The U.S. Food and Drug Administration on Monday
proposed a rule revoking the right of companies to
say soy protein protects the heart, while
potentially allowing a more circumspect health
The agency, which to date has never revoked a health
claim, said studies published since it authorized
the soy protein claim in 1999 had shown inconsistent
The American Heart Association has long advocated
revoking the soy health claim: in a 2008 comment on
the FDA’s intent to reevaluate the evidence, the
association said: “Direct cardiovascular health
benefit of soy protein or isoflavone supplements is
minimal at best.”
October 30, 2017
Statement from Susan Mayne, Ph.D., on proposal
to revoke health claim that soy protein reduces risk
of heart disease
"We’ve long recognized that some foods and
nutrients can help reduce the risk of certain
diseases or conditions.
Since 1990, the FDA has been responsible for
evaluating health claims on packaged foods to ensure
that they are rooted in strong science.
To date, we have authorized 12 such health
claims, such as the effect of calcium and vitamin D
in helping to lower the risk of osteoporosis or
certain fruits and vegetables to lower the risk of
FDA-authorized health claims reflect
well-established relationships based on the most
robust level of scientific evidence.
Today, we are proposing a rule to revoke a health
claim for soy protein and heart disease.
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
This proposed action, which has undergone a
thorough FDA review, underscores our commitment to
providing consumers with information they can trust
to make informed dietary choices.
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)
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 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
We look forward to working with stakeholders and
others interested in this topic throughout the
rulemaking process and invite them to submit
comments on the proposed rule.
The comment period will be open for 75 days, at
which time we will consider the comments received
along with the existing information we have to
determine whether to proceed with final rulemaking.
In the meantime, manufacturers will be allowed to
keep the current authorized claim on their products
until the agency makes a final decision.
For consumers who have questions about eating soy
products, we recommend they continue to follow
advice from the 2015-2020 Dietary Guidelines, which
state that a healthy eating pattern can include soy
beverages and a variety of protein foods, including
We note that the authorized health claim at issue
addresses only soy protein and reduced risk of
coronary heart disease.
Other purported health benefits of soy or
soy-derived food ingredients (such as soybean oil)
are not addressed as part of this proposed rule."
Dr. Mayne is director of the FDA’s Center for Food
Safety and Applied Nutrition.
For more information
U.S. Food and Drug Administration
American Heart Association