VMS industry rallies in support of soy protein health claim
The Food and Drug Administration is proposing to revoke its regulation allowing suppliers to make a health claim associating consumption of soy protein with prevention of coronary heart disease. Instead, the agency is proposing to allow manufacturers to make qualified claims supporting the consumption of soy protein, which is arguably less compelling to industry.
The claim was first authorized in 1999.
Both the Council for Responsible Nutrition and the Natural Products Association this week responded in support of the authorized health claim.
"We are concerned that FDA's proposal to revoke the regulation authorizing the us of the claim is inconsistent with evaluations by other international regulatory bodies," CRN submitted in a letter to the agency. CRN noted that Health Canada in 2015 concluded that the "evidence consistently supports a direction of effect toward a reduction in total and LDL cholesterol levels when soy protein is consumed."
“The FDA has failed to offer any compelling evidence in its proposal to eliminate the soy heart health claim,” Daniel Fabricant, president and CEO of NPA, said. Fabricant pointed to the significant amount amount of evidence that supports the health claim.
According to the NPA, not only does soy protein lower LDL cholesterol directly, but also indirectly by replacing animal protein sources with plant-based soy protein sources. The combined intrinsic and extrinsic effects of soy to lower LDL cholesterol is 10.3%, NPA reported, which is on par with the heart health claim for plant sterols and stanol esters to reduce LDL cholesterol by 10%.
The FDA made its proposal to revoke the soy protein health claim in October. "While some evidence continues to suggest a relationship between soy protein and a reduced risk of heart disease – including evidence reviewed by the FDA when the claim was authorized – the totality of currently available scientific evidence calls into question the certainty of this relationship," the agency stated in a release. "Should the FDA finalize this rule, the agency intends to allow the use of a qualified health claim as long as there is sufficient evidence to support a link between eating soy protein and a reduced risk of heart disease. A qualified health claim, which requires a lower scientific standard of evidence than an authorized health claim, would allow industry to use qualifying language that explains the limited evidence linking consumption of soy protein with heart disease risk reduction."
The agency has promised to review comments received on this matter before issuing a final decision.
The claim was first authorized in 1999.
Both the Council for Responsible Nutrition and the Natural Products Association this week responded in support of the authorized health claim.
"We are concerned that FDA's proposal to revoke the regulation authorizing the us of the claim is inconsistent with evaluations by other international regulatory bodies," CRN submitted in a letter to the agency. CRN noted that Health Canada in 2015 concluded that the "evidence consistently supports a direction of effect toward a reduction in total and LDL cholesterol levels when soy protein is consumed."
“The FDA has failed to offer any compelling evidence in its proposal to eliminate the soy heart health claim,” Daniel Fabricant, president and CEO of NPA, said. Fabricant pointed to the significant amount amount of evidence that supports the health claim.
According to the NPA, not only does soy protein lower LDL cholesterol directly, but also indirectly by replacing animal protein sources with plant-based soy protein sources. The combined intrinsic and extrinsic effects of soy to lower LDL cholesterol is 10.3%, NPA reported, which is on par with the heart health claim for plant sterols and stanol esters to reduce LDL cholesterol by 10%.
The FDA made its proposal to revoke the soy protein health claim in October. "While some evidence continues to suggest a relationship between soy protein and a reduced risk of heart disease – including evidence reviewed by the FDA when the claim was authorized – the totality of currently available scientific evidence calls into question the certainty of this relationship," the agency stated in a release. "Should the FDA finalize this rule, the agency intends to allow the use of a qualified health claim as long as there is sufficient evidence to support a link between eating soy protein and a reduced risk of heart disease. A qualified health claim, which requires a lower scientific standard of evidence than an authorized health claim, would allow industry to use qualifying language that explains the limited evidence linking consumption of soy protein with heart disease risk reduction."
The agency has promised to review comments received on this matter before issuing a final decision.