What happened
Original notice title
Sunstone, Inc. 4/17/17
From the archived source record
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. 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. 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.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 68c8b0e4413c
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →