Promotion of FDA-Regulated Medical Products 10
labeling is disseminated. As discussed below, the Federal
Trade Commission (FTC) is responsible for enforce-
ment against inaccurate or misleading medical device
promotional materials.
However, CDRH does issue Warning Letters
to entities that promote products for use as medical
devices even though no premarket approval or clear-
ance was obtained.28 In addition, CDRH enforces
regulations prohibiting promotional materials relating
to devices under an investigational device exemption,
discussed in Chapter 3.
The Federal Trade Commission and the
Balance of Power With FDA
FTC is an independent, bipartisan federal agency whose
primary mission consists of two elements: to protect
consumers from deceptive and unfair business prac-
tices and to promote competition among businesses.
Consistent with the authority granted in the Federal
Trade Commission Act (FTC Act), FTC pursues enforce-
ment actions against businesses that publish false and
misleading advertisements for products. In fact, the
FTC Act prohibits the dissemination of false advertise-
ments “by any means, for the purpose of inducing…
the purchase…of food, drugs, devices, services, or
cosmetics” and declares false advertising is an unfair or
deceptive trade practice.29
From this language, it appears FTC’s statutory
authority to enforce prohibitions against false and
misleading drug and device advertising overlaps with
FDA’s authority—and in a way it does. FTC polices
deceptive business practices related to all products
sold in commerce, and FDA protects the public from
adulterated and misbranded food, drugs and devices.
False statements in drug or device labeling can result
in product misbranding, so it is possible such matters
would fall within the jurisdictions of both FTC and
FDA. To avoid duplicating enforcement efforts, FTC
and FDA created a Memorandum of Understanding in
September 1971 that outlines each agency’s authority
with respect to the other. According to the memo, FTC
has authority to regulate “truth or falsity of advertis-
ing” of foods, cosmetics and over-the-counter (OTC)
drugs and devices, while FDA has primary authority to
regulate prescription drug advertising, advertising for
“restricted” medical devices (as defined by FDA) and all
matters relating to food, cosmetic and OTC drug and
device labeling.
Unlike FDA, FTC does not review promotional
materials before a product reaches the market. Instead,
FTC reviews advertisements already being disseminated
or broadcast to consumers and can issue inquiries
or initiate investigations if companies make false or
misleading statements about the advertised product.
FTC has no direct regulatory authority over the actual
medical product, but it applies general principles of fair
competition to ensure all product claims are properly
substantiated and do not mislead consumers. For
nonprescription drugs and devices, this means hav-
ing adequate support from scientific research studies.
Claims of medical or other benefits (e.g., relieves pain
for eight hours) or claims comparing the product to
a competitor (e.g., our product relieves pain for twice
as long as Brand X) are common examples of adver-
tising statements that receive FTC scrutiny if they do
not have proper substantiation or omit facts that are
material to ensuring the claim’s truthfulness. FDA and
FTC work closely together on product promotion reg-
ulations and enforcement, so manufacturers must take
care to follow FTC principles when promoting medical
products through testimonials, endorsements, native
advertising (sponsored promotional content that looks
like news articles, product reviews, entertainment and
other surrounding materials) and other advertising to
make sure content is truthful and not misleading. FTC
may challenge any false or misleading advertisements in
either administrative adjudication or US federal courts.
Council of Better Business Bureaus’
National Advertising Division
The National Advertising Division (NAD) is a part
of the Council of Better Business Bureaus, a private
organization that is not affiliated with any branch of the
US government. NAD plays a distinct independent role
in policing false and misleading advertising by promot-
ing industry self-regulation. Like FTC, NAD accepts
complaints about advertisers, including OTC drug and
dietary supplement manufacturers, from consumers,
competing businesses and local Better Business Bureaus
and reviews the implicated advertising for compliance
with false advertising and consumer protection laws. It
also can initiate reviews and advertising challenges on
its own.
NAD reviews and decisions typically are much
faster and less expensive than submitting a complaint
to FTC or filing a claim in the court system. In many
cases, advertisers challenged at the NAD choose to
comply with the organization’s recommendations to
improve compliance however, NAD does not have any
power to enforce a determination that an advertiser
violated the law. If NAD believes an alleged violation is
particularly egregious, or if an advertiser fails to correct
a confirmed violation, it will submit the case to FTC
labeling is disseminated. As discussed below, the Federal
Trade Commission (FTC) is responsible for enforce-
ment against inaccurate or misleading medical device
promotional materials.
However, CDRH does issue Warning Letters
to entities that promote products for use as medical
devices even though no premarket approval or clear-
ance was obtained.28 In addition, CDRH enforces
regulations prohibiting promotional materials relating
to devices under an investigational device exemption,
discussed in Chapter 3.
The Federal Trade Commission and the
Balance of Power With FDA
FTC is an independent, bipartisan federal agency whose
primary mission consists of two elements: to protect
consumers from deceptive and unfair business prac-
tices and to promote competition among businesses.
Consistent with the authority granted in the Federal
Trade Commission Act (FTC Act), FTC pursues enforce-
ment actions against businesses that publish false and
misleading advertisements for products. In fact, the
FTC Act prohibits the dissemination of false advertise-
ments “by any means, for the purpose of inducing…
the purchase…of food, drugs, devices, services, or
cosmetics” and declares false advertising is an unfair or
deceptive trade practice.29
From this language, it appears FTC’s statutory
authority to enforce prohibitions against false and
misleading drug and device advertising overlaps with
FDA’s authority—and in a way it does. FTC polices
deceptive business practices related to all products
sold in commerce, and FDA protects the public from
adulterated and misbranded food, drugs and devices.
False statements in drug or device labeling can result
in product misbranding, so it is possible such matters
would fall within the jurisdictions of both FTC and
FDA. To avoid duplicating enforcement efforts, FTC
and FDA created a Memorandum of Understanding in
September 1971 that outlines each agency’s authority
with respect to the other. According to the memo, FTC
has authority to regulate “truth or falsity of advertis-
ing” of foods, cosmetics and over-the-counter (OTC)
drugs and devices, while FDA has primary authority to
regulate prescription drug advertising, advertising for
“restricted” medical devices (as defined by FDA) and all
matters relating to food, cosmetic and OTC drug and
device labeling.
Unlike FDA, FTC does not review promotional
materials before a product reaches the market. Instead,
FTC reviews advertisements already being disseminated
or broadcast to consumers and can issue inquiries
or initiate investigations if companies make false or
misleading statements about the advertised product.
FTC has no direct regulatory authority over the actual
medical product, but it applies general principles of fair
competition to ensure all product claims are properly
substantiated and do not mislead consumers. For
nonprescription drugs and devices, this means hav-
ing adequate support from scientific research studies.
Claims of medical or other benefits (e.g., relieves pain
for eight hours) or claims comparing the product to
a competitor (e.g., our product relieves pain for twice
as long as Brand X) are common examples of adver-
tising statements that receive FTC scrutiny if they do
not have proper substantiation or omit facts that are
material to ensuring the claim’s truthfulness. FDA and
FTC work closely together on product promotion reg-
ulations and enforcement, so manufacturers must take
care to follow FTC principles when promoting medical
products through testimonials, endorsements, native
advertising (sponsored promotional content that looks
like news articles, product reviews, entertainment and
other surrounding materials) and other advertising to
make sure content is truthful and not misleading. FTC
may challenge any false or misleading advertisements in
either administrative adjudication or US federal courts.
Council of Better Business Bureaus’
National Advertising Division
The National Advertising Division (NAD) is a part
of the Council of Better Business Bureaus, a private
organization that is not affiliated with any branch of the
US government. NAD plays a distinct independent role
in policing false and misleading advertising by promot-
ing industry self-regulation. Like FTC, NAD accepts
complaints about advertisers, including OTC drug and
dietary supplement manufacturers, from consumers,
competing businesses and local Better Business Bureaus
and reviews the implicated advertising for compliance
with false advertising and consumer protection laws. It
also can initiate reviews and advertising challenges on
its own.
NAD reviews and decisions typically are much
faster and less expensive than submitting a complaint
to FTC or filing a claim in the court system. In many
cases, advertisers challenged at the NAD choose to
comply with the organization’s recommendations to
improve compliance however, NAD does not have any
power to enforce a determination that an advertiser
violated the law. If NAD believes an alleged violation is
particularly egregious, or if an advertiser fails to correct
a confirmed violation, it will submit the case to FTC