Nutrient Marketing and Commercial Free Speech

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12 Dec 2004 15:38:47 -0000

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Nutrient Marketing and Commercial Free Speech

 

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Nutrient Marketing and Commercial Free Speech

The Standard of Substantiation

 

 

 

Note from Tim Bolen - Ralph Fucetola has been a good friend, and

resource, for several years. For those of you who maintain a website

offering products or services, I recommend you pay CLOSE attention to

what he says... He'll keep you safe.

 

 

 

Sunday, December 12th, 2004

 

 

 

Guest Editorial by Ralph Fucetola, JD

http://www.vitaminlawyer.com/

ralph.fucetola

 

 

 

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. Businesses need to know what they

can claim and how they can substantiate those claims. In the " bad old

days " before DSHEA, claims were not an issue… since none were allowed!

In recent years, though, it seemed that the opening for honest speech

about nutrients created by DSHEA was floundering on state, national

and even (via Codex) international regulations, restrictions and

prohibitions. The banning of tryptophan and ephedra come to mind, as

does the highly restrictive European Union Food Supplement Directive.

 

However, a couple recent US court decisions and even 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 petition requirement.

 

Just one of these areas, Structure and Function claims, is the subject

of FDA rule making with over ninety pages of official explanations –

which is why marketers need the advise of savvy lawyers before they

speak about their products!

 

The first case to have broadened the FDA'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 just having to rely upon the

DSHEA mandated " FDA has not evaluated these statements " disclaimer.

 

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.

 

 

 

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) 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 regulation 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 is the position favored by the Health

Freedom and Freedom of Choice movements.

 

This case concerns a clause in the Food, Drug and Cosmetics Act that

allows " compounding " pharmacists to " compound " medications for

specific customers 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

 

 

 

FDA says it follows the FTC's view in determining the level of

substantiation needed for claims. In this context is it useful to

recall the 1996 comments of FTC Commissioner Starek, at the National

Infomercial Marketing Association (comments the FTC still 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.

 

 

 

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®

(6)). Thus, the Regulation requires only " substantiation " without

specifying a specific level of substantiation.

 

 

 

See also the Small Entity Compliance Guidance on Structure & Function

Claims - http://www.fda.gov/OHRMS/DOCKETS/98fr/98n-0044_gdl0001.pdf.

 

 

 

The Code of Medical Ethics of the American Medical Association has

begun to acknowledge the role of nutrition and other alternatives in

healing and thereby given us further thoughts on the issue of

substantiation. The original Hippocratic Oath, with its injunction to

" Do no harm. " has been replaced by a complex Code detailing the

relationship between physician and patient and alternative

practitioner. Recent changes reinforce the distinction between the

level of proof needed to claim a medical " cure " and the level of

substantiation required for nutrient claims.

 

 

 

While " treatment which has no scientific basis " remains condemned

(Opinion 3.01), under Opinion 3.04, physicians are free to refer a

patient " for therapeutic or diagnostic services to another physician,

limited practitioner or any other provider of health care services

permitted by law to furnish such services, whenever he or she believes

that this may benefit the patient. " Thus, unscientific " treatment " is

distinguished from " health care services permitted by law " and

" treatment " -- which means the use of standard medicine and surgery to

" cure " disease -- is distinguished from other health care services

which need only meet the lesser " may benefit " standard. Thus,

nutritional approaches can be seen to complement licensed medicine,

but not to be held to its strictures, nor limited in its practice to

licensed physicians. Nutrient marketers need not " prove " their claims

(with " significant scientific agreement " ) but need only show " benefit "

with competent scientific evidence.

 

 

 

Conclusion

 

 

 

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 of information can no

longer be regulated by government agencies so as to deny a Free People

access to Truth.

 

 

 

 

 

Ralph Fucetola, JD

http://www.vitaminlawyer.com

www.vitaminlawyernews.com

www.disclaimersforsale.com

www.nonprofitlawyer.org

 

www.internetinjunctionlawyer.com

 

© 2004