STATE OF TEXAS,
PERKINS MANAGEMENT, INC.
IN THE DISTRICT COURT
On this day came on for hearing in the above-entitled cause, Plaintiff's Request for a Temporary Injunction against Defendants Perkins Management, Inc., dba Maximum Efficiency Products and Brian Scott Peskin. On April 26, 2002, Plaintiff, State of Texas, filed its Original Petition and Application for Temporary and Permanent Injunction. Defendants have responded to said Original Petition, generally denying the claims alleged.
1. The parties, appearing by and through their attorneys of record, wish to make the following stipulations and agree to the entry of this Agreed Temporary Injunction without waiver of or prejudice to any claims or defenses they may have, all of which are specifically reserved. It is further stipulated that, subject to the foregoing reservations, Plaintiff and Defendants agree to and do not contest the entry of this agreed order.
2. The Court then proceeded to read the pleadings and stipulations of the parties, and it appears to the Court that all parties agree to this Agreed Temporary Injunction.
3. IT IS THEREFORE ORDERED that Defendants, Perkins Management, Inc., dba Maximum Efficiency Products and Brian Scott Peskin, their officers, agents, servants, employees, attorneys and any other persons in active concert or participation with them, who receive actual notice of this order by personal service or otherwise, whether acting directly or through any trust, corporation, subsidiary, division, or other devise, shall be restrained from engaging in the following acts or practices:
(1) Transferring, concealing, destroying, or removing from the jurisdiction of this Court any books, records, documents, invoices or other written materials relating to the business of Defendants currently or hereafter in Defendants' possession, custody or control except in response to further orders or subpoenas in this cause;
(2) Introducing or delivering for introduction into commerce any food or drug that is adulterated or misbranded in violation of TFDCA §431.021(a);
(3) Adulterating or misbranding any food or drug in commerce in violation of TFDCA §431.021(b);
(4) Distributing in commerce any consumer commodity, if such commodity is contained in a package or has labeling that does not conform to the provisions of Chapter 431 of the TFDCA;
(5) Manufacturing within this State any food or drug that is adulterated or misbranded within the meaning of Chapter 431 of the TFDCA;
(6) Engaging in the manufacture or processing of food products in Texas without first being properly licensed with the Department of Health as required by TFDCA §§ 431.222 and 431.021(y);
(7) Failing to completely comply with the scheduled process submitted and filed with the FDA for production of Defendants' "Herbal Essence" tonic;
(8) Failing to prepare, review and maintain, for a period of (3) years from date of manufacture, at Defendants' processing plant, all records of acidified food processing, records of deviations in acidified food processing, routine and required pH testing of acidified foods, temperature (hot fill) records relating to acidified food production, acidified food batch records, records of required/routine calibration of all necessary instruments utilized in the processing of acidified foods, such as thermometers and pH meters, and acidified food distribution records, as required by TFDCA §431.244(a), 21 C.F.R. 114, & 21 C.F.R. 108.25 (c)(1)-(2);
(9) Distributing any acidified food products, including, but not limited to Radiant Health Herbal Essence, with a finished equilibrium pH value of 4.3 or higher achieved within the time designated in any scheduled process submitted to the FDA, and to maintain such finished equilibrium pH value of 4.3 or lower in all finished foods;
(10) Introducing into commerce any food product which has been produced, prepared, packed or held by Defendants in any way whereby such product may have been rendered unwholesome or injurious to health as a result of any pH testing not in compliance with this Order or any deviation in processing from the scheduled process submitted to the FDA;
(11) Introducing any food product into commerce if the labeling on, or accompanying such product, is false or misleading in any particular as set forth in Chapter 431 of the TFDCA or any companion Texas Administrative Code provisions;
(12) Processing or manufacturing any food product which is introduced into commerce unless the label on, or accompanying such product, bears the common or usual name of the food, if any;
(13) Offering for sale, selling, or distributing into commerce any food product intended for human consumption if any claim is made on the label, or in any type of advertising related to the product, which expressly or impliedly refers to the nutrient content or a nutritional quality of the food product to a specific disease or condition of the human body, except as permitted by §403(r) of the Federal Food, Drug & Cosmetic Act;
(14) Offering for sale, selling, or distributing into commerce any food product intended for human consumption if any claim is made on the label, or in any type of advertising related to the product, which expressly or impliedly refers to the nutrient content of the product or to any health claims made by the product which is not in compliance with § 403(r) of the Federal Food, Drug & Cosmetic Act;
(15) Advertising or labeling any food product or drug which makes any express, implied, or similar claims that such product will (1) protect against heart disease; (2) reduce the risk of breast, prostate and other cancers; (3) eliminate varicose veins; (4) lower blood pressure; (5) lower cholesterol; (6) eliminate cellulite; (7) prevent diabetes; (8) manage ADD; (9) help children or other persons with ADD, ADHD, or hyperactivity; (10) be safe for infants, toddlers, or pregnant or nursing mothers; (11) make children smarter; (12) cure constipation; and
(16) any other express or implied health or disease claim which has not been substantiated by Defendants and approved by the FDA or satisfies the requirements of § 403(r)(6) of the Federal Food, Drug & Cosmetic Act.
(17) Using any vignette or symbol, including the "heart smart" vignette, on the labeling of any food or drug product advertised, manufactured, processed, sold, or distributed which makes any health or disease claim which has not been validated and approved by the FDA;
(18) Representing, expressly or by implication, in any labeling or advertising of food products, that such products will mitigate, treat, cure, or prevent specific diseases and classes of diseases, as well as performing any role in the human body's response to a disease, which subjects such products to regulations as a drug;
(19) Labeling and advertising products of any kind as drugs without prior FDA approval;
(20) Failing to properly label any food distributed into commerce, including, but not limited, to listing a "Nutrition Facts" panel or a "Supplement Facts" panel in the proper format on the label as required by law;
(21) Listing different serving sizes on the labeling of Basic Essence and Herbal Essence products;
(22) Introducing or delivering for introduction into commerce any new drug without a new drug application being approved by the FDA as required by TFDCA §431.114;
(23) Distributing, selling, shipping, mailing, delivering, or sending any of Defendants' products (Basic Essence, Mineral Essence or Herbal Essence) to any person, entity, or business subsequent to May 31, 2002, which Defendants know or by the exercise of reasonable diligence should have known, uses any of the following (or similar) express or implied representations in any advertising by such person, entity or business (including the Internet) relating to Defendants' food products: that Defendants' products will (1) protect against heart disease; (2) reduce the risk of breast, prostate and other cancers; (3) eliminate varicose veins; (4) lower blood pressure; (5) lower cholesterol; (6) eliminate cellulite; (7) prevent diabetes; (8) manage ADD; (9) help children or other persons with ADD, ADHD, or hyperactivity; (10) be safe for infants, toddlers and pregnant or nursing mothers; (11) make children smarter; (12) cure constipation; and (13) any other express or implied health or disease claim which has not been substantiated by Defendants and approved by the FDA or which satisfies the requirements of § 403(r)(6) of the Federal Food, Drug & Cosmetic Act.
(24) Distributing, selling, shipping, mailing, delivering, or sending any of Defendants' food products (Basic Essence, Mineral Essence or Herbal Essence) to any person, entity, or business, subsequent to May 31, 2002, which Defendants know or by the exercise of reasonable diligence should have known, uses any of the following (or similar) express or implied representations in any advertising (including the Internet) relating to the credentials, education, background or expertise of Brian Scott Peskin: (1) that Brian Scott Peskin is the "Holder [of the] Emeritus Life-Systems Engineering Chair, College of Pharmacy and Health Sciences, Texas Southern University;" (2) that Brian Scott Peskin is a doctor, scientist, professor or holder of a Ph.D.; or (3) any other representation that expressly or impliedly exaggerates the credentials, expertise, background or education of Brian Scott Peskin;
(25) Facilitating, assisting, consenting, or requesting any person or entity to engage in any advertising of Defendants' products which uses any of the express, implied (or similar) representations to which Defendant is prohibited from engaging in pursuant to the terms of this order (including the (2) preceding subparagraphs of this order).
(26) Distributing, selling, shipping, mailing, delivering or sending any of Defendants' Herbal Essence to any person, entity or business that previously received any such product from October 1, 2001 through April 16, 2002, without notifying them in a separate written letter in 12 point font with the requested shipment of the product as follows: "We request that any Radiant Health Herbal Essence tonic which may have been shipped to you in the last 6 months be returned to us for either a full refund, credit or replacement. Unfortunately, the Herbal Essence tonic shipped to customers during this time may not have been processed with normal quality controls, and in order to maintain the highest quality of the product, we request a return of the product for a full refund, credit or replacement. Please call us if you have any questions, or if you would like to dispose of the unused product instead of mailing it to us."
(27) Selling, distributing, sending, mailing, printing, giving, disseminating, advertising, referencing, or allowing any other person, entity or business to sell, distribute, send, give, mail, print, advertise, reference, or disseminate the book "Radiant HealthMoving Beyond the Zone" to any person, entity or business, at any time in which Defendants or others are producing, manufacturing, distributing, selling, giving, sending, advertising or marketing any of Defendants' current products (now) known as Radiant Health Herbal Essence, Mineral Essence and/or Basic Essence;
(28) Including health claims on the label or in labeling that expressly or by implication characterize the relationship of any substance in a food product to a disease or health-related condition other than those which are complete, truthful and not misleading in regard to the product and have been approved by the FDA
(29) Representing, expressly or by implication, in any advertising of any product, that Defendant Brian Scott Peskin is a "scientist," "Professor," or "Doctor," or that Brian Scott Peskin is the "holder of the Emeritus Life-Systems Engineering Chair, College of Pharmacy and Health Sciences at Texas Southern University;"
(30) Representing, expressly or by implication, in any type of advertising of any food or drug product, that Brian Scott Peskin is an MIT engineer, unless it is affirmatively and conspicuously disclosed in said advertising that such engineering degree was in electrical engineering ;
(30) Exaggerating, expressly or by implication, the credentials, expertise, or educational background of Brian Scott Peskin or any other person, employee, associate, or agent of Defendants associated in any way with the manufacture, production, marketing, distribution, or sale of any food or drug related product;
(32) Failing to include the following FDA disclaimer statement for structure/function claims on all labeling of dietary supplements: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease;
(33) Including descriptive claims for a dietary supplement on the label or in labeling unless Defendants have substantiation that the statements are truthful and not misleading;
4. IT IS ORDERED THAT the following terms, as defined below, apply to this Temporary Injunction:
a) "Adulterated" means a food, including a dietary supplement, which has been produced, prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered diseased, unwholesome, or injurious to health;
b) "Misbranded" means a food, including a dietary supplement, which has false or
misleading labeling in any particular, including 1) the failure to include the common or usual name of the food, if any, 2) if it is a food intended for human consumption and its label, labeling, and retail display do not comply with the requirements of § 403(r) of the Federal Food, Drug & Cosmetic Act pertaining to nutrient content and health claims, 3) if it is a food intended for human consumption and is offered for sale, and a claim is made on the label, labeling, or retail display relating to the nutrient content or a nutritional quality of the food to a specific disease or condition of the human body, except as permitted by § 403(r) of the Federal Food, Drug & Cosmetic Act, 4) its advertising is false or misleading in a material respect or its labeling is in violation of § 411(b)(2) of the Federal Food, Drug & Cosmetic Act; 5) if it purports to be, or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Texas Board of Health determines to be, and by rule prescribed, as necessary in order to fully inform purchasers as to its value for such uses, and 6) any other definition of "misbranded" as found in TFDCA §431.082;
c) "Food" or "food product" means articles used for food or drink for man; chewing gum; and articles used for components of any such article ("food" also includes dietary supplements);
d) "Drug" means articles recognized in the official U.S. Pharmacopoeia National Formulary, or any supplement to it, articles designed or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, articles, other than food, intended to affect the structure of any function of the body of man or other animals, and articles intended for use as a component of any article specified in TFDCA §431.002;
e) "Advertising" means all representations disseminated in any manner or by any means for the purpose of inducing, or that are likely to induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics;
f) "Consumer commodity" means any food, drug, device, or cosmetic, as those terms are defined by the TFDCA or the Federal Food, Drug & Cosmetic Act, and any other article, product, or commodity of any kind or class that is customarily produced or distributed for sale through retail sales agencies or instrumentalities for consumption by individuals, or for use by individuals for purposes of personal care or in the performance of services ordinarily rendered within the household, and that usually is consumed or expended in the course of the consumption or use;
g) "Label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of the TFDCA that any word, statement, or other information that appears on the label shall not be considered to be complied with unless the word, statement, or other information also appears on the outside container or wrapper, if any, of the retail package of the article, or is easily legible through the outside container or wrapper;
h) "Labeling" means 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;
i) "Manufacture" means the process of combining or purifying food or packaging food for sale to a person at wholesale or retail, and includes repackaging or labeling of any food;
j) "Package" means any container or wrapping in which a consumer commodity is enclosed for use in the delivery or display of that consumer commodity to retail purchasers.
k) "Person" means an individual, partnership, corporation, association, or other
group, however organized;
l) "Trade" & "commerce" mean the advertising, offering for sale, sale, lease, or
distribution of any good or service, of any property, tangible or intangible, real, personal, or mixed, and any other article, commodity, or thing of value, wherever situated, and shall include any trade or commerce directly or indirectly affecting the people of this state.
m) "Goods" means tangible chattels purchased or leased for use;
n) "FDA" means the U.S. Food & Drug Administration;
o) "TFDCA" means the Texas Food, Drug & Cosmetic Act as codified in Chapter 431 of the Texas Health & Safety Code;
p) "ADD" means Attention Deficit Disorder;
q) "ADHD" means Attention-Deficit/Hyperactivity Disorder;
r) "Disease" means damage to an organ, part, structure, or system of the body such that it does not function properly, or a state of health leading to such dysfunctioning; except that diseases resulting from essential nutrient deficiencies are not included in this definition;
s) "Disease claim" means a statement which claims to diagnose, mitigate, treat, cure, or prevent disease if it claims, explicitly or implicitly, that the product: (i) has an effect on a specific disease or class of diseases; (ii) has an effect on the characteristic signs or symptoms of a specific disease or class of diseases, using scientific or lay terminology; (iii) has an effect on an abnormal condition associated with a natural state or process, if the abnormal condition is uncommon or can cause significant or permanent harm; (iv) has an effect on a disease or diseases through one or more of the following factors: (A) the name of the product; (B) a statement about the formulation of the product, including a claim that the product contains an ingredient that has been regulated by the FDA as a drug and is well known to consumers for its use or claimed use in preventing or treating a disease; (C) Use of pictures, vignettes, symbols, or other means; (v) belongs to a class of products that is intended to diagnose, mitigate, treat, cure, or prevent a disease; (vi) is a substitute for a product that is a therapy for a disease; (vii) augments a particular therapy or drug action that is intended to diagnose, mitigate, treat, cure, or prevent a disease or class of diseases; or (viii) has a role in the body's response to a disease or vector of a disease;
t) "Health claim" means any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including third party references, written statements (e.g., a brand name including a term such as "heart"), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition. Implied health claims include those statements, symbols, vignettes, or other forms of communication that suggest, within the context in which they are presented, that a relationship exists between the presence or level of a substance in the food and a disease or health-related condition;
u) "Acidified foods" means low-acid foods to which acid(s) or acid food(s) are added; they have a water activity (aw) greater than 0.85 and have a finished equilibrium pH of 4.6 or below;
v) "Scheduled process" means the process selected by a processor as adequate for use under the conditions of manufacture for a food in achieving and maintaining a food that will not permit the growth of microorganisms having public health significance. It includes control of pH and other critical factors equivalent to the process established by a competent processing authority;
w) "Descriptive claim" means a claim made on the label or in labeling of a food,
including dietary supplements, that is not a nutrient content claim, a health claim, or a structure function claim which must be accompanied by a disclaimer that the statement has not been evaluated by the FDA and is not intended to diagnose, treat, cure or prevent any disease.
x) Dietary Supplement" means a product other than tobacco that is intended to
supplement the diet and that contains one or more of these dietary ingredients: vitamins or minerals; herbs or botanicals; amino acids; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above; and, satisfies all other elements of the definition set forth at §201(ff) of the Federal Food, Drug & Cosmetic Act.
y) "Reasonable diligence" means the oral and written request by Defendants that all
individuals, entities and businesses selling any of Defendants' products submit all advertising of any kind to Defendants prior to publication and dissemination, and the regular review and monitoring by Defendants of the content of the Internet web sites utilized by such person, entity or business.
IT IS FURTHER ORDERED that, no bond being required on the part of the Plaintiff, the State of Texas, this Temporary Injunction shall issue and become effective immediately.
Final trial in this matter is set for the ____ day of _________________, 200__.
SIGNED at Houston, Harris County, Texas on this the30 day
of April of 2002,
DISTRICT JUDGE PRESIDING
APPROVED AS TO BOTH FORM AND CONTENT:
Attorney General of Texas
HOWARD BALDWIN, JR.
First Assistant Attorney General
Deputy Attorney General for Litigation
PAUL CARMONA Chief, Consumer Protection Division
Assistant Attorney General
Consumer Protection Division
808 Travis, Suite 812
Houston, Texas 77002
713/223-5886, ext. 218
State Bar No. 15379200
ATTORNEY FOR PLAINTIFF
JAMES H. HUTCHINSON, III
Schaeffer, Hutchinson, Piper LLP
3118 Richmond Avenue, Suite 200
Houston, Texas 77098-3016
State Bar No. 10348300
ATTORNEY FOR DEFENDANTS
BRIAN SCOTT PESKIN, Individually,
and on behalf of Perkins Management,
Inc., dba Maximum Efficiency Products