Bottom line: while rejecting complaint counsel’s arguments
that double-blind, randomized clinical trials were required to substantiate
health claims of the sort made by Pom, the ALJ found that Pom didn’t meet the
somewhat lower standard of reliable and competent scientific evidence either
with respect to claims about heart health/disease, prostate health/disease, and
erectile function/dysfunction. Though I
don’t think the opinion explicitly says so in so many words, it implicitly
acknowledges what I think any honest observer of the general consumer market
would have to: ordinary consumers are unlikely to regularly distinguish between
a “supports health” claim and a “prevents disease” claim in any relevant way,
meaning that the DSHEA’s framework is fundamentally rotten. At the very least, the proceeding against Pom
helps to make that point to advertisers trying to finesse the distinction,
though of course I expect an appeal.
With respect to a number of ads, set out in the appendix
available on the FTC’s site, the ALJ found that reasonable consumers would
receive an implied claim that the Pom products treated, prevented, or reduced
the risk of heart disease, prostate cancer, or erectile dysfunction, and some
of the ads conveyed the further message that these effects were clinically
proven. With or without the explicit "clinically
proven" language, these claims weren’t sufficiently substantiated. The appropriate level of substantiation is
“competent and reliable scientific evidence.”
When a disease treatment/prevention/risk reduction claim is made in
connection with a safe food product not being offered as a substitute for
medical treatment, that doesn’t require double-blind, randomized,
placebo-controlled clinical trials (RCTs), but it does require some sort of
clinical studies adequate to show that the product does what it claims. Here, the weight of the expert testimony was
against the implied disease claims in the ads.
Crucially, whether the substantiation was adequate to
support either “highly qualified or generalized health claims” or “the express
language of the advertisements” didn’t matter.
Advertisers are responsible for (material) implied messages too. Pom argued that its ads were exaggeratedly
humorous and simply provided a general “healthy” message; to the extent the ads
made specific claims, Pom argued, they disclosed that the evidence came from preliminary
studies. The ALJ was unimpressed given
the specific health benefits mentioned, the claims of scientific support, and
sometimes references to clinical studies. Humor might draw attention to the ads at the
outset, but the presence of humor didn’t make every factual claim in the ads
into puffery. Likewise, the weasel words
in the ad didn’t help: whether a consumer interprets “can” help health as
“will” help health depends on context.
Pom argued that, in the context of a food ad, consumers
wouldn’t receive a “clinically proven” or other disease treatment/risk
reduction message, but would think of it more like “exercise reduces your
risks” instead of “drug Z reduces your risks by targeting a specific disease
mechanism.” I’m really not clear why
there’s a legally relevant difference between these, and the ALJ pointed out
that in either case the factual claim would still be within the scope of the
FTC’s complaint here. Nor did the
qualifiers “preliminary,” “promising,” “encouraging,” or “hopeful” change the
message to make it nondeceptive in the overall impression that the ads were
claiming clinical proof.
Ultimately, the ALJ concluded, a significant minority of
consumers acting reasonably would receive the message that there was scientific
support for the disease claims. The ads
offered basic syllogisms as a way of implying their claims. For example: free radicals cause or
contribute to heart disease; Pom products contain antioxidants that neutralize
free radicals; thus, the words and images of the ad implied that Pom products
would be effective at fighting heart disease.
Along the way, the ALJ made some other rulings of note:
first, TV appearances by one of Pom’s principals, during which she promoted the
health benefits of Pom’s products, weren’t ads within the jurisdiction of the
FTC if Pom didn’t pay for or sponsor them.
Given the jurisdictional limit, it wasn’t necessary to reach any First
Amendment argument.
Also: an intent to convey a message alone isn’t evidence
that the message was conveyed, since intent isn’t required for a violation of
the FTCA and it would be “incongruous” to make intent a sword but not a shield
(hmm, wish some trademark cases would think of that…). It was unnecessary here to examine Pom’s
intent because of the other evidence showing what messages were conveyed.
So, when are RCTs required?
The ALJ found that the best evidence was that RCTs would be required
substantiation for a nutrient supplement if the advertiser claimed that the
product treated/prevented/reduced the risk of a disease and offered it as a replacement for medical care. But RCTs aren’t required where the safety of
the product was known, it created no material risk of harm, and it wasn’t being
sold as an alternative to following medical advice.
It didn’t matter whether the claim was presented as “the
product reduces the risk of X” or “tests prove the product reduces the risk of
X.” In either case, experts in the
relevant scientific communities would require the same level of substantiation. (Courts sometimes recognize this in the
Lanham Act context as well: in the modern world, some types of claims—health
claims prominent among them--are inherently/necessarily based on scientific
evidence.)
Okay, if not RCTs, then what? The amount of substantiation experts in the
field would agree is reasonable is one factor to determine the appropriate
level of substantiation required for non-establishment claims. (Except that, as the ALJ’s findings indicate,
these are functionally establishment claims whether they use the words “tests
prove” or not, so one would think we ought to look upward and not downward for the standard ….)
The other factors are the products involved, the type of
claim, the benefits of a truthful claim, the ease of developing substantiation
for the claim, and the consequences of a false claim. The product involved (a well-known food
generally known to be safe and not claimed as a substitute for conventional
therapies) weighed in favor of a less-than-pharmaceutical-grade standard. The type of claim (health), by contrast, weighed in
favor of a high standard. The difficulty
and expense of substantiation through randomized double-blinded trials
(potentially hundreds of millions of dollars), combined with the potential
benefits of truthful health claims, weighed against requiring full-scale clinical
trials for substantiation where the product was a safe, natural food that had
been in use for centuries. Nor did the
risks of falsity loom large given these same product characteristics and given
that Pom wasn’t promoting its products as an alternative to conventional
treatment. Economic injury in spending
on a useless product is significant, but not as important as health harms, especially since this juice would be
considered a “premium” product anyway.
Taken together, the factors led the ALJ to conclude that “competent
and reliable evidence” must include clinical studies, though not necessarily
RCTs, showing that Pom products would treat, prevent, or
reduce the risk of the claimed conditions.
But Pom lacked such substantiation, according to the greater weight of
the expert testimony.
Pom, amazingly, argued that these claims weren’t
material. The FTC usually begins with
the presumption that the fact that a claim was made makes it material—you only
have so much time and money for advertising, so you try to spend it
wisely. But the presumption was
unnecessary here given the other evidence of materiality. Not only did common sense support the
materiality of health claims like these, Pom was well aware of the direct link
between providing a scientific reason to believe and sales, e.g. an article
reporting that “every time a new study [was] released touting” a health
benefit, there was a “spike in sales.”
Pom sponsored over 100 studies costing over $35 million over more than a
decade; it used those studies for marketing purposes as part of its “unique
selling proposition.” “[I]t defies
credulity to suggest that Respondents would advertise study results related to
these conditions if such advertising did not affect consumer behavior.” Pom’s survey evidence, which purportedly
found that consumers were interested in general “health” benefits rather than
specifics, didn’t sufficiently inquire into their underlying beliefs and thus
didn’t rebut the other evidence of materiality.
The ALJ ordered specific relief against the individual
defendants found to have participated in the deceptive advertising, as well as
restraints on Pom. The order applies to Pom’s
products as well as any other food, drug, or dietary supplement sold by Pom
entities (they also sell citrus fruits, nuts, Fiji water and wine). This multi-product order was justified given
the transferability of the conduct. Pom
argued that their other products didn’t involve pomegranates and were so
“dramatically different” that they wouldn’t use Pom research to “understand”
any components of the other products.
The ALJ noted that this argument was “beside the point because the
advertising technique, i.e.,
sponsoring research of a product’s health benefits and using the results to make
disease claims, is readily transferable to advertising any food, drug or
dietary supplement.” Indeed, respondents
have already sponsored research “exploring” the health benefits of Wonderful
Pistachios and Fiji Water. They argued
that they had a history of “not advertising those benefits until the science is
sufficiently developed.” (Now that's chutzpah!) The ALJ pointed out that this very
case demonstrated that “Respondents’ judgment … has not always been exercised
appropriately.”
The seriousness and deliberateness of the violations also
supported a multi-product order covering all foods, drugs, and dietary
supplements sold by Pom entities. The
ALJ specifically pointed to the seriousness of the health conditions at issue,
consumers’ inability to evaluate the evidence for themselves, and the extent of
the advertising. Pom argued that the ALJ
should give weight to Pom’s internal ad-vetting procedures, but those hadn’t
stopped a bunch of the ads at issue here.
Thus, respondents will be barred from making representations that any
covered product was effective in the diagnosis, cure, mitigation, treatment, or
prevention of any disease, unless at the time they were made the representations
were non-misleading and they possessed and relied upon competent and
reliable scientific evidence, sufficient in quality and quantity to
substantiate the representations, based on standards generally accepted in the
relevant scientific fields when considered in light of the entire body of
relevant and reliable scientific evidence.
The ALJ rejected complaint counsel’s request for an order
requiring FDA pre-approval for any direct prevention/treatment claim (as
opposed to “clinical studies suggest that …” claims otherwise supported by
competent and reliable evidence). The
FDA standard was too high for these particular claims about a safe, known food
not being promoted as an alternative to conventional medical treatment. Complaint counsel argued that an FDA standard
would provide clear and precise guidance, but the ALJ didn’t accept that as a
sufficient justification for these products, especially given that complaint counsel's proposed
standards have their own uncertainties and difficulties of interpretation, such
as what would count as an unqualified disease claim v. a qualified health
benefit claim. Anyway, there was no
reason to think that “competent and reliable evidence” was unclear.
Other parts of the order generally prohibited
misrepresentations and provided a safe harbor for claims approved by the FDA.
Overall, while a defeat for the FTC’s most aggressive
position, this case affirms that food etc. producers making health claims
need good clinical evidence substantiating their claims. Always assuming the order holds up (and,
because it adopted a less-than-RCT standard, I expect it is likely to do so),
it’s unlikely to represent much of a retreat in this area, where concerns about
consumers’ health and inability to evaluate scientific evidence for themselves
will remain persuasive.
Posts
No comments:
Post a Comment