Qualified Health Claims

Qualified Health Claims

Pauline M. Ippolito*Bureau of Economics

Federal Trade Commission * The views expressed in this presentation are my own and do not necessarily represent the views of the FTC, its staff or any individual Commissioner.

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Deception Statement &Advertising Substantiation Statement

Claims must be truthful and not misleading.

Firms must have a reasonable basis for any material claim that a substantial number of reasonable consumers would take from an ad.

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Research on Qualified Health Claims

Can uncertain scientific support be communicated to consumers?

Can different levels of support be communicated? Weight of the evidence versus weaker support?

Consumer research since the late 1990s.

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Mildly QualifiedClaim

Some medical studies are now suggesting that supplements containing these same antioxidant vitamins may also reduce the risk of cancer.

What This Means to You

It looks promising, but scientists won’t be sure until longer term research is completed.

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Tested Claims from Earlier Research

Proof Claim

Scientists have now proven that supplements containing these same antioxidant vitamins also reduce the risk of cancer. It’s a fact!

Mildly Qualified Claim



It looks promising, but scientists won’t be sure until longer term research is completed.

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Qualified Claim



It’s too early to tell for sure. Some studies have failed to show that these vitamins protect against cancer. Longer term research is needed.

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Highly Qualified Claim with Box Disclaimer

Some scientific evidence suggests that consumption of antioxidant vitamin supplements may reduce the risk of certain kinds of cancer. …

There is much scientific debate about whether antioxidant vitamin supplements reduce the risk of some kinds of cancer. Most studies have failed to show that these vitamin supplements reduce the risk of cancer.

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How Sure Are Scientists?Mean Response*

4.24

3.72

3.35

2.71

1

2

3

4

5

Proof MildlyQualified

Qualified Highly QualifiedBox Disclaimer

Sure

SomewhatSure

Neither Surenor Unsure

SomewhatUnsure

Unsure

Vitamin Ads* All differences are significant in one-tailed tests.

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How Sure Are Scientists?Mean Response*

4.24

3.72

3.35

2.71

4.30

1

2

3

4

5



Proof

Sure

SomewhatSure


SomewhatUnsure

Unsure

Cheese AdVitamin Ads

* All differences are significant in one-tailed tests except for two proof claims.

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How Sure Are Scientists?Percent Replying "Sure"*

58%

22%

10%5%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%



Sure

Vitamin Ads

* All differences are significant except for that between Qualified and Highly Qualified.

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How Sure Are Scientists?Percent Replying "Sure"

58%

22%

10%5%

62%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%



Proof

Sure

Cheese AdVitamin Ads

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Latest Round of Experiments

FDA Disclosure Language

Some scientific evidence suggests that consumption of antioxidant vitamin supplements may reduce the risk of certain kinds of cancers. However, FDA has determined that this evidence is limited and not conclusive.

FDA Report Card Language

Some scientific evidence suggests …. FDA evaluated the scientific evidence and gave it a “C” rating, based on a scale from A (strongest evidence) to D (weakest evidence).

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How Certain Is The Evidence?Mean Response*

4.043.71

3.33

1

2

3

4

5

6

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FDAReport Card

FDALanguage

Highly QualifiedBox Disclaimer

Not at AllCertain

SlightlyCertain

SomewhatCertain

VeryCertain

* The Report Card is significantly different from the Box Disclaimer.

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How Certain Is The Evidence?Percent Replying Somewhat Certain or Higher*

40%

47%

33%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

FDAReport Card

FDALanguage

Highly QualifiedBox Disclaimer

% Replying

* The FDA Language is significantly different from the Box Disclaimer.

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How Certain Is The Evidence?Responses for Highly Qualified Box Disclaimer

22%

10%

22%

5%

24%

2%7%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5 6 7

% Replying

Not at AllCertain

SlightlyCertain

SomewhatCertain

VeryCertain

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How Certain Is The Evidence?Responses for FDA Report Card

10%7%

16% 17%

26%

3%10%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5 6 7

% Replying

Not at AllCertain

SlightlyCertain

SomewhatCertain

VeryCertain

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How Certain Is The Evidence?Responses for FDA Language

21%

12%7% 9%

34%

5% 7%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5 6 7

% Replying

Not at AllCertain

SlightlyCertain

SomewhatCertain

VeryCertain

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Lycopene Fact SheetWhat We Know About Lycopene and Heart Disease

A number of studies have found that people who eat diets rich in tomatoes and tomato products tend to have fewer heart attacks and other heart problems. Scientists have also studied whether some of this benefit may be due to lycopene, which is a nutrient found mostly in tomatoes.

So far, we have learned that people with heart disease have less lycopene in their bodies than heart-healthy people do. Some studies have reported beneficial effects on cholesterol in the blood when people take lycopene supplements. But other studies have not found any benefits.

At present there are no long-term studies of whether people who take lycopene will actually lower their risk of having a heart attack. So we do not know whether there is any benefit from taking lycopene supplements. Carefully controlled and long-term clinical studies will be needed to answer this question.

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How Certain Is The Evidence?Responses for Lycopene Fact Sheet

22%

5%

17%

8%

28%

10% 10%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5 6 7

% Replying

Not at AllCertain

SlightlyCertain

SomewhatCertain

VeryCertain

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Some Conclusions Qualifying language does change the message consumers take away in

our tests.

• Mean consumer perceptions of scientific certainty fall with stronger qualifying language.

How Sure Are Scientists?Mean Response

4.24

3.72

3.35

2.71

1

2

3

4

5



Sure

SomewhatSure


SomewhatUnsure

Unsure

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Some Conclusions Consumers discount “proof” claims.

• Only 58% of consumers said scientists were “sure” for the vitamin “proof” claim; a bit more for cheese-osteoporosis “proof” claim.

• Implications for SSA claims?

Consumer interpretation of qualifying language varies widely.

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References

Dennis Murphy, “Consumer Perceptions of Qualified Health Claims in Advertising,” FTC Bureau of Economics Working Paper No. 277, July 2005.

Dennis Murphy, Theodore H. Hoppock, and Michelle K. Rusk, Generic Copy Test of Food Health Claims in Advertising, Joint Staff Report of the Bureaus of Economics and Consumer Protection, Federal Trade Commission, November 1998.

Qualified Health Claims

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