(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.
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 [email protected]
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