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Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 1 of 16
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE MIDDLE DISTRICT OF GEORGIA
`MACON DIVISION
`
`
`
`
`
`UNITED STATES OF AMERICA,
`
`
`
`
`
`BIOANUE LABORATORIES, INC.,
`a corporation, and
`GLORIA D. RABER, an individual, and
`KELLY RABER, an individual,
`
`
`
`
`
`
`
`
`v.
`
`
`
`
`
`
`
`Plaintiff,
`
`Defendants.
`
`CIVIL NO. _________________
`
`COMPLAINT FOR PERMANENT INJUNCTION
`
`
`
`
`Plaintiff, the United States of America, by its undersigned attorneys, respectfully
`
`represents to this Court as follows:
`
`1.
`
`This statutory injunction proceeding is brought under the Federal Food,
`
`Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 332(a), to enjoin and restrain Gloria D.
`
`Raber and Kelly Raber, individuals, and BioAnue Laboratories, Inc., a corporation, from
`
`violating:
`
`a.
`
`21 U.S.C. § 331(d), by introducing or delivering, and/or causing to
`
`be introduced or delivered, into interstate commerce any new drug within the meaning
`
`of 21 U.S.C. § 321(p) that is neither approved under 21 U.S.C. § 355(a) or (j), nor
`
`exempt from approval pursuant to 21 U.S.C. § 355(i);
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`

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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 2 of 16
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`b.
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`21 U.S.C. § 331(a), by introducing or delivering, and/or causing to
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`be introduced or delivered, into interstate commerce any article of drug that is
`
`misbranded within the meaning of 21 U.S.C. § 352(f)(1);
`
`c.
`
`21 U.S.C. § 331(k), by causing articles to become misbranded
`
`drugs within the meaning of 21 U.S.C. § 352(f)(1), in that their labeling fails to bear
`
`adequate directions for use, while such articles are held for sale after shipment of one
`
`or more or their components in interstate commerce;
`
`d.
`
`21 U.S.C. § 331(a), by introducing or delivering, and/or causing to
`
`be introduced or delivered, into interstate commerce articles of food (dietary
`
`supplements, as defined at 21 U.S.C. § 321(ff)) that are adulterated within the meaning
`
`of 21 U.S.C. § 342(g)(1); and
`
`e.
`
`21 U.S.C. § 331(k), by causing articles of food (dietary
`
`supplements, as defined at 21 U.S.C. § 321(ff)) to become adulterated within the
`
`meaning of 21 U.S.C. § 342(g)(1), while such articles are held for sale after shipment of
`
`one or more of their components in interstate commerce.
`
`JURISDICTION AND VENUE
`
`2.
`
`This Court has jurisdiction under 21 U.S.C. § 332(a) and 28 U.S.C.
`
`§§ 1331 and 1345.
`
`3.
`
`Venue in this District is proper under 28 U.S.C. § 1391(b) & (c).
`
`DEFENDANTS
`
`4.
`
`Defendant BioAnue Laboratories Inc. (“BioAnue”) is a privately-held
`
`Georgia corporation, incorporated in 2009. The firm has four full-time employees, and
`
`operates from its headquarters located at 123 Wood Tech Drive, Rochelle, Georgia.
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`
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`2
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 3 of 16
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`BioAnue sells products under its own brand names, which include BioAnue and
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`TumoRx.
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`5.
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`Defendant Gloria Raber is BioAnue’s Chief Executive Officer and is
`
`responsible for all operations for the firm.
`
`6.
`
`Defendant Kelly Raber is Defendant Gloria Raber’s husband. Defendant
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`Kelly Raber is the administrator of many of BioAnue’s websites, several of which
`
`contain his photograph and telephone number.
`
`7.
`
`Defendants Gloria Raber and BioAnue lease all of their finished product
`
`formulas from Free Speech Trust, an entity owned by Defendants Gloria Raber and
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`Kelly Raber. Free Speech Trust owns the trademarks for the name BioAnue and four
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`other trademarked names associated with BioAnue: Mender, Tumorx, Dailyzyme, and
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`Med-Anue.
`
`8.
`
`Defendants manufacture, promote, and distribute many products,
`
`including TumoRx Cardio Clean, TumoRx Apoptosis Full Strength, TumoRx Formula
`
`Cx, BioAnue Diabetic Mender, BioAnue Heart Mender, and Bovine Cartilage.
`
`9.
`
`Defendants operate six websites: www.bioanuelabs.com,
`
`www.vmhe.com, www.tumorx.org, www.tumorx.com, www.cancerx.org,
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`www.hopewelltechnoligieslimited.com. Defendants are solely responsible for the
`
`content of these websites.
`
`10. Defendants sell their products to customers through the www.vmhe.com
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`website and telephone orders. Defendants’ other websites provide information about
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`Defendants’ products and a link to www.vmhe.com, where products can be purchased.
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`
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`3
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 4 of 16
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`11. Defendants’ products are available for shipment throughout the country.
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`FDA has completed undercover purchases of Defendants’ products, documenting the
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`shipment of such products from Georgia to Maryland. Additionally, Defendants receive
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`component ingredients for their drugs and dietary supplements from outside Georgia.
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`UNAPPROVED DRUGS
`
`12.
`
`The introduction or delivery for introduction into interstate commerce of an
`
`unapproved new drug violates the Act. 21 U.S.C. § 331(d).
`
`13. Under the Act, a product is a drug if it is “intended for use in the diagnosis,
`
`cure, mitigation, treatment, or prevention of disease.” 21 U.S.C. § 321(g)(1)(B).
`
`Moreover, products (other than food) “intended to affect the structure or any function” of
`
`the human body are drugs within the meaning of 21 U.S.C. § 321(g)(1)(C).
`
`14.
`
`The intended use of a product may be determined from any relevant
`
`source, including labeling. 21 C.F.R. § 201.128.
`
`15.
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`The Act defines labeling as “all labels and other written, printed, or graphic
`
`matter (1) upon any article or any of its containers or wrappers, or (2) accompanying
`
`such article.” 21 U.S.C. § 321(m). The Supreme Court has held that the term
`
`“accompanying” in the second clause of 21 U.S.C. § 321(m) is not restricted to labels
`
`that are on or in the article at issue and that physical attachment to the article is not
`
`necessary. See Kordel v. United States, 335 U.S. 345, 349-50 (1948). Promotional
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`literature constitutes labeling because it is part of an integrated distribution program. Id.
`
`at 350.
`
`16. Defendants promote their products for use as drugs on the websites
`
`www.tumorx.org, www.tumorx.com, www.hopewelltechnologieslimited.com, and
`
`www.cancerx.org. These websites, which only promote products manufactured by
`
`
`
`4
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 5 of 16
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`BioAnue, are part of an integrated distribution scheme for Defendants’ products
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`because they each contain a link to www.vmhe.com from which customers can
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`purchase Defendants’ products. Defendants also promote their products through
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`brochures, which are available upon request.
`
`17. Defendants’ websites and product brochures make many drug claims
`
`about each product demonstrating that the products are to be used in the diagnosis,
`
`cure, mitigation, treatment, or prevention of numerous diseases, including cancer, heart
`
`disease, diabetes, and HIV/AIDS, and/or affect the structure or function of the body.
`
`For example, Defendants make the following claims:
`
`a.
`
`TumoRx Cardio Clean: “[W]ill go into the bloodstream and clean out your
`
`arteries and eliminate high cholesterol . . . .”;
`
`b.
`
`TumoRx Apoptosis Full Strength: The more [TumoRx Apoptis Full
`
`Strength] a person consumes, the more effective its [sic] at ridding he [sic] ridding of
`
`cancer.”;
`
`c.
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`TumoRx Formula Cx: “Metabolic acidosis can be reversed using TumoRx
`
`CX protocol.”;
`
`d.
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`BioAnue Diabetic Mender: “Diabetic Mender can start to control diabetes
`
`for most people within the first 2 capsules of the product. . . [Diabetic Mender] will in
`
`most people control, reverse and repair diabetes.”;
`
`e.
`
`BioAnue Heart Mender: “BioAnue Heart Mender repairs the structure and
`
`function of cells, allowing the body to rebuild and repair the cardiovascular system.”;
`
`
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`5
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 6 of 16
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`f.
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`Bovine Cartilage: “Here’s a list of cancers that have been tested and
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`shown a positive response to Bovine Cartilage: Brain… Breast… Ovarian… Lung…
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`Pancreatic… Kidney”;
`
`18. Based on these claims, and many others found on Defendants’ websites
`
`and brochures, these products and others promoted and distributed by Defendants are
`
`drugs under the Act.
`
`19. Under the Act, a “new drug” may not be introduced or delivered for
`
`introduction into interstate commerce unless FDA has approved a new drug application
`
`(“NDA”) or abbreviated new drug application (“ANDA”) with respect to such drug, or
`
`such drug is exempt from approval under an investigational new drug application
`
`(“IND”). 21 U.S.C. §§ 355(a), (b), (i), and (j).
`
`20. A “new drug” is defined as any drug “the composition of which is such that
`
`the drug is not generally recognized, among experts qualified by scientific training and
`
`experience to evaluate the safety and effectiveness of drugs, as safe and effective for
`
`use under the conditions prescribed, recommended, or suggested in the labeling
`
`thereof.” 21 U.S.C. § 321(p)(1). For a product to be deemed “generally recognized as
`
`safe and effective” (“GRAS/GRAE”), it must have substantial evidence of safety and
`
`effectiveness. 21 U.S.C. § 355(d). If it is an over-the-counter (“OTC”) drug, the product
`
`must comply with a monograph established pursuant to an FDA regulation. 21 C.F.R.
`
`§ 330.1.
`
`21. Defendants’ drugs are “new drugs” as defined by 21 U.S.C. § 321(p)(1),
`
`because they are not generally recognized, among experts qualified by scientific
`
`training and experience to evaluate the safety and effectiveness of drugs, as safe and
`
`
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`6
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 7 of 16
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`effective for use under the conditions prescribed, recommended, or suggested in their
`
`labeling, and do not conform to any monographs.
`
`22.
`
`FDA has searched its records for NDA, ANDA, and IND submissions by
`
`Defendants. Defendants have no such approvals on file from FDA. Moreover,
`
`Defendants’ drugs do not conform to the OTC monograph set forth in 21 C.F.R. § 330.1,
`
`or any other OTC drug monograph. As a result, Defendants’ drugs may not be
`
`distributed legally in interstate commerce.
`
`23. Defendants violate 21 U.S.C. § 331(d) by introducing or delivering for
`
`introduction into interstate commerce unapproved new drugs.
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`MISBRANDED DRUGS
`
`24.
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`The introduction or delivery for introduction into interstate commerce of
`
`any drug that is misbranded violates the Act. 21 U.S.C. § 331(a).
`
`25. Causing articles to become misbranded drugs within the meaning of 21
`
`U.S.C. § 352(f)(1), in that their labeling fails to bear adequate directions for use, while
`
`such articles are held for sale after shipment of one or more of their components in
`
`interstate commerce violates the Act. 21 U.S.C. § 331(k).
`
`26. A drug is misbranded under 21 U.S.C. § 352(f)(1) if its label fails to bear
`
`“adequate directions for use” as defined by 21 C.F.R. § 201.5(a), and it does not fall
`
`within a regulatory exemption from that requirement, 21 C.F.R. §§ 201.100(c)(2),
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`201.115.
`
`27.
`
`“Adequate directions for use” means “directions under which the layman
`
`can use a drug safely and for the purposes for which it is intended.” 21 C.F.R.
`
`§ 201.5(a)
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`
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 8 of 16
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`28. Defendants’ drug products are misbranded under 21 U.S.C. § 352(f)(1)
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`because they lack adequate directions for use and they are not exempt from that
`
`requirement. 21 C.F.R. §§ 201.100(c)(2), 201.115.
`
`29. Because they are unapproved new drugs, as described above,
`
`Defendants’ drugs are not exempt from the requirement for adequate directions for use.
`
`21 C.F.R. §§ 201.100(c)(2), 201.115.
`
`30. Defendants violate 21 U.S.C. § 331(a) by introducing or delivering for
`
`introduction into interstate commerce misbranded drugs.
`
`31. Defendants violate 21 U.S.C. § 331(k) by causing articles to become
`
`misbranded drugs within the meaning of 21 U.S.C. § 352(f)(1), in that their labeling fails
`
`to bear adequate directions for use, while such articles are held for sale after shipment
`
`of one or more of their components in interstate commerce.
`
`ADULTERATED DIETARY SUPPLEMENTS
`
`32.
`
`The introduction or delivery for introduction into interstate commerce of
`
`any food (here, dietary supplements), that are adulterated within the meaning of 21
`
`U.S.C. § 342(g)(1), violates the Act. 21 U.S.C. § 331(a).
`
`33. Causing food (dietary supplements) to become adulterated within the
`
`meaning of 21 U.S.C. § 342(g)(1) while such products are held for sale after shipment
`
`of one or more of their components in interstate commerce violates the Act. 21 U.S.C.
`
`§ 331(k).
`
`34.
`
`The Act defines “dietary supplement” as “a product (other than tobacco)
`
`intended to supplement the diet that bears or contains one or more of the following
`
`dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a
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`dietary substance for use by man to supplement the diet by increasing the total dietary
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 9 of 16
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`intake; or a concentrate, metabolite, constituent, extract or combination of [any of
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`them].” 21 U.S.C. § 321(ff). In addition, a dietary supplement must be “labeled as a
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`dietary supplement.” Id. Dietary supplements are deemed to be “food” under the Act,
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`except for purposes of 21 U.S.C. §§ 321(g) and 350f. Id.
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`35. Defendants’ products are labeled as dietary supplements on their principal
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`display panels, as defined in 21 C.F.R. § 101.1. Furthermore, each of Defendants’
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`products labeled as a dietary supplement contain at least one of the dietary ingredients
`
`specified in 21 U.S.C. § 321(ff).
`
`36.
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`In defining “dietary supplement,” the Act expressly provides that a product
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`that is a dietary supplement may also be a drug if it meets the definition of a “drug”
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`under 21 U.S.C. § 321(g). 21 U.S.C. § 321(ff).
`
`37.
`
`The Act requires dietary supplements manufacturers to operate in
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`compliance with current good manufacturing practice for dietary supplements (“Dietary
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`Supplement cGMP”). 21 U.S.C. § 342(g)(1). Dietary supplements not manufactured,
`
`prepared, packed, or held in conformance with Dietary Supplement cGMP are deemed
`
`to be adulterated. 21 U.S.C. § 342(g)(1). The Dietary Supplement cGMP regulations
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`are set forth at 21 C.F.R. Part 111.
`
`38.
`
`FDA investigators inspected Defendants’ facility on August 14-24, 2012
`
`(the “August 2012 inspection”). The inspection revealed significant deviations from
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`Dietary Supplement cGMP, including, but not limited to, the following:
`
`a.
`
`Failure to implement a system of production and in-process controls that
`
`cover all stages of manufacturing to ensure the quality of the dietary supplement and to
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 10 of 16
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`ensure that the dietary supplement is packaged and labeled as specified in the master
`
`manufacturing record, as required by 21 C.F.R. § 111.60.
`
`b.
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`Failure to prepare a written master manufacturing
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`record for each unique dietary supplement formulation, as required by 21 C.F.R. §
`
`111.205. This practice is insufficient to ensure quality and batch-to-batch uniformity of
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`the dietary supplements;
`
`c.
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`Failure to implement quality control operations in the manufacturing of
`
`dietary supplements in a way that ensures the quality of the dietary supplement and that
`
`ensures the dietary supplement is packaged and labeled as specified in the MMR, as
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`required by 21 C.F.R. § 111.65;
`
`d.
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`Failure to establish specifications for any point, step, or stage in the
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`manufacturing process where control is necessary to ensure the quality of the dietary
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`supplement and to ensure that the dietary supplement is packaged and labeled as
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`specified in the MMR, as required by 21 C.F.R. § 111.70(a), (b), (c), (d), (e), and (g);
`
`e.
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`Failure to prepare a batch production record for each batch of dietary
`
`supplement manufactured, as required by 21 C.F.R. § 111.255;
`
`f.
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`Failure to establish and follow written procedures
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`that specify responsibilities for quality control, as required by 21 C.F.R. § 111.103.
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`During the inspection, FDA investigators observed a total failure of quality control
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`operations to review all monitoring required by the MMR, batch production records, and
`
`manufacturing operations;
`
`g.
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`Failure to prepare a written MMR for each unique formulation of dietary
`
`supplement manufactured, as required by 21 C.F.R. § 111.205;
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 11 of 16
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`h.
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`Failure to conduct at least one appropriate test or examination to verify the
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`identity of any component that is a dietary ingredient, as required by 21 C.F.R.
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`§ 111.75(a)(1)(i); and
`
`i.
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`Failure of quality control personnel to withhold from release for distribution
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`any batch of dietary supplement that does not meet all product specifications as
`
`required by 21 C.F.R. § 111.123(a), in accordance with 21 C.F.R. § 111.70(e).
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`39. As a result of the cGMP violations, the dietary supplements manufactured
`
`by Defendants are adulterated within the meaning of 21 U.S.C. § 342(g)(1).
`
`40. Defendants violate 21 U.S.C. § 331(a) by introducing or delivering for
`
`introduction into interstate commerce articles of food (dietary supplements) that are
`
`adulterated within the meaning of 21 U.S.C. § 342(g)(1).
`
`41. Defendants violate 21 U.S.C. § 331(k) by causing articles of food (dietary
`
`supplements) to become adulterated within the meaning of 21 U.S.C. § 342(g)(1) while
`
`such articles are held for sale after shipment of one or more of their components in
`
`interstate commerce.
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`HISTORY
`
`42. Defendants are well aware that their conduct violates the law and that
`
`continued violations could lead to regulatory action.
`
`43.
`
`In February 2012 FDA reviewed Defendants’ websites and issued to
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`Defendant Gloria Raber and BioAnue a Warning Letter dated February 9, 2012, that
`
`informed Defendant Gloria Raber that she and BioAnue were marketing unapproved
`
`new drugs and introducing into interstate commerce misbranded drugs, in violation of
`
`the Act. See 21 U.S.C. § 331(a) and (d). The Warning Letter identified six products
`
`manufactured, marketed, and distributed by Defendant Gloria Raber and BioAnue that,
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 12 of 16
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`based on their labeling, are unapproved new drugs under the Act. The Warning Letter
`
`specifically outlined the claims observed in Defendants’ online promotional materials. It
`
`also explained that none of the listed products are generally recognized as safe and
`
`effective for the indications listed on their labeling, nor are they the subject of approved
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`NDAs, ANDAs, or INDs. The Warning Letter warned Defendant Gloria Raber and
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`BioAnue that the violations contained in the Warning Letter were not meant to be an all-
`
`inclusive list of deficiencies, and reminded them that it was their responsibility to ensure
`
`that all of their products are in compliance with the laws and regulations enforced by
`
`FDA.
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`44. On March 5, 2012, FDA received a response to its Warning Letter from
`
`counsel representing Defendant Gloria Raber and BioAnue. The letter disclaimed
`
`having any control over the websites identified in the Warning Letter, where claims
`
`about Defendants’ products are made, and denied any wrongdoing.
`
`45. At the close of the August 2012 inspection, FDA investigators met with
`
`Defendant Gloria Raber and presented her with a List of Inspectional Observations
`
`(“FDA Form 483”). At that time, the FDA investigators also informed Defendant Gloria
`
`Raber that Defendants violate the Dietary Supplement cGMP regulations.
`
`46. Defendants’ history of promoting products to cure, mitigate, treat, prevent,
`
`and/or reduce the risk of diseases including, but not limited to, cancer, diabetes,
`
`HIV/Aids, and heart disease and/or affect the structure or function of the body
`
`demonstrates their unwillingness to comply with the Act. Based on Defendants’
`
`conduct, as described above, it is evident that, unless restrained by order of this Court,
`
`Defendants will continue to violate the Act, 21 U.S.C. §§ 331(a), (k), and (d).
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 13 of 16
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`WHEREFORE, Plaintiff respectfully requests that the Court:
`
`I.
`
`Permanently restrain and enjoin, under 21 U.S.C. § 332(a), 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, from doing or causing to be done, any of the following
`
`acts:
`
`A.
`
`Violating 21 U.S.C. § 331(d), by distributing unapproved new drugs
`
`in interstate commerce;
`
`B.
`
`Violating 21 U.S.C. § 331(a), by distributing misbranded drugs in
`
`interstate commerce;
`
`C.
`
`Violating 21 U.S.C. § 331(k), by causing drugs
`
`that Defendants hold for sale after shipment in interstate commerce to become
`
`misbranded;
`
`D. Violating 21 U.S.C. § 331(a), by distributing adulterated dietary
`
`supplements in interstate commerce; and
`
`E. Violating 21 U.S.C. § 331(k), by causing dietary supplements that
`
`Defendants hold for sale after shipment interstate commerce to become adulterated;
`
`II.
`
`Permanently restrain and enjoin, under 21 U.S.C. § 332(a), 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, from promoting and distributing any drug or dietary
`
`supplement unless and until:
`
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 14 of 16
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`A.
`
`An approved new drug application or abbreviated new drug
`
`application pursuant to 21 U.S.C. § 355(a) or (j) is in effect for the product; or
`
`B.
`
`An investigational new drug exemption filed pursuant to 21 U.S.C. §
`
`355(i) is in effect for the product; or
`
`C.
`
`Defendants have removed all claims from their product labels,
`
`labeling, promotional materials, websites owned or controlled by or related to
`
`Defendants, and in any other media that cause that product to be a drug as defined by
`
`the Act;
`
`III.
`
`Permanently restrain and enjoin, under 21 U.S.C.
`
`§ 332(a), Defendants, and each and all of their directors, officers, agents,
`
`representatives, employees, attorneys, successors, and assigns, and any and all
`
`persons in active concert or participation with any of them, from manufacturing,
`
`processing, packing, labeling, holding, and/or distributing dietary supplements, unless
`
`and until Defendants’ methods, facilities, and controls used to manufacture, process,
`
`pack, label, and hold dietary supplements are established, operated, and administered
`
`in conformity with Dietary Supplement cGMP and the Act, in a manner that has been
`
`found acceptable by FDA;
`
`IV. Order that FDA be authorized pursuant to this injunction to inspect
`
`Defendants’ place(s) of business and all records relating to the receipt, manufacture,
`
`processing, packing, labeling, holding, and distribution of any drug or dietary
`
`supplement to ensure continuing compliance with the terms of the injunction, the costs
`
`of such inspections to be borne by Defendants at the rates prevailing at the time the
`
`inspections are accomplished; and
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`14
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 15 of 16
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`That Plaintiff be granted judgment for its costs herein, and that this Court grants
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`such other and further relief as it deems just and proper.
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`This the 29th day of May, 2013.
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`Michael J. Moore
`United States Attorney
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`BY:
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`/s/ William D. Gifford ____________________
`WILLIAM D. GIFFORD
`Assistant U.S. Attorney
`300 Mulberry Street, Suite 400
`Macon, GA 31201
`Phone: (478) 621-2729
`Fax: (478) 621-2737
`Bill.Gifford@usdoj.gov
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`/s/ Gerald C. Kell_______________________
`GERALD C. KELL
`Signature by WDG With Express Permission
`Senior Trial Counsel
`Consumer Protection Branch
`Civil Division
`U.S. Department of Justice
`P.O. Box 386
`Washington, DC 20044
`Phone: (202) 514-1586
`gerald.kell@usdoj.gov
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`15
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`Case 5:13-cv-00188-MTT Document 1 Filed 05/29/13 Page 16 of 16
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`OF COUNSEL:
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`WILLIAM B. SCHULTZ
`Acting General Counsel
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`ELIZABETH H. DICKINSON
`Chief Counsel
`Food and Drug Division
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`ANNAMARIE KEMPIC
`Deputy Chief Counsel
`Litigation
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`JILLIAN WEIN RILEY
`Assistant Chief Counsel for Enforcement
`United States Department of Health and
`Human Services
`Office of the General Counsel
`10903 New Hampshire Ave.
`Silver Spring, MD 20993-0002
`(301) 796-2918
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`16
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