Inspections, Compliance, Enforcement, and Criminal Investigations

Sunstone, Inc. 4/17/17

 

  

Black HHS-Blue FDA Logo

 

 

 
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.
  • “it has been used for cancer, cancer prevention, AIDS, diabetes . . .”
  • “Cancer and AIDS sufferers or other ill people may wish to take 2 fluid ounces of the tea twice daily on an empty stomach.”
Virxcan-X Salve
  • “remarkably-effective preparation for those suffering with moles, warts, and other growths!”
  • “Glycerin . . . and Turmeric are included in the formula to decrease scaring.”
  • “anti-inflammatory”
  • “Traditionally used for skin tags, warts, skin cancer and fungoid growths.”
  • “Antifungal, antitumor, antidementia, and antioxidant.”
  • “Traditionally used for liver congestion, arthritis, malignant growths, respiratory and urinary tract infection.”
  • “Traditionally used for cancer, and as a broad-spectrum internal and external antimicrobial to treat bacterial and fungal infections.”
  • “tumor-preventing activity.”
  • “Traditionally used for promoting removal of catabolic wastes from all parts of the body including a congested lymphatic system and swollen inflamed tissue of the throat, mammary glands and testicles.”
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
  • “absorbs and eliminates radiation, and may be an important element in warding off cancer, arthritis, and other disease.”
  • “Boron as a Radioactive contaminant Detoxifier . . .”
  • “boron is commonly recognized as a viable antidote, when taken internally, against severe, acute radioactive poisoning.”
  • “When we take boron internally, it enables our DNA to create a more powerful buffering system for warding off radiation and repairing breaks in chromosomes caused by radioactive contamination.”
Candida-X Tablets
  • “Effectively eliminates Candida albicans and other strains of damaging yeasts and fungi from your entire body . . .”
  • “used traditionally for killing fungus and yeast infestations . . .”
  • “if we’re interested in doing something proactive about eliminating the overabundance of Candida and other dangerous yeasts and fungi from our bodies, we need to start taking Candida-X Tablets . . .”
  • A customer testimonial on your website states, “I had a rip roaring vaginal yeast infection. I took 3 Candida-X tablets with breakfast every day. It took two weeks for it to entirely go away.”
  • “To ensure that all systemic yeast has been eradicated, consider taking 1 tablet/day for an additional week or two after the symptoms have disappeared.”
Circulatory Detox & Support Syrup 
  • “Circulatory system cleansing has traditionally been used as a cancer preventative.”
Colloidal Silver Spray
  • “used to fight bacterial and viral infections.”
  • “The spray cap facilitates applying colloidal silver to external wounds and infections!”
Fermented Yeast Culture
  • “People . . . who take FYC daily report staying healthy while others around them readily fall victim to colds and flus."
  • "More effective and efficient NK (natural killer) cell activity - Your body's first line of defense against invading pathogens or cancer cells."
  • “FYC's incredible ability to kill viruses, bacteria, and tumor cells, and, thus, prevent infectious diseases."
  • "People with chronic digestive problems of all kinds, such as indigestion, heartburn, acid reflux disorder, stomach ache, etc., respond well to a daily dosage of FYC."
General Body Detox & Support Tincture
  • “Excellent for killing infections without harming beneficial bacteria in the intestines.”
  • “used to quickly rid the body of infections (e.g., tooth, gums, ears, etc.), sudden illness of any kind, nuclear fallout, chemical exposure, and other toxic exposure, etc.”
  • “Dose: 1-2 teaspoons, 3 times a day until the infection symptoms are gone or, in cases of radioactive or chemical contamination, until you finish the bottle.”
  • Ingredient “red clover is a strong blood thinner.”
Koffaway Glycerite
  • “cough formula”
  • “Superbly-crafted for easing coughs and other respiratory ailments.”
  • “If you feel like you are coming down with a cold/cough, take Koffaway™ immediately to nip it in the bud.”
  • “With acute coughing, it can be taken every 15 minutes until the coughing begins to subside.”  
Lobelia Tincture
  • “Lobelia is an effective systemic relaxant, anti-spasmodic, and natural epileptic remedy.”
  • “Traditionally, it’s taken internally and rubbed on the chest for asthma, bronchitis, and other respiratory problems.”
  • “It can be rubbed on the neck and spine of . . . sick child . . .”
  • “It can act as an emetic . . . causing a person to vomit.”
Plague Buster Syrup
  • “Cold & Flu Fighter”
  • “Plague Buster™ Syrup, formerly named Anti-Plague, has traditionally been used for colds, sore throats, flu and respiratory ailments of all kinds.”
  • “includes anti-bacterial, anti-viral and anti-fungal properties.”
  • “Plague Buster prevents or stops flu and colds dead in their tracks!”
  • “most effective flu- and cold-fighter.”
  • “combination of powerful antibacterial/antiviral and well as immune system-enhancing herbs . . .”
  • “work with the body’s immune system to fight off the foreign invaders and generate new, healthy cells to replace damaged and sick ones.”
  • A customer testimonial on your website states, “It has cured us from the flu bug and cold in 1 or 2 days . . .”
Virxcan-X Tablets
  • “Virxcan-X Tablets are an effective formula for those suffering from moles, warts, and other growths both externally and internally!”
  • “Traditionally used for . . . warts, skin cancer and fungoid growths”
  • “Antibacterial, antifungal, anti-inflammatory . . .”
  • “Traditionally used for liver congestion, arthritis, malignant growths, respiratory and urinary tract infection.”
  • “antidementia”
  • “emetic, cathartic, antifungal.”
  • “relieving the pain of both eczema and psoriasis, for sores, burns, and as an aid against skin cancer.”
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)

 

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