On December 5, 2023, the FDA issued a Warning Letter to Ambaya Gold Health Products, LLC following review of the company’s website and social media, which found statements about the company’s 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+ products to be drug claims.

For example, Brain Balance products were promoted with statements such as, “Lithium orotate [an ingredient in Brain Balance] …great natural treatment for a wide range of mental health problems.” The company also promoted ashwagandha with statements such as, “HELPS FIGHT CANCER…helps in reducing the growth of tumors, prevents cancer cells from growing,” “REDUCES BLOOD SUGAR LEVELS…” and “REDUCES SYMP-TOMS OF DEPRES-SION… plays an essential role in reducing depression” on Facebook.

For more information about related products, see ConsumerLab’s Reviews of Ashwagandha and Low-Dose Lithium Supplements.

Also see:

Are there vitamins or supplements that can reduce my risk of breast cancer? Do any increase cancer risk?

Which supplements and foods can help lower or control blood sugar?

What are the best supplements for depression and anxiety?

Immune System Boost products were promoted with statements such as, “MSM [an ingredient in Immune System Boost] can decrease allergic reactions by lowering inflammation and inhibiting the release of cytokines and prostaglandins thanks to its anti-inflammatory and antioxidant effects,” “Silver [an ingredient in Immune System Boost] …well documented natural antibacterial,” and “Have you heard about MSM [an ingredient in Immune System Boost] …it can help with a variety of conditions, like arthritis and joint pain.”

For more information about related products, see ConsumerLab’s Review of Joint Health Supplements.

Also see:

Which supplements are best for seasonal allergies?

Is ingesting colloidal silver helpful for any condition and is it safe to use? Which supplements help with arthritis?

Magnesium Oil Spray products were promoted with statements such as, “Our fast acting topical Magnesium Oil Spray offers the benefits of pure Magnesium Oil in a proprietary Fulvic base....This convenient spray is designed is designed to provide relief from body tension and soreness quickly and effectively....For muscle cramps or pains, spray directly on problem area.”

For more information and tests of related products, see ConsumerLab’s Review of Magnesium Supplements.

Essensiac products were promoted with statements such as, “[H]ealth benefits of slippery elm bark [an ingredient in Essensiac] come from the biochemical compounds that are extracted from it. They include mucilage…[m]ucilage: Helps to soothe sore throats and suppress coughs…” Additionally, Fulvic Green products were promoted with statements such as, “[R]educes allergy symptoms,” “[G]reat anti-inflammation,” “[C]an reduce risk of cancer” under the heading “Benefits of Spirulina” on the company’s Facebook page.

For more information about related products, see ConsumerLab’s Reviews of Alginate and Fruits, Veggies, and Other Greens Supplements.

Additionally, some of the company’s products were found to be misbranded because products failed to bear adequate directions for use. PetHealth+ products were also found to be unapproved new animal drugs because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal.

The company must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

For more information, use the link below.

Warning: Ambaya Gold Health Products, LLC

See related recalls and warnings:

Belmont Eyecare Warned for Colloidal Silver, MSM, and Castor Oil Eye Drop Claims

Pacific BioLogic Co. Warned by FDA for Manufacturing Violations

FDA Warns Seller of Novid NASAL SPRAY for Allergy, Virus, and Cold Claims

Discover Health, LLC Warned for Promoting CBD Products for Cancer, Epilepsy, & More