idea.
“I think the approval of the health claims is a welcome step forward in the recognition of the multiple health benefits of omega-3 fatty acids. It’s not just about their effects on blood lipids, like triglycerides,” he said.
“They do affect other risk factors, like blood pressure and endothelial function,” Harris added.
Overall, GOED had submitted 717 studies linking omega-3s with blood pressure benefits. FDA responded positively in its standard form of issuing a letter of enforcement discretion, meaning if marketers stick to the approved language, the agency won’t go after them for putting a disease treatment claim on their labels.
Qualified, as opposed to authorized health claims
FDA determined that the overall evidence did not meet the ‘significant scientific agreement’ standard required for an authorized health claim (something GOED had been hoping for) but did meet the ‘credible evidence’ standard for a qualified health claim in the labeling of conventional foods and dietary supplements.
The officially approved claims read this way:
- 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.
- 3.a. 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.
- 3.b. 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.
In addition to the qualified health claims announced today, since 2004 the FDA has exercised enforcement discretion for the qualified health claim “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 certain circumstances.