What happened
Original notice title
Blue Ridge Silver MARCS-CMS 566247, February 05, 2019
From the archived source record
A recent study showed that people who had cases of gingivitis or periodontal disease tended to exhibit sings [sic] of early Alzheimer’s, dementia or extreme mental confusion.” “ . . . [G]ood oral health habits – including regular oral colloidal silver usage to keep populations of problematic oral pathogens at bay --- can lower your risk of heart-related ailments.” “ . . . [C]olloidal silver is a proven effective method for preventing the buildup of bacterial plaque.” “ . . .[A]ccording to a 1999 study conducted at Brigham Young University, the bacterium Streptococcus mutans , which is a major cause of dental plaque and tooth decay, was inhibited and destroyed using 5ppm of colloidal silver. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, your BLUE RIDGE SILVER TM Colloidal Silver products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Further, according to 21 CFR 310.548, any OTC drug product containing colloidal silver ingredients that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a “new drug” within the meaning of section 201(p) of the Act for which an approved application is required for marketing, without which such product is also misbranded under section 502 of the Act [21 U.S.C. 352]. 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.
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
- 1177037487b0
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.
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