FDA’s evidence not compelling enough to revoke soy protein heart-health claim, trade groups say

By Adi Menayang contact

- Last updated on GMT

iStock / Handmade Pictures
iStock / Handmade Pictures
The Council for Responsible Nutrition says that FDA’s proposal to revoke a law authorizing use of heart health claims for soy protein is inconsistent with stances of other international regulatory bodies, while the Natural Products Association president and CEO said the agency has not offered any compelling evidence to back the proposal.

The two industry groups recently submitted comments to the FDA regarding Docket no. FDA-2017-N-0763​ first announced by the agency in October 2017.

In a statement​issued at the time, Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, said the move followed an extensive scientific review.

However, the ‘extensive scientific review’ was not enough to back revoking a health claim for the ingredient, argued trade group Natural Products Association, or NPA.

“The FDA is proposing to revoke its regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease on the label or in the labeling of foods but has failed to perform its own meta-analysis,”​ according to a statement by the NPA.

CRN’s letter voiced the same concern. “It is unclear why a meta-analysis was not undertaken in the agency’s re-evaluation of the soy protein and coronary heart disease health claim,” ​read the letter, signed by vice president of scientific and regulatory affairs at CRN Dr. Andrea Wong, PhD.

American Heart Association backs FDA: ‘The health claim does not meet the significant scientific agreement’

The American Heart Association, together with the American Stroke Association, voiced their support for FDA’s proposal to revoke soy protein and coronary heart disease health claims in a comment​ they submitted on March 8.

“We agree with the Agency’s tentative conclusion: the health claim does not meet the significant scientific agreement (SSA) standard and should be revoked,”​ according to the association. AHA had “strongly recommended” ​that FDA revoke the soy protein and coronary heart disease health claim back in 2008.

“As AHA described in our previous 2008 correspondence to the Agency on this topic, we too have conducted multiple reviews of the evidence describing the relationship between soy protein and coronary heart disease, and like the FDA, we too have found that the evidence no longer supports a SSA level health claim.”

The association argued that later studies have not yet replicated soy protein’s favorable effects on LDL cholesterol and other cardiovascular disease risk factors. Instead, “the majority of that research suggested that a very large amount of soy protein, more than half the daily protein intake, may lower LDL cholesterol by a few percentage points when it replaces dairy protein or a mixture of animal proteins.

AHA: Claim revoked because insufficient evidence, not because eating soy protein is bad for your heart

fried tofu Crédits VeselovaElena
iStock / Veselova Elena

The American Heart Association backed FDA's proposal to revoke a heart health claim for soy protein, but it cautioned the agency to clearly explain to the public why it is doing so, if it does follow through with the revocation. "We know that replacing foods high in animal protein that contain saturated fat with plant protein such as soy is beneficial, and we do not want to unintentionally discourage consumers from doing so.

"Therefore, it will be important for the FDA to explain that the claim is being revoked because the evidence linking soy protein consumption and reduced risk of coronary heart disease is inclusive ​[sic] and is not sufficient to meet the standards of a significant scientific agreement claim, not that eating soy protein is bad for your heart or does not have any benefit.

"We are concerned that some media stories did not make that distinction clear when the FDA's proposed rule was released last fall." ​Read AHA's full comment HERE​.

“That reduction, however, was thought to be very small relative to the large amount of soy protein tested in those studies and those data were mainly from hypercholesterolemic individuals.”

It added: “As the FDA notes in the Federal Register notice, the science remains somewhat inconsistent and support for the claim weak.”

Discrepancy due to intrinsic and extrinsic soy effect on LDL cholesterol, NPA says

NPA conducted its own meta-analysis, which it submitted as a comment letter​ to the FDA. In it, the trade group found an overall effect size reduction in LDL cholesterol of 0.221 ± .024 mmol/L.”

The association argued that the best explanation for discrepancies reported in clinical trials and meta-analyses was the intrinsic and extrinsic soy effect on LDL cholesterol reduction.

“The isolated extrinsic effect of soy was due to displacement of saturated fats and cholesterol from animal food diets and calculated to be between 3.6-6.0% when displacing with soy (13-58 g/day range) using NHANES III population survey data. Therefore, a combined intrinsic and extrinsic effect of soy protein foods ranges anywhere between 7.9 to 10.3%,”

FDA's soy-heart health claim: 25g of soy protein per day remains clinically relevant, says DuPont

FDA-s-soy-heart-health-claim-25g-of-soy-protein-per-day-remains-clinically-relevant-says-DuPont_wrbm_large
Getty Images / naito8

The FDA is not meeting its mandate for providing clear, evidence-based guidance that is practical and actionable, say DuPont in comments on the Agency’s proposal to revoke the soy protein heart health claim. READ MORE

making soy one of the few food components that has consistently been shown to reduce serum cholesterol by greater than 4%.

Further validation that there are separate intrinsic and extrinsic soy effect were six studies excluded from both AHA’s review and the influential Anderson et al. meta-analysis from 1995, which intentionally substituted an average of 26.6 g soy protein for dairy products and meat without correcting for fatty acid profile and cholesterol intake.

“The FDA’s proposal to revoke its health claim for soy protein is not only bad public health policy but it will harm small business manufacturers, distributors, re-packers, and retailers who would be affected by this proposal,”​ argued Dr. Daniel Fabricant, president and CEO of NPA. 

“We are hopeful the FDA will take into account our new meta-analysis and conduct its own economic analysis on this proposal.”

CRN: FDA’s proposal to revoke soy protein heart-health claim inconsistent with findings by other international regulatory bodies

For the DC-based Council for Responsible Nutrition (or CRN), a big concern of the FDA’s proposal is that it is inconsistent with stances of other regulatory bodies, namely Health Canada, which authorized the use of a health claim about soy protein and cholesterol lowering.

“In 2015, Health Canada’s Food Directorate concluded​ that the ‘evidence consistently supports a direction of effect towards a reduction in total and LDL cholesterol levels when soy protein is consumed,’” ​read the comment to FDA, submitted  Monday by CRN’s Andrea Wong, PhD, vice president, scientific and regulatory affairs.

“Health Canada also conducted a meta-analysis of the available scientific literature, the results of which showed a ‘statistically significant reduction in total and LDL cholesterol levels with soy protein consumption.”

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