What happened
Original notice title
Dr. Green Mom, LLC MARCS-CMS 644546, January 30, 2023
From the archived source record
Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Act, 21 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the Act, 21 U.S.C. § 352. We request that you cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of mpox. There is also evidence that it may be effective against other viruses of interest including monkeypox, herpes, RSV, and viruses that cause upper respiratory tract infections (like influenza).” “Colloidal silver is an effective antimicrobial that can be helpful in treating bacterial, viral, and fungal infections.” On the product webpage for “Vitamin D3 (400IU)”: [see original source] “Neuroimmune Vitamin D3 (400IU) is a micellized vitamin formula used for…disease prevention like autoimmune and cancer.” “Alleviates Cold/Flu” “Alleviates Depression” In addition, FDA is particularly concerned that your market your Colloidal Silver product for use in infants and children. The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations such as children and infants who may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites. 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 Vitamin A, Vitamin D, Liquid Zinc, Immunity Boost, Mother’s Immunity, and Colloidal Silver 15ppm 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)].
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
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 20221485c914
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 →