• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

U.S.A Far Ocean Group LLC/Health & Beauty Group Inc. 10/24/12

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900 

WARNING LETTER

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

October 24, 2012
 

WL 05-13
 

Mr. Qingkun Wang, President
USA Far Ocean Group Inc.
Ms. Ting Li, President
Health & Beauty Group Inc.
1609 W. Valley Blvd., #338
Alhambra, CA 91803

Dear Mr. Wang and Ms. Li:

This letter concerns your firm's marketing and distribution of the following products: "U-Prosta," "Male Enhancer," "X-Hero," "New Prosta," ''New Hero," "New Prosta 2nd Generation," "Liver Care," "Power Up," "Cardio Care," "Glucose Balance," "Cholesto Care," "Quick Slim," "Female One," "Vagifresh Ball," "Vagifresh Moisturizing Gel," "Vagifresh Liquid," "Minimizer," "Spot & Whitening Cream," and "Instant Lift" on your websites www.hbherb.net, www.hbherb.com, www.kjlusa.com, www.conectone.com, www.tyloon.com/store/14841123; in your marketing brochures; and in other media. As described below, your marketing and distribution of these products violate the Federal Food, Drug, and Cosmetic Act (the Act). 

Tainted Supplements

The U.S. Food and Drug Administration (FDA) confirmed through laboratory analyses that your products, "U-Prosta," "Male Enhancer," and "X-Hero," contain terazosin, tadalafil, and sulfosildenafil, respectively. None of these ingredients were found on the product label. Terazosin is an alpha-1-selective adrenoceptor blocker and the active pharmaceutical ingredient (API) in the FDA-approved drug, Hytrin®, approved on September 29, 1993 for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tadalafil is a phosphodiesterase type-5 (PDE-5) inhibitor and the API in the FDA-approved drug, Cialis®, approved on November 21, 2003 for the treatment of erectile dysfunction (ED). Sulfosildenafil, a PDE-5 inhibitor, is an analogue of sildenafil, the active ingredient of the FDA-approved drug Viagra®, used for the treatment of ED.

You market "U-Prosta" and "Male Enhancer" as dietary supplements. According to section 201(ff)(3)(B) of the Act [21 U.S.C. § 321(ff)(3)(B)], dietary supplements cannot contain an article that is approved as a new drug under section 505 of the Act unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug. Given that neither terazosin nor tadalafil were marketed as dietary supplements or as foods before FDA's approval of Hytrin® and Cialis®, your "U-Prosta" and "Male Enhancer" are excluded from the definition of a dietary supplement under section 201(ff)(3)(B) of the Act [21 U.S.C. § 321(ff)(3)(B)].

Labeling statements for your products "U-Prosta" and "Male Enhancer" make clear they are drugs, as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)], because they are intended for use in the prevention, treatment, or cure of disease, and/or intended to affect the structure or any function of the body. Examples of labeling statements documenting the intended uses of "U-Prosta" and "Male Enhancer" include, but are not limited to, the following:

"U-Prosta"

• "To stop the hyperplasia of the prostate"
• "To relieve the lower urinary tract irritation and obstruction"
• "To stop prostate infection"
• "To help the prostate recover to normal status"
• "To prevent the occurrence and development of the prostate cancer"
 

"Male Enhancer"
 

• "Help to maintain healthy sperm production, motility"
• "Maintain healthy levels of sexual energy and stamina"
• "Promote systemic and hormonal balance in male reproductive system"
 

In addition, your product "X-Hero" is subject to regulation as a "drug" under the Act. Examples of labeling statements documenting the intended uses of "X-Hero" include, but are not limited to, the following:

"X-Hero"
 

• "The growth of the penis, increase erectile hardness"
• "Natural plant Viagra" (Translated)
• "SOD (superoxide dismutase) ... can improve the function of the kidney of the man .." 

"X-Hero" contains sulfosildenafil, an analogue of sildenafil, and a PDE-5 inhibitor. Under section 201 (g)(1) of the Act (last sentence), the structure/function claims made for a dietary supplement must be made in accordance with section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] or the product is subject to regulation as a drug. Section 403(r)(6) authorizes claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body, or that characterize the way in which a nutrient or dietary ingredient maintains the structure or function of the body. However, the structure/function claims quoted above for "X-Hero" do not describe the effects of nutrients or dietary ingredients in the product. Rather, the structure/function claims are made for the product as a whole and relate to the sulfosildenafil content. Since sulfosildenafil is not a nutrient or dietary ingredient, claims about improvement of sexual function do not conform to section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)]. Accordingly, the claims for "X-Hero" make it a drug within the meaning of section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. 

Moreover, "U-Prosta," "Male Enhancer," and "X-Hero" are "new drugs," as defined in section 201(p) of the Act [21 U.S.C. § 321(p)], because these products 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 sale of "U-Prosta," "Male Enhancer," and "X-Hero" without approved applications violates these provisions of the Act.

In addition, "U-Prosta," "Male Enhancer," and "X-Hero" 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, the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them. Indeed, all PDE-5 inhibitors and alpha-1-selective adrenoceptor blockers which have been approved for marketing by FDA are limited by an approved new drug application to use under the professional supervision of a practitioner licensed by law to administer such drugs.

According to section 502(f)(1) of the Act [21 U.S.C. § 352(t)(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 C.P.R. § 201.5]. Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write "adequate directions for use" for prescription drugs. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson [21 C.P.R. §§ 201.100(c)(2) and 201.115]. Because there are no FDA-approved applications for your firm's "U-Prosta," "Male Enhancer," and "X-Hero," their labeling fails to bear adequate directions for their intended use(s), 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 manner. Section 201(n) of the Act [21 U.S.C. § 321(n)] provides that, in determining whether a drug'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 .... " The labels of "U-Prosta," "Male Enhancer," and "X-Hero" do not declare that the products contain terazosin, tadalafil, and sulfosildenafil, respectively. The undeclared APIs or analogue of an API found in the products mentioned above may pose serious health risks because patients with underlying medical issues may take them without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, terazosin may cause excessive lowering of blood pressure and loss of consciousness, which are associated with the first dose or initial days of therapy. These effects may also occur with a rapid dose increase or with the concomitant administration of another blood pressure lowering medication. PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels. Patients with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Further, patients that have been advised against taking terazosin or PDE-5 inhibitors because of comorbidities or potential drug interactions may seek products like "U-Prosta," "Male Enhancer," and "X-Hero" because the products are marketed as not containing the active ingredients contained in the approved products. Accordingly, the failure to disclose the presence of terazosin, tadalafil, and sulfosildenafil renders the products' labeling false and misleading.

Furthermore, the undeclared ingredients in your products, "U-Prosta," "Male Enhancer," and "X-Hero," cause your products to also be misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)] in that their labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with these products, particularly since someone who takes them would be unaware of the presence of terazosin in "U-Prosta," tadalafil in "Male Enhancer," or sulfosildenafil in "X-Hero." 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)].

Unapproved and Misbranded Drugs Marketed as Dietary Supplements

"New Prosta," "New Hero," "New Prosta 2nd Generation," "Liver Care," "Power Up," "Cardio Care" "Glucose Balance" "Cholesto Care," and "Quick Slim" are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Examples of such disease claims found in the labeling of these products include, but are not limited to, the following:

"New Prosta"
• "Suggested Use: Men ... with voiding dysfunction; prostatic hyperplasia, BPI-I, prostate cancer ... sexual dysfunction, etc.''
• "Pygeum has also shown promise in preventing, combatting and reducing the symptoms of prostate cancer and chronic prostatis [sic]."

"New Hero" (10 capsule or 60 capsule versions)
• "New Hero combats both erectile dysfunction and premature ejaculation .... "
• "This product applies to male sexual function banier, decline of sexual desires, impotence .... "
• "Tongtat ali root extract ... Asian Viagra ... is used traditionally ... to increase libido ... as an erectile dysfunction treatment."

"New Prosta 2nd Generation"
• "[I]t will penetrate the blooded prostate baniers within 1-3 hours ... and will improve within 3 days the symptoms of frequent, urgent urination, difficulty urination .... "

"Liver Care"
• "It is very supportive to recover fat liver, alcoholic liver, chronic hepatitis, cirrhosis, etc, and helpful to effectively eliminate the chronic fatigue syndrome .... "
• "Suggested Use: ... Excessive alcohol and tobacco ... "

"Power Up"
• "'[P]ower up' ... for sexual dysfunction in men."
• "Suggested Use: ... experience nausea and vomiting ... Flank pain (between the ribs and hips) ... Impotence ... Neurasthenia ... Insomnia .... "

"Cardio Care"
• '"Cardio Care' could ... prevent thrombosis·ombosis."
• "Suggested Use: Myocardial ischemia, chest tightness, shortness of breath, heart palpitations ... angina pectoris .... "

"Glucose Balance"
• '"Glucose Balance' ... can effectively reduce blood sugar ... help people with diabetes ... "
• "Suggested Use: Assorted diabetes; Diabetes complications."

"Cholesto Care"
• "'Cholesto Care' ... extensively reduces coronary heart disease, myocardial infarction, stroke incidence, morbidity and mortality."
• "Suggested Use: Atherosclerosis, high cholesterol ... high blood pressure and obesity."

"Quick Slim"
• "Suggested Use: Obesity .... "

"New Prosta," "New Hero," "New Prosta 2nd Generation," "Liver Care," "Power Up," "Cardio Care," "Glucose Balance," "Cholesto Care," and "Quick Slim" are drugs, as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.

Moreover, the above-mentioned products are "new drugs," as defined in 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 sale of "New Prosta," "New Hero," "New Prosta 2nd Generation," "Liver Care," "Power Up," "Cardio Care," "Glucose Balance," "Cholesto Care," and "Quick Slim" without approved applications violates these provisions of the Act.

In addition, "New Prosta," "New Hero," "New Prosta 2nd Generation," "Liver Care," "Power Up" "Cardio Care" "Glucose Balance" "Cholesto Care" and "Quick Slim" are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for these drugs fail to bear adequate directions for use. "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 C.P.R. § 201.5]. Your above-mentioned products are offered for conditions which are not amenable to self diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions cannot be written so that a layman can use the above-mentioned products safely for their intended uses. FDA-approved drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 C.F.R. §§ 201.100(c)(2) and 201.115]. Because "New Prosta," "New Hero," "New Prosta 2nd Generation," "Liver Care," "Power Up," "Cardia Care," "Glucose Balance," "Cholesto Care," and "Quick Slim" lack FDA-approved applications, they are not exempt under 21 C.F.R. §§ 201.100(c)(2) and 201.115. For these reasons, these products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Introduction or delivery for introduction of misbranded drugs into interstate commerce violates section 301 (a) of the Act [21 U.S.C. § 331 (a)].

Unapproved and Misbranded Over-the-Counter (OTC) Drugs

In addition to the aforementioned products that you market as dietary supplements, your firms also market "Female One," "Vagifresh Ball," "Vagifresh Moisturizing Gel," "Vagifresh Liquid," "Minimizer," and "Spot & Whitening Cream." Based on the labeling statements for these products, they are drugs, as defined by section 201(g)(1) of the Act (21 U.S.C. § 321(g)(1)], because they are intended for use in the prevention, mitigation, treatment, or cure of disease, and/or intended to affect the structure or any function of the body. Examples of labeling statements documenting the intended uses of your products include, but are not limited to, the following:

"Female One''
• (Testimonial) "[A] friend said she had suffered endometriosis, dysmenonhea. After taking 'Female One', dysmenonhea was cured .... "
• (Testimonial) "I was found that the body has more than ten centimeters of ovarian cysts and two, three uterine fibroids . . .. I tried to use the 'Female One' . . .. The abdomen felt more comfortable and bloating feeling disappeared . . . doctor told me ovarian cysts were smaller now."
• (Testimonial) "I found 2 degrees of cervical erosion a routine inspection ... After a course, the previous abdominal distention and odor have disappeared . . . test results showed my cervix erosion has completely disappeared."

"Vagifresh Ball"
• "Help to regulate various kinds of gynaecologic problems. Regulate the endocrine system. Contract the vagina and removal the abnormal flavour of vagina. Help on removal prosopo-colored spot, cyasma, pimple, comedo ... "

"Vagifresh Moisturizing Gel"
• "Increase the elasticity ... of vaginal wall .... "

"Vagifresh Liquid"
• "Detoxifying and eliminating inflammation; Relieving itching."

"Minimizer"
• "Minimizer IS the newest and most innovative non-surgical solution for vaginal tightening."
• "Minimizer will also significantly reduce vagina discharges, reduce vaginal odor and vaginitis."

"Spot & Whitening Cream"
• "[H]elp get rid of ugly spots and freckles on your skin. This fantastic natural cream can also reduce those annoying dark under eye circles and other areas of skin discoloration."

"Female One," "Vagifresh Ball," "Vagifresh Moisturizing Gel," "Vagifresh Liquid," "Minimizer," and "Spot & Whitening Cream" are also "new drugs," as defined in section 201(p) of the Act [21 U.S.C. § 321(p)], because these products 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 sale of the above-mentioned products without approved applications violates these provisions of the Act.

Furthermore, "Female One," "Vagifresh Ball," "Vagifresh Moisturizing Gel," "Vagifresh Liquid," "Minimizer," and "Spot & Whitening Cream" are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for these drugs fail to bear adequate directions for use. Your above-mentioned products are offered for conditions which are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions cannot be written so that a layman can use the above-mentioned products safely for their intended uses. FDA-approved drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 C.F.R. §§ 201.100(c)(2) and 201.115]. Because your above-mentioned products lack FDA-approved applications, they are not exempt under 21 C.P.R. §§ 201.100(c)(2) and 201.115. Introduction or delivery for introduction of misbranded drugs into interstate commerce violates section 301(a) of the Act [21 U.S.C. § 331(a)].

Unapproved Topical Drug

Your firm's "Instant Lift" product is also an unapproved new drug under the Act. This product's labeling includes, but is not limited to, the following:

• "Instant Lift will cause acetylcholine to be released."
• "[C]an stimulate the growth of collagen .... "
• "Reduces under eye sagging."
• "Reduces dark under eye circles."

Under section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)] articles (other than food) that are intended to affect the structure or function of the body are defined as drugs. The claims mentioned above make clear that "Instant Lift" is intended to affect the structure or function of the human body. "Instant Lift" is also a "new drug," as defined in section 201(p) of the Act [21 U.S.C. § 321(p)], because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its 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 sale of "Instant Lift" without an approved application violates these provisions of the Act.
 

* * *

The issues and violations described above are not intended to be an all-inclusive list of your products' deficiencies. It is your responsibility to ensure that any products your firm manufactures and/or distributes meet all of the requirements of the Act and its implementing regulations. We advise you review all the information on your websites, product labels, and other labeling and promotional materials for your products to ensure the claims you make are not in violation of the Act. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

FDA acknowledges that USA Far Ocean Group Inc. issued voluntary nationwide recalls of "U-Prosta" on March 22 2011;1 "X-Hero" and "Male Enhancer" on March 25 2011;2 and "Vagifresh Ball" and "Vagifresh Gel" on January 18, 2012.3 Although you conducted a recall of your product, "Vagifresh Ball," due to bacterial contamination, it is your responsibility to make certain your products do not contain bacterial contamination. Similarly, FDA has not completed laboratory analysis of all of your products. It is your responsibility to make certain none of your products contain undeclared ingredient(s). You must immediately correct these violations, and prevent similar violations from occurring for your products in the future. Failure to promptly correct violations may result in legal action without further notice, including without limitation, seizure and injunction of illegal products 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].

You must notify this office in writing within 15 (fifteen) working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations. Include an explanation of each step taken to completely correct the current violations and to prevent similar violations and provide copies of related documentation. If corrective action cannot be completed within 15 (fifteen) working days, state the reason for the delay and the time within which the corrections will be made. Furthermore, please advise this office what actions you will take to address products that you have already distributed. Address your reply to the U.S. Food and Drug Administration, 222 N. Sepulveda Blvd., Suite 740, El Segundo, CA 90245, Attention: Dr. James Lin, Compliance Officer.

A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm09036l.htm. Any questions regarding this process should be directed to the U.S. Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
 

Sincerely,
/S/
Alonza Cruse, Director
Los Angeles District
 

Cc:
Ingeborg Small, Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue- MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413 

__________________________________________________

1 "U-Prosta": 30 capsule package size (UPC Code 689076499255); 60 capsule package size (UPC Code 88858100030); and 1 capsule package size (no UPC Code).
2 "X-Hero with English Label": 10 capsule package size (UPC Code 689087070995); 8 capsule package size (UPC Code 689076499255); and 1 capsule package size (no UPC Code). "X-Hero with Chinese/English Label": 8 capsule package size (UPC Code 689076499255). "Male Enhancer": 60 capsule package size (UPC Code 98201 0061205).
3 "Vagifresh Ball": 3 tablet individual pack/packaged with "Female One" (UPC Code 689076499156). "Vagifresh Gel": 2 fl. oz. tube individual pack/packaged with "Female One" (UPC Code 689076499057).