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WARNING LETTER

Herbal Doctor Remedies MARCS-CMS 515519 —

Recipient:
Herbal Doctor Remedies

United States

Issuing Office:
Los Angeles District Office

United States

 

  

Black HHS-Blue FDA Logo

 

 

 
Los Angeles District
19701 Fairchild Road
Los Angeles, CA  92612

 

WARNING LETTER
 
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
May 25, 2017
WL # 33-17
Mr. Hong J. Shen, Owner
Herbal Doctor Remedies
497 Cumbre St.
Monterey Park, CA 91754
 
Dear Mr. Shen:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your facility, Herbal Doctor Remedies, located in Monterey Park, California on November 15 to November 28, 2016. FDA reviewed the labeling of your products, including your websites www.herb-doc.com, www.ChinaSecretMed.com and www.theraherb.com, and determined that many of your marketed products, such as, but not limited to, Asma Aid, Awake, Baby Saver, Cardia Forte, Detensin, Glauco-Catar, Lipidtrol, Lupus Off, Mental Tonic, Pain Stopper, Prostatin, Stroke Saver, Thyro-H, Tumor Off, White Tiger, and Worm Off, are unapproved new and misbranded drugs within sections 505(a) and 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 355(a) and 352(f)(1)]. As described below, the marketing and distribution of your above products without FDA-approved applications is in violation of the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. 
 
Based on our review of product labels collected at your firm and labeling on your websites, www.herb-doc.com, www.ChinaSecretMed.com and www.theraherb.com, we have determined that you promote Asma Aid, Awake, Baby Saver, Cardia Forte, Detensin, Glauco-Catar, Lipidtrol, Lupus Off, Mental Tonic, Pain Stopper, Prostatin, Stroke Saver, Thyro-H, Tumor Off, White Tiger, and Worm Off 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.
 
Examples of claims that provide evidence that your products are intended for use as drugs include, but may not be limited to, the following:
 
Asma Aid
  • “This formula is very effective for treating . . . asthmatic cough . . ..”
  • “It is a great help for bronchitis, bronchial asthma, whooping cough, pneumonia and asthma in children.” 
Awake
  • “Indication . . . alcoholism . . . chronic Cole cystitis [sic], duodenal ulcer, chronic pancreatitis, cirrhosis of liver, malnutrition edema, anorexia . . ..” 
Baby Saver
  • “Usage: It helps stabilize the fetus, nourish the blood for fetal stability, difficult labor, pain in the waist and abdomen during pregnancy . . ..”
  • “Mainly for cases that have abortion symptoms at first stage of pregnancy . . ..” 
Cardia Forte
  • “You can use this formula to prevent heat [sic] attack, [sic] by lowering cholesterol, LDL, and blood clots.”
  • “[A] GREAT FORMULA for lowering cholesterol and for Angina Pectoris.”
Detensin
  • “Indication: This formula helps improve lowering blood pressure, strengthen capillary action, cardiac pump . . ..”
  • “[S]ymptoms associated include nervousness, anxiety, irritability, headache, high blood pressure, orbital and conjunctiva congestion, muscle spasm in the neck and shoulders, dizziness, palpitation and insomnia.”
Glauco-Catar
  • “The most famous formula for treatment and prevention of glaucoma, cataract without surgery, conjunctivitis, hyperemia, blurred vision, pink eyes, photophobia and dry eyes.”
Lipidtrol
  • “Indication: This formula can help reduce levels of serum cholesterol and triglyceride, reduce absorption of fatty food and enhance breakdown of fatty tissues; lowers serum glucose level and reduce synthesis of cholesterol and triglycerides; diuretic effects to reduce blood pressure, prevent coronary artery diseases, atherosclerosis and stroke.”
Lupus Off
  • “[F]or Lupus Erthematosus [sic].”
Mental Tonic
  • “It helps increase mental stability, palpitation, for insomnia, constipation, vertigo. It is also an effective treatment for nervousness in children or elderly and for epilepsy.”
Pain Stopper
  • “Indication: It will help relive [sic] pain, swelling and stiffness of the joints . . . for joint pain of limbs, swelling of the foot . . . and chest discomfort.”
  • “This formula can be used for the following autoimmune diseases: rheumatoid arthritis (RA), systemic lupus erythromotosus [sic] (SLE), and dermatomyositis/polymositis [sic], fibromyalgia and myalgic encelopathy [sic] (ME) or chronic fatigue immune deficiency syndrome (CFIDS).”
Prostatin
  • “It helps . . . reduce painful swelling in the urinary tract. For pain, swelling and itching in the genital area, blood in the urine, redness in mouth, tongue and eyes. It is used for prostatits [sic], urethritis, cystitis, and inflammation of vagina.”
Stroke Saver
  • “[F]or stroke sequela such as hemiplegia, facial deviation, aphasia, slobbering, lower limbs paralysis, incontinence of urine, etc.” 
Thyro-H
  • “The best herbal of choice for hyperthyroidism, substitute for . . . radioactive iodine and surgery.”
Tumor Off
  • “Used for tumor of unknown causes, fibrocystic disease, breast cancer, thyroma [sic], goiter, and cervical lymphadema [sic]. Or as a cancer prevention diet supplement.”
White Tiger
  • “This formula is for initial stage or medium stage of diabetes patients . . ..”
  • “To help reduce blood and urine glucose levels.”
Worm Off
  • “[F]or killing parasite in the intestine such as round worm, tapeworm[,] hooks worm [sic]. . ..”
It is clear from the claims above that your products are drugs under section 201(g)(1) of the Act. Moreover, your products are also “new drugs” under 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 the 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 the drug. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
 
Furthermore, your products are offered for conditions such as, pneumonia, chronic pancreatitis, complications associated with pregnancy, myocardial infarction, hypertension, glaucoma, coronary artery disease, lupus, epilepsy, chest pain, prostatitis, stroke, hyperthyroidism, cancer, diabetes, and parasitic infections 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)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your marketed products. FDA has cited only a few examples of products that you market with drug claims. As such, the cited violations in this letter should not be viewed to apply solely to the specific products mentioned in this letter. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. We note that the inspectional observations (Form FDA 483) issued to you at the conclusion of the FDA inspection documented serious product quality issues with your firm’s Current Good Manufacturing Practice (cGMP). It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations, including labeling and cGMP requirements.
 
You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. 
 
Please respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (15) working days, you should explain the reason for your delay and state when you will complete the corrections.
 
Your response should be sent to:
 
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612
 
If you have any questions about the content of this letter, please contact Jessica Mu, Compliance Officer, at 949-608-4477. Include Special Identifier FEI #3003040962 on all correspondence.
 
 
Sincerely,
/S/                       
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
 
 
Cc:      
David M. Mazzera, Ph.D.
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413
 
 
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