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United States v. Clifford Woods LLC

United States District Court, C.D. California

June 27, 2016

UNITED STATES OF AMERICA, Plaintiff,
v.
CLIFFORD WOODS LLC, a limited liability company d/b/a VIBRANT LIFE, and CLIFFORD WOODS, an individual, Defendants.

          BENJAMIN C. MIZER Principal Deputy Assistant Attorney General JONATHAN F. OLIN Deputy Assistant Attorney General MICHAEL S. BLUME, JILL FURMAN, DANIEL ZYTNICK, Trial Attorney.

          CONSENT DECREE OF PERMANENT INJUNCTION AND OTHER EQUITABLE RELIEF

         Plaintiff, the United States of America, by its undersigned counsel, having filed a Complaint for Injunction and Other Equitable Relief against Clifford Woods, LLC, a limited liability company doing business as Vibrant Life, and Clifford Woods, an individual (collectively, “Defendants”), and Defendants having appeared and consented to entry of this Decree without contest and before any testimony has been 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 and all parties to this action.

         2. The Complaint states a cause of action against Defendants under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (the “Act”), and the civil fraud injunction statute, 18 U.S.C. § 1345 (“Section 1345”).

         3. Defendants violate 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, as defined by 21 U.S.C. § 321(p), that are neither approved under 21 U.S.C. § 355 nor exempt from approval.

         4. Defendants violate 21 U.S.C. § 331(a) by introducing or delivering for introduction, or causing to be introduced or delivered for introduction, into interstate commerce drugs that are misbranded within the meaning of 21 U.S.C. § 352(f)(1) because their labeling fails to bear adequate directions for use.

         5. Defendants violate 18 U.S.C. §§ 1341 and 1343 by promoting, selling, and receiving money in exchange for products to cure, mitigate, treat, or prevent a disease despite the absence of well-controlled clinical studies or any other credible scientific substantiation to support those representations, and by (1) doing so using the United States mail and/or a private or commercial interstate carrier and (2) transmitting writings by wire in interstate commerce for the purpose of executing such scheme or artifice.

         6. This Court has authority pursuant to 21 U.S.C. § 332(a), and inherent authority, to order injunctive and other equitable relief remedying the unlawful activities described in paragraphs 3 and 4. This Court has authority pursuant to 18 U.S.C. § 1345, and inherent authority, to order injunctive and other equitable relief remedying the unlawful activities described in paragraph 5.

         7. Defendant Clifford Woods LLC is a California company that does business as Vibrant Life, and sells and distributes dietary supplements under the brand name Vibrant Life. Defendant Clifford Woods owns and operates Clifford Woods LLC and serves as executive director of Vibrant Life.

         8. The Food and Drug Administration (“FDA”) sent a Warning Letter, dated August 7, 2013, to Defendant Woods (operating at that time as Vibrant Life or Vibrant Life Vitamins) concerning products and claims found on Defendants’ websites. The Warning Letter advised Defendant Woods that the products were new drugs, which may not be legally introduced or delivered for introduction into interstate commerce without prior FDA approval. The Warning Letter further advised Defendant Woods that the products were misbranded drugs, whose introduction or delivery into interstate commerce also violates the Act.

         9. Upon entry of this Decree, Defendants represent to the Court that they are not directly or indirectly engaged in processing, packing, repacking, labeling, holding, or distributing any article of food (including but not limited to dietary supplements and their components) and/or any article of drug.

         10. If Defendants later intend to resume operation of Vibrant Life or any other enterprise engaged in manufacturing, processing, packing, labeling, holding, or distributing any article of food (including but not limited to dietary supplements and their components) and/or any article of drug, Defendants must notify FDA in writing at least ninety (90) days in advance of resuming operations and must comply with Paragraph 13 of this Decree.

         11. Defendants’ notice under Paragraph 10 shall identify the type(s) of products that Defendants intend to process, pack, repack, label, hold, and/or distribute, and the location(s) at which Defendants intend to resume operations.

         12. Defendants shall not resume operations until the conditions in Paragraphs 13(A)-(B) and 13(D) are satisfied, and Defendants have received written notice from FDA, as required by Paragraph 13(E), and then Defendants shall resume such operations only to the extent authorized in FDA’s written notice.

         PROHIBITED CONDUCT

         13. Upon entry of this Decree, Defendants and each and all of their directors, officers, agents, representatives, employees, attorneys, successors and assigns, and any and all persons or entities in active concert or participation with any of them (including individuals, partnerships, corporations, subsidiaries, affiliates, franchisees, and “doing business as” entities) (hereinafter, collectively referred to as “Associated Persons”) who have received actual notice of this Decree by personal service or otherwise, are permanently restrained and enjoined from directly or indirectly introducing and delivering for introduction into interstate commerce, causing to be introduced and delivered for introduction into interstate commerce, and holding for sale after shipment in interstate commerce, any product unless and until:

         A. Defendants have in effect with respect to the product a new drug application or abbreviated new drug application approved pursuant to 21 U.S.C. § 355(c) or (j), or an investigational new drug exemption filed pursuant to 21 U.S.C. § 355(i), or the following requirements are met:

         1. Defendants remove from their product labels, labeling, promotional material, websites (including but not limited to arthritisinformation.net, bulkmsm.com, chelationtherapyonline.com, heart-disease-bypass-surgery.com, oralchelation.com, vibrantlifemsm.com, and vibrantlifenews.com), branded Facebook pages, and any other media (a) all representations that their products or the ingredients in their products cure, mitigate, treat, or prevent disease, and all representations that otherwise cause any of their products to be a drug within the meaning of the Act, and (b) all links and references, direct or indirect, to other websites or other sources that contain representations that their products or the ingredients in their products cure, mitigate, treat, or prevent disease, and representations that otherwise cause any of their products to be a drug within the meaning of the Act;

         2. Defendants provide notice, by letter or electronic mail, to all persons who are or have been involved in the promotion, sale, distribution, or use of Defendants’ Taheebo Life Tea, Life Glow Plus, Germanium, Organic Sulfur (“MSM”), or any other product labeled as containing organic sulfur or methyl sulfonyl methane, informing those persons that, pursuant to an order of this Court, those products should not have been and can no longer be promoted, sold, or distributed for use in the cure, mitigation, treatment, or prevention of disease and that continued promotion, sale, or distribution of the products for the cure, mitigation, treatment, or prevention of disease is a violation of the Act. Prior to distribution, the notification shall be submitted to, and approved in writing by, FDA. After completing distribution of the notification required by this paragraph, Defendants shall provide FDA with ...


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