FDLI symposium on constitutional challenges to FDA

FDLI Symposium: Constitutional Challenges to FDA Law &
Regulation
 
Session 1:  Compelled
Speech
Moderator: Allison Zieve, Director, Public Citizen
Litigation Group, Vice-Chair, FDLI
 
First Amendment Limits on Compulsory Labeling
Nigel Barrella, Sole Practitioner, Washington DC
 
Review of commercial speech doctrine. Product labels are
commercial: propose a transaction.  Other
FDA “labeling”?  Labeling not sold direct
to consumers, such as Rx drugs, vaccines? 
Package inserts?  Medical
literature? (Caronia, Amarin case finding that it was unconstitutional to
regulate off-label promotion by the manufacturer.) 
 
DC Circuit’s rejection of tobacco images trying to promote
an emotional response; 6th Circuit pointed out that facts can
provoke emotions, but that doesn’t make them opinions.
 
Ongoing dispute: what does “uncontroversial” mean?  At a minimum, controversial can’t mean that
someone was willing to sue.
 
Ongoing cases: genetic engineering compulsory labeling for
foods; on appeal in 2d Cir.  Argument:
topic is simply too controversial for labeling. Vt. says the test is whether
the disclosure is factual, not opinion-based, not reasonably disputable.  Abortion regulations provide precedent for
saying that extremely controversial subject matter can’t be subject to
labeling, no matter how true it is.  If
that’s the test, though, then tobacco labeling shouldn’t have been allowed;
total fat etc. labeling shouldn’t be allowed.
 
Some cases suggest you can’t tell consumers what to do: “try
to quit smoking.”  But what about “Surgeon
General’s Warning”?  What about “This
statement hasn’t been evaluated by the FDA”?
 
Future of Zauderer: uncontroversial seems to be gravitating
to being fact-based; can’t tell consumers what to do but can provide them with
consensus.  Substantial interest in
things other than preventing deception as justification for disclosure?
 
Discussant: Bert Rein, Founding Partner, Wiley Rein
 
Zauderer: easy cases make bad law.  Deceptive by omission. If the alternatives
are ban or cure with disclosure, disclosure is what makes sense.  Listerine remedy case: disclosure that it
doesn’t kill germs corrects the falsehood you’ve been disseminating. 
 
Safety warnings: state’s interest is truth in market/health
and safety of consumers. That’s a reasonable interest, and the temptation is to
say “why not”?  Why not poison,
electrical hazard, flammability warning—state has a compelling interest no
matter what standard you apply. 
[Hunh?  Why isn’t public education
a less restrictive alternative?]  But you
can’t use that foundation of health, safety, fairness to go beyond and start
expressing opinions.   Also important to have standardized ways of
defining terms, like “gallons” or the names of foods—fairness/fair choice is an
important interest.  Another interest:
state using compelled speech to carry out a regulatory regime.  Labeling on OTC drugs—comprehensive responsibility
to take care of health and safety in drugs. 
Regulatory interest can be very important, and as part of that it may
need to regulate labeling.  That is a
generally recognized legit interest, but what is the limit on that?  44 Liquormart and compounding cases: you can
use speech regulation as part of a regulatory regime, but only as a last
resort.  Is this essential/can’t be done
another way?  Is it a reasonable advancement
of the interest the gov’t is serving?
 
The AMI case is therefore wrong.  There is no general regime governing safety
[of meat?].  Same with SEC disclosure of
conflict minerals—no relation to the overall regime.  [What counts as a general regime?]  Parsing the conflict minerals disclosure is itself
very difficult.
 
Suppose the gov’t was worried that people were ignoring
Christmas.  Could the gov’t require all
food sold in November to say “remember Xmas is coming on Dec. 25th”?  [No, because of the Establishment Clause, not
b/c of a general restriction on gov’t position-taking.]  That’s inconsistent w/1st
Amendment b/c inconsistent of your right to determine what you want to say,
though it’s truthful and beyond dispute (unless you are Greek Orthodox).  [Wow, where to start.  Okay: let me just say that the “you” is an
important issue here.  Does the
commercial speaker have interests of its own, or just interests in informing
consumers?]  Gov’t shouldn’t instruct
people what to buy.  State has no legit
interest in telling you (food seller) to put that message on food.  If the state can require GMO disclosure, then
it can also require you to disclose that there’s no benefit to GM-free food
that’s been shown.  [Yes, I believe that’s
the teaching of the modern understanding post-Lochner: the legislature in general gets to make these calls.  I’m not clear on why that’s the troublesome
outcome of the slippery slope.]
 
Authors: You Want a Warning with That? Sugar-Sweetened
Beverage Warnings and the Constitution
Sabrina Adler, ChangeLab Solutions, Oakland, CA (co-authored)
 
Increase in obesity; 135% increase in calorie intake from
sugar-sweetened beverage, half of Americans over age 2 drink at least one a
day. 63% of HS students.  Connection
between liquid sugar consumption and greater health problems v. solid
food.  Safety warning issues?  First Amendment, preemption under NLEA, and
dormant commerce clause.
 
Paper argues that the science justifies special treatment
for SSBs, and thus that warnings should be analyzed under Zauderer.  Current agreement
under courts of appeals: Zauderer is
not limited to the potential for consumer deception, but can extend to the
protection of public health.  Even if
substantial interest is required, health is such an interest.  No disclosure has ever been struck down under
Zauderer.
 
However, the evidence that labels decrease consumption (much less improve health outcomes) is weaker
than the evidence that labels increase
awareness
of the risk.  Would be at
risk if strict scrutiny were applied; there are less restrictive means of
conveying the info such as public education.  (Or we could, you know, ban SSBs without
running afoul of the First Amendment.) 
What about the possibility of gov’t speech?  Forcing message on someone else’s label—boundaries
have not been spelled out, but most proposed labels do attribute message to the
gov’t.
 
NLEA has express preemption, no implied preemption.  No definition of what constitutes “nutrition
labeling.”  They argue that it should
mean the quantitative info required on the label, not qualitative info.  Thus shouldn’t be preempted by nutrition
labeling.  Nutrient claim/Health claim:
relationship between ingredient and health conditions. This is technically what
an SSB warning would do. But we argue that “claims” refers to positive
statements made by producers to increase sales—that was what Congress was
concern about.  Regs specify a list of
permissible health claims, and they’re all positive.  Safety warning exception to preemption?  Lactose (not a warning); BPA in baby bottles
(FDA specifically exempted from labeling regulation, and thus warning exception
couldn’t apply); coloring in colas that California added to Prop. 65/potential
carcinogen list (FDA specifically found it to be GRAS/generally recognized it
as safe—court found that unrelated to labeling, but predicate to labeling; thus
this type of warning shouldn’t be preempted and was subject to safety warning
exception to preemption).
 
Stuart Pape, Shareholder, Polsinelli
First Amendment never came up in the 1970s at the FDA—pre Virginia Pharmacy.  Doesn’t envy the task now.  How do you make sense out of current doctrine
combined with regulations that have been around for decades?  How do you advise a client? The principles
aren’t clear enough.
 
If SSB warning has to be on 20% of billboard/other ads, how
does that work?  It’s not scientifically
apparent that two products—12 oz. of 100% organic apple juice, which SF favors
b/c it’s not regulated, and equivalent amount of cola, which does get regulated—are
different; the apple juice even has more calories. So how does the city
conclude there’s clear evidence that one product should get a warning and the
other shouldn’t?  That is part of what
makes the warning constitutional.  FDA is
currently considering an “added sugars” line on the nutrition panel, and
establish a daily reference value.  But
the evidence to support that is weak/unscientifically justified, according to
past FDA heads. If there’s serious controversy over mere disclosure of
amount/reference point that’s subject to the warning, the warning itself is
controversial—singles out one type of beverage and forces them to say “this is
a bad product.”
 
Court rejected disclosure about radiation from cellphones
for similar reasons. 
 
Also hard to demonstrate substantial interest b/c you require
warnings for some things/not other things (the apple juice)—swiss cheese
approach makes it harder to defend. 
Also, it’s just an opinion: we have to do something about obesity; the
scientific evidence about health f/x is compelling (he thinks both of these are
opinions).
 
Discussion among panelists: anti-regulationists say alcohol
label may be ok b/c of the scientific evidence that it is really bad, not like other things, which is an interesting thing to
be assessing under First Amendment standards.
 
Pape: Amarin case: the court observes that the entire
premarket approval system for pharma is at risk under current standards. While
pharma industry would like more freedom to communicate w/doctors, they’re not
looking to have a system in which pharma reg is more like dietary supplement
reg, which is a free for all. Bears watching. 
(Careful what you wish for?  The
First Amendment doesn’t enact Mr. Herbert Spencer’s Social Statics, and neither
does it enact Bayer’s wishlist.  Welcome
to your new competitor, GNC.)
 
Zieve: Congress, in response to health tragedies, organized
the regulatory structure: illegal until approved, and then approved only for
conditions it’s safe and effective for according
to FDA
. FDA doesn’t regulate the practice of medicine; FDA’s authority is
only over manufacturers. If you promote it for an unapproved use, that’s
illegal.
 
Rein: asymmetry: unlawful to tout, but lawful to use—that doesn’t
work.
 
Zieve: but the doctor isn’t engaging in off-label promotion.
 
Rein: what bothered ct in Amarin was that the manufacturer was disseminating information
based on well-controlled studies. If studies had been done by independent third
parties, would have been able to disseminate them.  May have promotional effect, but is
scientific speech. Disparity of regulation/intervention.  Nike v.
Kasky
: the same asymmetry.  [No, a different
one.]  Kasky is regulated only by
defamation standard when he says Nike uses child labor; Nike’s speech is
commercial when it denies it does.
 
Zieve: In your remarks before you mentioned a valid warning
as integral to regulatory process—so did you actually mean that?  Vt. did a study showing 90% of consumers
wanted to know whether the food they bought had GMO ingredients—would that
matter?
 
Barrella: the whole reason that we extended protection to
commercial speech was consumers’ interest in getting truthful information.  DC Circuit en banc did say that consumer
interest was substantial interest in itself for country of origin information.
 
Rein: overwhelming support is poor indicator of
constitutionality; NH residents “overwhelmingly supported” putting “Live Free
or Die” on license plates.
 
Zieve: Facts/opinion?
 
Adler: commercial speech also makes a difference from Live
Free or Die.
 
Q: What about the standards of identity?  Hampton Creek’s “Just Mayo”—barred on
standards of identity, which is integral to a regulatory process, but what’s
the compelling interest in saying you can’t label your product “Just Mayo” just
because it isn’t mayo according to the standards of identity. 
 
Barrella: it’s a Central Hudson question. 
 
Zieve: this is false and deceptive advertising. People think
mayo means a certain thing; it’s like calling Coke orange juice.  Standard of identity makes the deception
stronger, but calling it just mayo divorces “mayonnaise” from its meaning.
 
Pape: maybe historically people knew what mayo was; standard
of identity developed b/c producers were making things that people had once
made at home. Congress wanted consumer to be able to go to store and pick up
what he/she would have previously made in the kitchen. The standards of
identity are definitions.  “Cheese food.”  It’s not cheese.  Signal that it’s not cheese. Same thing with
mayo. There is something called “mayonnaise dressing”: like mayo, but not.  Interesting to consider whether standards of
identity are now vulnerable to the First Amendment.  [Yeah, interesting’s one word.]
 
Q: soy milk = milk? 
Industry was laughed out—why isn’t this the same question?  Soy milk has an ingredient list.
 
Zieve: why would you read the ingredient list?  Soy milk isn’t called “just milk.”
 
Rein: State puts up these markers to provide a basis for
comparison in the marketplace. It’s meaningless unless it’s enforced. If std of
identity for mayo is legit exercise of gov’t power, enforcement is ancillary to
that fundamental Q.
 
Q: where in the First Amendment analysis do we deal with
false/misleading speech, trademark, Lanham Act?
 
Barrella: that’s just outside the First Amendment.
 
Adler: there may be affirmative misrepresentations in our
areas, but we’re more worried here about a lack of information.  Slightly different issue.
 
Rien: Zauderer is
a case of fraud by omission.
 
Zieve: Also consider influence of POM v. FTC, where DC Circuit said that a 2 clinical trial standard
was too onerous.  Pom says that if it has
one study, it can make those claims, even if other studies show no effect. Can
drug companies take advantage of this? 
Keep watching—cert petition just filed.

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