Inspections, Compliance, Enforcement, and Criminal Investigations

LCW, INC. 2/6/15

  

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

 

February 6, 2015
 

WL# 07-15

Mr. Kevin H. Chen, President
LCW, Inc. dba uFresh Center and LDF (Leaders Maker)
1011 E. Las Tunas Dr.
San Gabriel, CA 91776
 

Dear Mr. Chen:

The United States Food and Drug Administration (FDA) conducted an inspection of LCW, Inc., located at 1011 E. Las Tunas Dr., San Gabriel, CA 91776, on October 15,2014. Based on our inspection and subsequent review of your product labeling collected during the inspection as well as your firm's website, www.ufreshcenter.com, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov.

The inspection and our review of your website and product labeling collected during the inspection revealed the following significant violations:

Unapproved New Drugs

The FDA reviewed your firm's website at www.ufreshcenter.com, in October and November 2014, and has determined that you take orders for several of your products, including your "uFresh," "Super Ganodetma,", "uLiver Pro," "uBrainy Formula," "uDiabetes Clear," ''uBeauty Formula," "uSlim Formula," "Anti-uAllergies," "uMan Formula," and "uBone Strength" products. Based on our review we have determined that these products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your product labels, "uFresh" flyer and website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

Specific examples of some of the disease claims on your product labels, "uFresh" flyer and website that provide evidence that your products are intended for use in the cure, mitigation, treatment, or prevention of disease are listed below.

"uFresh"
• "Ganoderma ... prevent artery thrombosis, lower the occurrence and development of all kinds of cardiovascular and cerebral vascular diseases ... "
• "[R]educe symptoms induced by psoriasis"
• "Help to prevent and fight against cancer"

"Super Ganoderma"
• "May restrain tumor growth"
• "May reduce side effects of chemotherapy"
• " [A]nti-cancer effects."
• "Can be used to supplement other forms of cancer treatment or help prevent the recurrence of melanomas."

"uLiver Pro"
• "May eliminate Hepatitis B & C."
• "[G]anoderma spore can improve ... aggregated human serum albumin blocking hepatitis B surface antigen, and hepatitis B cell DNA synthesis and repair."
• "[R]emoves hepatitis B viruses, directly clearing liver of toxins"

"uBrainy Formula"
• "May prevent senile dementia"
• "Ganodenna spores have the effect of being anti-cancer, hypoglycemic ... "
• "The product can clear congestion in the vessels and capillaries in the heart and brain, therefore increasing blood flow to reduce blood ... cholesterol, high blood sugar, high blood pressure ... "

"uDiabetes Clear"
• "uDiabetes Clear"
• "May regulate blood sugar"
• "May prevent diabetes complications"
• "[C]an significantly reduce blood sugar ... "
• "[C]an enhance the natural antibacterial immunity, detoxification, and prevention of diabetes complications"

"uBeauty Formula"
• "Regulates menstruation pain ... "

"uSlim Formula"
• "uSlim can help clear the body fat and cholesterol, protect the liver, tumorigenesis and growth. Lotus leaf contains organic acids that can adjust blood cholesterol..."

"Anti-uAllergies"
• "Improve the symptoms of pollen allergy including continuous nasal congestion, itchy nose, eyes and throat, red and swelling eyes, weeping, cough, short of breath, dizziness and headache, etc."
• "Ganoderrna spore has anti-allergic effects by maintaining the body's stability and combating foreign antigens that can cause hyperthyroidism."
• "Radix Saposhnikovia can prevent fevers with chills, headaches, body pains."

"uMan Formula"
• "May effectively prevent and mitigate the symptoms of prostate."
• "Cordyceps is a traditional herb with multiple functions including ... anti-cancer, antiinflammatory, anti-arrhythmic ... "
• "Morinda officinalis is ... proven to help with infertility, impotence ... "
• "The herb [Epidemii] proves to work like a male hormone that promotes semen excretion while lowering blood sugar. Long-term use, can delay physical aging, reduced nocturia."

"uBone Strength"
• "May prevent osteoporosis"
• "May eliminate arthritis"
• "uBone also has anticoagulant effects ... prevents thrombosis."
• "Buck grass can ... reduce blood pressure, and soften blood vessel effects."
• "[P]revents osteoporosis. Eucommia helps with waist discomfmt, joint pain, kidney deficiency, senile syndrome, asthma, high blood pressure and liver disease"
• "A lady who lives in Florida suffered from rheumatic diseases ... After 10 days, the toes were not only less curved, but also felt less pain"

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are "new drugs" under section 201 (p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 30l(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Furthermore, your "uFresh," "Super Ganoderma," "uLiver Pro," "uBrainy Formula," "uDiabetes Clear," "uSlim Formula," "uMan Formula," and "uBone Strength" products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(l) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 30l(a) ofthe Act [21 U.S.C. § 331(a)].

This letter is not an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for all of your products to ensure that the claims you make for your products do not cause them to violate the Act.

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 seizure and/or injunction.

Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Include any explanation of each step being taken to prevent. the recurrence of the 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 which you will complete the corrections.

Your response should be directed to:
 

Dr. James Lin, Compliance Officer
U.S. Food and Drug Administration
222 N. Sepulveda Blvd.
Suite 740
El Segundo, CA 90245
 

Sincerely,
/S/

Alonza Cruse
Director, Los Angeles District
 

Cc:
Harlan Loui, Acting Chief
California Depatiment of Public Health
Food and Drug Branch
1500 Capitol Avenue- MS 7602
P.O. Box 997435
Sacramento, California 95899-7435
Attn: FDA Correspondence

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