# FDA WARNING_LETTER - Glenn Burkett Naples Corporation - February 15, 2022

Source: https://www.keypedia.com/records/warning_letter/glenn-burkett-naples-corporation/92936bf9-9b5c-4dd0-95fb-b430b46d328d

> FDA WARNING_LETTER for Glenn Burkett Naples Corporation on February 15, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Glenn Burkett Naples Corporation
- Inspection Date: 2022-02-15
- Product Type: Food
- Office Name: Office of Human and Animal Food Operations East Division IV
- Summary: The FDA issued a Warning Letter to Glenn Burkett Wellness after reviewing their websites (glennburkettwellness.com, gb1com.com) and social media (facebook.com/GlennBurkettBeautyFitnessHealth/) in November 2021. The FDA determined that products such as Colloidal Silver 1400 ppm Dropper, Colloidal Silver 1400 Spray, Silver 750 Sinus Spray, Silver Eye Drops, and various kits (Candida, Cardiovascular, Diabetes) are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

The claims made on the websites and social media, including "Anti-Bacterial, Anti-Fungal, Anti-Viral," and intentions to treat conditions like heartburn, inflammation, depression, and diabetes, establish these products as drugs. Specifically, several colloidal silver products were cited for claims related to mitigating, preventing, treating, diagnosing, or curing COVID-19. The Colloidal Silver 1400 ppm Dropper was also cited for intended use in animals.

These products are considered "new drugs" because they are not generally recognized as safe and effective for their intended uses and lack FDA approval. They are also misbranded because they fail to bear adequate directions for use by a layperson, as they are intended for conditions requiring professional supervision. OTC colloidal silver products are explicitly deemed not GRASE by FDA regulations (21 CFR 31

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Company: https://www.keypedia.com/companies/glenn-burkett-naples-corporation/5605223c-a890-41b0-9581-f784e977ea39

Office: https://www.keypedia.com/offices/office-of-human-and-animal-food-operations-east-division-iv/29043e9a-ce51-494c-8f61-a5d82ef3fe1a