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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Shen Clinic, LLC. 5/14/13

  

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

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone (510) 337-6700 

 

VIA UNITED PARCEL SERVICE
 
Our Reference: FEI No. 3007615976
 
May 14, 2013
 
Mr. Joel Schreck
Ms. Betty Schreck
Shen Clinic, LLC
1071 San Pablo Avenue
Albany, CA 94706
 
689 Creston Road
Berkeley, CA 94708

WARNING LETTER
 
Dear Joel Schreck and Betty Schreck:
 
This is to advise you that the U.S. Food and Drug Administration (FDA) has reviewed the labeling claims on your website www.drshen.com for your marketed products which include, but are not limited to, “Acorus Tablets,” “Blue Citrus,” “Chih-ko and Curcuma,” “Paris 7,” “Reconciling Tablets,” “Tremella 14,” “Viola 12,” “Astra Isatis Herbal Supplement,” “Golden Book Pill (Jin Gui Shen Qi Wan),” “Dr. Shen’s Cold Stop,” “Dr. Shen’s Sinus,” “Shen Clinic Man’s Treasure,” “Shen Clinic Good Heart,” and “Shen Clinic Urinary Formula.”  As described below, the marketing of these products violates the Federal Food, Drug, and Cosmetic Act (the Act).
 
The claims you make for your marketed products on your website www.drshen.com may have serious public health implications. Many of your products are promoted for serious health conditions, such as (but not limited to), cancer, epilepsy, hepatitis, and HIV that require diagnosis and treatment by licensed medical practitioners. Serious health conditions are not amenable to self-diagnosis and treatment by individuals. By offering your products for sale on your website with such claims, consumers who purchase your products may forgo seeking their licensed healthcare providers to receive proper diagnosis and treatment for their disease(s). Delaying necessary treatment can increase the risk for serious harm or death. Cited below are some examples and these do not represent a comprehensive list of violative products you market on your website.
 
According to the labeling claims, “Acorus Tablets,” “Blue Citrus,” “Chih-ko and Curcuma,” “Paris 7,” “Reconciling Tablets,” “Tremella 14,” “Viola 12,” “Astra Isatis Herbal Supplement,” “Golden Book Pill (Jin Gui Shen Qi Wan),” “Dr. Shen’s Cold Stop,” “Dr. Shen’s Sinus,” “Shen Clinic Man’s Treasure,” “Shen Clinic Good Heart,” and “Shen Clinic Urinary Formula” are promoted for conditions that cause them to be drugs under 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 and/or intended to affect the structure or any function of the body. 
 
Specific examples of labeling claims observed on your website www.drshen.com for the above-mentioned products include, but may not be limited to, the following:
 
Acorus Tablets
  • “Indications for Use . . . attention deficit disorder, epilepsy, mental retardation, insomnia, anxiety attacks . . . neuromotor disorders . . .”
 
Blue Citrus
  • Chinese Medicine Activities . . . resolve masses . . .”
  • Indications for Use . . . breast lumps, chronic lung infection, hepatitis with fibrosis, adjunct therapy for beast [sic] and liver cancers . . .”
 
Chih-ko and Curcuma
  • Chinese Medicine Activities . . . resolves masses . . .”
  • Indications for Use . . . tumours, abscesses . . .”
  • “This formula was inspired by . . . a formula called Pingxiao Dan for treating most cancers . . . [t]he first three ingredients of Chih ko/Curcuma are key ingredients of Pingxiao Dan.”
  • “Chih ko/Curcuma . . . may be used . . . for pre-cancerous conditions, such as cervical dysplasia.”
 
Paris 7
  • Indications for Use . . . cancer, viral hepatitis or other chronic viral infections, lung infections . . .” 
  • “This formula is intended for . . . the treatment of chronic viral infections or cancer . . ..”
  • “Paris 7 was designed to have two dominant uses: treating patients with cancer and treating chronic viral diseases, such as hepatitis . . ..”
 
Reconciling Tablets
  • Indications active phase of autoimmune disorders, such as lupus, rheumatoid arthritis, multiple sclerosis . . .”
  • “This formula is intended for . . . use during the inflammatory stage of autoimmune disorders . . .”
 
Tremella 14
  • Indications for Use . . . chronic feverish condition, hepatitis, pneumonia, bronchitis, tuberculosis, diabetes, nephritis, immune deficiency . . .”
 
Viola 12
  • Chinese Medicine Activities . . . resolve toxic swellings . . .”
  • Indications for Use immune deficiency disorders complicated by swellings or chronic infections, cancer therapies, lymph node swelling of unknown origin . . .”
 
Astra Isatis Herbal Supplement
  • Therapeutic Actions: Serve as an immune system tonic for viral infections and inflammations accompanied by . . . lymphatic swelling. Useful for chronic fatigue syndrome, herpes simplex, HIV, hepatitis.”
 
Golden Book Pill (Jin Gui Shen Qi Wan)
  • For diabetes involving the kidneys marked by frequent urination, use Jin Gui Shen Qi Wan (Golden Book Pills) . . ..”
 
Dr. Shen’s Cold Stop
  • “Used at the first sign or during the first two days of cold.”
  • “Also used when exposed, or likely to be exposed to cold.”
  • The actual, long sought cure for the common cold . . ..”
  • Serving: At the first sign of Cold: Take six pills immediately . . . [f]or prevention: Take three tablets . . ..”
 
Dr. Shen’s Sinus (also known as Pe Min Kan Wan)
  • “Used for nasal and sinus discomforts caused by colds, sinusitis, rhinitis, and allergies.”
  • Sinus & Nose Pill Ingredients: Angelica Dahurica . . . alleviates pain, reduces swelling . . .”
 
Shen Clinic Man’s Treasure
  • Suggested Use: . . . the inability to get or maintain an erection.”
  • “[T]hese medicines also are used for infertility . . ..”
  • Man’s Treasure Ingredients: . . . Tu Su Zi – 15% . . . [u]ses include impotence . . ..”
 
Shen Clinic Good Heart
  • Traditional Uses: . . .[r]educe [c]holesterol.”
  • Harthorne-based formula is used . . . for cholesterol reduction.”
 
Shen Clinic Urinary Formula
  • “For Urinary Tract inflammation.”
 
The above-mentioned claims make clear your products, “Acorus Tablets,” “Blue Citrus,” “Chih-ko and Curcuma,” “Paris 7,” “Reconciling Tablets,” “Tremella 14,” “Viola 12,” “Astra Isatis Herbal Supplement,” “Golden Book Pill (Jin Gui Shen Qi Wan),” “Dr. Shen’s Cold Stop,” “Dr. Shen’s Sinus,” “Shen Clinic Man’s Treasure,” “Shen Clinic Good Heart,” and “Shen Clinic Urinary Formula,” are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)].  Furthermore, these products 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 products “Acorus Tablets,” “Blue Citrus,” “Chih-ko and Curcuma,” “Paris 7,” “Reconciling Tablets,” “Tremella 14,” “Viola 12,” “Astra Isatis Herbal Supplement,” “Golden Book Pill (Jin Gui Shen Qi Wan),” “Shen Clinic Man’s Treasure,” “Shen Clinic Good Heart,” and “Shen Clinic Urinary Formula” are also misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], because 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 CFR § 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 CFR §§ 201.100(c)(2) and 201.115]. Because “Acorus Tablets,” “Blue Citrus,” “Chih-ko and Curcuma,” “Paris 7,” “Reconciling Tablets,” “Tremella 14,” “Viola 12,” “Astra Isatis Herbal Supplement,” “Golden Book Pill (Jin Gui Shen Qi Wan),” “Shen Clinic Man’s Treasure,” “Shen Clinic Good Heart,” and “Shen Clinic Urinary Formula” lack FDA-approved applications, they are not exempt under 21 CFR §§ 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)]. The introduction or delivery for introduction of misbranded drugs into interstate commerce violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
*          *          *
 
The issues and violations described above are not meant to be an all-inclusive list of deficiencies in your products and their labeling. Only examples of violative products marketed on your website have been included in this Warning Letter, not all. It is your responsibility to ensure that all products your firm manufactures and/or distributes are in compliance with the laws and regulations enforced by FDA. We advise you review all the information on your website(s), product labels, and other labeling and promotional materials for your products to ensure the claims you make are not in violation of the Act.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in regulatory 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]. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
 
Within fifteen (15) 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 (15) working days, state the reason for the delay and the time within which you will complete the correction.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Lawton W. Lum, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have questions regarding any issues in this letter, please contact Compliance Officer Erlinda Figueroa at (510) 337-6795.
 
Sincerely,                                                                   
/S/ 
Elizabeth A. Kage
Acting District Director
San Francisco District