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.
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:
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