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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Healthy People CO 9/28/12

  

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

Public Health Service
Food and Drug Administration
 
Los Angeles District
Import Operations
222 W. 6th Street, Suite 700
San Pedro, CA 90731
Telephone:  (310) 971-2280
FAX:  (310) 971-2363

 

WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
                                                                                                                                   
September 28, 2012
WL 47-12
Ms. Selomith Ramirez, CEO/President
Mr. Jocsan Aguilar, General Manager
Healthy People Co.
13105 Ramona Blvd. Suite F-G
Irwindale, CA 91706
 
Dear Ms. Ramirez and Mr. Aguilar:

The United States Food and Drug Administration (FDA) conducted an inspection at your distribution center located at 13105 Ramona Blvd., Suite F-G, Irwindale, CA 91706, on September 26, 2011, and follow-up inspections at this facility on February 14 and 21, 2012.  Inspections were also conducted at your second distribution facility located at 5965 Pacific Avenue, Huntington Park, CA 90255, on February 9 and 23, 2012. We have also reviewed your websites at www.buyhealthypeople.com and www.menshealthypeopleco.com.

This letter concerns many products that your firm markets to independent distributors.  During the inspections noted above, FDA investigators collected samples and product labeling of some of the products, including “Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” “EverLax Capsules,” “Herbal Drink Acai-man mangosteen,” “Perfect Men,” “Prosvid,” “Gojiman,” “Healthy Coffee,” “Rivere,” “Ancestral,” “Bevida,” “Green Oxygen,” “Max Clean Fiber,” and “Nerval.”  As described below, these products are unapproved new drugs in violation of sections 505(a) and 301(d) of the Act [21 U.S.C. §§ 355(a) and 331(d)] and misbranded drugs in violation of section 502 [21 U.S.C. §§ 352] of the Federal Food, Drug, and Cosmetic Act (the Act).  
 
Tainted Sexual Enhancement and Weight Loss Products
You have marketed “Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” “EverLax Capsules,” “Herbal Drink Acai-man mangosteen,” and “Perfect Men,” as dietary supplements. However, under section 201(ff)(3)(B)(ii) of the Act [21.U.S.C. § 321(ff)(3)(B)(ii)], a dietary supplement may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or food before its authorization as a new drug.
 
FDA confirmed through laboratory analysis that “Mince Belle Capsules” (Lot #: HPMCMB/10-016, HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, and HPCMB/10-021);  “EverSlim Capsules” (Lot #: HPCES-079, HPCES-070, HPCES-071, and HPCES/038); “EverSlim Shake (Strawberry)” (Lot #: HPESSF/168); “EverSlim Shake (Chocolate)” (Lot # HPESSC/061); and “EverLax Capsules” (Lot #: HPCEX/074, HPCEX/076, HPCEX/072, and HPCEX/032) contained undeclared sibutramine hydrochloride (sibutramine).  Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity, and subsequently, withdrawn from the United States market on December 21, 2010, after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.
 
The investigational new drug (IND) application for Meridia (sibutramine) was received by FDA on December 24, 1985, and sibutramine became authorized for investigation as a new drug under an IND on January 23, 1986.  When Meridia was approved for marketing as a new drug in the United States, the existence of substantial clinical investigations of sibutramine became public.  Given that sibutramine was not marketed as a dietary supplement or as a food before Meridia was authorized for investigation as a new drug, “Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” and “EverLax Capsules,” which contain sibutramine, are excluded from the definition of dietary supplement under section 201(ff)(3)(B)(ii) of the Act [21.U.S.C. § 321(ff)(3)(B)(ii)].
 
In addition, FDA laboratory analysis confirmed that your “Herbal Drink Acai-man mangosteen” (Lot # HPJAC/004) and “Perfect Men” (Lot # HPCPM/002) contained undeclared tadalafil, the active pharmaceutical ingredient in Cialis, an FDA-approved drug used to treat erectile dysfunction (ED). Moreover, FDA approved Cialis as a new drug on November 21, 2003, and tadalafil was not marketed as a dietary supplement or as a food before this date.  As such, “Herbal Drink Acai-man mangosteen” and “Perfect Men” are not considered dietary supplements.  
 
“Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” “EverLax Capsules,” “Herbal Drink Acai-man mangosteen,” and “Perfect Men” are intended for use in the cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body, and, thus, are drugs, as defined by sections 201(g)(1)(B) and (C) of the Act [21 U.S.C. §321(g)(1)(B) and (C)]. Labeling statements documenting the intended uses of these products, include, but are not limited to the following:
 
Perfect Men
 
  • “Key Benefits: *Impotence *Early ejaculation * Weak erections . . ..”
 
Herbal Drink Acai-man mangosteen
 
  • Key Benefits: . . . *Cholesterol *Arthritis . . . *To Facilitate the Erection *Blood Pressure . . . *Impotence *Cellular Oxidation. . . *Urinary Tract infections . . ..”
 
EverSlim
 
  • Key Benefits: *Reduce appetite. . . *Reduce Cholesterol *Strengthens the Heart . . ., Circulation Activates *Reduce inflammation of the stomach . . . *Oxygenates Blood”
 
EverSlim Shake (Strawberry)
 
  • Key Benefits: . . . *Remove fat without causing disturbances *Increase metabolism *Fat Burner *Reduce the level of blood sugar in blood stream *Lower cholesterol levels in the blood”
 
EverSlim Shake (Chocolate)
 
  • “Key Benefits: . . . *Remove fat without causing disturbances *Increase metabolism *Fat Burner *Reduce the level of blood sugar in blood stream *Lower cholesterol levels in the blood”
 
Mince Belle
 
  • Used For: . . . *Stomach inflammation. . . *Prevent cellulite”
 
  • “Mince Belle formula is made from medicinal plants used to prevent overweight and obesity.”
 
  • “Aides with: . . . Stomach Inflammation, Appetite Reduction, . . . Circulation, . . . Preventing Cellulite. . ..”
 
Everlax Capsules
 
  • “Key Benefits: . . . *Obesity *Nervous Colitis *Reduce body fat in hips *Stomach Inflammation *Eliminate Retained Fluids *Tonifies Liver *Digestive Disorders”
 
  • “It is used as an aid to relieve: …*Obesity *Nervous colitis . . ..”
 
Moreover, “Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” “EverLax Capsules,” “Herbal Drink Acai-man mangosteen,” and “Perfect Men” are new drugs as defined by section 201(p) of the Act [21 U.S.C. § 321 (p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the Act [21 U.S.C §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your marketing and distribution of “Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” “EverLax Capsules,” “Herbal Drink Acai-man mangosteen,” and “Perfect Men” without such approved applications violates these provisions of the Act.
 
Furthermore, “Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” “EverLax Capsules,” “Herbal Drink Acai-man mangosteen,” and “Perfect Men” are “prescription drugs” as defined in section 503(b)(1)(A) of the Act [21 U.S.C §
 
353(b)(1)(A)], because, in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. “Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” and “EverLax Capsules,” which contain undeclared sibutramine, are prescription drugs because prior to withdrawal of Meridia’s approval, FDA approval of sibutramine was limited to use under the professional supervision of a practitioner licensed by law to administer such drugs.  They are also prescription drugs because the FDA approval of Meridia was withdrawn because of serious safety risks.  Your “Herbal Drink Acai-man mangosteen” and “Perfect Men” are prescription drugs because they contain undeclared tadalafil; all PDE-5 inhibitors which have been approved for marketing by FDA are limited by an approved new drug application to use under the supervision of a practitioner licensed by law to administer them.
 
According to section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Prescription drugs can be used safely only at the direction and under the supervision of a licensed practitioner. Therefore, it is not viable to write “adequate direction for use” for prescription drugs.  FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115].  Because there is no FDA-approved application for your firm’s “Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” “EverLax Capsules,” “Herbal Drink Acai-man mangosteen,” and “Perfect Men,” their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
 
Additionally, under section 502(a) of the Act [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the Act [21 U.S.C § 321(n)] provides that in determining whether an article’s labeling or advertising “is misleading, there shall be taken into account … not only representations made or suggested … but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations . . . ..”  Your products, “Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” and “EverLax Capsules,” are misbranded under section 502(a) of the Act because their labeling fails to reveal facts material with respect to consequences that may result from the use of these products.  Sibutramine, contained in your “Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” and “EverLax Capsules”; and tadalafil, contained in your “Herbal Drink Acai-man mangosteen” and “Perfect Men” products may pose serious health risks to consumers, which are only compounded by the fact that these ingredients are not declared on the respective product labels.  The undeclared PDE-5 inhibitor in “Herbal Drink Acai-man mangosteen” and “Perfect Man” may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates; PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Further, consumers who have been advised against taking PDE-5 inhibitors because of comorbidities or the potential drug interaction may seek products like “Herbal Drink Acai-man mangosteen” and “Perfect Men” because they are marketed as not containing the active ingredients in approved ED drugs.
 
“Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” “EverLax Capsules,” “Herbal Drink Acai-man mangosteen,” and “Perfect Men” are also misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)], because the products’ labeling lack adequate warnings for the protection of users. As noted, there is potential for adverse events associate with the use of these products, particularly since someone who takes them would be unaware of the presence of sibutramine in your “Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” and “EverLax Capsules,” or tadalafil in your “Herbal Drink Acai-man mangosteen,” and “Perfect Men” products. 
 
Additionally, your “Mince Belle Capsules,” “EverSlim Capsules,” “EverSlim Shake (Strawberry),” “EverSlim Shake (Chocolate),” and “EverLax Capsules,” are misbranded under section 502(j) of the Act [21 U.S.C. § 352(j)] because they are dangerous to health when used in the dosage or manner recommended in their labeling.  As previously noted, sibutramine may pose serious health risks to consumers, including adverse health consequences such as heart attack, stroke, increased blood pressure, hallucinations, coma, and tachycardia for individuals with existing medical conditions.
 
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act [21 U.S.C § 331(a)].
 
Additional Unapproved New Drugs
 
Based on a review of labeling of other products collected during our inspection and/or review of your firm’s website at www.menshealthypeopleco.com, “Prosvid,” “Gojiman,” “Healthy Coffee,” “Rivere,” “Ancestral,” “Bevida,” “Green Oxygen,” “Max Clean Fiber,” and “Nerval”  are intended for use in the cure, mitigation, treatment, or prevention of disease.  Examples of the disease claims on your product labels and/or on your website include, but are not limited to:
 
1.   Prosvid
 
“*Prostate inflammation . . .*Urinary tract Infections *Rheumatism *Slow urination”
 
2.   Gojiman
 
“*Reduce cholesterol *Stabilize blood pressure . . . *Reduce Blood Sugar . . . *Inhibit the Growth of Tumors . . . *Improve the Blood by Stimulating Production of Red Blood Cells”
 
3.   Healthy Coffee
 
“Key Benefits: –Diabetes . . . –Paralysis –Addictions –Migrains . . . Cholesterol –Gastritis”
 
4.   Rivere
 
“Key Benefits: *Poor blood circulation . . . *Certain Heart Conditions”
 
5.   Ancestral
 
“Key Benefits: *Diabetes *Detoxifying the Liver *Reduce the levels of Blood Glucose *Tone the Pancreas *Remove Cholesterol and Triglycerides . . . *Stimulate Bile Secretion”
 
6.   Bevida
 
“Key Benefits: Gastritis, Colitis, Diverticulitis, Intoxicated Liver . . . Asthma, . . . Herpes, . . ..”
 
7.   Green Oxygen
 
“Key Benefits: . . . Helps prevent Osteoporosis *Oxygenates your cells blood and brain *Liver inflammation *Combat uric acid . . . Regular blood pressure *Improve circulation . . ..”
 
8.   Max Clean Fiber
 
“Key Benefits: Inflammation of the stomach, Colitis, Gastritis, . . . Gastric ulcers, . . . Cholesterol, Diabetes, . . ..”
 
9.   Nerval
 
“Key Benefits: . . . *Depression . . ..”
 
These products, as well as others that you may promote and market, are drugs as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)] because, according to their labeling, they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.  Moreover, they are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)] because there is no such evidence that these products are generally recognized as safe and effective for their intended uses.  Since these products are “new drugs” they may not be legally marketed in the United States without approved new drug applications under section 505(a) of the Act [21 U.S.C. § 355(a)].
 
Furthermore, because all of the aforementioned products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, your products' labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].  The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act [21 U.S.C § 331(a)].
 
The issues and violation in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence as well as the occurrence of other violations.  It is your responsibility to ensure that your firm, and any drug or dietary supplement product manufactured or distributed by you or your firm, comply with all requirements of federal law and FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure, injunction, and/or prosecution as the Act authorizes under sections 302 and 304 of the Act [21 U.S.C §§ 332 and 334]. In addition, there is criminal liability for all violations of the prohibited acts described in section 301 of the Act [21 U.S.C. § 331]. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates or approval of pending new drug applications listing your facility as a manufacturer until the above violations are corrected.
 
FDA acknowledges that you initiated a voluntary nationwide recall of “Mince Belle Capsules” (Lot #: HPMCMB/10-016, HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, and HPCMB/10-021); “EverSlim Capsules” (Lot #: HPCES-079, HPCES-070, HPCES-071, and HPCES/038); “EverSlim Shake (Strawberry)” (Lot #: HPESSF/168); “EverSlim Shake (Chocolate)” (Lot # HPESSC/061); “EverLax Capsules” (Lot #: HPCEX/074, HPCEX/076, HPCEX/072, and HPCEX/032); “Herbal Drink Acai-man mangosteen” (Lot # HPJAC/004); and “Perfect Men” (Lot # HPCPM/002) on February 2, 2012. We also recognize that, on February 22, 2012, you initiated a voluntary recall to include all of the above-mentioned products, regardless of the lot numbers referenced herein, and to the extent these products were bought or sold on or before October 25, 2011. You have also committed to ensure that drug ingredients will not be included in any of the firm’s products in the future.
 
With fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within you will complete the correction. You can find guidance and information for the regulated industry regarding regulations for drug products through links at FDA’s website at http://fda.gov/oc/industry.
 
Your response should be sent to:
      
            U.S. Food and Drug Administration
            Los Angeles District Office
            Import Operations
            222 W. 6th Street, Suite 700
            San Pedro, CA  90731
 
 
Sincerely,
/S/                                                                   
Alonza E. Cruse, Director
Los Angeles District
 
 
Cc: Ms. Ingeborg Small, Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS 7602
P.O. Box 997435
Sacramento, CA 95899-7435