FOOD MARKETING AND

ADVERTISING

Todd M. Kossow

Assistant Director, Midwest Region

U.S. Federal Trade Commission

October 1, 2013

DISCLAIMER

My comments today reflect my own views. They do not

necessarily reflect the views of the Federal Trade

Commission, any individual Commissioner, or any other

person.

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BACKGROUND ON THE FTC

Who we are

Independent federal agency with five Commissioners

Nation’s consumer protection agency

What we do

Can bring enforcement actions in own name

Can file administrative or federal district court

actions

Typically seek injunctive relief, equitable monetary

relief, corrective advertising, and compliance

monitoring provisions

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MARKETING PRACTICES

BCP

ADVERTISING PRACTICES

FINANCIAL PRACTICES

PLANNING & INFORMATION

ENFORCEMENT PRIVACY AND

IDENDITY PROTECTION

CONSUMER & BUSINESS EDUCATION

REGIONS

REGULATORY OVERVIEW

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 for any food, drug, device, service, or cosmetics.

FDA has primary jurisdiction over the labeling of food, dietary supplements, drugs, and cosmetics and the advertising and labeling of prescription drugs and restricted medical devices.

FTC has primary jurisdiction over the advertising of food, dietary supplements, OTC drugs, and cosmetics.

Some articles are both labeling and advertising, e.g., many Internet web sites.

Primary jurisdiction means that we are required to consult before taking action.

HOW THE FTC & FDA ARE DIFFERENT

Law Enforcement Agency

No pre-market approval process

No regulatory distinction between product categories

(e.g., homeopathic products are governed by the

same substantiation standards as other products)

No regulatory distinction between disease, health, and

structure/function claims

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FTC/FDA COORDINATION

Complementary, consistent actions

Defer to FDA on content, purity, and safety

determinations

Rely on nutrition and science expertise of FDA in

addition to independent analysis from other scientific

experts

Joint warning letters

Agencies continue to coordinate closely on food and

dietary supplement issues

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WHY DOES IT MATTER?

A significant number of consumers believe

that the advertiser has tested the product

on people to show that it is effective.

Failure to possess a reasonable basis for

an objective performance claim is unfair

(Pfizer) and deceptive (Thompson

Medical).

STEP ONE: AD INTERPRETATION

WHAT CLAIMS ARE CONVEYED?

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AD INTERPRETATION

General Principles for Reviewing and Interpreting Ads

Claims can be express or implied

Advertisers are responsible for all reasonable

interpretations

Viewed from the perspective of the target audience

“Net impression” based on all of the ad’s elements

(e.g., text, graphics, photos, sound)

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ESTABLISHMENT CLAIMS

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.

These claims are either true or false.

ESTABLISHMENT CLAIMS

“Tests Prove . . .”

“Doctors Recommend . . .”

“Studies Show . . .”

“Clinically Proven to . . .”

Evidence acceptable to the relevant scientific

community.

Gerber (consent order)

“UP TO” CLAIMS

Some older FTC cases have used language

suggesting that an “up to” performance claim is

deceptive unless an “appreciable number” can

obtain the maximum promised performance.

Research recently released by the FTC suggests

that consumers do not see the words “up to” as a

qualifier and instead view the ad as conveying

that users are likely to obtain the maximum

amount promised.

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STEP TWO: CLAIM SUBSTANTIATION

ARE THE CLAIMS SUPPORTED?

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HOW MUCH SUBSTANTIATION DOES AN

ADVERTISER NEED?

An Advertiser must have a Reasonable Basis

for all express and implied objective claims

before they are made.

- FTC Policy Statement Regarding Advertising Substantiation,

appended to Thompson Medical Co., 104 F.T.C. 648, 839 (1984).

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HEALTH-RELATED CLAIMS

As a general principle, objective health

benefit claims must be substantiated with

Competent and Reliable Scientific

Evidence at the time of dissemination.

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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.

ABOUT SUBSTANTIATION

Rigorous but flexible with the accent on rigorous

Question of fact to be determined in each case

Claims driven analysis

Product category (drug, food, dietary supplement

doesn’t really matter)

FTC relies on outside experts as well as experts

from other government agencies such as the FDA

COMMON QUESTIONS ABOUT

SUBSTANTIATION?

Are two well controlled clinical studies required to

support a health claim?

Is it sufficient that my expert has evaluated the

science and advised me that my claims are

substantiated?

When are studies of the product required, as opposed

to studies of the ingredients contained in the product?

SUBSTANTIATION: COMMON MISCONCEPTIONS

The opinions of experts, no matter how qualified, are

no substitute for well-conducted studies.

For the advertiser, the question is whether the

substantiation is reasonable, not whether the

advertiser acted reasonably in relying on the

substantiation.

SOME ILLUSTRATIVE CASES

Nestlé Healthcare Nutrition

The Dannon Company

POM

Beverage Alcohol Cases

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Nestlé Healthcare Nutrition Probiotic straw and drink

Claims included: prevention of

upper respiratory infections;

protection against cold & flu; reduced

school absences; reduced duration of

acute diarrhea; clinically proven

Some good evidence but claims

went beyond science

Order Provisions included:

- FDA approval for disease claims (i.e., cold,

flu, and upper respiratory infection)

- 2 clinical studies for claims of reduced

duration of acute diarrhea

In the Matter of Nestlé Healthcare Nutrition, Inc. (consent 2011)

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The Dannon Company Dairy drink and yogurt with

probiotics

Claims included:

DanActive reduces the risk of colds and flu

Activia relieves temporary irregularity and help with slow intestinal transit time

Evidence on Activia showed 3 servings/day needed

Order Provisions included:

FDA approval for disease claims (cold & flu)

2 clinical studies for irregularity and intestinal transit time claims

In the Matter of The Dannon Company, Inc. (consent 2011)

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POM WONDERFUL

POM Wonderful 100% Pomegranate Juice & POMx supplements

National multi-media campaign

Claims to treat, prevent, or reduce risk of: • heart disease,

• prostate cancer, and

• erectile dysfunction

“Clinically proven” results

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• Disease claims were unsubstantiated and therefore deceptive

• Due to lack of substantiation, “clinically proven” claims were false as well

• Empirical or extrinsic evidence of consumer takeaway is not necessarily required for the Commission to conclude that implied claims are actually misleading

• FTC’s “intuitive” facial reading of ad is enough

FTC’s POM Decision

BEVERAGE ALCOHOL CASES • 2013: FTC settlement with

Phusion re: alcohol content claims/depictions

• 2010: Four Loko, Joose and 2 others remove caffeine in response to warning letters from FDA, FTC, TTB

• 2009: Settlement with Constellation Brands for deceptive alertness claims for Wide Eye Caffeinated Schnapps; brand withdrawn

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Constellation Brands, FTC Dkt. No. C-4266 (consent order 2009)

RECENT CLOSING LETTERS

Horizon Organic Milk with

Omega-3 (Dec. 2011) – claims

that DHA improved or supported:

brain or cognitive

development/function,

intelligence, kids’ learning

abilities

Vitaminwater (Jan. 2012) –

claims re: reducing likelihood of

illness (cold/flu), improved

eyesight, preventing eye disease

Devotion Spirits (Oct. 2012) –

claims of significant amounts of

protein, help build muscle mass,

not cause hangovers 28

FOOD MARKETING TO YOUTH

Several initiatives

over the last

several years

Published follow-

up report at the

end of 2012

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FOOD FOR THOUGHT Advertisers are responsible for all reasonable

interpretations

Attn: implied claims, net impression

Strive for clarity in your message

Be transparent with the information that is

important to consumer decision-making

Make sure the claim matches the science

Don’t make the claim if the weight of the

evidence contradicts

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FOR MORE INFORMATION

• FTC BCP Business

Center

– http://business.ftc.gov

• General FTC website

– http://www.ftc.gov

• Contact me

– tkossow@ftc.gov

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