What happened
Original notice title
Ambaya Gold Health Products, LLC MARCS-CMS 648130, December 05, 2023
From the archived source record
Unapproved New Drugs Examples of some of the website claims that provide evidence that your products are intended for use as drugs include: Brain Balance product On the Brain Balance product webpage ([see original source] • “Lithium orotate [an ingredient in Brain Balance] …great natural treatment for a wide range of mental health problems.” On the “What is Ashwagandha?” blog post, dated June 20, 2022, ([see original source] which contains a hyperlink to purchase Brain Balance: • Under the heading “Benefits of Top Rated Ashwagandha Supplements”: − “1. Both are known for their antibacterial properties and can be very effective at reducing harmful bacteria. Testing…showed the spirulina increased the production of antibodies as well as infection-fighting proteins and cells that help to protect against cancer…spirulina could have potential to prevent a number of other diseases” − “Protect Against Liver Disease…Protection against liver disease” − “Detox from Heavy Metals…Spirulina acts as a detox for your body, especially from heavy metals, like arsenic. …United States is one of the countries that are most affected by arsenic poisoning. Spirulina is a natural remedy for getting rid of that arsenic and other metals that have accumulated in the body.” − “Reduce Cholesterol…Spirulina can greatly reduce cholesterol as well. Over time, toxins and radiation can build up to dangerous levels, leading to disease, chronic fatigue, brain fog and even cancer.” Silver Spray product On the Silver Spray product webpage ([see original source] “AMBAYA GOLD . . . SILVER SPRAY . . . wide-spectrum antibacterial solution minimizes risk of infections” [from your product label for SILVER SPRAY] “Silver Spray . . .
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
- 0466d8b4dd09
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 →