|
by Mike Adams
the Health Ranger
October 21, 2008
from
NaturalNews Website
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.
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:
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
(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 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, 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@naturalnews.com
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), 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
-
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 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
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
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(r)(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(r)(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. 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 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 Director, 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
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