FDA WARNING_LETTER - Ambaya Gold Health Products, LLC - December 05, 2023

On December 5, 2023, the FDA issued a Warning Letter to Ms. Martin of Ambaya Gold, following reviews of their websites (www.ambayagold.com and www.facebook.com/AmbayaGoldHealth) in April and November 2023. The FDA determined that Ambaya Gold sells products, including Brain Balance, Immune System Boost, Dentist In A Bottle, Essensiac, Fulvic Green, Silver Solution, Detox Cleanse Renew, Magnesium Oil Spray, Silver Spray, and Pet Health+, with claims establishing them as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

The FDA cited numerous claims on Ambaya Gold's websites and social media that indicate the products are intended for disease treatment, cure, mitigation, prevention, or to affect body structure/function. For example, "Brain Balance" was marketed for mental health problems, depression, and cancer, while "Immune System Boost" was advertised for allergies and anti-inflammatory effects. "Dentist In A Bottle" claimed to prevent and remediate gum and tooth decay, and "Pet Health+" was promoted for detox, parasite protection, and wound recovery in animals.

The FDA stated that Brain Balance, Immune System Boost, Dentist In A Bottle, Essensiac, Fulvic Green, Silver Solution, and Detox Cleanse Renew are "new drugs" lacking FDA approval, violating sections 301(d) and