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. orgGrab 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. htmlWe'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. comThe 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.
72-10183; 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