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FTC & FDA Thrashed But Still Dangerous

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NATIONAL HEALTH FEDERATION

A NOT-FOR-PROFIT HEALTH-FREEDOM ORGANIZATION

PRESS RELEASE

THE FDA AND FTC GET THRASHED,

BUT BEWARE THEY ARE COMING BACK FOR MORE

By C. Tips, J.D.

President, National Health Federation

June 6, 2010

“Better a cruel truth than a comfortable delusion.†- Abbey

The National Health Federation was misquoted recently by one critic, which

reminded me of the old adage “the more I see of dogs, the less I think of

men.†Yet, we cannot be devoid of faith and optimism, even in the face of

an off-the-wall attack. The ill-informed critic even called us “Waxman

lovers.†That’s funny, because the NHF has been fighting Representative

Henry Waxman (D-CA) and his anti-health-freedom agenda tooth and nail since he

first took office, and long before that critic even had a passing thought

of health freedom or its significance in our lives.

So, “Waxman lovers� Hardly. But, dedicated to the brutal truth, even

if it is not what we want to hear? Absolutely. And so should you be,

because that is the only way that we will win – knowing the facts and then

acting on those facts. Sensationalism has no place here; leave that for

Hollywood actors, Washington politicians, and charlatans. Sensationalism

catches

the eye but misdirects the heart.

What follows is what we know:

The Victory Against the FTC

As we’ve said before, in Senate Bill 3217, the Federal Trade Commission

(FTC), among other things, sought and would have been given " Fast Track "

rulemaking authority as well as aiding and abetting authority. This dangerous

change would have affected all industries that advertise but was not

specifically targeted against the supplement industry, which would have been

swept up in this along with everyone else.

Many different industry segments, not just the Natural Products

Association for the supplement industry, successfully argued against this

new-sought

authority. The opposition by all industry segments was incredibly

extensive and the pro-FTC amendment to the Senate bill, which would have

granted

the FTC more sweeping powers, did not pass. However, the amendment proposed

by Senators Rockefeller and Hutchinson that would limit FTC’s increased

rulemaking power to just the financial-services sector did pass.

Now, the Senate and the House must confer and reconcile the differences

between the Senate and the House versions of their respective bills

(S.3217/H.R.4173). That reconciliation has not yet taken place, and while it

is

expected by most that the House version of the bill – which does contain a

grant of more-sweeping powers to the FTC – will not survive the conference,

we

cannot take that chance, and all are urged to re-contact your Senators and

Representatives to let them know that the FTC does not need additional new

powers to do what it does best: keeping truthful and non-misleading

information out of the hands of health-conscious consumers.

But the FTC Strikes Back

Still, there is another grasping arm to this FTC power grab that has

eluded most other observers. As NHF Lobbyist Lee Bechtel has aptly noted, and

as has been confirmed by the D.C. law firm of Venable LLP, the FTC will be

changing the way in which it handles product advertising claims in the

dietary-supplement and the functional-food markets. The FTC will be proposing

a

new definition of competent and reliable scientific substantiation, to be

used in its new consent decrees, with the likely goal of extending it

throughout the entire dietary-supplement industry by changing its

Dietary-Supplement Advertising Guide.

In short, the FTC will require at least two “adequate†(to the FTC) and

well-controlled human studies of the product or of a substantially-similar

product, conducted by different experts, independently of each other. These

studies will have to conform to acceptable designs and protocols with

results that, when considered in light of the entire body of relevant and

reliable scientific evidence, are sufficient to substantiate the advertising

representations being made are in fact true.

Most unfairly, however, while a company cannot rely on third-party studies

to back its claims, the FTC can use third-party studies to refute a company

’s study. This is a huge change in the current interpretation of existing

administrative law for advertising claims. This change will do to

advertising regulation what the FDA did with its use of studies to support its

ban

on ephedrine alkaloid-containing supplements.

However, this development stems from the Lane Labs case, and is not

related to the phantom “Waxman†amendment in H.R.4173. Importantly, this

new

development will fundamentally change the industry and not in a good way.

Ultimately, this will be far more important than any FTC language in H.R.4173.

The Court Victory Against the FDA

Last week, the United States District Court in the District of Columbia

ruled that the Food and Drug Administration (FDA) had violated the First

Amendment free-speech rights of a dietary-supplement company when it

arbitrarily censored truthful and non-misleading claims about selenium’s

benefits in

reducing the risk of cancer. The FDA has never wanted the real truth about

the benefits of supplements and true nutrition to come out. This is not

the first time, nor will it be the last time, that the FDA must have its

face pressed to the table and its arm twisted behind its back before it cries

“

uncle!†– albeit with fingers crossed.

This latest victory in court against the FDA is the seventh in a long line

of cases against the FDA, generally known as the Pearson (for NHF

supporter Durk Pearson) cases. These lawsuits quite properly sought to restore

to

companies and individuals the right to make truthful and non-misleading

statements about the products they are selling. In fact, the National Health

Federation was one of the plaintiffs in the first such case; and, as such,

we helped to win that very important first lawsuit that set the tone and

winning streak for all of the subsequent cases up to the present win. Had we

been invited to join in the recent legal action, then we would have done

so; but no such invitation was given as many persons now – having seen the

fame that has accrued to being the lead (i.e., the first-named) plaintiff in

a successful case – scramble quickly to achieve the same fame by being the

plaintiff in such a case. ly, after having hit the FDA hard over the

head six plus times, the Courts have made it a bit of a no-brainer to win

this seventh time in court on the same basic issue.

But it was different in the 1990s. Durk Pearson and Sandy Shaw deserve

the lion’s share of the credit for having blazed the trail in the late 1990s

with their idea to tackle the FDA at a time when few thought they could

win. The NHF joined in, both as a named plaintiff and with money. This was

all a big gamble at the time, as we had few if any legal precedents to

support our claim that the FDA had no right to restrict health claims that were

truthful and non-misleading. The attorney then, as now, was the

irrepressible Emord, while another attorney, Jim of Citizens

for

Health, helped with the appeal. The latest plaintiff did not even exist as an

organization during these early, hard days of litigation, but they are

still to be commended for jumping in now more than ten years later to continue

the winning streak. But, above all, it is Emord, long a strong

proponent of First-Amendment rights, who deserves the real thanks for his

tireless efforts and steadfast commitment during this entire time.

However, in the end, we are dealing with an outlaw Agency, one that

clearly does not follow the Courts’ directives and orders. Will there need

to be

an eighth or a ninth case? A tenth case even, before the FDA finally

obeys the law? If you want to be famous as a plaintiff, just step up to the

plate, plunk down your money, and swing the bat on the next case. The target

is a pushover now because the hard work happened when the trail was blazed

in the 90s.

Thrashed But Still Dangerous

The FTC and the FDA have both received hard blows, one in the Senate and

the other in the courtroom. But these are still dangerous Agencies, with an

active agenda to take away our health and other freedoms. They must be

opposed if we are to regain freedoms lost, and expand beyond to freedoms

deserved. Especially, we must redouble our efforts to stop S.510 (the

so-called Food Safety Modernization Act) and the FTC’s Advertising Guidance

document.

To that end, we must stay dedicated to the truth and not just react in a

knee-jerk fashion every time someone hoists a boogeyman on a pole and shouts

“boo!†Fortunately, there are two groups that share the same high

standards as the Federation, our friends and colleagues at the National Health

Freedom Action and the Texas Health Freedom Coalition, and we work with them

towards greater freedom. They are the epitome of truth-seekers, unwavering

in this regard, as are of course all of our NHF members and supporters who

have stood with us these many years. Remember, it does not take a

majority to win, just a dedicated and active minority.

********************

As the oldest and best-respected health-freedom group on Capitol Hill, the

NHF continues to be the credible source of objective assessment of, and

proactive actions on, Congressional legislation and FDA matters that have

material impact upon our freedom-of-health choices and access to dietary

supplements and nutritional foods.

********************

_Click here for the permanent link to this press release, use this link to

inform others._ (http://www.thenhf.com/press_releases/pr_06_jun_2010.html)

National Health Federation: Established in 1955, the National Health

Federation is a consumer-education, health-freedom organization working to

protect individuals' rights to choose to consume healthy food, take supplements

and use alternative therapies without unnecessary government restrictions.

The NHF is the only such organization with recognized observer-delegate

status at Codex meetings. _www.thenhf.com_ (http://www.thenhf.com)

**************************************

FIND US ON FACEBOOK!

P.O. Box 688, Monrovia, CA 91017 USA ~ 1 (626) 357-2181 ~ Fax 1 (626)

303-0642

Website: _www.thenhf.com_ (http://www.thenhf.com)

E-mail: _contact-us@..._ (mailto:contact-us@...)

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