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  The Vitamin Lawyer Consultancy

Ralph Fucetola JD

Your Right to the Truth
To Learn & Communicate; to Heal and Be Healed.



Nutrient Marketing and Commercial Free Speech
The Standard of Substantiation

By: Ralph Fucetola, JD

DSHEA Requirements and Court Decisions
Thompson v Western States
FTC & Substantiation
The Standard for Substantiation
Continuing Developments

Introduction to Dietary Regulations

Not since the heady days just after the Dietary Supplement Health and Education Act (DSHEA) was adopted in '94 and the nutrient market became wide-open, has it been possible to sustain supplement claims to a reasonable degree of certainty. In the "bad old days" before DSHEA, claims were not an issue… since none were allowed! In recent years, though, it seemed that the DSHEA opening was floundering on state, national and even (via Codex) international regulations, restrictions and prohibitions.

However, a couple recent US court decisions and FDA/FTC regulatory actions point in a good direction and suggest a broader scope for claims. Led by a slim Supreme Court majority, the Right of the Public to Information is being given increasing protection.


DSHEA Requirements & Recent Court Actions

Basically, DSHEA allows (1) general wellness claims, (2) structure and function claims (with post-market notice to the FDA) and (3) health claims (with pre-market FDA approval). Also, new dietary substances have a pre-market FDA notice requirement.

Just one of these areas, Structure and Function claims, is the subject of FDA rule making with over ninety pages of official explanations.

The first case to have broadened the agency's horizons was the case won by research scientists Durk Pearson and Sandy Shaw in the DC District Court, Pearson v Shalala, in 2000. This case mandated the FDA to consider disclaimers and explanatory language before summarily disallowing claims, and specifically health claims (health claims are claims that characterize the relationship between a nutrient and a disease, while structure and function claims are those that characterize the relationship between a nutrient and normal structure and function).

As I learned in the Diabetiksâ
matter, the FDA is actually responding to the court mandate. In that matter, The Green Turtle Bay Vitamin Company, Inc. - www.energywave.com - offered a disclaimer when the FDA wanted a change in the product name (it makes an implied health claim by using the name of a disease). The disclaimer, which was rather more of a claim -- and a powerful one at that -- was accepted and the name remains unchanged, but now, the company can say that the FDA has permitted the claim – instead of having to rely upon the DSHEA mandated "FDA has not evaluated these statements" disclaimer.  See, diabetiksfda.html.

Further, during the joint FDA/FTC "Operation Cure-All" in 2001, several Internet purveyors of targeted products avoided citation, recall and fine, by stripping all claims from their sites and "running naked" on word of mouth alone. This does not seem to have decreased their sales significantly.


Thompson v Western States Decision

More recently, the United States Supreme Court (Thompson v. Western States Medical Center - 01-344, decided on April 29, 2002 - 535 U.S. 357) has offered significant support to Commercial Free Speech.

This decision has not received the attention of the marketplace that it deserves. The 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. The Supreme Court held that the restriction on Commercial Speech was unconstitutional, using language that will help broaden not just the rights of pharmacists, but also the rights of all people in the health and wellness field, including those who sell nutrients. We might dub it the Public’s Right to Truth Decision. Some of the language used in Justice O'Connor's Majority Decision that sets the tone 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 constitutionally permitted government restrictions on Commercial Speech (speech that makes or is about an offer for a transaction) 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).


Substantiation and the FTC

In this context is it useful to recall the 1996 comments of FTC Commissioner Starek, at the National Infomercial Marketing Association (comments the FTC maintains on its web site). 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. The Supreme Court decision in Thompson supports the lower court decision in Pearson.


The Standard for Substantiation

What is the proper level of substantiation for Nutrient Claims?  It is not the "significant scientific agreement" required of drug claims, but rather, the general "competent scientific evidence" standard that applies to all commercial claims.  In 2004 FDA stated, "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'.''
That does not necessarily mean that Dietary Supplement purveyors need to have multiple double-blind experiments (as may be required for drug approval).  Such substantiation just needs to be competent and scientific.  This means  research studies (which is when scientists review the work of others and apply it to specific questions) and clinical trials (which can be as formal as double-blind, placebo controlled investigations) as well as traditional knowledge and clinical experience all have a role to play, but ultimately, such substantiation must rest on the informed professional opinion of some credentialed person who can sign onto the Structure and Function Claims Notice to the FDA, attesting that
"the notifying firm has substantiation that the Statement(s) to which this Notice applies is truthful and not misleading." (Regulations under 21 U.S.C. 403(r) (6)).

See also the Small Entity Compliance Guidance on Structure & Function Claims - http://www.fda.gov/OHRMS/DOCKETS/98fr/98n-0044_gdl0001.pdf  and my memo on Traditional Uses as Substantiation, traditionaluses.htm.

Update: Substantiation Guideline: http://www.cfsan.fda.gov/~dms/dsclmgu2.html - December 2008


Continuing Developments

Cases continue to be brought by leading figures and attorneys in the health care field, to test the limits of the Thompson v Western States doctrine.  A July 28, 2003 press release from the law offices of Emord & Associates P.C. states,

"The United States Court of Appeals for the D.C. Circuit has set November 10, 2003 at 9:30 AM as the time for oral argument in the case Whitaker v. Thompson.  That case involves the First Amendment challenge of Julian M. Whitaker, M.D.; Pure Encapsulations, Inc.; Durk Pearson and Sandy Shaw; and the American Association for Health Freedom to an FDA decision banning the following claim on the labels and in the labeling of saw palmetto dietary supplements: 'Consumption of 320 mg daily of Saw Palmetto extract may improve urine flow, reduce nocturia and reduce voiding urgency associated with mild benign prostatic hyperplasia (BPH).'"

"The landmark case asks the question whether FDA may constitutionally suppress truthful claims about the effects of foods and dietary supplements on existing diseases and disease conditions.  FDA says such “treatment” claims can only be made if the products are approved as drugs.  Whitaker et al. say that the tens of millions of dollars required to obtain drug approval, the fact that FDA has already stated that foods and supplements are not likely approvable under the drug standard, the fact that foods and supplements are largely unpatentable, and the fact that FDA’s ban is absolute on supplement and food labels violate the First Amendment. 

There are other important commercial speech cases moving through the legal system that will further test the Supreme Court majority's commitment to Free Speech.  See: http://library.lp.findlaw.com/articles/file/00105/008947/title/Subject/topic for a review of recent developments in the Nike case coming out of California.  This case has not been finally resolved and may be back before the Supreme Court in a few years, but for now, in California at least, corporations must be very careful to make only "truthful and not misleading" statements about political issues that touch their commercial interests.  I discuss other national and international political and regulatory developments in nutrient marketing at:

cGMP Report.htm
FDA Inspection.htm
Traditional Uses.htm
FDA_& FTC Requirements.htm
Health Freedom


Properly advised by knowledgeable counsel, nutrient purveyors need to continually review the claims they are making to ensure that the claims are both permitted by law and the strongest the law will allow, to the end that the Right of the Public to Truthful Wellness Information may be preserved. This is a necessary step in preserving the even more central Right of Individuals to Freedom of Choice in Health Care. Never doubt that, in this great clash between the right of the public to know and the power of the government to restrict, the free flow in information, as offered by private organizations like the Life Extension Foundation – www.lef.org – can no longer be regulated by government agencies to deny a Free People access to the Truth.

© 2003, 2007


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