Denver District Office
Denver Federal Center, Bldg 20
Denver, CO 80225 

VIA OVERNIGHT DELIVERY

RETURN RECEIPT REQUESTED
 
 
WARNING LETTER
Ref. # DEN-17-03-WL
 
April 17, 2017
 
 
Mr. Einar Bjarnson
Sunstone, Inc.
1243 East Hillside Drive
Pleasant Grove, Utah 84062
 
 
Dear Mr. Bjarnson,    
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.sunstoneformulas.com, from which you take orders for the following products: Essiac Tea, Virxcan-X Salve, Chelated Boron, Candida-X Tablets, Circulatory Detox & Support Syrup, Colloidal Silver Spray, Fermented Yeast Culture, General Body Detox & Support Tincture, Koffaway Glycerite, Lobelia Tincture, Plague Buster Syrup, and Virxcan-X Tablets. 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.  
 
Unapproved New Drugs and Misbranded Drugs
 
Based on the labeling claims on your website, your marketed products, Essiac Tea, Premium Organic, 8 oz., and Virxcan-X Salve, 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 providing evidence that these products are intended for use as drugs on your website include, but may not be limited to, the following:
 
Essiac Tea, Premium Organic, 8 oz.
Virxcan-X Salve
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 [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. 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)].
 
Unapproved New Drugs and Misbranded Drugs Marketed as Dietary Supplements
 
Based on the labeling claims on your website, your products marketed as dietary supplements, Chelated Boron, Candida-X Tablets, Circulatory Detox & Support Syrup, Colloidal Silver Spray, Fermented Yeast Culture, General Body Detox & Support Tincture, Koffaway Glycerite, Lobelia Tincture, Plague Buster Syrup, and Virxcan-X Tablets, 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:
  
Chelated Boron
Candida-X Tablets
Circulatory Detox & Support Syrup 
Colloidal Silver Spray
Fermented Yeast Culture
General Body Detox & Support Tincture
Koffaway Glycerite
Lobelia Tincture
Plague Buster Syrup
Virxcan-X Tablets
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 [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. 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 written response should refer to the Warning Letter number above (REF# DEN-17-03-WL). Please send your response to Matthew R. Dionne, Pharm.D., Compliance Officer, U.S. Food and Drug Administration, 6th Avenue & Kipling Street – Building 20 DFC, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Dr. Dionne at (303) 236-3064 or via email at Matthew.Dionne@fda.hhs.gov.
 
 
Sincerely,
/S/ 
LaTonya M. Mitchell
District Director
Denver District
 
 
cc:
 
Mr. Einar Bjarnson
(b)(6)

This page was posted on January 25, 2019.

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