Posted by the Vitamin Lawyer

Thompson v Western States Medical Center
Decided by the U.S. Supreme Court on April 29, 2002


Update:  The Right of the Public to the Truth:  Claims and Substantiation Standards (05/30/03)


United States Supreme Court
Thompson v. Western States Medical Center (01-344)
Argued: Feb. 26, 2002
Decided: April 29, 2002

This Case Note concerns a US Supreme Court decision last month that has not received the attention of the marketplace that it deserves. This 5 to 4 majority decision revealed a Court deeply divided on the issue of Commercial Free Speech. One large minority of four justices, led by the Chief Justice, would give the government far greater leeway to regulate Commercial Speech than the majority decision allows. The other large minority of four, led by Justice O'Connor, repeated the Two Prong Test of prior cases, applying it to FDA statutory requirements. The swing vote, Justice Thomas, is most telling. In his Concurring Opinion, the Justice refers to "Commercial Speech" only in quotes, indicating that he takes the position that there is no "Commercial" Speech, just Speech, protected by the First Amendment.

This case concerns a clause in the Food, Drug and Cosmetics Act that allows pharmacists to "compound" medications for specific prescriptions without safety testing and FDA prior approval, but forbids pharmacists from advertising the specific compounds they make. Supreme Court held that the restriction was unconstitutional, using language that will help broaden not just the rights of pharmacists, but also the rights of those who sell nutrients. Some of the language used in Justice O'Connor's Majority Decision that will help is as follows:

"If the First Amendment means anything, it means that regulating
speech must be a last - not first - resort."

"We have previously rejected the notion that the Government has an
interest in preventing the dissemination of truthful commercial
information in order to prevent members of the public from making bad
decisions with the information."

"Even if the Government did argue that it had an interest in
preventing misleading advertisements, this interest could be satisfied
by the far less restrictive alternative of requiring each compounded
drug to be labeled with a warning that the drug had not undergone
FDA testing and that its risks were unknown."


The basic rule announced by the case to determine what government restrictions on Commercial Speech (speech that makes or is about an offer for a transaction) is permitted by the Constitution is a Two Prong Test: the first prong is to ask two questions: (1) is the speech in question about unlawful activity and (2) is the speech misleading. If "no" to both, the speech is entitled to protection unless the Government can carry its burden and prove (1) the governmental interest involved is "substantial", (2) the regulation must "directly advance" the governmental interest and (3) the regulation of Commercial Speech cannot be "more extensive than is necessary to serve that interest" (quoting Central Hudson v Public Service, 447 US 557, at 566).

In this context is it useful to recall the 1996 comments of FTC Commissioner Starek, at the National Infomercial Marketing Association. He explained the issue to which the Court alluded - preventing misleading advertisements.

"As many of you know, the FTC is charged with protecting consumers from
unfair or deceptive acts or practices. In advertising and marketing, the
law requires that objective claims be truthful and substantiated. The
FTC does not pursue subjective claims or puffery -- claims like "this is
the best hairspray in the world."But if there is an objective component
to the claim -- such as "more consumers prefer our hairspray to any
other" or "our hairspray lasts longer than the most popular brands" --
then you need to be sure that the claim is not deceptive and that you
have adequate substantiation before you make the claim. These
requirements apply both to explicit or express claims and to implied
claims. Also, a statement that is literally true can have a deceptive
implication when considered in the context of the whole advertisement,
even if that implication is not the only possible interpretation."

"The substantiation requirement exists because every time an advertiser
makes an objective claim, the advertiser also implies that there is a
reasonable basis for the claim. This reasonable basis is substantiation.
What constitutes a reasonable basis for a particular claim can vary,
depending upon the nature of the claim, the product, the consequences of
a false claim, the benefits of a truthful claim, the cost of developing
substantiation for the claim, and the amount of substantiation that
experts in the field believe is reasonable. Health and safety claims
generally require competent and reliable scientific evidence. And if a
marketer makes a representation that a claim has a particular level of
support -- for example, "clinical studies prove..." -- the law requires
at least that level of substantiation."

Thus, Commercial Speech, if properly substantiated, is protected by Constitution and Law. As Justice O'Connor intimates, properly worded disclaimers and warnings are the preferred method for ensuring that Commercial Speech is truthful and protected.

In the noted case, the High Court addressed Claims and Disclaimers, emphasizing the proper use of such statements. If your web site needs a proper Site Use Statement -- Disclaimer Page [of course it does!!] The Vitamin Lawyer has the right form for you, just click here: SUS.

2002, 2003 
Posted 06/09/02, updated through 10/2003

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