FDA Running Extortion Racket: Natural Supplement Companies Threatened with Arres

[Guest guest]

FDA Running Extortion Racket: Natural Supplement Companies Threatened with

Arrest if They Don't Pay Up

_http://www.naturalnews.com/024567.html_

(http://www.naturalnews.com/024567.html)

 

by Mike Adams

 

(NaturalNews) NaturalNews has learned the U.S. Food and Drug Administration

is running a criminal extortion racket designed to drain cash from health

supplement companies and shift it into the pockets of top FDA contractors. This

organized crime operation has been running for years, and it has operated

with impunity because each company targeted by the scam feels isolated and

alone, unable to face the astronomical legal bills of going to court and

battling

the FDA. So one by one, they agree to " settle " with the FDA for crimes they

never committed. Part of the settlement, of course, involves the payment of

FDA employees or contractors who pocket the money extorted from health

companies.

 

NaturalNews has interviewed executives from three different companies who

have been targeted for extortion by U.S. Food and Drug Administration

employees. At their request, the names of those companies are being kept

confidential

until legal action being taken against them is resolved. Interviews have been

recorded, with permission, with two of those companies and will be released

to the public at a later date. Documents proving this FDA extortion racket

are included here.

 

 

How the FDA extorts money from nutritional supplement companies

 

The FDA extortion racket works like this: FDA employees use keyword-scanning

software to scan the web pages of natural health product and supplement

companies, searching for terms like cancer, cures, treatment, remedies and

other

" forbidden " words. FDA employees then review the discovered pages to

determine if they contain any words that might inform consumers of the health

benefits of the nutritional products. FDA employees also look for links that

might

point web users to scientific articles from peer-reviewed medical journals

that further explain the health benefits of specific foods, supplements or

nutrients.

 

When offending words or links are found by the FDA, their extortion team

goes into full swing. First, they contact the company and warn them to remove

all information and links from their websites. This is the most important step

from the FDA's standpoint, because by doing this, they can keep the

health-conscious public in a state of nutritional ignorance about the

scientifically-supported healing properties of natural supplements. Cherry

products, for

example, cannot link to scientific articles explaining the simple biological

fact

that cherries ease inflammation in human beings. Such links are considered

" drug claims " by the FDA.

 

NaturalNews has even learned that companies are now being targeted for

simply posting customer testimonials, even when those testimonials make

absolutely

no health claims. FDA and FTC agents are now threatening the owners of such

companies with imprisonment if they do not immediately remove all customer

testimonials from their websites and marketing materials.

 

If the company being targeted for extortion refuses to fully comply with the

FDA's requests to remove all educational information from their website, the

FDA then escalates the extortion tactics by threatening the company

principals with arrest and seizure unless they agree to pay hundreds of

thousands of

dollars to top FDA contractors and sign a " consent decree " where the company

" admits " to committing various crimes (see below). This consent decree is a

blatant violation of the Constitutional rights of U.S. citizens, of course,

and it violates numerous sections of the Bill of Rights (Amendments #1 and #5,

at the very least).

 

The FDA employees or contractors receiving the extorted money, it is

claimed, are being paid to " review web pages " to make sure they don't contain

anything that might inform consumers about the scientifically-validated

benefits of

the health products being sold. FDA extortion agreements specify that FDA

employees should be paid the rate of $100 per hour, with no limit on the number

of hours they may bill the company for. The extortion agreement also

requires companies to pay for all the following:

 

• $100 per hour for the travel time of FDA employees.

• Hotel rooms for FDA employees.

• Storage fees for all products seized by the FDA.

 

The same agreement also requires the company to comply with FDA demands by

never placing any links or " illegal " information on its website, where

" illegal " means anything that offers an accurate description of the health

benefits

offered by natural health products.

 

 

The Consent Decree

 

Part of the FDA*s strategy for oppression and control is to force targeted

companies to sign a " consent decree " where they admit to crimes they never

committed. NaturalNews obtained a copy of a public court document the FruitFast

company was forced to sign due to FDA threats and extortion tactics.

 

You can view this document yourself at:

_http://www.naturalnews.com/investigations/FruitFastConsentDecree.pdf_

(http://www.naturalnews.com/investigations/FruitFastConsentDecree.pdf)

 

This document requires the FruitFast company to admit to crimes it did not

commit; namely:

 

**Violating the Act, by introducing or delivering for introduction, or

causing to be introduced or delivered for introduction, into interstate

commerce

articles of drug that are misbranded within the meaning of 21 U.S.C. SS

352(f)(1).**

 

What *drugs* did the FruitFast company introduce that were *misbranded?*

Cherries, it turns out. Cherry juice concentrate was being sold with the

accurate statement that it helped eliminate gout (which it does). This,

according to

the FDA, was enough to magically transform cherry juice into an " unapproved

drug " and cause it to be " misbranded. "

 

It also requires targeted companies to contractually agree that they have:

 

**...removed all claims from Defendants* product labels, labeling,

promotional materials, websites owned or controlled by Defendants, and in any

other

media that cause that product to be a drug and/or contain unapproved or

unauthorized health claims within the meaning of the Act; and

 

(ii) removed, from their product labels, labeling, promotional materials,

and websites owned or controlled by Defendants, references to or endorsements

of any other website that conveys information about Defendants' products that

cause those products to be a drug and/or contain unapproved or unauthorized

health claims within the meaning of the Act.**

 

This means, of course, that these companies can no longer even LINK to other

websites, including websites of scientific journals that discuss the proven

health benefits of such natural products (foods, herbs, etc.)

 

 

The truth is now subject to FDA approval

 

Once a company removes all educational information and links from their

website, they are then required to submit to draconian measures of **censorship

enforcement** by the FDA. This is fully explained in this section of the FDA's

Consent Decree: (bolding added for emphasis)

 

Within ten (10) calendar days of FDA*s request for any labels, labeling,

promotional materials, and/or downloaded copies (on CD-Rom) of any internet

websites owned or controlled by Defendants or websites referenced by, endorsed,

or adopted directly or indirectly by Defendants, Defendants shall submit a

copy of the requested materials to FDA at the address specified in paragraph

19.

 

Within twenty (20) calendar days of entry of this Decree, Defendants shall

submit to FDA a certification of compliance, signed by each of the

individually-named Defendants in this matter, each Defendant stating that he:

(a) has

personally reviewed all of Defendants' product labels, labeling, promotional

materials, and the internet websites referred to in paragraph 8 above; and (b)

personally certifies that the product labels, labeling, promotional

materials, and internet websites strictly comply with the requirements of the

Act and

its regulations and do not include unapproved or unauthorized claims that the

products cure, mitigate, treat, prevent and/or reduce the risk of disease.

Thereafter, Defendants shall submit certifications of compliance every three

(3) months for a period of two (2) years.

 

Furthermore, the FDA then requires that the company being targeted by the

extortion racket hire a person (called the *expert*) to enforce all this

censorship the company has agreed to.

 

As you'll note in the language below, this *expert* must be paid $100 an

hour, for an unlimited number of hours, to conduct surprise inspections of the

company's administrative offices, warehouses and fulfillment centers:

 

Within fourteen (14) calendar days of entry of this Decree, Defendants shall

retain an independent person or persons (the *expert*)... who by reason of

background, experience, education, and training is qualified to assess

Defendants' compliance with the Act, to review the claims Defendants make for

all of

their products on their product labels, labeling, promotional material, any

internet websites owned or controlled by Defendants, including, but not

limited to, the websites referred to in paragraph 8 above. At the conclusion of

the expert's review, the expert shall prepare a written report analyzing

whether Defendants are operating in compliance with the Act and in particular,

certify whether Defendants have omitted all claims from their product labels,

labeling, promotional materials, websites owned or controlled by Defendants,

and

in any other media, that make any of their products drugs and/or constitute

unapproved or unauthorized health claims within the meaning of the Act. The

expert shall also review Defendants' product labels, labeling, promotional

materials, and websites owned or controlled by Defendants to determine whether

these include any references to or endorsements of any other websites that

convey information about Defendants' products that cause those products to be a

drug and/or contain unapproved or unauthorized health claims within the

meaning of the Act, and certify in the written report whether Defendants have

omitted any such references or endorsements. The expert shall submit this

report

to FDA and Defendants within thirty-five (35) calendar days of the entry of

this Decree. If the expert reports any violations of the Act, Defendants

shall, within seven (7) calendar days of receipt of the report, correct those

deviations, unless FDA notifies Defendants that a shorter time period is

necessary.

 

In other words, this section requires the company being targeted to pay the

*Expert* huge fees to make sure it doesn't " illegally " link to other websites

that might tell the truth about the health products in question.

 

 

FDA tyranny unleashed

 

So what happens if the company slips up and does something illegal like,

let's say, posting a clickable link to a science journal that discusses

research

citing the health benefits of cherries? As you'll see below, there are no

limits to the action the FDA can take in retribution, including the seizure of

all company assets and the arrest of its principals.

 

Specifically, the Consent Decree forces company owners to agree to the

following:

 

If, at any time after this Decree has been entered, FDA determines, based on

the results of an inspection, the analyses of Defendants' product labels,

labeling, promotional materials, websites owned or controlled by Defendants, or

websites referenced by, endorsed, or adopted directly or indirectly by

Defendants that convey information about Defendants' products, a report

prepared

by Defendants' expert, or any other information, that additional corrective

actions are necessary to achieve compliance with the Act, applicable

regulations, or this Decree, FDA may, as and when it deems necessary, direct

Defendants, in writing, to take one or more of the actions:

 

A. Cease manufacturing, processing, packing, labeling, holding, and/or

distributing any article(s);

 

B. Submit additional reports or information to FDA;

 

C. Recall any article(s) at Defendants' expense; or

 

D. Take any other reasonable corrective action(s) as FDA, in its discretion,

deems necessary to bring Defendants and their products into compliance with

the Act, applicable regulations, and this Decree.

 

 

Surprise inspections, secret police and non-stop persecution

 

Just to keep the targeted company in a state of constant fear (which is why

I have labeled the FDA a terrorist organization), the FDA forces it to agree

to surprise inspections where it must pay FDA " compliance officers " to

rummage through their product shelves and paperwork, looking for evidence of

non-compliance:

 

Duly authorized representatives of FDA shall be permitted, without prior

notice and as and when FDA deems necessary, to make [surprise] inspections of

Defendants' facilities and, without prior notice, take any other measures

necessary to monitor and ensure continuing compliance with the terms of this

Decree. During such inspections, FDA representatives shall be permitted prompt

access to buildings, equipment, in-process and finished materials, containers,

labeling and other materials therein; to take photographs and make video

recordings; to take samples of Defendants' finished and unfinished materials

and

products, containers, labels, labeling, and other promotional materials; and

to examine and copy all records relating to the receipt, manufacture,

processing, packing, labeling, promoting, holding, and distribution of any and

all

Defendants' products in order to ensure continuing compliance with the terms of

this Decree. The inspections shall be permitted upon presentation of a copy

of this Decree and appropriate credentials. The inspection authority granted

by this Decree is separate from, and in addition to, the authority to conduct

inspections under the Act, 21 U.S.C. §374.

 

And just to make sure the company is further driven into bankruptcy, the FDA

requires them to PAY for all these surprise " compliance " investigations! As

stated in the Consent Decree:

 

Defendants shall reimburse FDA for the costs of all FDA inspections,

investigations, supervision, reviews, examinations, and analyses specified in

this

Decree or that FDA deems necessary to evaluate Defendants' compliance with

this Decree. The costs of such inspections shall be borne by Defendants at the

prevailing rates in effect at the time the costs are incurred. As of the date

that this Decree is signed by the parties, these rates are: $78.09 per hour

and fraction thereof per representative for inspection work; $93.61 per hour

or fraction thereof per representative for analytical or review work; $0.485

per mile for travel expenses by automobile; government rate or the equivalent

for travel by air or other means; and the published government per diem rate

or the equivalent for the areas in which the inspections are performed

per-day, per-representative for subsistence expenses, where necessary. In the

event

that the standard rates applicable to FDA supervision of court-ordered

compliance are modified, these rates shall be increased or decreased without

further order of the Court. "

 

Are you getting the picture here? The FDA can simply show up on a " surprise "

inspection, bring ten FDA agents, bill the company for thousands of hours,

and bankrupt the company while padding its own pockets.

 

Doesn't this sound a lot like the King's Consent Decree against the American

colonies? The FDA's agreement reads amazingly like a document a King might

force his subjects to sign as he's taking over their land and gold,

imprisoning them in his kingdom.

 

But it gets better: The FDA also requires the Defendants to reveal all sorts

of details about their business operations:

 

" Within ten (10) calendar days of entry of this Decree, Defendants shall

provide FDA a list of all domain names and IP addresses they use to market or

describe any product, regardless of whether such sites mention specific

products Defendants sell.

 

Defendants shall notify the District Director, FDA Detroit District Office,

in writing at least fifteen (15) calendar days before any change in

ownership, character, or name of its business.

 

If Defendants fail to comply with any of the provisions of this Decree,

including any time frame imposed by this Decree, then, on motion of the United

States in this proceeding, Defendants Brownwood Acres and/or Cherry Capital

shall pay to the United States of America the sum of one thousand dollars

($1,000) in liquidated damages per violation per day so long as such violation

continues.

 

Should the United States bring, and prevail in, a contempt action to enforce

the terms of this Decree, Defendants shall, in addition to other remedies,

reimburse the United States for its attorneys* fees, investigational expenses,

expert witness fees, travel expenses incurred by attorneys and witnesses,

and administrative court costs relating to such contempt proceedings.

 

And finally, just to make sure everybody knows who's in charge, here's what

the agreement says about final judgment:

 

All decisions specified in this Decree shall be vested in the discretion of

FDA and shall be final.

 

In other words, the FDA is the King. It is above the law. It answers to no

one but itself.

 

Welcome to the United States of Tyranny, FDA style.

 

The full text of the FDA's agreement, including the names of the top FDA

criminals who signed it, is included at the end of this article.

 

 

 

This brand of tyranny is reserved for health supplement companies

 

While the FDA gives drug companies a free pass of easy approval for

dangerous drugs, this Consent Decree is the kind of treatment it slams down

upon

health product companies. As you can see from the text in the decree, above,

this

is a document of outright tyranny and oppression.

 

Any company signing this document gives the FDA all the tools it needs to

drive that company completely out of business. Sadly, dozens of companies have

signed this in just the last year. The FDA's reign of terror is working. It's

putting health companies out of business and forcing them to censor

themselves. It even forces them to remove all web links to information sources

like

NaturalNews.com or peer-reviewed science journals.

 

This is all part of the FDA's campaign of health illiteracy -- a war of

disinformation being waged against the American people. It is a secret war

being

fought out of the view of the mainstream media (which refuses to report this

story) and far from the scrutiny of the U.S. Dept. of Justice (which doesn't

care about the real tyrants running loose in this country).

 

As I have often stated here on NaturalNews.com, the FDA is an

out-of-control, rogue agency engaged in acts of terrorism against the American

people. By

itself, it is negligent in the deaths of tens of millions of Americans, and it

has taken it upon itself to increase the body count by making sure consumers

have zero access to honest, truthful, scientifically-validated information

about the healing properties of health supplements.

 

The FDA, by any account, is a much greater threat to the security and safety

of the American people than any terrorist group, and if the U.S. really

wanted to fight terror and tyranny, it would start by arresting top FDA

officials

at gunpoint. Those targeted for arrest and prosecution should also include

the lawyers and paper pushers involved in this very agreement (see their names

on the legal documents at the end of this article).

 

In my view, these people are the real criminals at work here. They are the

masterminds of this campaign of extortion and terror being leveled against

health companies by the rogue U.S. Food and Drug Administration. Much like

Hitler's top generals, they play an important role in the mass disinformation

that's resulting in the needless death of millions of people. By any account,

they are all guilty of crimes against humanity and should be arrested and

prosecuted as such. We should all be so fortunate to live to the day where we

can

see these white-collar criminals behind bars, perhaps sharing their jail cells

with other war criminals from the Bush Administration.

 

 

Sign this or you'll be arrested

 

What you haven't yet seen in all this is the barrage of threats leveled

against companies if they don't sign this Consent Decree! Company executives

receive both written and verbal threats from top FDA " enforcement officers " who

claim they will " throw you in prison " if you don't sign the agreement.

 

Every major health trade show hosts an FDA compliance officer (much like a

Nazi Gestapo officer) whose job it is to walk the show floor and threaten

companies into compliance. This includes shows like Expo West and Expo East,

where show organizers also serve as de facto FDA agents themselves, barring the

participation of exhibitors who dare to tell the truth about their natural

products. This smacks of KGB secret police operations in the former Soviet

Union. But secret FDA police are now a reality in the United States of America.

 

NaturalNews has learned of numerous verbal threats from FDA compliance

officers directed at health supplement companies during trade shows, including

threats to " put you out of business, " " throw you in prison " or " take every last

dollar you've ever earned. "

 

FDA compliance officers are the foot soldiers of the agency's war against

the truth. They seek out any health claim that might inform consumers about the

properties of nutritional supplements, then they work to squash such

statements before they become too well known. In essence, they are censorship

officers who enforce nutritional illiteracy and prevent knowledge from being

shared.

 

As such, they are acting not merely as secret police on a mission to destroy

small American businesses; they are actually agents of disinformation, bent

on destroying knowledge and enforcing a system of mandatory ignorance. This

is entirely consistent with the FDA's history of ordering the destruction of

recipe books that promoted the use of the natural herb stevia, among many

other examples of information suppression.

 

 

The FDA's campaign of health illiteracy and enforced ignorance

 

It is the FDA's position that there is no such thing as any food, beverage,

supplement or herb that has any health benefit whatsoever. Merely making such

a claim instantly qualifies your product as a " new and unapproved drug, "

according to the FDA.

 

Officially, the FDA claims all health products are inert and have no

properties other than their macronutrients (fiber, carbohydrates, protein,

etc.).

 

There is only one class of substances that have any biological effect on the

human body, the FDA claims: Pharmaceuticals. Only those patented, synthetic

chemicals are allowed to be described as having benefits to human health.

 

This convenient position is entirely consistent with the protection of the

profits of drug companies. It's no coincidence that the drug companies fund

the FDA through " user fees, " and most FDA employees are dependent on drug

company money... except, of course, those FDA people earning their living by

extorting millions of dollars from health product companies.

 

The upshot of the FDA's campaign against health supplements is that most of

the American people remain nutritionally illiterate, oblivious to the

scientifically-validated health benefits offered by tens of thousands of

different

nutrients, plants, supplements and products. To say that zinc speeds healing,

or that vitamin D prevents cancer, or that resveratrol lowers high

cholesterol is common sense in the scientific community, but it's a crime in the

eyes

of the FDA.

 

 

It's time to stop the FDA's reign of terror over health supplements

 

It is time to end the FDA's extortion racket, restore Free Speech rights to

health supplements, and bring the organized crime kingpins at the FDA to

justice.

 

NaturalNews is organizing a list of companies who wish to help fund legal

action against the FDA. We intend to take part in a lawsuit against the FDA

that would reign in the FDA's control over nutritional supplements and defend

health freedoms for American consumers.

 

To do this, we need to gather information from those companies who are

willing to help fund this legal action, which may cost several hundred thousand

dollars. If you represent a company willing to take part in this legal action

against the FDA, contact us now at _StopTheFDA_

(StopTheFDA)

 

Simply email us your name and contact phone number. We'll contact you to

continue the conversation. Any information sent to us is kept strictly

confidential. We will refuse to turn over such information even with a court

order.

 

With enough support from the natural products community, we will take part

in the reporting and grassroots organization of this legal action.

 

 

We must stop the FDA now

 

It is the belief of NaturalNews that the FDA is being run as a system of

organized crime, using the exact same extortion tactics as the Mob. Through

intimidation, censorship and threats of imprisonment, the FDA is right now

extorting tens of millions of dollars from the very same health supplement

companies you depend on to bring you lifesaving, disease-reversing products.

 

Even worse, the FDA is getting away with it. Backed by the threat of

imprisonment and the ability to conduct armed raids against health product

companies

(see the history of armed FDA raids against vitamin companies here:

_http://www.naturalnews.com/021791.html_

(http://www.naturalnews.com/021791.html) ),

the FDA is able to overpower health product companies when they stand alone.

 

The industry must band together if it hopes to defend itself against this

tyranny. A lone villager cannot defend himself against a band of marauders, but

an organized and well-defended band of villagers can fight off attackers

many times their size. If it wishes to survive, the natural products industry

must band together and defend itself against the FDA. It must take back its

right to tell the truth about health supplements, and it must forever banish

censorship and ignorance from the health products marketplace.

 

The FDA will not stop its reign of terror, you see, until every health

supplement companies is silenced, every company founder is imprisoned and every

consumer is enslaved in a state of outright nutritional illiteracy. They will

seize products and let them rot in warehouses; they'll recruit armed law

enforcement personnel to conduct SWAT-style raids on vitamin shops; they'll

extort

millions of dollars from health companies and pocket the profits; and

they'll do it all while burning taxpayer dollars and claiming they're working

to

" protect " consumers from natural health products like cherry juice concentrate,

which is of course so incredibly dangerous that we need an entire government

agency just to make sure we don't find out it might ease arthritis

inflammation.

 

 

What you can do right now to help halt the FDA's reign of terror

 

As a consumer, you can use your voice to help stop the FDA from destroying

the natural products marketplace. Simply go to _www.ReformFDA.org_

(http://www.ReformFDA.org) and sign the petition there.

 

It's sponsored by the American Association for Health Freedom (AAHF), an

organization fighting to end the FDA's tyrannical rule over the health of the

American people.

 

Sign that petition and spread the word: NaturalNews and the AAHF are working

together to bring back honesty, freedom and free speech to the health

supplements industry, and we need your help to get it done.

 

You can also protest the FDA with your Congressperson or Senator. Contact

them and insist that they support efforts to end the reign of FDA tyranny and

reestablish Free Speech rights for nutritional supplement companies.

 

Notably, Rep. Ron Paul has sponsored the Health Freedom Protection Act,

which you can read here: _http://www.StopFDACensorship.org_

(http://www.StopFDACensorship.org)

 

 

Grab your cameras, folks

 

Finally, NaturalNews urges those in the natural health community to go out

and buy video cameras and still cameras and start snapping photos of rogue FDA

agents arresting people, seizing products, accepting bribes or other

outrageous acts. We cannot simply lie down and let the FDA march in to our

company

warehouses and seize products. One video can change the world. It's up to you

to get that video recorded and get it to us here at NaturalNews. Use our

feedback form to contact us: _www.NaturalNews.com/feedback.html_

(http://www.NaturalNews.com/feedback.html)

 

We've also opened up an audio tips line, where FDA employees who wish to

leak information to NaturalNews can anonymously call us and leave a message:

(323) 924-1664

 

With your help, we will soon start publishing videos and photos showing FDA

agents directly engaged in acts of tyranny against health companies. And for

those who'd like to earn some extra money snapping photos, we're willing to

pay you for photos of FDA " compliance officers " walking trade show floors

where they threaten companies in person. Contact us for details if you're a

photographer with a long lens who would like to start earning money snapping

photos of FDA agents engaged in their dirty work.

 

It's time to shed light on the real actions of the FDA. We can no longer sit

back and allow this criminal organization to operate in secret. But grabbing

the public's attention all comes down to getting this on video. This is the

YouTube era. If it's not on video, it doesn't exist. But if it's on video, we

can likely get it on mainstream news. (I can see it now: the FDA raids a

warehouse and handcuffs the screaming, crying business owner. And why? Because

their bottle said, " Eases inflammation. " The public won't stand for it.)

 

The FDA, of course, will have its own people doing the same thing to people

like me. They're trying to catch us eating at McDonald's or going through the

local pharmacy drive-thru. All I can say about that is they'll be waiting a

long, long time to see that day!

 

Please forward this story to everyone you know. We the People must either

prevail in this fight for our freedom, or we will all end up illiterate,

imprisoned or silenced. The FDA will take away your rights, your speech and

your

health, and it will laugh all the way to the bank while it steals your

hard-earned money. It will break every law, ignore every court order and commit

every

crime necessary to bring health companies into line... UNLESS we fight back

and do our part to end this grave threat to our health, safety and freedoms.

 

The FDA is the enemy of the People. It is a criminal organization bent on

destroying American freedoms and consumer health. It operates with impunity,

using its own secret compliance officers, wreaking death and destruction across

our nation like a dark plague unleashed. If we hope to ever regain our

health, our freedoms and the basic human right to tell the truth about the

healing

properties of simple foods, then we must bring this agency to justice and

prosecute its mob bosses for their many crimes against the People.

 

It is time to stand up for your health freedoms, or lose them forever.

Please join me in this courageous stand against tyranny and oppression.

 

- Mike Adams, the Health Ranger, editor of NaturalNews.com

 

 

The Full Consent Decree of Permanent Injunction

 

Here's the full text of the Consent Decree in case you want to read it

yourself.

 

February 12, 2008 3:11 PM

 

RONALD C. WESTON, SR., CLERK

 

U.S. DISTRICT COURT WESTERN DISTRICT OF MICHIGAN

 

IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF MICHIGAN

SOUTHERN DIVISION

 

UNITED STATES OF AMERICA,

 

Plaintiff,

 

v.

 

BROWNWOOD ACRES FOODS, INC., and CHERRY CAPITAL SERVICES, INC. d.b.a.

FLAVONOID SCIENCES, corporations, and STEPHEN C. de TAR and ROBERT L.

UNDERWOOD,

individuals,

 

Defendants.

 

Plaintiff, United States of America, having commenced this action by filing

its Complaint for Permanent Injunction, and Brownwood Acres Foods, Inc.

( " Brownwood Acres " ) and Cherry Capital Services, Inc., d.b.a. Flavonoid

Sciences

( " Cherry Capital " ), corporations, and Stephen C. de Tar and Robert L.

Underwood, individuals (hereafter collectively, " Defendants " ), having appeared

and

consented to the entry of this Decree without contest and before any testimony

was taken, and the United States of America, having consented to this Decree;

 

IT IS HEREBY ORDERED, ADJUDGED, AND DECREED as follows: 1. This Court has

jurisdiction over the subject matter of this action and has personal

jurisdiction over all parties to this action.

 

CIVIL NO

 

1:08-cv-148

 

HON Paul L Maloney

 

US District Judge

 

CONSENT DECREE OF PERMANENT INJUNCTION

 

2. The Complaint for Permanent Injunction states a cause of action against

Defendants under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§

301-397 (the " Act " ).

 

3. Defendants violate the Act, 21 U.S.C. § 331 (d), by introducing or

delivering for introduction, or causing to be introduced or delivered for

introduction, into interstate commerce new drugs within the meaning of 21

U.S.C. § 321

(p) that are neither approved under 21 U.S.C. § 355(a), nor exempt from

approval pursuant to 21 U.S.C. § 355(t).

 

4. Defendants violate the Act, 21 U.S.C. § 331 (a), by introducing or

delivering for introduction, or causing to be introduced or delivered for

introduction, into interstate commerce articles of drug that are misbranded

within the

meaning of 21 U.S.C. § 352(f)(1).

 

5. Defendants violate the Act, 21 U.S.C. § 331(a), by introducing or

delivering for introduction, or causing to be introduced or delivered for

introduction, into interstate commerce food that is misbranded within the

meaning of 21

U.S.C. §343®(1)(B).

 

6. Upon entry of this Decree, Defendants and each and all of their

directors, officers, agents, representatives, employees, attorneys, successors,

assigns, and any and all persons in active concert or participation with any of

them who receive actual notice of this Decree by personal service or otherwise,

are permanently restrained and enjoined from introducing or delivering for

introduction, or causing to be introduced or delivered for introduction, into

interstate commerce any product unless and until:

 

A. An approved new drug application or abbreviated new drug application

filed pursuant to 21 U.S.C. § 355(a) or (j) is effective with respect to the

product; or

 

B. An effective investigational new drug exemption filed pursuant to 21

U.S.C. § 355(i) is in effect for the product; or

 

C. The product's claims comport with an authorized health claim set forth in

21 C.F.R. § 101.72-101.83; or

 

D. Defendants have received a letter of enforcement discretion for a

qualified health claim from FDA for that product; or

 

E. Defendants have:

 

(i) removed all claims from Defendants' product labels, labeling,

promotional materials, websites owned or controlled by Defendants, and in any

other

media that cause that product to be a drug and/or contain unapproved or

unauthorized health claims within the meaning of the Act; and

 

(ii) removed, from their product labels, labeling, promotional materials,

and websites owned or controlled by Defendants, references to or endorsements

of any other website that conveys information about Defendants' products that

cause those products to be a drug and/or contain unapproved or unauthorized

health claims within the meaning of the Act.

 

7. Upon entry of this Decree, Defendants and each and all of their

directors, officers, agents, representatives, employees, attorneys, successors,

assigns, and any and all persons in active concert or participation with any of

them who receive actual

 

notice of this Decree by personal service or otherwise, are permanently

restrained and enjoined from directly or indirectly doing or causing to be done

any act that:

 

A. Violates 21 U.S.C. § 331(d), by introducing or delivering for

introduction, or causing to be introduced or delivered for introduction, into

interstate

commerce new drugs within the meaning of 21 U.S.C. § 321 (p) that are

neither approved pursuant to 21 U.S.C. § 355(a), nor exempt from approval

pursuant

to 21 U.S.C. §355(i);

 

B. Violates 21 U.S.C. § 331(a), by introducing or delivering for

introduction, or causing to be introduced or delivered for introduction, into

interstate

commerce articles of drug that are misbranded within the meaning of 21 U.S.C.

 

§ 352(f)(1); and

 

C. Violates 21 U.S.C. § 331(a), by introducing or delivering for

introduction, or causing to be introduced or delivered for introduction, into

interstate

commerce food that is misbranded within the meaning of 21 U.S.C. §

343®(1)(B).

 

8. Within ten (10) calendar days of FDA's request for any labels, labeling,

promotional materials, and/or downloaded copies (on CD-Rom) of any internet

websites owned or controlled by Defendants or websites referenced by,

endorsed, or adopted directly or indirectly by Defendants, Defendants shall

submit a

copy of the requested materials to FDA at the address specified in paragraph

19.

 

9. Within twenty (20) calendar days of entry of this Decree, Defendants

shall submit to FDA a certification of compliance, signed by each of the

individually-named Defendants in this matter, each Defendant stating that he:

(a) has

personally reviewed

 

all of Defendants' product labels, labeling, promotional materials, and the

internet websites referred to in paragraph 8 above; and (b) personally

certifies that the product labels, labeling, promotional materials, and

internet

websites strictly comply with the requirements of the Act and its regulations

and do not include unapproved or unauthorized claims that the products cure,

mitigate, treat, prevent and/or reduce the risk of disease. Thereafter,

Defendants shall submit certifications of compliance every three (3) months for

a

period of two (2) years.

 

10. Within fourteen (14) calendar days of entry of this Decree, Defendants

shall retain an independent person or persons (the " expert " ), without

personal, financial (other than the consulting agreement between the parties),

or

familial ties to Defendants or their immediate families, who by reason of

background, experience, education, and training is qualified to assess

Defendants'

compliance with the Act, to review the claims Defendants make for all of

their products on their product labels, labeling, promotional material, any

internet websites owned or controlled by Defendants, including, but not limited

to, the websites referred to in paragraph 8 above. At the conclusion of the

expert's review, the expert shall prepare a written report analyzing whether

Defendants are operating in compliance with the Act and in particular, certify

whether Defendants have omitted all claims from their product labels, labeling,

promotional materials, websites owned or controlled by Defendants, and in

any other media, that make any of their products drugs and/or constitute

unapproved or unauthorized health claims within the meaning of the Act. The

expert

shall also review Defendants' product labels, labeling, promotional

materials, and websites owned or controlled by Defendants to determine whether

these

include any references to or endorsements of any other

 

websites that convey information about Defendants' products that cause those

products to be a drug and/or contain unapproved or unauthorized health

claims within the meaning of the Act, and certify in the written report whether

Defendants have omitted any such references or endorsements. The expert shall

submit this report to FDA and Defendants within thirty-five (35) calendar days

of the entry of this Decree. If the expert reports any violations of the

Act, Defendants shall, within seven (7) calendar days of receipt of the report,

correct those deviations, unless FDA notifies Defendants that a shorter time

period is necessary.

 

11. If, at any time after this Decree has been entered, FDA determines,

based on the results of an inspection, the analyses of Defendants' product

labels, labeling, promotional materials, websites owned or controlled by

Defendants, or websites referenced by, endorsed, or adopted directly or

indirectly by

Defendants that convey information about Defendants' products, a report

prepared by Defendants' expert, or any other information, that additional

corrective actions are necessary to achieve compliance with the Act, applicable

regulations, or this Decree, FDA may, as and when it deems necessary, direct

Defendants, in writing, to take one or more of the actions:

 

A. Cease manufacturing, processing, packing, labeling, holding, and/or

distributing any article(s);

 

B. Submit additional reports or information to FDA;

 

C. Recall any article(s) at Defendants' expense; or

 

D. Take any other reasonable corrective action(s) as FDA, in its discretion,

deems necessary to bring Defendants and their products into compliance with

the Act, applicable regulations, and this Decree.

 

12. Any cessation of operations as described above shall continue until FDA

notifies Defendants in writing that Defendants appear to be in compliance

with the.Act and the requirements of this Decree, and that Defendants may

resume

operations. Such notification by FDA may not be unreasonably delayed.

 

13. Duly authorized representatives of FDA shall be permitted, without prior

notice and as and when FDA deems necessary, to make inspections of

Defendants' facilities and, without prior notice, take any other measures

necessary to

monitor and ensure continuing compliance with the terms of this Decree.

During such inspections, FDA representatives shall be permitted prompt access

to

buildings, equipment, in-process and finished materials, containers, labeling

and other materials therein; to take photographs and make video recordings;

to take samples of Defendants' finished and unfinished materials and

products, containers, labels, labeling, and other promotional materials; and to

examine and copy all records relating to the receipt, manufacture, processing,

packing, labeling, promoting, holding, and distribution of any and all

Defendants' products in order to ensure continuing compliance with the terms of

this

Decree. The inspections shall be permitted upon presentation of a copy of this

Decree and appropriate credentials. The inspection authority granted by this

Decree is separate from, and in addition to, the authority to conduct

inspections under the Act, 21 U.S.C. §374.

 

14. Defendants shall reimburse FDA for the costs of all FDA inspections,

investigations, supervision, reviews, examinations, and analyses specified in

this Decree or that FDA deems necessary to evaluate Defendants' compliance with

this Decree. For the purposes of this Decree, inspections include FDA's

review and

 

analysis of Defendants' claims for their products in the product labels,

labeling, promotional materials, any and all websites owned or controlled by

Defendants, and any and all websites referenced by, endorsed, or adopted

directly or indirectly by Defendants that convey information about Defendants'

products. The costs of such inspections shall be borne by Defendants at the

prevailing rates in effect at the time the costs are incurred. As of the date

that

this Decree is signed by the parties, these rates are: $78.09 per hour and

fraction thereof per representative for inspection work; $93.61 per hour or

fraction thereof per representative for analytical or review work; $0,485 per

mile for travel expenses by automobile; government rate or the equivalent for

travel by air or other means; and the published government per diem rate or the

equivalent for the areas in which the inspections are performed per-day,

per-representative for subsistence expenses, where necessary. In the event that

the standard rates applicable to FDA supervision of court-ordered compliance

are modified, these rates shall be increased or decreased without further

order of the Court.

 

15. Within ten (10) calendar days after the entry of this Decree, Defendants

shall provide a copy of this Decree, by personal service or certified mail

(restricted delivery, return receipt requested), to each and all of its

directors, officers, agents, representatives, employees, successors, assigns,

attorneys, and any and all persons in active concert or participation with any

of

them (including " doing business as " entities) (hereafter collectively

referred to as " associated persons " ). Wthin thirty-five (35) calendar days of

the

date of entry of this Decree, Defendants shall provide to FDA an affidavit of

compliance, stating the fact and manner of compliance with the provisions of

this paragraph and identifying the names and positions of all associated

persons who

 

have received a copy of this Decree and the manner of notification. In the

event that Defendants become associated, at any time after the entry of this

Decree, with new associated persons, Defendants shall: (a) within fifteen (15)

calendar days of such association, provide a copy of this Decree to each

such associated person by personal service or certified mail (restricted

delivery, return receipt requested), and (b) on a quarterly basis, notify FDA

in

writing when, how, and to whom the Decree was provided.

 

16. Within ten (10) calendar days of entry of this Decree, Defendants shall

post a copy of this Decree on a bulletin board in a common area at any of

their manufacturing or distribution facilities, and shall ensure that the

Decree

remains posted for a period of twelve (12) months at each location.

 

17. Wthin ten (10) calendar days of entry of this Decree, Defendants shall

provide FDA a list of all domain names and IP addresses they use to market or

describe any product, regardless of whether such sites mention specific

products Defendants sell. Defendants thereafter shall notify FDA within ten

(10)

days of any change to this list (either additions or deletions).

 

18. Defendants shall notify the District Director, FDA Detroit District

Office, in writing at least fifteen (15) calendar days before any change in

ownership, character, or name of its business, such as dissolution, assignment,

or

sale resulting in the emergence of a successor corporation, the creation or

dissolution of subsidiaries, franchises, affiliates, or " doing business as "

entities, or any other change in the corporate structure of Defendants

Brownwood Acres or Cherry Capital, or in the sale or assignment of any business

assets, such as buildings, equipment, or inventory, that may affect compliance

with this Decree. Defendants shall provide a copy of this Decree to any

potential successor or assignee at least fifteen (15) calendar days before any

sale

or assignment. Defendants shall furnish FDA with an affidavit of compliance

with this paragraph no later than ten (10) calendar days prior to such

assignment or change in ownership.

 

19. All notifications, certifications, reports, correspondence, and other

communications to FDA required by this Decree shall be addressed to the, FDA Detroit District Office, 300 River Place, Suite 5900, Detroit,

Michigan 48207.

 

20. If Defendants fail to comply with any of the provisions of this Decree,

including any time frame imposed by this Decree, then, on motion of the

United States in this proceeding, Defendants Brownwood Acres and/or Cherry

Capital

shall pay to the United States of America the sum of one thousand dollars

($1,000) in liquidated damages per violation per day so long as such violation

continues. For the purposes of this paragraph, a " violation " is defined as

each time any Defendant introduces or delivers for introduction into interstate

commerce any product that is accompanied by (on the product's label,

labeling, promotional materials, websites owned or controlled by Defendants, or

in

any other media) a claim(s) that causes the product to be a drug or

constitutes a health claim within the meaning of the Act, unless the product is

an

approved new drug or such claim is authorized by FDA.

 

21. Should the United States bring, and prevail in, a contempt action to

enforce the terms of this Decree, Defendants shall, in addition to other

remedies, reimburse the United States for its attorneys* fees, investigational

expenses, expert witness fees, travel expenses incurred by attorneys and

witnesses, and administrative court costs relating to such contempt

proceedings.

 

22. All decisions specified in this Decree shall be vested in the discretion

of FDA and shall be final. If contested, FDA's decisions under this Decree

shall be reviewed by the Court under the arbitrary and capricious standard set

forth in 5 U.S.C. § 706(2)(A). Review shall be based exclusively on the

written record before FDA at the time the decision was made. No discovery shall

be taken by either party.

 

23. If, in FDA's judgment, Defendants maintain a continuous state of

compliance with this Decree and the Act for a period of three (3) years after

the

date of entry of this Decree, and FDA has not notified Defendants that there

has been a significant violation of this Decree or the Act during such time,

the government will not oppose Defendants' petition to the Court to dissolve

the Decree.

 

24. This Court retains jurisdiction of this action for the purpose of

enforcing or modifying this Decree and for the purpose of granting such

additional

relief as may be necessary or appropriate.

 

IT IS SO ORDERED:

 

Dated this_day of_, 2008.

 

UNITED STATES DISTRICT JUDGE

 

 

FOR PLAINTIFF

 

CHARLES R. GROSS

United States Attorney Western District of Michigan

 

W. FRANCESCA FERGUSON

Assistant U.S. Attorney

 

ALAN J. PHELPS

Trial Attorney

Office of Consumer Litigation Department of Justice Civil Division P.O. Box

386 Washington, D.C. 20044

 

OF COUNSEL:

 

JAMES C. STANSEL

Acting General Counsel

 

GERALD F. MASOUDI

Chief Counsel

Food and Drug Division

 

ERIC M. BLUMBERG

Deputy Chief Counsel, Litigation

 

MICHELE LEE SVONKIN

Associate Chief Counsel for Enforcement United States Department of Health

and Human Services Office of the General Counsel

 

 

 

 

 

[Guest guest]

You know what bothers me most about this is the medications that

don't cure anything can be advertised as the cure, yet nutriceuticals

that are helping people return to a healthier state can't make any

claims.

 

Nutriceuticals may not cure, but taking a quality supplement, along

with a healthy diet will most definitely help the immune system do

it's job by keeping the body well and this don't only work on the one

health challenge, it treats the entire body to better health.

 

I live with Rheumatoid ARthritis and for the first 2 years after

diagnosis the pain and suffering was beyond belief, that was WHILE I

took the recommended medications.

 

Years later I have recovered, through healthier lifestyle

modifications and now I see the advertising for medication in

relation to RA and I am sickened.

 

Fear mongering advertising seems to be the way of the future with

medication......If you don't do this, here will be your result. I

stand proudly today saying this is just not true.

 

Susan

 

 

,

bestsurprise2002 wrote:

>

> FDA Running Extortion Racket: Natural Supplement Companies

Threatened with

> Arrest if They Don't Pay Up

> _http://www.naturalnews.com/024567.html_

> (http://www.naturalnews.com/024567.html)

>

> by Mike Adams

>

>

[Guest guest]

Susan...what you have stated is absolutely true. The real kicker is

that a lot of the pharmaceuticals that are advertised actually do

way more harm to your body rather than help it. That is the sickest

part.

 

 

, " Susan "

<ddorey wrote:

>

> You know what bothers me most about this is the medications that

> don't cure anything can be advertised as the cure, yet

nutriceuticals

> that are helping people return to a healthier state can't make any

> claims.

>

> Nutriceuticals may not cure, but taking a quality supplement, along

> with a healthy diet will most definitely help the immune system do

> it's job by keeping the body well and this don't only work on the

one

> health challenge, it treats the entire body to better health.

>

> I live with Rheumatoid ARthritis and for the first 2 years after

> diagnosis the pain and suffering was beyond belief, that was WHILE

I

> took the recommended medications.

>

> Years later I have recovered, through healthier lifestyle

> modifications and now I see the advertising for medication in

> relation to RA and I am sickened.

>

> Fear mongering advertising seems to be the way of the future with

> medication......If you don't do this, here will be your result. I

> stand proudly today saying this is just not true.

>

> Susan

>

>

> ,

> bestsurprise2002@ wrote:

> >

> > FDA Running Extortion Racket: Natural Supplement Companies

> Threatened with

> > Arrest if They Don't Pay Up

> > _http://www.naturalnews.com/024567.html_

> > (http://www.naturalnews.com/024567.html)

> >

> > by Mike Adams

> >

> >

>