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
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
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
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