Case 5:13-cv-00188-MTT Document 52 Filed 05/06/21 Page 1 of 5
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE MIDDLE DISTRICT OF GEORGIA
`MACON DIVISION
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`CIVIL ACTION NO. 5:13-CV-188 (MTT)
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`UNITED STATES OF AMERICA,
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`Plaintiff,
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`v.
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`BIOANUE LABORATORIES, INC.,
`GLORIA D. RABER, and KELLY
`RABER,
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`Defendants.
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`ORDER
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`Defendants Gloria Raber and Kelly Raber move to vacate the Court’s Order that
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`permanently restrained and enjoined the defendants from selling any drug or dietary
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`supplement unless and until certain requirements were met. Docs. 27; 48; 49. Based
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`on the arguments in the motion (Doc. 48), a letter to the Court (Doc. 49), and the
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`Government’s response (Doc. 51), the defendants will be allowed an additional
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`opportunity to reply before the Court rules on the motion.
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`On May 29, 2013, the Government filed a complaint for injunctive relief against
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`the defendants, alleging that they violated various provisions of the Federal Food, Drug,
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`and Cosmetic Act (“the Act”) by misbranding and adulterating unapproved new drugs
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`and dietary supplements while selling them in interstate commerce. Doc. 1 ¶ 1(a)-(e)
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`(citing 21 U.S.C. § 331(a), (d), (k)).
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE MIDDLE DISTRICT OF GEORGIA
`MACON DIVISION
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`CIVIL ACTION NO. 5:13-CV-188 (MTT)
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`UNITED STATES OF AMERICA,
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`
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`
`
`Plaintiff,
`
`v.
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`
`BIOANUE LABORATORIES, INC.,
`GLORIA D. RABER, and KELLY
`RABER,
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`Defendants.
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`ORDER
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`Defendants Gloria Raber and Kelly Raber move to vacate the Court’s Order that
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`permanently restrained and enjoined the defendants from selling any drug or dietary
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`supplement unless and until certain requirements were met. Docs. 27; 48; 49. Based
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`on the arguments in the motion (Doc. 48), a letter to the Court (Doc. 49), and the
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`Government’s response (Doc. 51), the defendants will be allowed an additional
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`opportunity to reply before the Court rules on the motion.
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`
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`On May 29, 2013, the Government filed a complaint for injunctive relief against
`
`the defendants, alleging that they violated various provisions of the Federal Food, Drug,
`
`and Cosmetic Act (“the Act”) by misbranding and adulterating unapproved new drugs
`
`and dietary supplements while selling them in interstate commerce. Doc. 1 ¶ 1(a)-(e)
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`(citing 21 U.S.C. § 331(a), (d), (k)).
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`Case 5:13-cv-00188-MTT Document 52 Filed 05/06/21 Page 2 of 5
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`On July 23, 2014, the Court granted the Government’s motion for summary
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`judgment. Doc. 26. The Court concluded that (1) the defendants violated the Act
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`because their products are “new drugs” that have not been approved by the Food and
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`Drug Administration (“FDA”) and are not generally recognized as safe and effective; (2)
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`even if the products were dietary supplements rather than drugs, the defendants “still
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`have violated the law by not adhering to FDA regulations in their manufacturing process
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`and causing their food products to become ‘adulterated;’” and (3) Defendant Kelly
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`Raber acted in concert with BioAnue Laboratories, Inc. and Gloria Raber when
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`formulating BioAnue products. Id. at 12, 15.
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`The Court also entered an Order that permanently enjoined the defendants from
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`selling any drug or dietary supplement unless and until certain requirements were met.
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`Doc. 27 ¶ 8. These requirements are listed in Paragraph 8 of the Injunction. Id. ¶ 8(A)-
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`(J). For the purposes of this Order, the Court quotes in full the language in Paragraph 8
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`that precedes ¶ 8(A)-(J):
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`“Upon entry of this Order, Defendants, and each and all of their directors,
`officers, agents, representatives, employees, attorneys, successors,
`assigns, and any and all person in active concert or participation with any
`of them who receive actual notice of this Order by personal service or
`otherwise (collectively, “Associated Persons”), are permanently restrained
`and enjoined under 21 U.S.C. § 332(a) from introducing or delivering for
`introduction, and/or causing to be introduced or delivered for introduction,
`into interstate commerce any drug or dietary supplement unless and
`until…”
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`Id. ¶ 8.
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`The defendants argue that they have been in “full compliance” with the Injunction
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`for seven years and that their circumstance has “changed greatly.” Doc. 48 at 2. As
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`part of their changed circumstance, the defendants wanted to open an online store to
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`- 2 -
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`Case 5:13-cv-00188-MTT Document 52 Filed 05/06/21 Page 3 of 5
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`resell dietary supplements that they did not manufacture. Id. at 3. When the
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`defendants asked for permission to pursue this new venture, the FDA said they were
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`“prohibited from buying dietary supplements and reselling to the public.” Id. In a letter
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`to the Court, the defendants say they “fully understand” that they “must comply with the
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`FDA’s most current policies” if they want to resume manufacturing dietary supplements.
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`Doc. 49. But the defendants “do not understand … why [they are] banned from selling
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`dietary supplements that are already on the market—products manufactured and sold
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`by other FDA-registered companies.” Id. at 1. Specifically, they question “[w]hy [they
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`are] prohibited from buying a dietary supplement as a wholesaler and selling that
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`product to consumers [on their] online health food store.” Id.
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`The Government argues that “the Injunction is necessary to ensure [the
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`defendants] and any new business continues to follow the laws that [the] Court found
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`that [they] had previously violated.” Doc. 51 at 2. The Government further argues that
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`the defendants “ignore[] the fact that the underlying statute and regulations, which the
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`Injunction enforced, apply to [their] proposed new business.” Id. at 6. The defendants,
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`according to the Government, “must first comply with the terms of the Injunction before
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`any proposed new business activity involving the distribution of dietary supplements in
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`interstate commerce may occur.” Id. The terms include “the sale of third-party
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`produced dietary supplements” because “[d]istributing dietary supplements, even if
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`manufactured by a third party, is still ‘introducing’ supplements ‘into interstate
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`commerce.’” Id.
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`- 3 -
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`Case 5:13-cv-00188-MTT Document 52 Filed 05/06/21 Page 4 of 5
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`The Government points to two sets of requirements of the Injunction and the
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`Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., that the
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`defendants’ proposed new venture must satisfy.
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`First, they argue that the proposed business must comply with the Dietary
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`Supplement cGMP requirements of the Injunction and the FDCA. Id. at 7-8. The
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`Government argues that 21 C.F.R. § 111.1 applies to the defendants’ new business
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`because it “would ‘hold’ supplements when it receives them from the manufacturer and
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`then distribute[] them to consumers through interstate commerce.” Id. at 7. Further, the
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`Government says that the defendants would have to “maintain a control system that is
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`designed to ensure supplements are held in a manner that will ensure the quality of the
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`supplement.” Id. (citing 21 C.F.R. § 111.60). Additionally, the Government argues that
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`the defendants “must establish and follow written procedures for quality control as
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`required under 21 C.F.R. Part 111, Subpart F (beginning at § 111.103).” Id. And the
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`Government says that because of the defendants’ previous violations, the Injunction
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`requires an expert to confirm the defendants’ compliance with the Dietary Supplement
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`cGMP regulations. Id. at 8.
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` Second, the Government argues that the defendants’ proposed business must
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`conform to the labeling requirements of the Injunction and the FDCA. Id. at 8-10. The
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`Government argues that the FDCA misbranding provisions “would still apply to [the
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`defendants’] proposed new business” because “[u]nder the FDCA, labeling is not limited
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`to statements by the manufacturer, but can include statements made by any entity
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`introducing the product into interstate commerce.” Id. at 9. (citing 21 U.S.C. § 321(m);
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`Krobel v. United States, 335 U.S. 345, 349-50 (1948)). According to the Government,
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`Case 5:13-cv-00188-MTT Document 52 Filed 05/06/21 Page 5 of 5
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`“[a]ny statements that [the defendants] make[] regarding the dietary supplements that
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`[they] distribute[]—whether [they] or someone else manufactures them—are ‘labeling’
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`and must comply with the FDCA.” Id. Finally, like the Dietary Supplement cGMP
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`regulations, the Government argues that “an expert remains necessary to review any
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`claims made by [the defendants] about the supplement—regardless of who
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`manufactures them.” Id.
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`The defendants did not reply to the Government’s response. Specifically, they
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`make no effort to show how their new venture will conform to the relevant regulations.
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`Doc. 49 at 1. Therefore, within 30 days, the defendants must submit documentation to
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`the Court that details how their proposed new business will comply with the relevant
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`FDA regulations.1
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`SO ORDERED, this 6th day of May, 2021.
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`S/ Marc T. Treadwell
`MARC T. TREADWELL, CHIEF JUDGE
`UNITED STATES DISTRICT COURT
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`1 The parties make other arguments in the motion to vacate (Doc. 48) and the response (Doc. 51) that the
`Court will also address in a separate Order.
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