FDA
Running Extortion Racket: Natural Supplement Companies
Threatened with Arrest if They Don't Pay Up
Tuesday, October 21, 2008 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/investigatio...
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@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
here:
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
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. 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 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
|
