Inspections, Compliance, Enforcement, and Criminal Investigations

Modern Herb Shop 2/26/15

  

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

Public Health Service
Food and Drug Administration
  

 

February 26, 2015
 
WARNING LETTER
 
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
Melanie Fine
Modern Herb Shop Inc.
PO Box 1706
3045 Sacramento St.
Sacramento, CA 95667
 
Dear Melanie Fine:                                                                                         
 
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.modernherbshop.com/ in February 2015. Based on our review, FDA has determined that you take orders there for several products; a select sampling of such products include, but are not limited to “Bone Knitting Powder,” “Bu Zhong Yi Qi Wan | Central Chi Teapills,” “Burn Ointment | Ching Wan Hung Soothing Herbal Balm,” “Chuan Xin Lian,” “Huang Lian Su,” “San Huang San  | Herbal Ice,” “Si Miao San Herb Extract Powder,” “Wu Yang Brand Pain Relieving Medicated Plaster,” “Yunnan Baiyao Capsules and Powder,” and “Zheng Gu Shui.” FDA has determined that your website promotes these products, for conditions that cause them 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)], because they are intended to cure, mitigate, treat, or prevent disease conditions and/or under section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)], because they are intended to affect the structure or function of the body. 
 
The intended use of a product may be determined by, among other things, its labeling claims, advertising, and circumstances surrounding its distribution. [21 C.F.R. §201.128]. Statements documenting the intended use of your above listed products include, but are not limited to, the following:
 
Bone Knitting Powder
“recommended for the use of bone fractures, dislocations, torn or damaged ligaments, such as neck, ACL or Medial Collateral Ligament . . . .”
“promotes circulation, prevents atrophy, repairs damaged tissue . . . strengthens and heals broken bones . . . .”
 
Bu Zhong Yi Qi Wan | Central Chi Teapills
“Use for spleen deficiency leading to organ prolapse and liver-spleen disorders such as hypoglycemia, epigastric distension, esophageal reflux and certain autoimmune diseases, and to combat the effects of chemotherapy.”
“Applicable for uterine bleeding due to spleen deficiency, poor digestion due to chronic hepatitis or cirrhosis, and certain wei patterns, including myasthenia gravis and multiple
sclerosis.”
 
Burn Ointment | Ching Wan Hung Soothing Herbal Balm
“used for serious third degree burns in hospitals.”
“decreases inflammation, and promotes the regeneration of damaged tissues due to burns.”
“Use topically for first, second, and third degree burns with blistering, redness and pain.”
 
Chuan Xin Lian
“Effective for viral tonsillitis, viral hepatitis, herpes simplex and zoster, common cold, influenza, measles, mumps, and chicken pox.”
“Also used for bacterial infections causing sore throat, tonsillitis, sinusitis, bacterial dysentery, and skin infections such as boils.”
“Can also be used for acute gastroenteritis, urinary tract infection, pelvic inflammatory disease, ear infections, gum infections and bronchitis.”
 
Huang Lian Su
“Use for intestinal bacteria causing bacterial dysentery, diarrhea, food poisoning, gastroenteritis, abdominal distension; also acute and chronic appendicitis . . . .”
“may be used for a variety of intestinal pathogens including the vacteria Proteus, Citrobacter, E.Coli, the fungus Candida Albicans, and intestinal protozoa including giardia.”
“effective for various strep and staph infections causing tooth abscess, canker sore, strep throat, sinus infection, and skin boil.”
 
San Huang San | Herbal Ice
“premiere external gao for 1st stage sinew and bone injuries with swelling, pain and redness (heat).”
“reduce[s] inflammation while dispersing congealed blood and fluids.”
“Reduces pain and inflammation”
“Speeds healing”
 
Si Miao San Herb Extract Powder
“used to treat infectious arthritis (bacterial, Lyme disease) and immune-mediated polyarthritis.”
“Useful in rheumatoid arthritis, and in painful joints due to rheumatic fever, gout or lupus.”
 
 
Wu Yang Brand Pain Relieving Medicated Plaster
“application of choice for . . . acute traumatic swelling . . .”
“indicated for neuralgia, rheumatoid arthritis, spasms, swelling and pain . . . sprain, and fracture.”
 
Yunnan Baiyao Capsules and Powder
“considered a sort of miracle herbal formula for wounds, pain, and hemorrhage” [and] “its reputation is similar to that of Penicillin . . . .”
“Chronic stomachache, gastric & bleeding ulcers”
“Gynecological blood stasis, including amenorrhea, irregular menstruation, menorrhagia, uterine bleeding and leucorrhoea, and postpartum blood stasis.”
“Hemoptysis caused by bronchitis, pneumonia, bronchiectasia, and tuberculosis”
“Blood in urine or stool.”
“Acute traumatic bleeding”
“Knife wounds”
“Gunshot wounds”
“Hot or oozing sores”
“Poisoned sores”
 
Zheng Gu Shui
“well known for its effectiveness at healing deep bone bruises and fractures.”
“In case of fractures, set the bones first.”
 
These products are also “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 the above referenced uses nor are your products marketed in conformity with any over-the-counter (OTC) Drug Monograph. Under section 505(a) of the Act [21 U.S.C. § 355(a)], a new drug may not be legally marketed in the United States without an FDA approved application. 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. There are no FDA approved applications in effect for your “new drugs.” Thus, the marketing and distribution of these products for their intended uses violate this provision of the Act.   The introduction of an unapproved new drug into interstate commerce is a violation of section 301(d) of the Act [21 U.S.C. § 331(d)].
 
Furthermore, many of the conditions for which these products are offered, such as hepatitis, multiple sclerosis, autoimmune diseases, tonsillitis, measles, mumps, chicken pox, skin infections, gastroenteritis, urinary tract infections, pelvic inflammatory disease, ear and gum infections, and bronchitis 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 layman can use these drugs safely for these intended purposes. Each product's labeling fails to bear adequate directions for these intended uses, causing each product to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)]. 
 
Additionally, we note that your product labels for “Bu Zhong Yi Qi Wan | Central Chi Teapills” and “Chuan Xin Lian” include a statement of identity as herbal supplements. Under the Act, as amended by the Dietary Supplement Health and Education Act, dietary supplements may be legally marketed with truthful and non-misleading claims to affect the structure or function of the body (i.e., structure/function claims) if certain requirements are met. However, with the exception of certain health claims specifically and expressly authorized by FDA, any claims that dietary supplement products are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims) cause such products to be drugs rather than dietary supplements.[1]
 
Also, topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements under section 201(ff) of the Act [21 U.S.C. § 321(ff)]. Both disease claims and structure/function claims cause these non-ingested products to be new drugs.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products and their labeling. 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. It is your responsibility to assure that your firm complies 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 and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps 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 which you will complete the correction. Your response should be sent to:
 
U.S. Food and Drug Administration                                                             
CDER/OC/OUDLC
10903 New Hampshire Avenue, WO51
Silver Spring, MD 20993-0002
 
 
Sincerely,
/s/
Cynthia Schnedar, J.D.
Director
Office of Compliance
Center for Drug Evaluation and Research
 
 
Cc:
Melanie Fine
2223 Jim Valley Rd
Placerville, CA 95667
 
Rhonda A Hughes
3274 6th Ave
Sacramento, CA 95817


[1] For more information regarding the difference between structure/function claims and disease claims, see FDA’s final rule at http://www.gpo.gov/fdsys/pkg/FR-2000-01-06/html/00-53.htm (codified at Title 21 of the Code of Federal Regulations (21 C.F.R.) § 101.93(g)). Also see 21 C.F.R., Parts 310 and 330-358, which contain FDA's regulations on over-the-counter drugs, for information regarding certain over-the-counter drugs that are not new drugs and may be legally marketed without prior approval from FDA.
 

 

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