http:\/\/www.healthfreedomusa.org\/?p=4790<\/a><\/p>\nAnd here is the Complaint as filed:<\/p>\n
United States District Court for the
\nDistrict of Columbia<\/p>\n
——————————————————–<\/p>\n
Holistic Candlers and Consumers Association
\nNatural Solutions Foundation
\nFoundation for Health Choice
\nHarmony Cone
\nKing Cone
\nC and H Ranch
\nBeck Naturals
\nFarist Enterprises,
\nGarden of Eden Reflexology & Skin Care
\nSo Fine Distribution Regalabs
\nWholistic Health Solutions
\nJohn and Jane Doe
\n Plaintiffs,<\/p>\n
\tv.<\/p>\n
U.S. Food and Drug Administration
\nKathleen Sebelius,
\nin her official capacity as Secretary of
\nHealth and Human Services,
\nU.S. Department of Health and Human Services
\nMargaret A. Hamburg, MD,
\nin her official capacity as
\nCommissioner of Food and Drugs
\n Defendants.
\n——————————————————–<\/p>\n
COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF<\/p>\n
I. INTRODUCTION<\/p>\n
1. This action involves a case or controversy in which the Court is empowered to declare the lawfulness, or lack thereof, of certain official actions of the named Defendants and to grant injunctive and other relief.<\/p>\n
2. Plaintiffs in this action, as more fully set forth below, are several nongovernmental organizations and private associations that advocate natural alternatives to government-licensed health care (herein, the NGOs), various natural product manufacturers, distributors, practitioners and consumers who are all members of the NGOs.<\/p>\n
3. This Civil Action seeks to challenge the recent actions of Defendants which effectively outlaw the manufacture and use of Holistic Candles (sometimes also referred to as \u201cEar Candles\u201d) as unapproved Medical Devices under the Safe Medical Devices Act, as amended, 21 U.S.C. 321.<\/p>\n
Plaintiff asserts and claims that the Holistic Candle is a generic product that is exempt from defendant FDA\u2019s device regulation requirements. <\/p>\n
4. This Court is not being asked to merely interpose its august authority between the Plaintiffs and Federal Executive authority, but to fashion appropriate remedies that will advance natural and personal health care options in the United States and reduce adverse events. Plaintiffs seek a Declaratory Judgment and a Permanent Injunction protecting important judiciable interests of the Plaintiffs and all Americans. <\/p>\n
5. Plaintiffs seek, in part, Remedies fashioned under the logic of Thompson v. Western States Medical Center (535 U.S. 357, 2002). This First Amendment case concerns a clause in the Food, Drug and Cosmetics Act that allowed pharmacists to “compound” medications for specific prescriptions without safety testing, but forbade pharmacists from advertising the specific compounds they make. The Supreme Court held that the statutory restriction was unconstitutional, stating, <\/p>\n
“We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. \u2026Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown.” <\/p>\n
6. Thus, one of the Remedies Plaintiffs seek is that proper Disclosure and Disclaimers be given with regard to Holistic Candles, to save them from being considered Medical Devices. Plaintiffs contend, (1) Holistic Candles are not Medical Devices under 21 U.S.C. 321; (2) in the alternative, if Holistic Candles are Medical Devices then they are exempt from registration as Class I Devices and (3) in the alternative, if Holistic Candles are not exempt Class I Devices, they are Grandfathered as having been in use prior to 1974. A Brief History of Holistic or Ear Candling is attached hereto as Exhibit A.<\/p>\n
7. Plaintiffs further seek a mandate from this Court that the Defendants shall cease to claim that Holistic Candles are unapproved Medical Devices. Plaintiffs allege there is no significant scientific agreement that they are used for Medical Treatment. To the contrary, Holistic Candles are traditionally used for holistic relaxation and comfort. <\/p>\n
8. The Defendants are bound by the Data Quality Act to produce and disseminate only truthful information to the people of the United States. They have woefully failed in that duty and are thereby harming these Plaintiffs. The Court should therefore act with judicious restraint to fashion a permanent injunction that requires only truthful and not misleading public health care advice and information from these Defendants regarding Holistic Candling. The impact of the Defendants\u2019 actions, based on these Defendants\u2019 unlawful categorization of Holistic Candles as \u201cMedical Devices\u201d puts these Plaintiffs at imminent risk of loss of income or other valuable rights. <\/p>\n
II. STATEMENT OF THE CASE<\/p>\n
9. The Complaint in this matter involves the February 2010 Warning Letters issued by the Defendant Food and Drug Administration (herein, FDA) to fifteen Holistic Candle Companies (herein the Mandated Companies) ordering them to cease and desist from distributing Holistic Candles as they have been determined to be unapproved Medical Devices. In discussions thereafter with the Mandated Companies agents of the FDA indicated that, contrary to the holding in Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), rehearing denied 172 F.3d 72 (1999), there is no Disclaimer or Disclosure that the Mandated Companies could make that would save Holistic Candles from being banned.<\/p>\n
III. JURISDICTION AND RIPENESS<\/p>\n
10. This Court has jurisdiction over this action pursuant to 28 U.S.C. \u00a7 1331 (federal question) and 28 U.S.C. \u00a7 1361 (mandamus). The relief requested is authorized pursuant to 28 U.S.C. \u00a7 1651 (all writs act); 28 U.S.C. \u00a7 2201 (declaratory relief); and 28 U.S.C. \u00a7 2202 (further relief). Plaintiffs have a right to bring this action pursuant to the Administrative Procedures Act because the Defendants, including the FDA, have engaged in final agency actions that \u201care contrary to law\u201d (in the language of the Administrative Procedures Act – APA) presenting actual controversies for which these Plaintiffs are entitled to relief. Venue is proper in this district pursuant to 28 U.S.C. \u00a7 1391(e) because this is a civil action in which at least one of the Defendants is an officer of the United States that resides in this judicial district or an agency of the United States that resides in this judicial district. <\/p>\n
11. This matter is ripe for adjudication as the fifteen-day period that the Mandated Companies were given to cease and desist has expired without extension.<\/p>\n
IV. STANDING<\/p>\n
12. The Plaintiffs are all nongovernmental organizations and individual United States citizens who are members or supporters of the organizations and who are manufacturers, distributors, consumers or other users of Holistic Candles. The specific harm which the individual Plaintiffs will suffer as a result of the FDA actions complained of herein are set forth in this Verified Complaint and in the Plaintiffs\u2019 Declarations which are included herein as though fully set forth. <\/p>\n
13. Plaintiffs therefore have standing to challenge the defendant\u2019s determination that Holistic Candles are unapproved Medical Devices.<\/p>\n
14. These Plaintiffs stand in imminent peril of risk of health or life, loss of liberty, property, livelihood or licensure, or other public. Thus, they have been harmed by the acts of the Defendants.<\/p>\n
V. PARTIES<\/p>\n
15. Plaintiffs in this action are several nongovernmental organizations and private associations that advocate natural alternatives to government-licensed health care (herein, the NGOs), various natural product manufacturers (the Mandated Companies), distributors, practitioners and consumers who are all members of the NGOs.<\/p>\n
(a) Holistic Candlers and Consumers Association by Ralph Fucetola JD, 58 Plotts Road, Newton, NJ 07860, its trustee in formation, is an unincorporated private association of holistic candle manufacturers, distributors, practitioners and consumers.<\/p>\n
(b) Natural Solutions Foundation by Ralph Fucetola JD, 58 Plotts Road, Newton, NJ 07860, its trustee, is a Nevada nonprofit corporation duly recognized as an exempt nongovernmental organization which educates the public and decision makers regarding natural approaches to health; the Foundation provides Holistic Candles to its private associates through its web site.<\/p>\n
(c) Foundation for Health Choice [describe]<\/p>\n
(d) The holistic candle manufacturers and distributors listed as parties plaintiff are all enterprises which have, in some cases prior to 1974, manufactured or distributed holistic candles, with varying claims, and all have received cease and desist letters from the FDA during February, 2010.<\/p>\n
(e) J. Doe, representing all other consumers who wish to continue to use Holistic Candles.<\/p>\n
16. The Defendants are all United States Agencies and Officials: United States Food and Drug Administration [10903 New Hampshire Ave. Silver Spring, MD 20993], Kathleen Sebelius, Secretary of Health and Human Services [200 Independence Avenue, S.W. Washington, D.C. 20201], Department of Health and Human Services [200 Independence Avenue, S.W.. Washington, D.C. 20201], Margaret A. Hamburg, MD, Commissioner of the Food and Drug Administration [10903 New Hampshire Ave. Silver Spring, MD 20993.<\/p>\n
COUNT ONE<\/p>\n
17. On or about February 22, 2010, each Mandated Company received a letter from the FDA dated on or about February 17, 2010 announcing the FDA\u2019s determination that Holistic Candles are, per se, unapproved Medical Devices and cannot be sold in the United States and in the several States. The FDA determination was made without the prior petition of Citizens and without an FDA Request for Comments. The letter requested a reply within 15 days setting forth what the Mandated Companies would do to conform to the FDA determination. <\/p>\n
\t18. Plaintiffs deny the contention of the FDA that the holistic relaxation and comfort products, sometimes known as \u201cear candles\u201d (herein, the \u201cHolistic Candles\u201d) are \u201cmedical devices.\u201d A device is defined via 21 U.S.C. \u00a7 321:<\/p>\n
(h) The term “device” (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is \u2013 <\/p>\n
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, <\/p>\n
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or<\/p>\n
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.<\/p>\n
\t19. Holistic Candles are not medical devices. Properly made Holistic Candles are a natural holistic modality are used for and intended to be used for relaxation, comfort, reduction of stress and for the natural furtherance of the well-being of the user. The relaxation process, from the viewpoint of any alternative health modality, is for the fostering of and the support for the human body\u2019s own propensity to spontaneously seek natural homeostasis, via relaxed and stress-reducing circumstances, catalysts, or environments. <\/p>\n
\t20. Such traditional and intended use, usually in a family or private association context, does not \u201ctreat or cure\u201d any condition of illness, and does not specifically affect any body function. Alternative modalities simply allow the body to do what the human body does naturally, and that is to find a proper and necessary balance between the integrated components of the mind-body-spirit. This, in essence, is what homeostasis is.<\/p>\n
\t21. As such, homeostasis is the natural human biologic\/physiologic\/emotional balancing activity that is necessary for optimum health (and life), as we know and understand it. This natural human process can also be assisted by a variety of non-medical, environmental, alternative, or holistic modalities. Thus, human homeostasis is the natural tendency to seek and obtain a stable equilibrium between interdependent elements. Such modalities that relax the body to allow it to achieve homeostasis are not \u201cthe treatment of disease\u201d but, rather, they create relaxation that allows the body to achieve metabolic equilibrium actively that is maintained by several complex biological mechanisms that operate via the autonomic nervous system to offset disrupting changes.<\/p>\n
\t22. Holistic therapies foster the user’s sense of comfort and well-being and focuses upon health promotion, balance, comfort, and the ability to draw upon one\u2019s own healing capacities (i.e.: homeostasis). Consequently, many of the alternative modalities and holistic systems have been in existence and use throughout human history, and are an integral part of cultures, customs and traditions. The beneficial claims are permitted Traditional Use claims.<\/p>\n
\t23. The use and effectiveness of such therapy have been well established and legitimized by using or integrating holistic methodology and techniques in modern practices. Additionally, natural healing, as we know it, does not equate to effecting a \u201ccuring,\u201d rather it creates relaxation that allows the body to reach homeostasis which on some occasions might allow the body to \u201cheal\u201d or rebalnce some aspect of itself. <\/p>\n
\t24. But, presuming that Holistic Candles may be medical devices, they would be nothing but generic \u201cClass I Devices.\u201d An ear candle \u201c(I) is not represented to be and is not used to support or sustain human life and the product is not used for the purpose of preventing other impairments or risks to human health. Plaintiff’s products (II) do not present a potential unreasonable risk of illness or injury.” See \u00a7 360c(a)(1)(A). <\/p>\n
25. There have been, at most, three FDA adverse events reported in recent decades that specifically involve the use of ear candles.<\/p>\n
\t26. Under 21 U.S.C. \u00a7 379a, FDCA presumes jurisdiction for any actions taken by FDA: \u201cIn any action to enforce the requirements of this chapter respecting a device, food, drug, or cosmetic[,] the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist.\u201d The exercise of FDA regulatory power under this statutory provision is unconstitutional because the regulatory power belongs to the several States and to the people respectively as secured by the 10th Amendment to the U.S. Constitution. This principle was expressed very early during the days of the creation of this country by Federalist No. 45: <\/p>\n
“The powers delegated by the proposed Constitution to the Federal Government, are few and defined. Those which are to remain in the State Governments are numerous and indefinite. The former will be exercised principally on external objects, as war, peace, negotiation and foreign commerce; with which last the power of taxation will for the most part be connected. The powers reserved to the several States will extend to all the objects, which, in the ordinary course of affairs, concern the lives, liberties and properties of the people; and the internal order, improvement, and prosperity of the State.”<\/p>\n
\t27. To enforce certain portions of the FDCA, the FDA must use procedures and take actions that ultimately lead to federal courts. Defendants have threatened to commence an action to seize and confiscate Plaintiff’s property, to restrain Plaintiffs from marketing, promoting and distributing ear candle products, and to obtain pecuniary penalties against Plaintiffs. Defendants knew or should have known that 21 U.S.C. \u00a7 379a, enforced without appropriate procedures, is an unconstitutional exercise of power. <\/p>\n
\t28. Furthermore, federal law prohibits a federal agency from acting outside the jurisdiction delegated to it. See 5 U.S.C. \u00a7558. Defendants knew or should have known that they were acting outside of the agency\u2019s jurisdiction were committing and threatening to commit ultra vires acts against the Plaintiffs.<\/p>\n
\t29. By statute, the regulatory jurisdiction of the FDA extends to two distinct areas. Pursuant to 21 U.S.C. \u00a7331(g), the FDA can regulate and control the \u201cmanufacture within any Territory of any food, drug, device, or cosmetic that is adulterated or misbranded.\u201d Via 21 U.S.C. \u00a7 331(a), (b), (c), and (d), the FDA has jurisdiction over the following:<\/p>\n
(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.
\n(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.
\n(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
\n(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 355, or 360bbb-3 of this title.<\/p>\n
Plaintiffs products do not fall within the scope and purview of a device under the relevant laws of the United States and the products were not adulterated, misbranded or mislabeled.<\/p>\n
\t30. Thus those parts of the FDCA that concern the manufacture of “devices” only relate to the manufacturing of devices in U.S. territories, which is within the scope of 21 U.S.C. \u00a7331(g). Defendants knew or should have known that the FDA cannot constitutionally or statutorily regulate the manufacture of devices within the jurisdiction of any particular State of the Union. <\/p>\n
\t31. In its letters, FDA capriciously contends that the Mandated Companies have distributed adulterated devices by making ear candles available for purchase. The specific criteria for what constitutes an adulterated device are set forth as follows in 21 U.S.C. \u00a7 351: <\/p>\n
A drug or device shall be deemed to be adulterated \u2013
\n(a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture
\n(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or
\n(2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or
\n(3) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
\nor
\n(4) if (A) it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 379e(a) of this title, or (B) it is a color additive the intended use of which in or on drugs or devices is for purposes of coloring only and is unsafe within the meaning of section 379e(a) of this title; or <\/p>\n
Plaintiffs do not manufacture and distribute adulterated products and FDA had no adverse events reports or other substantive evidence to show that Plaintiffs had in fact manufactured or distributed adulterated products.<\/p>\n
\t32. In its letters, the FDA also contends that the Mandated Companies have distributed misbranded devices by making ear candles available for purchase. The statutory criteria for misbranded devices are set forth in 21 U.S.C. \u00a7 352: <\/p>\n
A drug or device shall be deemed to be misbranded \u2014
\n(a) False or misleading label \u2014 If its labeling is false or misleading in any particular.
\n(b) Package form; contents of label \u2014 If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count:
\n(c) Prominence of information on label \u2014 If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
\n(d) Repealed.
\n(e) Designation of drugs or devices by established names.
\n* * *
\n(2) If it is a device and it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name (as defined in subparagraph (4)) prominently printed in type at least half as large as that used thereon for any proprietary name or designation for such device, except that to the extent compliance with the requirements of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary.
\n* * *
\n(4) As used in subparagraph (2), the term “established name” with respect to a device means (A) the applicable official name of the device designated pursuant to section 358 of this title, (B) if there is no such name and such device is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this subparagraph applies, then any common or usual name of such device.
\n(f) Directions for use and warnings on label \u2014 Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, except that where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement.
\n(j) Health-endangering when used as prescribed \u2014 If it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.
\n(k) Repealed.
\n(l) Repealed.
\n(m) Color additives; packing and labeling \u2014 If it is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive, as may be contained in regulations issued under section 379e of this title.
\n(o) Drugs or devices from nonregistered establishments \u2014 If it was manufactured, prepared, propagated, compounded, or processed in an establishment in any State not duly registered under section 360 of this title, if it was not included in a list required by section 360(j) of this title, if a notice or other information respecting it was not provided as required by such section or section 360(k) of this title, or if it does not bear such symbols from the uniform system for identification of devices prescribed under section 360(e) of this title as the Secretary by regulations requires.
\n(q) Restricted devices using false or misleading advertising or used in violation of regulations \u2014 In the case of any restricted device distributed or offered for sale in any State, if (1) its advertising is false or misleading in any particular, or (2) it is sold, distributed, or used in violation of regulations prescribed under section 360j(e) of this title.
\n(r) Restricted devices not carrying requisite accompanying statements in advertisements and other descriptive printed matter \u2014 In the case of any restricted device distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that device (1) a true statement of the device’s established name as defined in subsection (e) of this section, printed prominently and in type at least half as large as that used for any trade or brand name thereof, and (2) a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications and, in the case of specific devices made subject to a finding by the Secretary after notice and opportunity for comment that such action is necessary to protect the public health, a full description of the components of such device or the formula showing quantitatively each ingredient of such device to the extent required in regulations which shall be issued by the Secretary after an opportunity for a hearing. Except in extraordinary circumstances, no regulation issued under this paragraph shall require prior approval by the Secretary of the content of any advertisement and no advertisement of a restricted device, published after the effective date of this paragraph shall, with respect to the matters specified in this paragraph or covered by regulations issued hereunder, be subject to the provisions of sections 52 through 55 of title 15. This paragraph shall not be applicable to any printed matter which the Secretary determines to be labeling as defined in section 321(m) of this title.
\n(s) Devices subject to performance standards not bearing requisite labeling \u2014 If it is a device subject to a performance standard established under section 360d of this title, unless it bears such labeling as may be prescribed in such performance standard.
\n(t) Devices for which there has been a failure or refusal to give required notification or to furnish required material or information \u2014 If it is a device and there was a failure or refusal (1) to comply with any requirement prescribed under section 360h of this title respecting the device, (2) to furnish any material or information required by or under section 360i of this title respecting the device, or (3) to comply with a requirement under section 360l of this title.
\n(u) Identification of manufacturer.
\n(1) Subject to paragraph (2), if it is a reprocessed single-use device, unless it, or an attachment thereto, prominently and conspicuously bears the name of the manufacturer of the reprocessed device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer.
\n(2) If the original device or an attachment thereto does not prominently and conspicuously bear the name of the manufacturer of the original device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, a reprocessed device may satisfy the requirements of paragraph (1) through the use of a detachable label on the packaging that identifies the manufacturer and is intended to be affixed to the medical record of a patient.
\n(v) Reprocessed single-use devices \u2014 If it is a reprocessed single-use device, unless all labeling of the device prominently and conspicuously bears the statement “Reprocessed device for single use. Reprocessed by ____.” The name of the manufacturer of the reprocessed device shall be placed in the space identifying the person responsible for reprocessing.<\/p><\/blockquote>\n
Plaintiffs did not misbrand products and FDA had no adverse events reports or other substantive evidence that Plaintiffs had and intended to manufacture or distributed misbranded products. <\/p>\n
\t33. Holistic Candles are not misbranded and consequently not violative of \u00a7 352. Following the various subsections of \u00a7 352, the reasons why Holistic Candles are not misbranded are:
\n\t(a) False or misleading label \u2014 The labels are not false or misleading.
\n\t(b) Package form; contents of label \u2014 Holistic Candles contain the proper contents for the labels.
\n\t(c) Prominence of information on label \u2014 The required information is prominently displayed.
\n\t(e) Designation of drugs or devices by established names \u2014 The common name for the Holistic Candles, \u201cholistic candles,\u201d appears on the label.
\n\t(f) Directions for use and warnings on label \u2014 There are directions for the use of ear candles.
\n\t(m) Color additives; packing and labeling \u2014 There is no coloring added to the ear candles.
\n\t(o) Drugs or devices from nonregistered establishments \u2014 It is contended that this requirement is unconstitutional as discussed below.
\n\t(q) Restricted devices using false or misleading advertising or used in violation of regulations \u2014 The Holistic Candles are not restricted devices.
\n\t(r) Restricted devices not carrying requisite accompanying statements in advertisements and other descriptive printed matter \u2014 The Holistic Candles are not restricted devices.
\n\t(s) Devices subject to performance standards not bearing requisite labeling \u2014 The Holistic Candles are not subject to any performance standard.
\n\t(t) Devices for which there has been a failure or refusal to give required notification or to furnish required material or information \u2014 The procedures required by \u00a7 360h have not yet occurred, and the ear candles do not present an unreasonable risk of harm (substantial or otherwise); since the Mandated Companies are not manufacturers or importers of such \u201cdevices\u201d, \u00a7 360i does not apply; and finally, the procedures set forth in \u00a7360l have not occurred, and the Mandated Companies are not manufacturers to which this section would apply.
\n\t(u) Identification of manufacturer \u2014 The ear candles are not reprocessed single-use device.
\n\t(v) Reprocessed single-use devices \u2014 The Ear Candles are consumed by use and incapable of being re-used.<\/p>\n
\t34. As noted above, some of the alleged requirements imposed by FDA upon Plaintiffs products, and as set forth in \u00a7 352 (o) are unconstitutional.<\/p>\n
\t35. 21 U.S.C. \u00a7 352 (o) imposes requirements based on \u00a7 360 that mandate registration of manufacturers in any State. Section 360 provides:<\/p>\n
21 U.S.C. \u00a7 360: Registration of producers of drugs or devices.
\n(b) Annual registration.
\nOn or before December 31 of each year every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs or a device or devices shall register with the Secretary his name, places of business, and all such establishments.
\n(c) New producers. Every person upon first engaging in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs or a device or devices in any establishment which he owns or operates in any State shall immediately register with the Secretary his name, place of business, and such establishment.<\/p><\/blockquote>\n
Defendants knew or reasonably should have known that Congress was not vested with power to regulate production within any of the several States of the Union and that the assertion of regulatory powers by the FDA against Plaintiffs was unconstitutional.<\/p>\n
\t36. Defendants knew or should have known that the statutory definition of “device” was so vague and ambiguous that it would allow FDA to exercise arbitrary powers against Plaintiffs that were intended to completely and permanently take away and destroy the livelihood of Plaintiffs, and prohibit each of the Plaintiffs from using, enjoying and disposing of their property in a lawful manner. <\/p>\n
\t37. 21 U.S.C. \u00a7 352 (o) also imposes requirements based on \u00a7 360(j), which adopts the requirements of \u00a7\u00a7 351, 352, 360, and 360i. Section 360i requires reports of certain incidences pursuant to regulations adopted by the Secretary which, via subparagraph (a)(1)(B)(i), \u201cshall be submitted in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations)\u201d. However, the reporting requirement regulations that appear in 21 C.F.R. Part 803 have not been assigned and do not display OMB control numbers as required by 44 U.S.C. \u00a7\u00a7 3501, et. seq. For the consequences of the failure of a regulation that is an \u201cinformation collection request\u201d but does not display an OMB control number. <\/p>\n
\t38. 21 U.S.C. \u00a7 352 (o) also imposes requirements based on \u00a7 360(k), which provides that \u201cno State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement \u2014 (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.\u201d <\/p>\n
Defendants knew or reasonably should have known that the same said statute is in contravention to the separation of powers mandated by the Constitution for the United States of America, Amendment 10.<\/p>\n
\t39. 21 U.S.C. \u00a7 352 (o) also imposes requirements based on \u00a7 360e, which concerns premarket approvals. <\/p>\n
Defendants knew or should have known that Plaintiffs products were not subject to and were immune from FDA premarket approval requirements.<\/p>\n
\t40. Defendants contend and administratively allege that the Mandated Companies have violated the FDCA because of claims made about ear candles and demands that Plaintiffs remove any reference to their product on their Internet web sites. <\/p>\n
Defendants knew or should have known that their demand made upon Plaintiffs to cease and desist from communicating with others about their products was in violation of Plaintiff’s right to free speech as secured and protected by the Constitution for the United States of America, Amendment 1.<\/p>\n
\t41. Wherefore the Mandated Companies and the distributors, practitioners and consumers who depend upon Plaintiffs for relevant information, manufacturing, distribution and proper and safe use of Holistic Candles, are not in violation of the FDCA and ought to be free from arbitrary and capricious interference by the named Defendants and FDA.<\/p>\n
Requests for Relief<\/p>\n
42. Wherefore, the Plaintiffs herein petition this Honorable Court for an opportunity to be heard on an application for injunctive relief, binding upon the Defendants, and all subordinate agents and agencies thereof, restraining the Commissioner et al., until further Order of the Court, (1) staying the unapproved Medical Device determination under 21 USC 321; (2) a Declaration that the said determination is void; (3) an order that the judicial determination voiding the FDA action is contingent upon clear Disclaimers and Disclosures mandating informed consent and voluntary use of Holistic Candles solely as a traditional use holistic relaxation and comfort modality, and not as a \u201ctreatment of disease\u201d or other Medical Device use, so that the citizens\u2019 First and Fourteenth Amendment and other rights shall be preserved, and (4) for such other and further relief to which the Plaintiffs may be entitled. <\/p>\n
COUNT TWO<\/p>\n
43. The Plaintiffs re-allege and repeat all of the allegations in Counts One through Three as though fully set forth herein.<\/p>\n
\t44. Plaintiffs or some of them use Holistic Candles as part of the ordinary activities of their religion, or as part of private expressive association activities.<\/p>\n
45. Defendants administrative acts and threats of action discriminate against those observing particular religious beliefs or private associational beliefs, customs and traditions. <\/p>\n
46. Some users of Plaintiff’s products have such deep convictions that include a belief in and use of natural alternative modalities such as Holistic Candling. The right to said lawful use of Plaintiff’s products is protected by the Religious Freedom Restoration Act of 1993. 42 U.S.C. \u00a7 2000bb<\/p>\n
47. Based upon the foregoing liberty and secured rights, the FDA determination to outlaw Holistic Candles can and would impose arbitrary burdens upon these religious or private associational beliefs in violation of the Free Exercise Clause.<\/p>\n
Request for Relief<\/p>\n
48. Wherefore, the Plaintiffs request on this Count, in addition to the relief sought in the previous Count, a Declaratory Judgment that does not limit the rights of Plaintiffs to manufacture, distribute, use or consume Holistic Candles on private associational or religious grounds. <\/p>\n
COUNT THREE<\/p>\n
49. The Plaintiffs re-allege and repeat all of the allegations in Counts One through Three as though fully set forth herein.<\/p>\n
50. Defendants have violated Plaintiffs\u2019 Ninth Amendment rights that have been left to the people individually.<\/p>\n
51. The Ninth Amendment\u2019s protection of fundamental rights includes private rights to communicate about, obtain, use and enjoy natural, alternative, choices that are inherent in man’s natural tendency to seek and obtain a stable equilibrium between interdependent elements. <\/p>\n
52. Defendants knew or should have known that their administrative actions would abrogate the liberty and rights of the people as secured by the Constitution for the United States of America, Amendment 9.<\/p>\n
Request for Relief<\/p>\n
53. Wherefore, the Plaintiffs request the determination and order of this Court, in addition to the relief sought in the previous Counts, a Declaratory Judgment that the FDA determination that Holistic Candles are unapproved Medical Devices violates their Ninth Amendment rights.<\/p>\n
Dated: April 9, 2010 <\/p>\n
_____________________________
\nJames S. Turner, Esq.
\nSwankin & Turner
\nAttorneys for Plaintiffs
\n1400 16th Street, NW, Suite 101
\nWashington, DC 20036
\nPhone: (202) 462-8800
\nFax: (202) 265-6564
\nDC Bar #082479 \t <\/p>\n
Of Counsel:
\nLarry Becraft, JD
\nRalph Fucetola, JD<\/p>\n","protected":false},"excerpt":{"rendered":"
Natural Solutions Foundation The Voice of Global Health Freedom\u2122 www.HealthFreedomUSA.org www.GlobalHealthFreedom.org During February 2010 the Food and Drug Administration, with an excess of zeal, has ordered 15 known Ear Candles companies in the United States to cease all activities, since the agency now deems Ear Candles \u201cmedical devices\u201d without hearing from the Public, findings of […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"open","template":"","meta":[],"_links":{"self":[{"href":"http:\/\/www.healthfreedomusa.org\/index.php?rest_route=\/wp\/v2\/pages\/5209"}],"collection":[{"href":"http:\/\/www.healthfreedomusa.org\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"http:\/\/www.healthfreedomusa.org\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"http:\/\/www.healthfreedomusa.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.healthfreedomusa.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=5209"}],"version-history":[{"count":7,"href":"http:\/\/www.healthfreedomusa.org\/index.php?rest_route=\/wp\/v2\/pages\/5209\/revisions"}],"predecessor-version":[{"id":8990,"href":"http:\/\/www.healthfreedomusa.org\/index.php?rest_route=\/wp\/v2\/pages\/5209\/revisions\/8990"}],"wp:attachment":[{"href":"http:\/\/www.healthfreedomusa.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=5209"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}