Substantiation of Health Claims in
Advertising:
Probiotics
Richard L. Cleland
Division of Advertising Practices
Federal Trade Commission
Disclaimer
My comments reflect my own views and
do not necessarily reflect the views of
the Commission or any individual
Commissioner.
Regulatory Framework
• Section 5 of the FTC Act prohibits “unfair
or deceptive acts or practices in or
affecting commerce.”
• Section 12 of the FTC Act prohibits
disseminating or causing the
dissemination of a false advertisement in
commerce for the purpose of inducing, or
that is likely to induce, the purchase of any
food, drug, device, service, or cosmetics.
Deceptive and Misleading
Advertising
• An advertisement is deceptive if it contains
a representation or omission of fact that is
likely to mislead a consumer acting
reasonably under the circumstances, and
that representation is material to a
consumer’s purchasing decision.
– False claims
– Failure to disclose material facts
– Unsubstantiated claims
Ad Meaning
• Ads are interpreted from the perspective of a reasonable
consumer in the target audience.
• Ads may have more than one reasonable interpretation.
• Where an ad conveys more than one meaning, only one
of which is misleading, a seller is liable for the
misleading interpretation even if nonmisleading
interpretations are possible.
• An ad is misleading if a significant minority of reasonable
consumers are likely to take away the misleading claim.
Evidence of Ad Meaning
•
The primary evidence of what representations an advertisement conveys is the
advertisement itself.
•
Express claims directly state the representation at issue and the representation itself
establishes the meaning of the ad claim.
•
In determining what claim or claims an ad communicates to reasonable consumers, it
is necessary to look “at the interaction between and among the constituent elements
of the ad to determine the ‘net impression’ that is conveyed by the ad as a whole.”
•
The Commission may rely on the ad itself and need not resort to extrinsic evidence if
the text or depictions are clear enough that the Commission can “conclude with
confidence” that the claim is conveyed to reasonable consumers.
•
Extrinsic evidence can “include common usage of terms, expert opinion as to how an
advertisement might reasonable by interpreted, copy tests, generally accepted
principles of consumer behavior, surveys, or ‘any other reliable evidence of consumer
interpretation.’”
Nestlé Healthcare Nutrition
 Probiotic straw and drink for
children
 Ad Claims: prevention of
upper respiratory infections;
protects against cold & flu;
reduces school absences;
reduces duration of acute
diarrhea in children
 Some good evidence but
claims went beyond science
In the Matter of Nestlé Healthcare Nutrition, Inc., FTC File No. 092 3087
(proposed consent 2010)
Advertisers must have
substantiation for objective
product claims
• Making objective claims without a
reasonable basis is a deceptive practice.
• Advertising claims made for a food, dietary
supplement, drug, cosmetic or service
without a reasonable basis constitute false
advertising.
Level of Substantiation
• Where an advertisement represents, either
expressly or by implication, that the claim
is supported by a certain amount or level
of substantiation, the advertiser must
possess, prior to dissemination of the
advertisement, at least that level of
support for the claim.
Determining the Reasonable Basis
• Relevant factors include:
– the type of claim (health or safety claim?)
– the product (experience or credence claim?)
– the consequences of a false claim
– the benefits of a truthful claim
– the cost of developing substantiation for the
claim
– the amount of substantiation experts in the
field believe is reasonable
Health-related Claims
• Generally, health-related claims must be
substantiated by competent and reliable
scientific evidence.
• Competent and reliable scientific evidence
is evidence that is sufficient to satisfy the
relevant scientific community that the
claim is true.
Health Claims: Competent
and Reliable Scientific
Evidence
• Evidence, consisting of tests, analyses, research, or
studies that have been conducted and evaluated in an
objective manner by qualified persons and are generally
accepted in the profession to yield accurate and reliable
results, that is sufficient in quality and quantity based on
standards generally accepted in the relevant scientific
fields, when considered in light of the entire body of
relevant and reliable scientific evidence, to substantiate
that the representation is true.
Therapeutic Claims
• One or more clinical trials
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Placebo controlled
Double blind
Randomized
Product vs. ingredient testing
Independently conducted (two studies)
Valid statistical analysis (between group)
Relevant endpoint
Sufficient data for evaluation
Conducted by qualified persons
It May Not Be the Study!
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Different product?
Different ingredients?
Different dosage?
Different form of administration?
Different directions of use?
Was the sample representative of the target population?
Was the study population significantly different than the
target audience for the advertising?
• Does the study have the right endpoints to support the
advertising claims?
• Do the results matter?
Flawed and Inapposite
Scientific Evidence
• Failure to distinguish between prevention and treatment;
• Relying on unvalidated biomarkers, e.g., cellular effects on the
immune system (natural killer cells or t-lymphocytes);
• Relying on supplementation studies when products were not
promoted for daily use;
• Relying on studies using different methods of administration;
• No statistical analysis and data not available;
• Failing to identify inclusion criteria;
• Relying on non-representative circumstances (ultra-marathon
runners);
• Relying on studies not adequately blinded; and
• Used unvalidated symptom scales.