Further Notes on Brian Peskin ||| Quackwatch Home Page

Permanent Injunction against Brian Peskin


In January 2003, a Texas District Court issued this injunction ordering Brian S. Peskin and his company to pay $100,000 to the State of Texas and to refrain from making a long list of unsubstantiated claims about their Radiant Health Products and Peskin's credentials.


STATE OF TEXAS,
  Plaintiff

v.

PERKINS MANAGEMENT, INC.
D/B/A MAXIMUM EFFICIENCY
PRODUCTS & BRIAN SCOTT PESKIN
  Defendant

§
§
§
§
§
§
§
§
§

IN THE DISTRICT COURT

HARRIS COUNTY


55th District Court

No. 2002-21594


AGREED FINAL JUDGMENT AND PERMANENT IN.JUNCTION

This Agreed Final Judgment and Permanent Injunction is entered into against Defendants Perkins Management. Inc., dba Maximum Efficiency Products and Brian Scott Peskin, and in favor of Plaintiff, the State of Texas. The parties, appearing by and through their attorneys of record, wish to make the following stipulations and agree to the entry of this Judgment. It is stipulated that the parties have compromised and settled all claims stated by Plaintiff in this cause without the necessity of a trial. It is further stipulated that Plaintiff and Defendants agree to, and do not contest, the entry of this Judgment. Upon review of the pleadings and stipulations of the parties, it appears to the Court that the parties agree to and approve the entry of this Judgment.

IT IS TIIEREFORE ORDERED, ADJUDGED AND DECREED that Defendants Perkins Management, Inc., dba Maximum Efficiency Products, and Brian Scott Peskin, their successors, assigns, 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 shall be permanently restrained from engaging in the following acts or practices:

1. Introducing or delivering for introduction into commerce any food or drug that is adulterated or misbranded in violation of TFDCA § 431.021(a);

2. Adulterating or misbranding any food or drug in commerce in violation of TFDCA § 431.021(b);

3. 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;

4. Manufacturing within this State any food or drug that is adulterated or misbranded within the meaning of Chapter 431 of the TFDCA;

5. 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 §§ 43 1.222 and 431.021 (y);

6. Failing to completely comply with the scheduled process submitted and filed with the FDA for production of Defendants' "Herbal Essence" tonic;

7. Failing to prepare, review and maintain, for a period of (3) years from date of manufacture, at Defendants' processing plant. all records of acidified toad processing, records of deviations in acidified food processing, routine and required pH testing of acidified foods, acidified foods, such as thermometers and pH meters, and acidified food distribution records, as records of required/routine calibration of all necessary instruments utilized in the processing of temperature (hot fill) records relating to acidified food production, acidified food batch records, required by TFDCA § 431.244(a), 21 C.F.R. 114, & 21 C.F.R. 108.25 (c)(1)-(2);

8. 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;

9. 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;

10. 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;

11. 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;

12. 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;

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 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;

14. Advertising or labeling any food product or drug sold or marketed by any defendant 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 (13) 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. No Defendant will provide or discuss any general nutritional information or theories in connection with the advertising of any particular brand of nutritional supplement;

15. 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;

16. Representing, expressly or by implication. in any labeling or advertising of food products, that such products will mitigate, treat, cure, or prevent specific 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;

17. Labeling and. advertising products of any kind as drugs without prior FDA approval;

18. 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;

19. Listing different serving sizes on the labeling of Basic Essence and Herbal Essence products;

20. 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;

21. Distributing, selling, shipping, mailing, delivering, or sending any of Defendants' products (Basic Essence, Mineral Essence or Herbal Essence) to any person, entity, or business 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;

[Footnote 1: Defendants arc hereby ordered to affirmatively exercise reasonable diligence in attempting to persuade any person. entity or business known to the Defendants to be engaging in the: type of false advertising prohibited in this order to cease and desist such advertising. Defendants shall not sell or distribute any of their Radiant Health product to any person, entity or business known to Defendants to be engaging in the type of advertising prohibited in this order after the exercise of reasonable diligence by Defendants to ascertain same. Defendants shall be under a continual duty to utilize personal diligence to determine whether or not any person, entity or business is engaging in the type of advertising of Defendants' products as prohibited in this order prior to shipping or distributing any products to them.]

22. 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 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, 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;

23. 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);

24. Selling, distributing, sending, mailing, printing, giving, disseminating, advertising, referencing, or allowing any other person, entity or business affiliated with Defendants or subject. to their control, directly Or indirectly to sell, distribute, send, give, mail, print, advertise, reference, or disseminate the book "Radiant Health—Moving 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;

25. 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;

[Footnote 2: Nothing herein shall prohibit Defendant Brian Scott Peskin from stating or advertising that he received an appointment as an Adjunct Professor at Texas Southern University.]

[Footnote 3: Defendants are hereby ordered to affirmatively exercise reasonable diligence in attempting to persuade any person, entity or business known to the Defendants to be engaging in the type of false advertising prohibited in this order to cease and desist such advertising, Defendants shall not sell or distribute any other Radiant Health products to any person. entity or business known to Defendants to be engaging in the type of advertising prohibited in this order after the exercise of reasonable diligence by Defendants to ascertain same Defendants shall be under a continuing duty to utilize reasonable diligence to determine whether or not any person, entity or business is engaging in the type of advertising of Defendants' products as prohibited in this order prior to shipping or distributing any products to them.]

26. Representing. expressly or by implication, in any advertising of any product, that Defendant Brian Scott Peskin is a "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;"

[Footnote 4: Nothing herein shall prohibit Defendant Brian Scott Peskin from stating or advertising that he received an appointment as an Adjunct Professor at Texas Southern University.]

27. Representing, expressly or by implication, in any type of advertising of any food or drug product, that Brian Scott Peskin is an MIT engineer, or any type of engineer, unless it is affirmatively and conspicuously disclosed in said advertising that such engineering degree was in electrical engineering;

28. 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;

29. 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;" and

30. 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.

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 warn 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 1FDCA § 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 TFDGA 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 TFDC A 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(ft) of the Federal Food. Drug & Cosmetic Act; and

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, ADJUDGED AND DECREED that Plaintiff, State of Texas, have Judgment and recover from Defendants, Perkins Management; Inc., dba Maximum Efficiency Products and Brian Scott Peskin, jointly and severally, a civil fine and penalty to or for the benefit of the State of Texas, a governmental unit, which is not compensation for any actual or pecuniary loss, in the amount of Twelve Thousand Dollars and No Cents ($12,000.00).

IT IS FURTHER ORDERED that Plaintiff State of Texas, have Judgment and recover from Defendants Perkins Management, Inc.. dba Maximum Efficiency Products and Brian Scott Peskin, jointly and severally, the sum of Seventy Three Thousand Dollars and No Cents ($73,000.00) for reimbursement of attorney fees and investigative costs which were incurred on behalf of the Plaintiff and which do not constitute an antecedent debt with respect to this litigation.

IT IS FURTHER ORDERED that the Texas, Department of Health have Judgment and recover from Defendants Perkins Management. Inc., dba Maximum Efficiency Products and Brian Scott Peskin, jointly and severally, the sum of Fifteen Thousand Dollars and No Cents ($15,000.00) for reimbursement of investigative costs which were incurred on behalf of the Texas Department of Health, and which do not constitute an antecedent debt with respect to this litigation. All costs of Court expended or incurred in this cause are hereby adjudged against the party incurring same for which let execution issue.

The clerk of this court is hereby directed to issue a Writ of Permanent Injunction to Defendants and to issue such writs of execution or other process necessary to enforce this Agreed Final Judgment and Permanent Injunction.

All relief not granted herein is denied.

SIGNED at Houston, Harris County, Texas on this 7th day of January 2003.

/s/ Jeff Brown
JUDGE PRESIDING

APPROVED AND AGREED AS TO FORM AND SUBSTANCE:

/s/ JOHN OWENS
Assistant Attorney General
Consumer Protection Division
808 Travis, Suite 300
Houston, Texas 77002
713/223~5886. ext 218
713/223-5821 (fax)
State Bar No. 15379200
ATTORNEY FOR PLAINTIFF

/s/ JAMES H. HUTCHINSON, III
Schaeffer, Hutchinson, Piper LLP
3118 Richmond Avenue. Suite 200
Houston. Texas 77098~3016
713/524-7359
713-528-5677 (fax)
State Bar No. 10348300
ATTORNEY FOR DEFENDANTS

/s/ BRIAN SCOTT PESKIN, Individually,
And on behalf of Peskin Management,
Inc., dba Maximum Efficiency Products

Further Notes on Brian Peskin ||| Quackwatch Home Page

This page was posted on December 4, 2003.