Transcript www.law.umaryland.edu

Claims – Consumer
Perspective
David Schardt
Center for Science in the Public Interest (CSPI)
3 kinds of health-related claims:
health claims
structure/function claims
nutrient content claims
Health claims characterize the
relationship of any substance to a
disease or health-related condition
Requires significant scientific
agreement based on the totality of
publicly available information
Legal health claim
Diets low in saturated fat and
cholesterol and rich in fruits,
vegetables, and grain products that
contain some types of dietary fiber,
particularly soluble fiber, may reduce
the risk of heart disease, a disease
associated with many factors.
Illegal health claims
How Lifeway Kefir Helps You
Autoimmune Disorders: Helps manage or alleviate
symptoms.
Crohn’s and Colitis: Reduces the severity of
symptoms, lessening abdominal pain, diarrhea and
nausea.
Yeast Infections: Several studies show that Kefir
can reduce both the number and severity of yeast
infections.
http://www.lifeway.net/HealthWellness/HowKefirHelpsYou.aspx
Qualified health claim
Very limited and preliminary scientific
research suggests that eating one-half
to one cup of tomatoes and/or tomato
sauce a week may reduce the risk of
prostate cancer. FDA concludes that
there is little scientific evidence
supporting this claim.
Structure/function claims
Describe the role of, or characterize the
mechanism by which a nutrient affects
a body structure or function
Health claims
FDA has approved only 12 health claims
and about 20 qualified health claims
Structure/function claims
Thousands of structure/function claims on
foods and dietary supplements
All legal claims for probiotics are
structure/function claims
Manufacturers can say almost anything
they want in a S/F claim, short of a
disease claim.
They’re supposed to have substantiation
But there are no requirements about the
kinds of evidence a company is
supposed to have
No requirements about providing that
evidence to FDA
FDA does not have the authority to
demand the evidence
FDA does not review the basis for
S/F claims
Industry controls structure/function claims,
not FDA
Little wonder why it likes them
Cheap, easy to do, no accountability
AND
Consumers think S/F claims are just as
good as health claims
FOOD LABELING
FDA Needs to Reassess Its
Approach to Protecting Consumers
from False or Misleading Claims
GAO
January 2011
GAO-11-102
According to research conducted by FDA,
the International Food Information Council,
and academia,
“consumers have difficulty distinguishing
among the many different types of claims on
food labels, including health claims, qualified
health claims, structure/function claims, and
nutrient content claims.”
According to a 2008 industry study,
“consumers rate the level of scientific
evidence and other attributes associated
with a product containing a structure/
function claim as similar to the evidence and
other attributes of health claims with
significant scientific agreement on a
product.”
“consumers are just as likely to purchase a
product with a structure/function claim,
which FDA does not review, as they
are to purchase a product with a health
claim supported by significant scientific
agreement, which FDA does review.”
“structure/ function claims were perhaps the
most popular of all the claims the council
tested:
Most consumers liked their brevity and
general health messages more than health
claims, which they saw as too wordy and too
disease specific.”
Diets low in saturated fat and
cholesterol and rich in fruits,
vegetables, and grain products that
contain some types of dietary fiber,
particularly soluble fiber, may reduce
the risk of heart disease, a disease
associated with many factors.
vs
“promotes a healthy heart”
“consumers find it difficult to understand
the degree of scientific support for
qualified health claims on food labels.”
“none of the tested language, whether
appearing in real or fictitious product
advertisements, communicated serious
limitations in scientific evidence.
In addition, consumers interpreted all of
the tested advertisements in a disparate
fashion.”
If S/F claims were truthful and not misleading,
this wouldn’t be such a problem
Based on small, preliminary unpublished
studies
•Studied in clinical populations
•Using different formulations
•And different dosages
•Looking at markers of unknown significance
•Sometimes, the research shows the product
doesn't work as claimed
•
Probiotics have an additional problem:
Manufacturers don’t have to disclose which
strain(s) they use in their products
Or how much they use