Harry Rice, PhD, VP of regulatory & scientific affairs, for GOED, told us that he is confident a qualified health claim will be allowed. He added that he is also hopeful that the FDA scientific review may elevate this to a full health claim. The petition can be viewed HERE.
Meta-analysis
The health claim petition is based on the meta-analysis of 70 randomized controlled trials published earlier this year (and commissioned by GOED), which concluded that consuming omega-3 supplements or omega-3-rich food may be as effective as reducing sodium or alcohol, or increasing exercise for reducing blood pressure.
Elevated blood pressure and hypertension are risk factors for heart disease, stroke, and chronic kidney disease, according to the health claim petition. Hypertension, which is defined as having systolic blood pressure of 140 mmHg or higher and/or diastolic blood pressure of 90 mmHg or higher, currently affects 31% of Americans, while another 30% are considered pre-hypertensive (systolic blood pressure of 120-139 mmHg or diastolic blood pressure of 80-89 mmHg).
Compared with placebo, consumption of EPA and DHA omega-3s was associated with an average 1.52 mmHg and 0.99 mmHg reduction in systolic and diastolic blood pressure, respectively, according to data published in the American Journal of Hypertension (doi: 10.1093/ajh/hpu024).
The cardiovascular benefits were greater still for untreated hypertensive subjects, who experienced average reductions of systolic and diastolic blood pressure of 4.51 mmHg and 3.05 mmHg, respectively.
Moreover, the benefits were not limited to hypertensives, with normotensive subjects also experiencing beneficial reductions of 1.25 mmHg and 0.62 mmHg reduction in systolic and diastolic blood pressure, respectively.
“The FDA will go through the 70 studies and look at the different outcomes, some of which are positive, and some are negative or null,” explained Dr Rice. “The benefit of a meta-analysis is that the studies get weighed according to quality, and in the case of this omega-3 – blood pressure meta-analysis, the lesser quality studies are the ones we see not having an effect, so the analysis is weighted towards the good quality positive studies.
“My understanding is that the Agency will look at the meta-analysis as a whole, but the main consideration is each study within the meta-analysis.”
Scientific Review
After the comment period closes, there are a number of different options open to the FDA in their review of the evidence. For example, the agency may conduct the review internally, it may convene an advisory subcommittee, or it may use appropriate third-party reviewers under contract to FDA, such as the Agency for Healthcare Quality and Research (AHRQ).
If the petition is forwarded to AHRQ, AHRQ will send this to an Evidence-Based Practice Center (EPC) with which it has a contract to review the scientific evidence in the petition and to rank the degree of scientific certainty of the validity of the substance/disease relationship. The EPC can also review science-related public comments received by FDA that discuss or provide evidence. Within 120 days after the commencement of the third party review, the agency would expect to receive a report that includes a description of the evidence reviewed, an analysis of that evidence, a summary of and response to public comments that pertain to the evidence, and its assessment as to the degree of scientific certainty in support of the substance/disease relationship.
Dr Rice noted that he expects an extension to the timeline since GOED plans to meet with the FDA for further discussions about the submitted evidence.
Proposed claims made in the petition include:
EPA and DHA help lower blood pressure in the general population.
EPA and DHA reduce BP, a risk factor for CHD.
EPA and DHA reduce the risk of CHD.
Research shows that EPA and DHA may be beneficial for moderating BP, a risk factor for CHD.
CHD
The health claim, if successful, would be the second for omega-3s, following a 2004 qualified health claim approval for omega-3s fatty acids and coronary heart disease (Docket No. 2003Q-0401).
The claim statement allowed in that instance is: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [Name of the food] provides [ ] gram of EPA and DHA omega-3 fatty acids.”
To read the new blood pressure-related health claim petition and to comment, please click HERE.