Inspections, Compliance, Enforcement, and Criminal Investigations

Everything Herbs 4/17/17

 

  

Black HHS-Blue FDA Logo

 

 

 
Atlanta District Office
60 8th Street NE
Atlanta, GA 30309 

 

April 17, 2017
 
VIA OVERNIGHT DELIVERY
and CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
Iris Sylvia
Everything Herbs
P.O. Box 581
Montmorenci, SC 29839
 
WARNING LETTER  
(17-ATL-07)
 
Dear Ms. Sylvia,        
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.everythingherbs.com, from which you take orders for the following products: Art.-C, Black Walnut, Cleavers, Inkberry, Korean Ginseng, Lapacho, Red Clover, and Whole Apricot. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.  
 
Based on the labeling claims on your website, your products are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because they are articles 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 may not be limited to, the following:
 
Art.-C
  • “Helps to provide occasional joint relief after periods of exercise.”
  • “ART.-C was developed . . . to solve the agonies of arthritis and joint pain.” 
Black Walnut
  • “PROPERTIES AND USES: . . . Antibiotic . . . Antiseptic . . . Lymphatic cleaner”
  • “Black Walnut kills the parasites . . .”
  • “As iodine is contained in this valuable hull, thyroid problems are often corrected at the same time . . .”
  • “Black Walnut also reduces lymphatic swellings.” 
Cleavers
  • “PROPERTIES AND USES: . . . Cancer Disorders and Tumors . . . Epilepsy . . . Seizures . . .”
  • “Especially good for . . . cancer of the tongue, skin and all types of cancers.” 
Inkberry
  • “PROPERTIES AND USES: . . . Cancer Disorders . . . Tumors and Prevention . . . Mercury Poisoning . . .”
  • “For daily maintenance as a prevention of cancers or tumors . . .”
  • “If dissolving a cancer or tumor, 40 to 80 drops two to three times per day.”
  • “The root of this herb has the particular ability to excite the entire glandular system to expel mercury.”
  • “It has achieved distinction in the battle to dissolves [sic] cancers and tumors.”
  • “It is taken by Native Americans to prevent and dissolve cancers and tumors.”
Korean Ginseng
  • “Ginseng has been used, successfully, for conditions as different as rheumatoid arthritis, AIDS, allergies, high cholesterol, candida yeast infections, cancer and viral infections.” 
Lapacho
  • “Cancer and Cancer Preventative . . .”
  • “quick relief of pain for cancers of all types as well as their cure within one month in many cases.”
  • “list of problems that medical doctors using Lapacho have solved: Anemia, leukemia, cancer of all types, lupus, inflammation of the reproductive organs, Hodgkin’s disease, Parkinson’s disease, colitis, arteriosclerosis, gastric problems, Leukorrhea, cystitis, hemorrhages, prostate inflammation, polyps, psoriasis and eczema.”
Red Clover
  • “Apply or spray . . . if external cancer or shingles.”
  • “It promotes an alkaline environment of the blood stream which is antagonistic to cancer.”
  • “It has been long recognized as a anti-Cancer herb which promotes a healthy granulation of the afflictions and their dissolution.”
  • “correcting lymphatic problems, kidney conditions, malignant ulcers and sores of long standing.”
  • “responsible for removing external cancer and old skin ulcers.”
Whole Apricot
  • “Cancer preventative”
  • “40 drops to 1 Tbl. 3 times per day, if cancer in the body.”
  • “if a person eats 6-12 apricots kernels per day, they will never have to worry about cancer.”
  • “Contained within these kernels is a very small amount of a substance called nitriloside amygdalin . . . It goes directly to a cancer cell, stings it, and kills it.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. 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 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, your products 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)]. It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded drug under 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 statement of violations that exist in connection with your products. 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 you comply 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.
 
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 the 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 actions within fifteen (15) 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, Lakisha N. Morton, Compliance Officer, Food and Drug Administration, 60 8th Street NE; Atlanta, GA 30309. If you have any questions with regard to this letter, please contact Mrs. Morton at 404-253-1285 or email Lakisha.Morton@fda.hhs.gov.
 
Sincerely,
/S/ 
Ingrid A. Zambrana
District Director
Atlanta District Office
Southeast Region, Office of Regulatory Affairs
U. S. Food and Drug Administration

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