Legal Review
FTC Doubles Down on
Substantiation
The Federal Trade Commission (FTC) says that advertisers must have a “reasonable basis” for objective advertising claims. But two new con- sent orders reinforce something we’ve known for
a long time: that the Monday-morning quarterbacks at
the FTC really expect you to have more than just a “
reasonable basis” to support your claims. Perhaps “beyond a
reasonable doubt” is a more accurate description of what
the FTC wants.
Those of us who keep a close eye on what the FTC is
up to started hearing rumors months ago that the agency
was going to up the ante when it came to substantiation
requirements in advertising orders involving health-related claims. Those rumors recently became reality when
the FTC announced consents with Iovate Health Sciences USA and Nestle HealthCare Nutrition.
The most obvious difference between the two orders
is a matter of what Woody Guthrie once called the “
do-re-mi”: Iovate ponied up $5.5 million to settle with the
FTC, while Nestle — whose parent is the world’s largest
food and nutrition company, with sales of over $100 billion in 2009 — didn’t have to pay a penny.
One area of consistency between the two orders is
how many scientific studies these companies will be required to have to substantiate certain claims for dietary
supplements in the future.
Just more than 20 years ago, in a case involving per-
manent hair-removal claims that a tweezer-type epilator
removed hair permanently, the Commission split right
down the middle on the question of whether such claims
had to be substantiated by at least two well-controlled
clinical tests or whether one scientific study was enough.
The Iovate order makes it clear that the FTC doesn’t see
one study as an option any more for future weight-loss
claims by this company — it requires “at least two ad-
equate and well-controlled human clinical studies.”
In addition, those two studies will have to have been
performed on the product in question — or “an essen-
tially equivalent product”
(defined as “a product
that contains the same
ingredients, except for in-
active ingredients, in the
same form and dosage”)
— and must have been conducted “by different research-
ers, independently of each other.”
And even if the company has two studies that meet
those standards, the FTC will look at them in the con-
text of “the entire body of relevant and reliable scientific
evidence.” So Iovate will have to worry about everyone
else’s studies as well.
There are two other provisions in the Iovate order
that have troubling implications for supplement and
over-the-counter (OTC) drug marketers — especially
those that advertise homeopathic products.
First, Iovate allegedly claimed that its products prevented or reduced the risk of colds and flu, and provided
relief from allergies. The Iovate order prohibits such
claims unless they have been approved by the Food and
Drug Administration (FDA) — either in an OTC drug
monograph or through a new drug application.
In other words, it doesn’t matter how much substantiation Iovate has for such claims: Without a stamp of
approval from the FDA, it can’t make cold or flu claims.
(Oddly, the Nestle order — which also alleges unsubstantiated claims for cold and flu prevention — does not
contain this requirement.)
The FTC’s press release admits that FDA approval
of health-related claims generally is not required for
compliance with the FTC Act, but that this provision
was included here because “the FTC determined that
requiring FDA pre-approval before the defendants make
disease claims for dietary supplements and drugs will
provide clearer guidance … and make the order easier to
enforce.” But this begs the question of why the FTC is
applying FDA law instead of just requiring that any future
claims are truthful and substantiated.
Second, Iovate was accused of misrepresenting that
one of its allergy-relief products was homeopathic when,
in fact, it did not meet the standards to qualify as a homeopathic product. But the provision discussed above
contains no exception for legitimate homeopathic products.
Therefore, it appears that even if Iovate’s product is a
true homeopathic drug, Iovate can not make allergy-pre-vention claims for it unless it is included in an FDA monograph or an approved new drug — which simply isn’t
the way homeopathic drugs are handled by the FDA. ■
