Tuesday, 4 December 2012

HERBALIFE CASE FILES

Permanent Injunction against Herbalife (1986)


JOHN K. VAN DE KAMP, Attorney General of the State of California
HERSCHEL T. ELKINS & CHARLTON HOLLAND
Assistant Attorneys General
ALBERT NORMAN SHELDEN (619) 137-7754
PETER G. DeMAURO (916) 324-5331
Deputy Attorneys General
1515 K Street, Suite 511
Sacramento, California 95814

ARTHUR DANNER III, District Attorney of Santa Cruz County
DON GARTNER (408) 425-2071
Assistant District Attorney
701 Ocean Street
Santa Cruz, California 95060

Attorneys for Plaintiffs
LAW OFFICES Of CONRAD LEE KLEIN
CONRAD LEE KLEIN
14001 Ventura Boulevard
Sherman Oaks, California 91423
Telephone: (818) 986-8600

Attorneys for Defendants

SUPERIOR COURT OF THE STATE OF CALIFORNIA
COUNTY OF SANTA CRUZ

PEOPLE OF THE STATE OF CALIFORNIA AND
THE DIRECTOR OF THE DEPARTMENT. OF
HEALTH SERVICES,

Plaintiffs,
vs.
HERBALFE INTERNATIONAL, INC.,
a California corporation, and
MARK HUGHES, et al.

Defendants

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No. 92767
FINAL JUDGMENT
AND
PERMANENT INJUNCTION
The People of the State of California and the Director of the Department of Health Services, having filed their complaint here in and defendants having been served with a summons and a copy of the complaint tiled herein; and defendants Herbalife International, Inc. (herein Herbalife), a California corporation, and Mark Hughes, an individual, having filed their answer to the complaint; and plaintiffs appearing through their attorneys John Van de Kamp, Attorney General, Herschel T. Elkins and Charlton Holland, Assistant Attorneys General; Albert Norman Shelden and Peter G. DeMauro, Deputy Attorneys General, by Albert Norman Shelden and Peter G. DeMauro, and Arthur Danner III, District Attorney of Santa Cruz, Don Gartner, Assistant District Attorney, by Don Gartner; and defendants Herbalife and Mark Hughes appearing through their attorneys Law Offices of Conrad Lee Klein by Conrad Lee Klein; and
It appearing that plaintiffs, the People of the State of California and the Director of the Department of Health Services, and defendants above named, personally and through their- attorneys, have stipulated and consented to the entry of this final judgment and permanent injunction prior to the taking of any proof and without trial or adjudication of any fact or law herein and without this final judgment constituting evidence or an admission by said defendants regarding any issue or any fact alleged in said complaint, defendants having denied the allegations in the complaint;
NOW, THEREFORE, IT IS HEREBY ORDERED, ADJUDGED, AND DECREED:
1. This court has jurisdiction in the State of California over the subject matter hereof and the parties hereto.
2. The provisions of this final judgment are applicable to: (a) defendants, Herbalife, Mark Hughes, and each of them, and their respective successors in interest, whether corporate or otherwise, and (b) those officers, directors and employees of said defendants and any other entities acting under, by or on behalf of either such defendant or pursuant to their direction, who have notice of this injunction.
3. Pursuant to Business and Professions Code Sections 17203 and 17535, defendants are hereby permanently enjoined and restrained from:
A. Using or causing to be used pages B-3 through B-10 of the Official Career Book which bears a copyright date of 1982.
B. Representing that defendants' products contain herbs: (1) which in and of themselves naturally curb the appetite; (2) which burn of£ calories; or, (3) which naturally cleanse the system. Defendants, however, are not restrained from representing that the herbs when used in the quantity recommended by defendants assist the natural self-cleansing function of the body, if there is a reasonable basis therefore
C. Representing that one who uses defendants' products will lose weight without a reduction in the user's caloric intake.
D. Representing that defendants' Formula #2 is helpful for the conditions or organs enumerated in the complaint on file at page 14, lines 8-27.
E. Representing that because of its iodine content, the use of kelp in Formula #2 is valuable in a weight reduction program.
F. Representing that the inclusion of lecithin in Formula #2 will result in an inch loss from fatty areas.
G. Representing that the manner in which  defendants include cider vinegar in Formula #2 acts to help curb the appetite.
H. Representing that because of the herbs and the manner in which they are included in Herbalife's products, the use of such products will cleanse the villi and help prevent the clogging of the villi in the intestine.  defendants however, are not restrained from representing that the effect of the herbs as used in their product on the villous portion of the digestive tract is to aid its nutrient absorption function, if there is a reasonable basis therefor.
I. Representing that the Herbalife Cell-U-Loss product: (1) contains herbs which on their own naturally eliminate “cellulite” or the appearance of “cellulite"; ( 2) has the medicinal properties which are helpful for the conditions or organs enumerated in the complaint herein at pages 15-16 lines 25-3; or (3) directs weight loss to particular portions of the body. Defendants, however, are not restrained from representing that Cell-U-Loss is a unique vitamin, mineral and herb formula which assists elimination of excess fluids and helps reduce the appearance of “cellulite,” if there is a reasonable basis therefor.
J. Representing that the Herbalife N.R.G product: (1) naturally increases energy; (2) naturally provides a nutritional lift; (3) has the medical action and uses enumerated in the complaint herein at page 16, lines 19-24; (4) helps to reduce hunger; or (5) that the product is a nutritional factor in health. Defendants, however, are not restrained from representing that N.R.G. provides a tremendous lift, aids mental alertness and reduces feelings of fatigue, if there is a reasonable basis therefor.
K. Failing to disclose in the career book and on the label that one of guarana's components is caffeine.
L. Representing that the Herbalifeline product: (1) dissipates the abnormal build-up of plaque in the arteries, or (2) provides protection for the entire vascular system. Defendants, however, are not restrained from representing that Herbalifeline includes several nutritional factors important for health, in a base of carefully selected herbs and supplies a full-spectrum marine source lipid complex, which is particularly rich in Omega 3 tatty acids, which are considered by various scientific experts to playa role in good cardiovascular health, if there is a reasonable basis therefore.
M. Representing that the Herbalife Schizandra Plus product helps to combat damage that can lead to premature aging. defendants, however, are not restrained from representing that the nutrients in this product help combat premature damage to cells from toxins in the environment, and did cell integrity, if there is reasonable basis therefor.
N. Representing that Tang Kuei relieves menstrual disorders.  defendants, however, are not restrained from representing that Tang Kuei is an herbally based formula which nutritionally helps with the normal discomforts associated with the menstrual function, if there is a reasonable basis therefor.
O. Representing that Flora Fiber restores flow in the intestine and prevents disease. Defendants, however, are not restrained from representing that Flora fiber helps reconstitute and maintain essential flora of the gastrointestinal tract, provides fiber for a natural cleansing effect on the intestinal tract and helps contribute to a proper diet, if there is a reasonable basis therefor.
P. Representing that K-8 stops or affects psycho-neurotic depression.  defendants, however, are not restrained from representing that K-8 is an herbal formula with amino acids which helps to naturally offset feelings of temporary stress and moodiness, if there is a reasonable basis therefor;
Q. Making false or misleading representations with respect to any specific goals for participants in  defendants' marketing program relating to the number of new customers or new participants a participant may obtain within a specific time period or an amount of money a participant may earn through bonuses and overrides.
R. Representing that defendants' otter their products with a “100% Satisfaction Guarantee (or your money back) or any other such refund otter unless: (1)  defendants in a clear and conspicuous manner disclose any limitations which apply to the refund offer at the time the refund offer is disclosed; and, (2) defendants continue to clearly inform participants in their marketing program of such participants' obligations vis-a-vis a purchaser who invokes the refund offer, if participants in defendants' marketing program have any such obligation.
S. Defendants shall not use any “live" testimonials relating to the experience the individual giving the testimonial had with one or more of  defendants' products unless prior to the taking of any testimonials at live presentations, defendants shall indicate, orally or in a conspicuous writing, to those giving testimonials that: (1) testimonials cannot contain any untrue or misleading representations; (2) testimonials regarding any of  defendants' weight loss products or products for- special dietary use may not describe curative or preventive properties or experiences for disease or illness. Provided, however,  defendants may indicate that an individual giving a testimonial may, if it is true as to that individual, make reference to general feelings of well-being as well as make reference to a product's effect to the same extent that defendants can refer to that product's effect. If defendants have reason to believe that a testimonial in contravention of the above has been given. they shall, no later than at the conclusion of the testimonial portion of the presentation, disavow such testimonial to those physically in the audience, and shall not thereafter utilize such contravening testimonial in any manner. If defendants have reason to believe that an individual either gave a testimonial in violation of (1), above, or continues to give testimonials in violation of (2). above, then defendants shall not permit that. person to again otter testimonials for  defendants' product(s). The provisions of this paragraph .S. shall not apply to any live training meetings given only for and attended by distributors of Herbalife products; provided, however, representations or claims for defendants products not allowed to be made pursuant to this judgment shall not be made at such meetings.
T. (1) Subject to the exceptions in Section 6, below, engaging in the following described conduct: (a) Representing or implying that any current product of defendants diagnoses, cures, mitigates, treats or prevents disease if the product is a "new drug" as defined in Health and Safety Code Section 26021 unless defendants have first complied with the requirements of Health and Safety Code Section 26670 (a) or (b), and having the representations made for any products comply with the provisions of Health and Safety Code Sections 26660 and 26661, if those sections are applicable; (b) Offering for sale any drug unless it is safe and effective or any food unless it is sate and defendants have a reasonable basis for the claims made for such drug or food; (c) Representing that  defendants' Formula 2 is helpful for any physical disorder or disease. The provisions set forth in subsection (a) of Section T do not apply to Herbatan and APR because those products, as of the date of this judgment, are not considered new drugs by the plaintiffs so long as the products are in compliance with proposed or final over-the-counter monographs of the Food and Drug Administration and advertising for such is in conformity with the standards therein; but plaintiffs' right to enforce applicable laws are not affected hereby.
(2) If plaintiffs claim that any conduct not con forming to the preceding paragraph has been engaged in, then plaintiffs shall proceed against defendants therefor, if at ail, by taking action pursuant to Business and Professions Code sections 17200 et seq. and 17500 et seq., or the applicable Health and Safety Code sections, or any other statutory provisions, but not by direct enforcement of this judgment, as for example, by way of contempt.
(3) Nothing contained in this Section T shall be deemed to be a limitation on any other provision, or the method of enforcement of any other provision, of this judgment nor the penalties, if any, which may be available under the provisions of Sections 17207 and 17535.5 of the California Business and Professions Code.
4. Whenever a reasonable basis. for a representation or claim is required pursuant to the terms of this judgment, such bas is does not exist. if the defendants knew or in the exercise of reasonable care should have known that the representation or claim was untrue or misleading at the time it was made.
5. A.  defendants shall not establish, maintain or operate a marketing program in which:
(1) A participant pays a valuable consideration for the chance in whole or in part, to receive, either directly or indirectly, compensation, which is based on other than retail sales for introducing one or more additional persons into participation in  defendants' marketing program or for the chance to receive compensation., either directly or- indirectly, when the newly introduced participant introduces a new participant into defendants' marketing program;
 (2) Any compensation, however denominated (including but not limited to “commissions,” “overrides,” “achievement bonuses,” or any term of similar import), defendants pay or participants receive is based upon anything other than the retail sale of  defendants' products; and
(3) A participant can obtain any specific level in defendants' Marketing program based upon criteria other than the amount of retail sales made by the participant or person (s) introduced into  defendants' marketing program by the participant.
B.  defendants shall be in compliance with this Section 5, as long as a verification or documentation system they implement allows them, at any given point in time, to verify or: document to plaintiffs that any and all participants who receive commissions, bonuses, overrides and/or advancement from defendants in  defendants marketing program, after entry of this judgment, are based on retail sales made by or through such participant(s) or others introduced directly or indirectly under participant(s). Plaintiffs shall not seek such verification or documentation prior to 90 days after entry of this judgment., and defendants shall be in compliance with this verification or documentation requirement it their records are current and accurate to a point in time which does not precede plaintiffs' request for verification or documentation by more than 90 days. Plaintiffs' request for verification or documentation of retail sales shall be made to  defendants counsel of record.
C. The term “retail sale” as used in this Section 5 means a sale at defendants' product(s) in any of the following situations: (1) to persons who are not part of defendant's marketing program or distribution system; or, (2) to persons who are not buying to become part of  defendants marketing program or distribution system; or, (3) to persons who, although desirous of becoming or who are a part of defendants' marketing plan or distribution system are buying for their own personal or family use.
6. Notwithstanding anything to the contrary herein, defendants shall not be in violation of this final judgment and permanent injunction by advertising, offering or selling products:
A. In compliance with Federal regulations relating to foods for special dietary use as such regulations are adopted by California Health and Safety Code Section 26208 or any successor sections; provided however, advertisements or otters which exceed the scope of such regulations or relate to issues not covered by such regulations are to that extent, subject to the provisions of Section 3.
B. In compliance with guidelines established and approved by the Federal Food and Drug Administration in over-the-counter monographs; or other Federal Food and Drug Administration criteria, provided however, advertisements or otters which exceed the scope of such guidelines or relate to issues not covered by such guidelines are to that extent, subject to the provisions of Section 3.
C. In compliance with California Health and Safety Code Sections 26000 through ~6851, commonly known as the Sherman Food, Drug and Cosmetic Act.
D. Which are introduced after the date of this judgment or which are current but which in a material manner have been reformulated and for which there is a reasonable basis to support any claims or representations made for such products.
E. For which there is a newly acquired reasonable basis to support any claims or representations made for such products.
F. In manner now prohibited by law but which subsequently becomes legally permissible.
7.  defendants shall not represent in advertising that their marketing plan or product claims have been approved by this court, the California Attorney General's office, the California Department of Health Services, the Santa Cruz County District Attorney's office or any other governmental agency. Provided, however, defendants may represent, after the entry of this judgment, that the action evidenced by the complaint on file herein, has been settled and is no longer pending and  defendants in conformity with the provisions hereof can legally continue to conduct business in California.
8. A. Defendant, Herbalife, is hereby ordered to pay to Plaintiffs, State of California, the sum of $850,000.00, as and for reimbursement to plaintiffs for costs, attorneys tees, expenses of investigation and other expenses and pursuant to Business and Professions Code Sections l7206 and 17536.
B. Payment is to be made at the office of the Attorney General of the State of California, 110 West .A Street, Suite 700, San Diego, California 92101. Payment, if made by check, is to be made to the order of the California Attorney General. Payments shall be made according to the following schedule:
1.
Upon Filing of Judgment
120 Days After Filing
$75,000.00
$75,000.00

First Period
$150,000.00
2.
December 15, 1987
April 15, 1988
August 15, 1998
$50,000.00
$50,000.00
$50,000 .00

Second Period
$150,000.00
3.
October 15, 1988
December 15, 1988
February 15, 1989
April 15, 1989
July 15, 1989
$35,000.00
$35,000.00
$35,000.00
$35,000.00
$35,000.00

Third Period
$175,000.00
4.
October 15, 1989
December 15, 1989
February 15, 1990
April 15, 1990
July 15, 1990
$35,000.00
$35,000.00
$35,000.00
$35,000.00
$35,000.00

Fourth Period
$175,000.00
5.
September 15, 1990
December 15, 1990
March 15, 1991
June 15, 1991
September 15, 1991
$40,000.00
$40,000.00
$40,000.00
$40,000.00
$40,000.00

Fifth Period
$200,000.00
C. Two Hundred Thousand Dollars ($200,000.00) of said $850,000.00 payment is to reimburse the California Department of Health Services for its attorneys tees, costs of investigation and other expenses; said Department shall be entitled to one-quarter (1/4) of each payment received until the full amount of its said reimbursement is received by it.
D. If defendant Herbalife is more than twenty-five days late in making any scheduled payment the entire unpaid balance shall be due and payable if thereafter and with in five days after Herbalife receives written notice of its failure to make such scheduled payment it further fails to make the same.
9. Defendant Mark Hughes is hereby ordered to post security with plaintiffs in the amount of $400,000.00, or in the aggregate amount due to plaintiffs pursuant to Sect ion 8, above, whichever amount is less, from time to time. In the event defendant Herbalife defaults in any payment due pursuant to Section 8, above, plaintiff may collect from said security the amount due pursuant to this judgment, to a maximum amount of $400,000.00. In no event shall the amount paid by defendant Herbalife and the amount collected by plaintiffs from the security posted by defendant Hughes, exceed the total amounts to be paid pursuant to Sect ion 8, above. Such security may consist of cash, cash equivalents, personal or real property, marketable securities, or appropriate sureties. If during the course of the payments required to be made hereunder, plaintiff and Mark Hughes agree to a substitution of security designated above, such new security as agreed upon may be substituted.
10. To insure compliance with the injunctive provisions of this judgment, defendants shall give a full copy of or a summary of the injunctive provisions of this judgment to each officer and each director, who controls, manages, directs or otherwise takes part in developing advertisements for defendants' products or  defendants' marketing plan.  Defendants shall report to plaintiffs on compliance with this Section within thirty days after entry of judgment.
11. In the event that plaintiffs or their counsel become informed and believe that defendants are violating any provision of this judgment, prior to initiating any enforcement action plaintiffs, through the office of the attorney general to which payments hereunder are last made, shall give defendants written notice by mail or otherwise of the nature of the alleged violation and thirty days to undertake correction thereof. If  defendants tail to undertake and diligently pursue appropriate corrective activities plaintiffs may then institute such legal action as is appropriate under the law. Provided, however, if plaintiffs determine, in their sole discretion, that the best interest of the people of the State of California require action plaintiffs may proceed with or without first giving the notice and opportunity to correct which is provided for herein.
12. A. Jurisdiction is retained for the purpose of enabling any party to this final judgment to apply to the court any time for such further orders and directions as may be necessary or appropriate for the construction or carrying out of this final judgment, for the modification of any of  the injunctive provisions hereof, for the enforcement or compliance herewith, for relief herefrom, and for the punishment of violations hereof.
B. The right to seek relief pursuant to this Section l2 shall include the right to seek to have the injunctive provisions of this judgment terminated as to either or both defendants because, for example, the defendant's conduct has for a sufficient period of time indicated that the public interest does not require the continuation of this injunction.
C. (1) If any proceeding is initiated or sought to be maintained by or against a defendant hereto pursuant to the provision of this Section 12 or any other provision of this judgment the venue therefor shall be determined in accordance with generally applicable law for a period of one year after the date of this Judgment, after that period the venue therefor shall be in the Superior Court of the County of Los Angeles and, upon motion of any party or upon the Courts own motion the venue shall be so transferred.
(2) A motion to change the venue of this action to the Superior Court of the County of Los Angeles may be made at any time.
13. Whenever, by the express terms of this judgment, a notice shall or may be given to a party, such notice may be given to the party's then current attorney of record or to the party itself.
14. This final judgment shall take effect immediately upon the entry thereof.
15. The Clerk is ordered to enter this final judgment forthwith.
Dated: October 14, 1986
_________________________
JUDGE OF THE SUPERIOR COURT

Herbalife Sued for Fraud and Negligence

Stephen Barrett, M.D. This article was posted on June 26, 2008.


Phyllis Chen, a 29-year-old woman who acquired acute liver problems after taking Herbalife products has filed suit against the company and several other companies that manufacture its products and ingredients. The complaint (shown belkow) states that Chen suffered acute liver problems that required hospitalization as a result of using a combination of Herbalife products. Chen is suing Herbalife for breach of express warranty, breach of implied warranty, strict liability, negligence, and fraud. In a press release, Chen's attorney Christopher Grell stated thatChen's health had deteriorated within a few months after she began taking 23 Herbalife products. She could not hold food down, was nauseous, and was constantly fatigued. Her symptoms stopped when she stopped taking the products and returned (worse) after she resumed their use. After noticing blood in her urine, she sought emergency care. The doctors opined that the most likely cause of her liver problems were the Herbalife products and instructed her to stop taking them immediately. Two recent journal articles have reported on 22 other cases of severe liver toxicity associated with the use of Herbalife products. [Schoepfer AM and others. Herbal does not mean innocuous: 10 cases of severe hepatoxicity from dietary supplements from Herbalife. Journal of Hepatology 47:521-526, 2007 and Elinov E and others. Association between consumption of Herbalife nutritional supplements and acute hepatotocity. Journal of Hepatology 47:514-520, 2007] Tests commissioned by the Fraud Discovery Institute (FDI) have found high levels of lead in at least two of the Herbalife products that Ms. Chen had consumed.

IN THE SUPERIOR COURT OF THE STATE OF CALIFORNIA
IN AND FOR THE COUNTY OF LOS ANGELES
UNLIMITED JURISDICTION

YUGING "PHILLIS" CHEN,
Plaintiff,
v.
HERRALIFE INTERNATIONAL, INC.,
HERBALlFE INTERNATIONAL OF AMERICA, INC.,
HERBALIFE LTD., NBTY aka NATURE'S BOUNTY,
PHARMACHEM LABORATORJES,
JB LABS, FINE FOODS (ITALY),
AMERICAN INGREDIENTS, INC,
AND DOES 1 THROUGH 100, INCLUSIVE,

Defendants.

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Case No. BC392373

COMPLAINT FOR DAMAGES
(PERSONAL INJURIES)

1) Breach of Express Warranty
2) Breach of Implied Warranty
3) Strict Liability
4) Negligence
5) Fraud

GENERAL ALLEGATIONS

Plaintiff, YUGING "PHILLIS" CHEN ("Plaintiff"), Complains of Defendants, and Each of Them,
1. Plaintiff is a resident of the State of California.
2. The true names and capacities, whether individual, corporate, associate, govemmen.tal or otherwise, of Defendants FIRST DOE through ONE HUNDREDTH DOE, inclusive, are unknown to Plaintiff at this time. who therefore su.es said Defendants by su.ch fictitious names, When the true names and capacities of said Defendants have been ascertain ed, Plaintiff will amend this complaint accordingly. Plaintiff is informed and believes, and thereon alleges, that each Defendant designated herein as a DOE is responsible, negligently or in some other actionable manner, for the events and happenings hereinafter referred to, and caused injuries and damages proximately thereby to the Plaintiff, as herein after alleged.
3. At all times herein mentioned, each of the Defendants was the agent, servant, employee and/or joint venture of his co-defendants, and each of them, and at all said times, each Defendant was acting in the full course and scope of said agency, service, employment and/or joint venture.
4. Plaintiff is informed and believes, and thereon alleges that at all times herein mentioned, Defendants HERBALIFE INTERNATIONAL, INC. is a corporation organized and existing under and by virtue of the laws of the State of California and that said Defendant was and is authorized to do and is doing business in the State of California. This Defendant distributes, markets and sells Herbalife products.
5. Plaintiff is informed and believes, and thereon alleges that at all times herein mentioned,  Defendant HERBALIFE INTERNATIONAL OF AMERICA, INC., is a California corporation organized and existing under and by virtue of the laws of the State of California, or the laws of some other state jurisdiction, and that said Defendant is authorized to do and is doing business in the State of 'California. This Defendant distributes, markets and sells Herbalife products.
6. Plaintiff is informed and believes, and thereon alleges that at all times herein mentioned, Defendant HERBALIFE, LTD. is a corporation organized and existing under and by virtue of the laws of the State of California, or the laws of some other state jurisdiction, and that said Defendant is authorized to do and is doing business in the State of California. This Defendant distributes, markets and sells Herbalife products.
7. Plaintiff is informed and believes, and thereon alleges that at all times herein mentioned, Defendant NBTV aka NATURE'S BEAUTY is a corporation organized and existing and by virtue of the laws of the State of California, or the laws of some other state jurisdiction, and that said Defendant is authorized to do and is doing business in the State of California. This Defendant manufactures, assembles and distributes products Herbalife sells to the public.
8. Plaintiff is informed and believes, and thereon alleges that at all times herein mentioned, Defendant PHARMACHEM LAB ORA TORIES ("PharmaChem") is a corporation organized and existing and by virtue of the laws of the State of California, or the laws of some other state jurisdiction, and that said Defendant is authorized to do and is doing business in the State of California. This Defendant manufactures, assembles and distributes products sold to the public by Herbalife.
9. Plaintiff is informed and believes, and thereon alleges that at all times herein mentioned, Defendant JB LABS is a corporation organized and existing and by virtue of the laws of the State of California, or the laws of some other state jurisdiction, and that said Defendant is authorized to do and is doing business in the State of California. This Defendant manufactures, assembles and distributes products sold to the public by Herbalife.
10. Plaintiff is informed and believes, and thereon alleges that all times herein mentioned, Defendant FINE FOODS (IT AL Y) is a corporation organized and existing and by virtue of the laws of the State of California, or the laws of some other state jurisdiction, and that said Defendant is authorized to do and is doing business in the State of California. This Defendant provides the constituent ingredients used by the manufacturers to make the Herbalife products sold to the public.
11. Plaintiff is informed and believes, and thereon alleges that all times herein mentioned, Defendant AMERICAN INGREDIENTS, INC. is a California corporation organized and existing and i by virtue of the laws of the State of California, or the laws of some other state jurisdiction, and that said Defendant is authorized to do and is doing business in the State of California.
12. At all times herein mentioned, each of the Defendants was the successor, successor in business, successor in product line or a portion thereof, assign, predecessor, predecessor in business, predecessor in product line or a portion thereof, parent, subsidiary, wholly or partially owned by, or the whole or partial owner of or member in an entity researching, manufacturing, labeling, distributing, offering for sale, selling, inspecting, marketing, warranting, rebranding, manufacturing for other, packing and advertising certain products, the name of which are: Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products"). Said entities shall hereinafter collectively be called "alternate entitles." Each of the herein named Defendants are liable for the tortuous conduct of each successor, successor in business, successor in product line, or a portion thereof, assign, predecessor, predecessor in business, predecessor in product line or a portion thereof, parent, subsidiary, whole or partial owner, or wholly or partially owned entity, or entity that manufactured, labeled, distributed, offered for sale, sold, inspected, marketed, warranted, rebranded, manufactured for others and advertised certain products, the names of which are: Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products").
13. The Defendants, their "alternate entities", and each of them, are corporations organized and existing under and by virtue of the laws of the State of California, or the laws of some other state or foreign jurisdictions, and said Defendants, their "alternate entities", and each of them, were and are authorized to do and are doing business in the State of California, and said Defendants, their "alternate entities", and each of them, have regularly conducted business in the State of California.
14. At all times herein mentioned, Defendants, their "alternate entities", and each of them, were and are engaged in the business of researching, manufacturing, labeling, distributing, offering for sale, selling, inspecting, marketing warranting, rebranding, packaging and advertising a certain product, the name of which are: Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products").
15. Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products") are sold to the public as a Food Supplement, not a drug. These products are represented as containing no harmful ingredients. These products are represented to safe, all natural nutrition health products.
16. The Defendants, their "alternate entities", and each of them, knew that these representations were false, based on knowledge they had and chose to conceal this from the Plaintiff, and the general public.
17. At all times mentioned, and each of them, knew or in the exercise of reasonable care, should have known that Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products") were not safe products that could and did cause adverse reactions and injury, including severe liver injury.
18. At all times mentioned, Defendants, and each of them, knew or in the exercise of reasonable care, should have known that Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, Herbalifeline, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products") were of a nature that if it were not properly manufactured, compounded, packaged, labeled, designed, constructed, fabricated, distributed, tested, analyzed, recommended, merchandised, advertised, inspected, promoted, supplied, sold, purchased, prescribed and administered to consumers for the use and purpose for which it was intended, it was likely to cause injury to Plaintiff and the general public.
19. Prior to the herein described injury of Plaintiff, the Defendants, and each of them, manufactured, compounded, packaged, labeled, designed, constructed, fabricated, distributed, tested, analyzed, recommended, merchandised, advertised, inspected, promoted, supplied, sold, purchased, . prescribed and administered the Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products") with its components, ingredients, and constituents, which was intended by said Defendants to be used for the purpose of nutritional support and weight loss.
20. Beginning on or about October or November 2007, and continuing through April 1, 2008, Plaintiff began consuming "The Products" which were manufactured, compounded, packaged, labeled, designed, constructed, fabricated, distributed, tested, analyzed, recommended, merchandised, advertised, inspected, promoted, supplied, sold, purchased, prescribed and administered by the Defendants, and each of them.
21. Plaintiff was blamelessly ignorant of the cause of her injuries which included liver injury and toxicity until sometime in mid-May 2008 when Plaintiffs treating doctors suspected that Plaintiff’s injuries and liver toxicity was probably related to "The Products" and informed Plaintiff that her liver injury was most likely caused by "The Product."
22. Plaintiff was blamelessly ignorant of Defendants' wrongdoing or that "The Products" were defective and caused Plaintiff injury until late May, early June 2008 after Plaintiff reviewed articles attributing liver toxicity to "The Products" including reports that "The Products" contained levels of lead in excess of the maximum daily allowable limits set by California law known as Proposition 65.
23. Plaintiff could not, by the exercise of reasonable diligence, have discovered such facts at an earlier time, since the cause of her injury could not have been discovered until Plaintiffs injury was manifested and sufficient facts were made known or available to Plaintiff concerning "The Products'" role in causing Plaintiffs injury, and that Plaintiffs injuries were caused by Defendants' negligence and/or defect in "'The Products."
24. Furthermore, no literature or warning was ever furnished to Plaintiff by Defendants regarding the harmful and adverse properties associated with use of "The Products" and their component ingredients.
25. To the contrary, Defendants denied and fraudulently, and with reckless disregard for the safety of Plaintiff, concealed this information from Plaintiff which Defendants knew about because of published peer-reviewed medical articles and, at least, one county's decision to ban the sale of Defendants' products in that county.
26. As a proximate result of the herein described conduct of Defendants, and each of them, Plaintiff was caused to suffer grievous, serious and severe injuries, thereby causing Plaintiff damages as set forth below.
27. As a further proximate result of the herein described conduct of Defendants, and each of them, Plaintiff was required to, and did, employ physicians and surgeons to examine, treat and care for her, and Plaintiff further did incur hospital, medical and incidental expenses. The exact amount of said medical expenses are unknown at this time, but Plaintiff will seek leave to amend this pleading and set forth the exact amount thereof when the same has been asceliained.
28. As a further proximate result of the said conduct of Defendants, and each of them, Plaintiff suffered damages for pain and suffering, and loss of earnings. The exact amount of same is unknown to Plaintiff at this time and she will amend this complaint when the same has been ascertained.
29. Prior to the dates upon which Plaintiff was exposed to and ingested "The Products" and their component ingredients, Defendants, and each of them, knew that said products were dangerous and unsafe. In spite of their knowledge of said dangerous properties, and with conscious disregard of the persons who would ingest "The Products", Defendants, and each of them, willfully and knowingly placed "The Products" on the market, knowing that they would be sold, and used without knowledge of the hazards attendant thereto. Defendants, and each of them, failed to take appropriate action to cure the nature of said defects or to appropriately warn users of the dangerous properties of "The Products." Said Defendants, and each of them, thereby acted with malice towards Plaintiff and Plaintiff accordingly request that the trier of fact, in the exercise of its sound discretion, award Plaintiff punitive damages for the sake of example and for the purpose of punishing said Defendants for their conduct, in an amount reasonably related to Plaintiffs actual damages and Defendants' wealth, and sufficiently large to be an example to others and to deter these Defendants and others from engaging in similar conduct in the future.

FIRST CAUSE OF ACTION FOR BREACH OF EXPRESS
WARRANTY BROUGHT BY PLAINTIFF AGAINST DEFENDANTS

30. Plaintiff hereby incorporates by reference, as if fully set forth herein, each and every allegation contained in Paragraphs 1 through 29, inclusive, of the complaint herein.
3l. Defendants, and each of them, manufactured, compounded, packaged, designed, distributed, tested, constructed, fabricated, analyzed, recommended, merchandised, advertised, promoted and sold Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products") which were intended by Defendants, and each of them, to be used as a nutritional supplement to improve health.
32. At all times herein mentioned, Defendants, and each of them, by its officers and director utilized advertising media to urge the use "The Products" and expressly warranted and represented t Plaintiff, and members of the general public that "The Products" were a safe all natural supplement that could be used for as long as necessary to assist in maintaining a healthy state of being.
33. At the time of making said express warranties, Defendants, and each of them, had knowledge of the purpose for which "The Products" and their component ingredients ("The Products" were to be used and warranted the same to be, in all respects, fit, safe and effective and proper for such purpose.
34. Plaintiff and the general public reasonably relied upon the skill and. judgment of the Defendants, and each of them, and upon said express warranties and representations.
35. Said Defendants, and each of them, possessed superior knowledge and failed to disclose said knowledge to Plaintiff and the general community that Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products") were not a safe all natural product but was an unsafe product which contained harmful ingredients, unsafe ingredients, including, but no limited to, contaminants, including, but not limited to, lead.
36. Said warranties and representations were untrue in that Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products") caused Plaintiffs damages and of the injuries because "The Products" were unsuited and unsafe for the sue for which it was intended, and could and did, thereby proximately cause Plaintiff to sustain damages and injuries as herein set forth.
37. As soon as the true nature of the product and the fact that the warranty and representation were false were ascertained, Defendants, and each of them, were duly notified, as required by law.
WHEREFORE, Plaintiff prays for judgment against Defendants, and each of them, as hereinafter set forth.

SECOND CAUSE OF ACTION FOR BREACH OF IMPLIED
WARRANTY BROUGHT BY PLAINTIFF AGAINST DEFENDANTS

38. Plaintiff hereby incorporates by reference, as if fully set forth herein, each and every allegation contained in Paragraphs 1 through 37, inclusive, of the complaint herein.
39. At all times herein mentioned, the Defendants, and each of them, manufactured, compounded, packaged, distributed, recommended, merchandised, advertised, promoted, sold, purchased, prescribed and administered the aforesaid Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products"), as hereinabove described, and prior to the time that Plaintifl used said products, Defendants, and each of them, impliedly warranted to Plaintiff and the general public that "The Products" was of merchantable quality and safe for the use for which it was intended, a dietary supplement.
40. Plaintiff relied on the skill and judgment of Defendants, and each of them, in suing Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products").
41. "The Products" were unsafe for their intended use and it was not of merchantable quality, a warranted by the Defendants, and each of them, in that "The Products" had dangerous properties when put to its intended use became unsafe in that it would cause serious and severe injuries including, but no limited to, liver injury and toxicity requiring hospitalization. The said defective "Products" did proximately cause Plaintiff to sustain injuries as herein set forth.
42. After Plaintiff was made aware of the injuries as a result of said defective products, notice was duly given to the Defendants, and each of them, of the breach of said warranty.
WHEREFORE, Plaintiff prays for judgment against Defendants, and each of them, as hereinafter set forth.

THIRD CAUSE OF ACTION FOR STRICT LIABILITY
BROUGHT BY PLAINTIFF AGAINST DEFENDANTS

43. Plaintiff hereby incorporates by reference, as if fully set forth herein, each and every allegation contained in Paragraphs 1 through 42, inclusive, ofthe complaint herein.
44. Defendants, and each of them, manufactured, compounded, packaged, designed, distributed, tested, constructed, fabricated, analyzed, recommended, merchandised, advertised, promoted and sold Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products"), which were intended by Defendants, and each ofthem, to be used as a dietary supplement.
45. At all times herein mentioned, Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products") were defective and unsafe for its intended purpose by reasons of defects in its component ingredients manufacturing, compounding, testing packaging, labeling, warnings, lack of warnings, over promotion, and contents.
46. Defendants, and each of them, knew that "The Products" were ingested by Plaintiff and was ngested by Plaintiff without inspection for defects arising from, but not limited to, the manufacturing compounding, testing, labeling, packaging, merchandising, and advertising processes of said Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products").
47. At all times herein mentioned, said defective products, were being used by Plaintiff in the manner in which it was intended to be used and/or misused in a manner which was reasonably foreseeable by Defendants, and each of them. As a direct and proximate result of said defective products, Plaintiff sustained the injuries and damages as herein alleged.
WHEREFORE, Plaintiff prays for judgment against Defendants, and each of them, as hereinafter set forth.

FOURTH CAUSE OF ACTION FOR NEGLIGENCE
BROUGHT BY PLAINTIFF AGAINST DEFENDANTS

48. Plaintiff hereby incorporates by reference, as if fully set forth herein, each and every allegation contained in Paragraphs 1 through 47, inclusive, of the complaint herein.
49. At all times herein mentioned, Defendants, and each of them, so negligently and carelessly manufactured, compounded, packaged, labeled, designed, constructed, fabricated, distributed, tested or failed to test, analyzed, recommended, merchandised, advertised, inspected, promoted, supplied, sold purchased, prescribed and administered the afore described Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products") and thereby administered said product to Plaintiff for the purpose for which it was intended to be used.
50. As a proximate result of the aforesaid carelessness and negligence of the Defendants, and each of them, "The Products" caused severe damages and injuries as herein set forth.
WHEREFORE, Plaintiff prays for judgment against Defendants, and each of them, as hereinafter set forth.

FIFTH CAUSE OF ACTION FOR FRAUD
BROUGHT BY PLAINTIFF AGAINST DEFENDANTS

51. Plaintiff hereby incorporates by reference, as if fully set forth herein, each and every allegation contained in Paragraphs 1 through 50, inclusive, of the complaint herein.
52. Defendants, and each of them, manufactured, compounded, packaged, designed, distributed tested, constructed, fabricated, analyzed, recommended, merchandised, advertised, promoted and sole Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products") which were intended by Defendants, and each ofthem, to be used as a safe nutritional, all natural product.
53. At all times herein mentioned, Defendants, and each of them, falsely and fraudulently represented to Plaintiff and members of the general public that the product was safe and that:
1) Adverse reactions had not been reported; and that
2) Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products") were safe, all natural products.
The representations made by Defendants were, in fact, false. In truth, Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products") were unfit for human use as dietary supplements and were, in fact, unsafe and defective products containing harmfu ingredients, including heavy metals such as lead, a known carcinogen.
55. Said Defendants, and each of them, possessed superior knowledge and failed to disclose and caused said failure to disclose said knowledge to Plaintiff and the general community.
56. At all relevant times when Defendants, and each of them, made and/or concealed the aforementioned representations and information regarding the safety and efficacy of Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products") to Plaintiff, the agent of Plaintiff, the medical comnunity, and the members of the general public who were ignorant of the falsity of said Defendants' representation and reasonably believed them to be true. In reliance upon these representations, Plaintiff was induced to, and did, take Formula 1 Nutritional Shake Mix, Formula 2 Multivitamin Complex, Cell Activator, Snack Defense, Total Control, Cell-V-Loss, Herbal Concentrate, Aminogen, Thermo-Bond, N-R-G Nature's Raw Guarana, Niteworks Powder Mix, Tri-Shield, HerbaIifeIine, Mega Garlic Plus, Xtra-Cal, Tang Kuei Plus, Triple Berry Complex, Ocular Defense Formula, Herbal Aloe Drink Concentrate, Active Fiber Drink Mix, Florafiber, 21-Day Herbal Cleansing, Garden 7, Schizandra Plus, RoseOx, Best Defense, Bulk & Muscle Formula Protein Drink Mix and their component ingredients ("The Products"). Had Plaintiff known the actual facts, she would not have ingested The Products and their component ingredients. The reliance of Plaintiff, the agents of Plaintiffs, the medical community and the members of the general public upon Defendants' representation was justified because the representations were made by individuals and entities who appeared to be or were in a superior position to know the true facts.
57. As a proximate and direct result of Defendants' fraud and deceit and the facts alleged herein, Plaintiff  was caused to sustain the injuries and damages herein set forth.
58. By reason of said Defendants' fraud, malice, oppression, willful and wanton misconduct with conscious and reckless disregard of Plaintiff and the general public's well-being, Plaintiff is entitled tc exemplary damages.
WHEREFORE, Plaintiff prays for judgment against Defendants, and each of them, as hereinafter set forth.
WHEREFORE, Plaintiff prays for judgment against Defendants, and each of them, in the First through Fifth Causes of Action as follows:
  1. For general damages in an amount well in excess of the minimum jurisdictional amount required by this Court;
  2. For exemplary damages;
  3. For special damages according to proof;
  4. For interest at the rate of 10% per annum from the date of filing the complaint until judgment is paid; and
  5. For such other and further relief as the Court may deem just and proper.
Date: June 9, 2008
LAW OFFICES OF CHRISTOPHER E. GRELL
The Broadlake Plaza
Christopher E. Grell (SBN. 88498)
Richard F. Rescho (SEN 108086)
360 22ND Street, Suite 320
Oakland, CA 94612
Telephone: (510) 832-2980

Attorneys for Plaintiff
PHILLIS CHEN 

------------------

Coats International Holdings, Inc 3/30/10

   

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128
March 30, 2010
2010-DAL-WL-08
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Billy C. Coats, President and CEO
Coats International Holdings, Inc.
9660 Dilworth Road
Dallas, Texas 75243

Dear Mr. Coats:
On September 1 through September 18, 2009, the U.S. Food and Drug Administration (FDA) performed an inspection of your firm located at 9660 Dilworth Road, Dallas, Texas. Our investigator found a number of violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
The inspection revealed that your Herbalife Ready Herbal Aloe for Digestive Health Dietary Supplement and Herbalife Herbal Aloe Concentrate for Digestive Health Dietary Supplement, products manufactured in your facility, are adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the dietary supplements have been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations for dietary supplements. These observations were presented to you in an FDA-483 at the conclusion of our inspection on September 18, 2009.
The inspection revealed the following deficiencies:
1. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient prior to its use, to comply with 21 CFR 111.75(a)(1)(i). Specifically, your firm uses aloe as an ingredient in your Herbalife Ready Herbal Aloe for Digestive Health Dietary Supplement (32 fl oz and 1 gallon sizes) and Herbalife Herbal Aloe Concentrate for Digestive Health Dietary Supplement, but your firm does not perform an appropriate identity test or examination on the aloe raw material. Although your firm performs (b)(4) and appearance testing for this material, such testing is not appropriate. As discussed with your staff, such testing would not indicate whether, for example, a dietary component was a mixture of aloe, thickeners, and/or other ingredients.
We acknowledge receipt of your October 12, 2009, response to the FDA 483; however, it does not adequately address your failure to conduct at least one appropriate test or examination to verify the identity of the aloe ingredient prior to its use. Your letter stated that you have ordered an aloe standard and that you would use the (b)(4) chromatography methodology accompanying the standard to verify the identity of aloe if you were able to successfully replicate that methodology. However, you did not specify how you intended to verify the identity of aloe used to manufacture your dietary supplements until December 18, 2009 (your anticipated correction date). Similarly, your letter did not specify the identity test or examination your firm would implement in the event that your firm could not successfully replicate the proposed identity methodology.
2. Your firm failed to make and keep documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for identity, purity, strength, and composition; and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, to comply with 21 CFR 111.95(b)(3). Specifically, you have no documentation to explain the rationale behind the specifications that you have for raw materials(such as aloe, chamomile, water, citric acid, and preservatives) used in your dietary supplements and in-process samples (samples taken of  product before packaging) of these dietary supplements. Additionally, you did not make and keep documentation demonstrating why the results of appropriate tests or examinations for the product specifications selected under 111.75(c)(1) ensure that your dietary supplements meets all product specifications, in accordance with 21 CFR 111.95(b)(4).
Your October 12th response indicates your firm has begun implementation of a HACCP plan. While we acknowledge the evaluation of critical control points in the processing of dietary supplements can be useful, this response is inadequate because it did not indicate that your HACCP plan will document the rationale required under 21 CFR 111.95(b)(3) and (b)(4). Further, your letter states that you have created a new SOP titled "Development of a New (b)(4) Product," which was to be implemented by October 31, 2009. Your response states that the SOP will explain the rationale behind your manufacturing process, product specifications, and testing practice. However, your response is inadequate because you did not submit this SOP for our evaluation, and therefore, we cannot determine whether it meets the requirements of 21 CFR 111.95(b)(3) and (b)(4).
3. You did not follow your written procedure, "Approval/Rejection of Raw Materials and Packaging Components" for collecting representative samples of each unique shipment of components. Under 21 CFR 111.153, you must establish and follow written procedures for fulfilling the requirements of subpart G. This subpart includes the requirement that you collect representative samples of each unique lot of components (21 CFR 111.155(c)(1)). Specifically, you did not follow your written procedures stating that you will sample the (b)(4) of the number of containers in a shipment. Our investigator observed that only one box of potassium sorbate had been opened for sampling out of a shipment of (b)(4) boxes. Also, only one bag of trisodium citrate dihydrate had been opened for sampling out of a shipment of (b)(4) bags.
Your October 12th response indicated that your firm's SOP "Approval/Rejection of Raw Materials and Packaging Components" was revised to better define "container." Your response states that "container" is now defined as a (b)(4) and, with this change, multiple cases will be sampled across a single manufacturer's lot of raw material or packaging components. The revised SOP was to be implemented by November 20, 2009. Your response does not adequately address this observation because it does not provide assurance that your staff has been trained to follow your written procedures for collecting representative samples.
4. Your quality control program is not adequate. For example:
a. Your quality control operations did not include periodic review of all records for calibration of instruments and controls, as required by 21 CFR 111.117(b). Specifically, your firm does not periodically review calibration records for production equipment, including scales and water meters used to measure dietary supplement ingredients.
Your response letter indicates SOP 1590, "Quality Review of Equipment/Instrument Calibrations" was implemented on October 7, 2009, and that QC will review records for all equipment requiring calibration through the plant. However, your response did not include a copy of the new SOP or evidence of implementation. We will address the sufficiency of this correction during the next inspection.
b. Your master manufacturing record does not include written instructions for manual operations that include one person verifying the addition of a component, as required by 21 CFR 111.210(h)(3)(ii)(B). Specifically, you have one employee working in the food compounding area (b)(4). This employee adds components of your dietary supplements without a second employee verifying the addition. According to management, a (b)(4) employee checks the next day to ensure that the (b)(4) employee has completed the required paperwork, and signs off on the paperwork to indicate that he has done so. However, your master manufacturing record does not include instructions that the addition of components by one employee must be verified by another employee.
Your response indicates that all dietary supplement compounding activities were moved to (b)(4) and your firm is currently evaluating resources to support future (b)(4). This response is not adequate because it does not indicate that you have revised your master manufacturing record to include a second employee verifying the addition of a component by another employee. We will address the sufficiency of this correction during the next inspection.
c. Your firm failed to include documentation, at the time of performance, in the batch production record that quality control personnel approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement, to comply with 21 CFR 111.260(1)(4). Specifically, our investigator observed that quality control personnel did not document approval and release, or rejection, of the finished product in the batch production record. Although the quality assurance forms in your batch records document review of appropriate records, they do not document release of finished product.
Your response letter indicates that forms QA041 and QA042 will be revised to clearly state: "Batch Released by Quality Assurance:______," the line indicating signature and date. Your letter specifies that corrections were to be completed by October 31, 2009. This response is inadequate because it does not explain that your personnel have been trained to use these revised forms to document release or rejection of a dietary supplement at the time of performance. We will address the sufficiency of this correction during the next inspection.
5. Your master manufacturing record did not include a statement of the theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, to comply with 21 CFR 111.210(f).
Your response indicates that your batch production records will be revised to include a section to record bulk yields, and a bulk yield specification will be added to the in-process release specification section of the batch production records. This response is inadequate because it addresses changes you intend to make to your batch production records, rather than your master manufacturing records.
6. Your batch production records did not include a statement of the percentage of theoretical yield at appropriate phases of processing in accordance with 21 CFR 111.260(f).
Your response indicates revisions will be made to all batch production records for dietary supplements to include a section for recording bulk yields. Your response states, in addition, that a bulk yield specification will be added to the in-process release specification section of the batch production records, and that your firm will also revise the Job Completion Report to include a statement of the percentage of theoretical yield at appropriate phases of processing. However, this response is inadequate because you have not provided a copy of these revisions. We will address the sufficiency of these corrections during the next inspection.
7. The written instructions in your master manufacturing records did not include corrective action plans to use when a specification is not met, in accordance with 21 CFR 111.210(h)(5).
Your letter indicates the statement, "If the above standard specifications are not met, a product investigation will be initiated to determine the root cause," will be added to the Standard Specifications section of the batch production record. This response is inadequate because it indicates that you intend to revise your batch production records, rather than your master manufacturing records.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you market comply with the Act and its implementing regulations.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
Please advise this office in writing within 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
Please send your reply to the Food and Drug Administration, Attention: Sherrie L. Krolczyk, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in this letter, please contact Sherrie L. Krolczyk at (214) 253-5312.

Sincerely,

/s/

Reynaldo R. Rodriguez, Jr.
Dallas District Director

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