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
Genital Wart Remover & Relief
Skin Cancer Treatment
Smokeless Tobacco Cancer Treatment for Gums, and Lip Sores
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

This page was posted on April 30, 2019.

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