11.18.13
The Global Organization for EPA and DHA Omega-3s (GOED) has submitted its petition to the U.S. FDA for an authorized health claim for Eicosapentaenoic and Docosahexaenoic Acids and Reduction of Blood Pressure in the General Population.
The basis for the GOED petition is a comprehensive meta-analysis of 70 randomized controlled trials, pertaining to EPA+DHA provision and blood pressure reduction, according to the organization. Collectively, the totality of evidence indicates that provision of EPA+DHA significantly reduces both systolic blood pressure and diastolic blood pressure among study participants representative of the general population. The data across all studies are overwhelmingly consistent, GOED said, suggesting an independent causal relationship.
It has been more than nine years since the FDA announced it would allow the following claim to be used on foods and dietary supplements with EPA and DHA: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”
In 2004, when FDA responded to the health claim petitions, high blood pressure was recognized as a surrogate endpoint for coronary heart disease (CHD). More recently, on August 1st of this year, GOED, along with its consultants from Exponent Inc. Health Sciences and Van Elswyk Consulting Inc., visited the FDA and the agency’s position was confirmed.
Timeline
The review process will likely be lengthy, according to GOED, particularly given the number of studies included in the meta-analysis. The FDA was clear when GOED met with the agency in August that each study included in the meta-analysis will need to be reviewed. Below is a paraphrased version of the timeline provided in 21CFR101.70.
• Within 15 days of receipt of the petition, the petitioner will be notified that the petition is undergoing review and that the petitioner will be notified of the agency’s decision to file for comprehensive review or deny the petition.
• Within 100 days of the date of receipt of the petition, the FDA will notify the petitioner that the petition has either been filed for comprehensive review or denied. Assuming the petition is filed, the date of the notification becomes the date of filing. If FDA does not act within 100 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by FDA and the petitioner.
• Within 90 days of the date of filing, the FDA will either deny the petition or inform the petitioner that a proposed regulation to provide for the requested use of the health claim will be published in the Federal Register. Assuming the petition proceeds, FDA will publish the proposal to amend the regulations to provide for the requested use of the health claim in the Federal Register within 90 days of the date of filing. The proposal will also announce the availability of the petition for public review. If the FDA does not act within 90 days of the date of filing, the petition shall be deemed to be denied unless an extension is mutually agreed upon by FDA and the petitioner.
• Within 270 days of the date of publication of the proposal, FDA will publish a final rule that either authorizes use of the health claim or explains why the agency has decided not to authorize one.
• FDA may extend, no more than twice, the period in which it will publish a final rule and each such extension will be for no more than 90 days.
The basis for the GOED petition is a comprehensive meta-analysis of 70 randomized controlled trials, pertaining to EPA+DHA provision and blood pressure reduction, according to the organization. Collectively, the totality of evidence indicates that provision of EPA+DHA significantly reduces both systolic blood pressure and diastolic blood pressure among study participants representative of the general population. The data across all studies are overwhelmingly consistent, GOED said, suggesting an independent causal relationship.
It has been more than nine years since the FDA announced it would allow the following claim to be used on foods and dietary supplements with EPA and DHA: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”
In 2004, when FDA responded to the health claim petitions, high blood pressure was recognized as a surrogate endpoint for coronary heart disease (CHD). More recently, on August 1st of this year, GOED, along with its consultants from Exponent Inc. Health Sciences and Van Elswyk Consulting Inc., visited the FDA and the agency’s position was confirmed.
Timeline
The review process will likely be lengthy, according to GOED, particularly given the number of studies included in the meta-analysis. The FDA was clear when GOED met with the agency in August that each study included in the meta-analysis will need to be reviewed. Below is a paraphrased version of the timeline provided in 21CFR101.70.
• Within 15 days of receipt of the petition, the petitioner will be notified that the petition is undergoing review and that the petitioner will be notified of the agency’s decision to file for comprehensive review or deny the petition.
• Within 100 days of the date of receipt of the petition, the FDA will notify the petitioner that the petition has either been filed for comprehensive review or denied. Assuming the petition is filed, the date of the notification becomes the date of filing. If FDA does not act within 100 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by FDA and the petitioner.
• Within 90 days of the date of filing, the FDA will either deny the petition or inform the petitioner that a proposed regulation to provide for the requested use of the health claim will be published in the Federal Register. Assuming the petition proceeds, FDA will publish the proposal to amend the regulations to provide for the requested use of the health claim in the Federal Register within 90 days of the date of filing. The proposal will also announce the availability of the petition for public review. If the FDA does not act within 90 days of the date of filing, the petition shall be deemed to be denied unless an extension is mutually agreed upon by FDA and the petitioner.
• Within 270 days of the date of publication of the proposal, FDA will publish a final rule that either authorizes use of the health claim or explains why the agency has decided not to authorize one.
• FDA may extend, no more than twice, the period in which it will publish a final rule and each such extension will be for no more than 90 days.
