Inspections, Compliance, Enforcement, and Criminal Investigations

Hawk Dok Natural Salve, LLC 4/17/17

 

  

Black HHS-Blue FDA Logo

 

 

 
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612 

 

WARNING LETTER
 
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
April 17, 2017
WL # 22-17
Christopher Haines
Hawk Dok Natural Salve, LLC
71125 Cedar Avenue
Wenden, Arizona 85357
 
 
Dear Mr. Haines,    
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.hawkdok.com, from where you promote the following products to sell on www.Amazon.com: Booster Cleansing Tablets, Genital Wart Remover & Relief, Skin Cancer Treatment, and Smokeless Tobacco Cancer Treatment for Gums, and Lip Sores. 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 marketed products, Booster Cleansing Tablets, Genital Wart Remover & Relief, Skin Cancer Treatment, and Smokeless Tobacco Cancer Treatment for Gums, and Lip Sores, 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 and/or articles intended to affect the structure or any function of the human body.
 
Examples of some of the labeling claims that provide evidence that these products are intended for use as drugs on your website include, but may not be limited to, the following:
 
Booster Cleansing Tablets
  • “Booster Cleansing Tablets are designed for internal cleansing.”
  • “It works also for post cancer treatment and [as] a maintenance program.” 
Genital Wart Remover & Relief
  • “We want your warts gone and your skin healthy. Hawk Dok Genital Wart Remover can do that for you.”
  • “Removes Genital Warts and Jock itch.”
  • “Get your Warts finally off . . .”
  • “attacks and destroys abnormal tissues and does not harm the surrounding healthy tissue.”
  • “Hawk Dok has refined the original formula that was developed by American Indians as a healing salve for comman [sic] ailments such as tumors, moles, warts, skintags and other malignancies.”
  • “My product kills the roots and pulls the virus out.”
Skin Cancer Treatment
  • “Hawk Dok Natural Salve is used to treat skin cancer.”
  • “attacks and destroys abnormal tissues and dose [sic] not harm the surrounding healthy tissue.”
  • “If there is a virus in the wart of skin tags and moles then the salve will attack it and if not it will harm your skin.”
  • “the herbs pull out the virus and cancer . . .”
  • “It cleans cancer out of the body.”
  • “It also helps with PMS and menopause.”
  • “It pulls out bad cells, it helps draw out inflammation and pain.”
  • Ingredients “Sheep Sorrel cleans out the cells and Blood Root pulls it ou[t] and rejuvenates and repairs the skin.”
  • Ingredient “Galangal is used for healing . . . the system. It heals the throat, and esophagus and has been proven to heal mouth and gum sores.”
  • Ingredient “Red Closer is used for cancer prevention, indigestion, high cholesterol, whooping cough, asthma, bronchitis, and sexually transmitted diseases STD’s.” 
Smokeless Tobacco Cancer Treatment for Gums, and Lip Sores
  • “cancer treatment for gums, and lip sores”
  • “Apply on the white sores and gums. Keep using it until sores are gone.”
  • “Hawk Dok Natural Salve Smokess Tobacco Treatment has been designed to help those with cancer sores, gum disease, blisters in the mouth, peptic ulcers, and many other effects from years of smokeless tobacco use.”
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 working days, state the reason for the delay and the time within which you will complete the correction.
 
Your response should be sent to:
 
Kelly D. Sheppard, Director
Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA   92612
 
If you have any questions about the content of this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at 949-608-2918 or raymond.brullo@fda.hhs.gov.
 
Sincerely,
/S/
CDR Steven E. Porter, Jr., Director
Los Angeles District
 
 
cc:      
Arizona State Board of Pharmacy
Kamlesh "Kam" Gandhi
Executive Director
PO Box 18520
Phoenix, AZ 85005-8520
 

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