Fda running extortion racket

[Lare]

>
> FDA Running Extortion Racket: Natural Supplement Companies
> Threatened with Arrest if They Don't Pay Up
> by Mike Adams (see all articles by this author)
>
> (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
>
>
>
>
>
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