(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 approvalOnce 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 unleashedSo 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.
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 approvalOnce 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.
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 unleashedSo 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.
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