In a statement issued this morning, Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, said the move followed an extensive scientific review.
“For the first time, we have considered it necessary to propose a rule to revoke a health claim because numerous studies published since the claim was authorized in 1999 have presented inconsistent findings on the relationship between soy protein and heart disease.
“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.
“For example, some studies, published after the FDA authorized the health claim, show inconsistent findings concerning the ability of soy protein to lower heart-damaging low-density lipoprotein (LDL) cholesterol. Our review of that evidence has led us to conclude that the relationship between soy protein and heart disease does not meet the rigorous standard for an FDA-authorized health claim.”
Should the FDA finalize the proposed rule, which is subject to a 75-day comment period, 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, she added.
Brands currently using the health claim on pack will be permitted to continue to do so until the agency makes a final decision.
Soyfoods Association 'concerned'
The Soyfoods Association of North America said it was "concerned" by the move, and that it planned to "advocate for continuation of an unqualified claim, based on the totality of the evidence demonstrating that soy protein lowers LDL-cholesterol."
It added: "Numerous scientific studies published before and since the soy protein health claim was approved in 1999 consistently show that soy protein lowers LDL-cholesterol and that the totality of the evidence supports continued approval of an unqualified claim."
It also noted that the FDA’s decision was "inconsistent with 12 other countries that have authorized health claims on soy protein and heart disease, including Health Canada’s most recent approval of such a claim in 2015."
NPA: FDA approach not ideal
Daniel Fabricant, PhD, president and CEO of the Natural Products Association, said he was aware that the FDA was reviewing the evidence, but said it was "somewhat unexpected" to see the FDA revoke the claim without explaining what the tipping point was with regards to the evidence.
"Now what's going to happen is that their minds are made up and they will revoke the claim, and they'll probably get sued. Look at Central Hudson [Central Hudson Gas & Electric Corp. v. Public Service Commission, a case decided by the Supreme Court that laid out a four-part test for determining when restrictions on commercial speech violate the first amendment].
"For the government to restrict speech, they have to meet these four criteria and I don't see how this does. There are also issues of labeling costs and the FDA typically underestimates these. Why not have an ongoing dialog? Where was the discussion leading up to this decision?"
But isn't this what the FDA is supposed do? Periodically review health claims to ensure that the significant scientific agreement standard is still being met?
Yes, acknowledged Dr Fabricant. "But instead of going out and proposing to revoke the claim, why not have a public meeting, a public discussion saying we're considering changing the claim. Was the claim fine until now - did new data just come out saying it wasn't, what changed? What was the weighting of the newer studies? Do they want more people to go through the health claim process, I think the answer is yes. Is this the way to do it? I think the answer is no."
The FDA notes that it published a notice in the Federal Register in 2007 announcing plans to reevaluate the scientific evidence for certain health claims.
While it denied a 2008 citizen's petition calling for it to revoke the soy protein health claim based on the evidence submitted as part of the petition in January 2016, it also noted that it was "actively reviewing the entire body of scientific evidence to allow the agency to make a more well-informed decision regarding next steps for this health claim."
Dr Fabricant added: "What changed publicly from January 16 to October 2017 that was so monumental seems to be the question du jour for the agency."
The current approved health claim: '25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.'
No significant scientific agreement
In the proposal - which you can read in full HERE - the FDA explains that it reviewed 700+ publications and homed in on 58 "well-designed, well-conducted intervention studies" testing the impact of soy protein consumption on cholesterol and blood pressure to include in its evaluation.
Several intervention studies published after 1999 (see p20 onwards in the proposal) did not show a statistically meaningful reduction in these biomarkers in the intervention groups vs controls, said the FDA: "The additional evidence now available to us includes a number of new studies that do not support the relationship, and a number of studies that are inconclusive that also do not support a relationship.
"Of the 46 intervention studies that looked at the relationship between blood total cholesterol and/or LDL cholesterol and soy protein intake, only 19 intervention studies showed a benefit in significantly reducing the risk of coronary heart disease, while the other 27 intervention studies did not... Of the 12 high or moderate quality intervention studies that measured systolic blood pressure (SBP) and diastolic blood pressure (DBP) from which a conclusion could be drawn, only 4 showed a benefit in lowering SBP or DBP with soy protein consumption, while the other 8 studies did not show a benefit."
Meanwhile, "scientific conclusions cannot be drawn from observational studies on foods for soy protein as a food ingredient or component of food," added the FDA, noting that in many cases, even if the data indicated that soy foods reduced the risk of CHD, it was not possible to determine if this was due to soy protein or other components in soy.
It added: "We tentatively conclude, based on our re-evaluation of the totality of the publicly available scientific evidence now available, that the evidence does not support our previous determination that there is significant scientific agreement to support an authorized health claim for the relationship between soy protein and reduced risk of coronary heart disease."
More reaction to follow...
To comment on the proposal, stakeholders can go to the regulations.gov website and reference the docket: FDA-2017-N-0763