The FDA Initiative to provide more and better information to consumers about
the health benefits of food products sprung from the belief that significant
public health improvement can be achieved when consumers have scientifically
based information available for the food they purchase. FDA has expanded the
range of acceptable qualified health claims by defining an evidence-based rating
system that rates the strength of the evidence behind a proposed health relationship
on a continuum from A-D with an A rating representing significant scientific
agreement.
Two final qualified health claims guidance documents
were made available by the FDA in the July 10, 2003, Federal Register. They
describe: 1) the process
FDA will use for evaluating and ranking the scientific evidence for a qualified
health claim, and 2) how applicants can seek a qualified health claim. This
information is also available on the FDA website at www.fda.gov/oc/mcclellan/chbn.html.
The following FAQ’s address the most common areas of
clarification:
1. Why is the new qualified health claims information released as guidance
documents and not regulations?
The FDA’s current recommendations are just a first step in realizing
the broad health claims potential of food. Work will continue in phases to
make the process more effective and useful. In phase one the FDA will complete
and encourage others to do consumer studies designed to improve the understanding
of the most effective way to present scientifically based, truthful and non-misleading
information to consumers. They will also identify the kinds of information
known to be misleading. In the second phase, the agency intends to develop
regulations based on further public comment, further research studies, and
FDA’s experience in phase one.
2. How were the guidelines developed?
The guidelines were developed by an FDA task force made up of government experts
on health information and nutrition from FDA, the Federal Trade Commission,
and the National Institutes of Health.
3. What type of scientific evidence is necessary to make a qualified health
claim in the new system?
The following four tiered ranking system will categorize the quality and strength
of the scientific evidence for qualified health claims.
• “A” means that there is significant scientific agreement.
• “B” indicates the evidence is not entirely conclusive.
• “C” would apply to claims for which the evidence is limited
and inconclusive.
• “D” would be given to claims with little scientific evidence
to support them.
4. Does a qualified health claim need to be reviewed and approved by FDA?
FDA must review and expressly permit the use of all qualified health claims.
5. What is the timing for FDA review of qualified health claims?
Once a petition is filed, FDA has 45 days to let the petitioner know if the
submission is complete and filed. Upon filing of a petition, FDA intends to
post the petition on its website and request public comment for 60 days. Once
the comment period is closed, FDA may review the claim internally, convene
an advisory subcommittee, or contract a third-party to do the review. If a
third party is contracted, FDA will expect a report to be submitted to the
Agency within 120-days. Within 270 days of the filing of the petition, FDA
will either permit or deny the proposed qualified health claim.
6. What is the relationship between a qualified health claim and a structure/function
claim?
There is no express relationship between structure/function
claims, i.e., claims relating the effect a nutrient or a food may have on
the body’s
structure or function (e.g., nuts help maintain a healthy heart), and qualified
health claims, i.e., claims relating to the effect a nutrient or a food may
have on a disease (e.g,. nuts reduce the risk of heart disease). Additionally,
unlike qualified health claims, structure/function claims may be made without
FDA's permission. However, there is an indirect relationship that must be considered.
It is quite possible that a consumer perception study may reveal that consumers
interpret a particular structure/function claim to also have an implied disease
reduction meaning. For instance, the claim "nuts help maintain a healthy
heart" may be perceived by the reasonable consumer that eating nuts will
reduce the risk of heart disease. Because FDA has reviewed the relevant scientific
literature and has concluded that the evidence is only significant in combination
with a low-fat and low-cholesterol diet, it is likely that both the Federal
Trade Commission and the FDA would take the position that the “heart
health” structure/function claim must likewise be qualified.
The decision to petition for an FDA qualified health claim petition should
be considered carefully. A focused FDA review of the scientific literature
to assess the significance of the health claim may require that the unqualified
structure/function claim(s) presently being made for the food must also
go through the health claim qualification process.
