Warning letter · FDA Warning Letters

Glenn Burkett Naples Corporation: FDA Warning Letter 613126 (Jan 19, 2022)

Agency action: Jan 19, 2022Record ID: fda_warning_-69b9f0fabe639415
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What happened

Original notice title

Glenn Burkett Naples Corporation MARCS-CMS 613126, January 19, 2022

From the archived source record

Unapproved New and Misbranded Human Drug Products Examples of claims observed on your websites that provide evidence that your products are intended for use as drugs include: On your webpages [see original source] and [see original source] Silver Eye Drops • “SILVER EYE DROPS Anti-Bacterial, Anti-Fungal, Anti-Viral.” Colloidal Silver 1400 ppm Dropper 4 oz • “The Ultimate Silver 1400 ppm is colloidal silver, Anti-Candida(fungal), Bacteria, Virus” • “Dr. Popular heartburn drugs may increase esophageal cancer risk and weaken bones.” Joint Muscle & Back Support • “JOINT MUSCLE & BACK SUPPORT…provide . . . anti-inflammatory . . . Note: Cholesterol, Diabetic, and Blood Pressure medications deplete CoQ10 which could lead to . . . heart, liver or kidney disease, Diabetes, Dementia, Gastrointestinal disorders, and Thyroid problems.” • “Daily108 [included in the Cardiovascular Kit]: . . . Krill Oil • “Krill Oil…aids skin protection against harmful UV rays.” [On your “All Products” Page and “Krill Oil” Product Page] Mellow Life • “This combination formula has several ingredients designed to relieve . . . depression, and anxiety.” On your social media website [see original source] Thyroid Nourishment • “Thyroid Nourishment product on my website GlennBurkett.com Prescription drugs for thyroid causes bone loss osteoporosis” [From September 10, 2020 Facebook Post] Manuka CBD Silver Spray • “Anti-Inflammatory, kills bacteria, viruses, yeast/fungi. 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, Colloidal Silver 1400 ppm Dropper, Colloidal Silver 1400 Spray, Silver 750 Sinus Spray, Silver Eye Drops, Daily 108, Daily Detox, Digest Foods Capsule, Mellow Life, Candida Kit, Cardiovascular Kit, and Diabetes Kit fail to bear adequate directions for their intended uses 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.

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Status and source details

Status recorded in the archive
No closeout listed in FDA table
Source checked
Jul 16, 2026
Record revision
25ea6a1ea9a0

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 →

What is affected

Product
All Products; Cholesterol, Blood Pressure, Heart Attack, Stroke; Diabetes Kit; Krill Oil…aids skin protection against harmful UV rays; Krill Oil; Suggested Use; Suggested use: Place applicator in nostril, squeeze container and inhale; Silver Eye Drops; Silver 750 Sinus Spray; Silver Eye Drops products as dietary supplements; Colloidal Silver 1400 ppm Dropper; page for Silver 750 Sinus Spray; Suggested use: Place applicator in nostril; page for Silver Eye Drops includes a statement
Company
Glenn Burkett Naples Corporation
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.