WARNING LETTER
Glenn Burkett Naples Corporation
MARCS-CMS 613126 —
January 19, 2022
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Mr. Glenn Burkett
Recipient Title
President
Glenn Burkett Naples Corporation
298 Smith Drive
Santa Rosa Beach
,
FL
32459
United States
gb1com@aol.com
Issuing Office:
Office of Human and Animal Food Operations East Division IV
United States
WARNING LETTER
22-HAFE4-WL-01 / CMS No. 613126
Dear Mr. Burkett:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at https://glennburkettwellness.com and https://gb1com.com in November 2021 and has determined that you take orders for the products Colloidal Silver 1400 ppm Dropper, Colloidal Silver 1400 Spray, Silver 750 Sinus Spray, Silver Eye Drops,
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Daily 108, Daily Detox, Digest Foods Capsules, Joint Muscle and Back Support, Krill Oil, Mellow Life, Candida Kit, Cardiovascular Kit, Diabetes Kit”, “Thyroid Nourishment. We also reviewed your social media website at https://www.facebook.com/GlennBurkettBeautyFitnessHealth/, where you direct consumers to your websites, www.glennburkett.com and www.myglennburkett.com, both of which automatically redirect to www.gb1com.com, to purchase your products. The claims on your websites establish that the products are drugs under section 201(g)(1)(B) and/or (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 321(g)(1)(B) and/or (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body. Furthermore, your Colloidal Silver 1400 ppm Dropper, Colloidal Silver 1400 Spray, Silver 750 Sinus Spray, Silver Eye Drops and Manuka CBD Silver Spray are intended to mitigate, prevent, treat, diagnose, or cure COVID-19
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in people. In addition, your products Colloidal Silver 1400 ppm Dropper are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in animals, which makes them drugs. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
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 https://glennburkettwellness.com and https://gb1com.com:
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. Collins at Harvard Medical has a protocol using Silver to make antibiotics 10 to 1,000 times more effective against infection”
• “Silver 1400 is a natural anti-fungal.”
Digest Foods Capsules
• “Supports . . . against symptoms of heartburn, acid reflux, indigestion, Gerd, . . . diarrhea, constipation, hemorrhoids, colitis, IBS, IBD, diverticulitis, Crohn's disease and malabsorption. Popular heartburn drugs may increase esophageal cancer risk and weaken bones.”
Joint Muscle & Back Support
• “JOINT MUSCLE & BACK SUPPORT…provide . . . anti-inflammatory . . . Reduced inflammation equals less pain and swelling.” [On your “All Products” Page and “Joint Muscle & Back Support” Product Page]
Daily Detox Product
• “DAILY DETOX …Some symptoms of this condition can include depression… acid indigestion and allergies.” [On All Products page under Daily Detox]
Candida Kit
• On an infographic on your Candida Kit product page: “…BODY WIDE SYMPTOMS FROM CANDIDA…Depression, Anxiety…Sore throat, Allergies, Nagging cough . . . Asthma, Bronchitis, Kidney/Bladder infections, Yeast infections . . . Arthritic or joint pain, Jock itch, Athletes foot, Nail fungus, Ear infections, Acne . . . Sinus infections, Heartburn, Acid reflux, Gerd . . . Constipation, Diarrhea, Abdominal pain, Diverticulitis, IBS/IBD, Colitis, Crohn’s.”
• “Silver 1400 [included in the Candida Kit] is a natural anti-fungal.”
• “Digest Foods [included in the Candida Kit] Supports digestion & absorption for persons with indigestion, heartburn, or acid reflux.”
• “Krill Oil [included in the Candida Kit] Omega-3 supports immune system against Candida”
Cardiovascular Kit
• “Cholesterol, Blood Pressure, Heart Attack, Stroke” [listed on the Cardiovascular Kit product page]
• “Heart & Cardio [included in the Cardiovascular Kit] . . . Alpha Lipoic acid that helps lower LDL, Resveratrol helps clear arteries of plaque buildup, Amino acids to help dilate the artieries [sic] . . . Hawthorn . . . lowers blood pressure, MSM to relieve inflammation.”
• “CoQ10 [included in the Cardiovascular Kit]: . . . 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]: . . . Helps improve and reduce artery blockage . . . Reduces high blood pressure”
• “Krill Oil [included in the Cardiovascular Kit]: . . . Reduces blood pressure”
Diabetes Kit
• “Joint, Muscle & Back Multiple [included in the Diabetes kit]: Ingredients . . . specifically helpful for reducing inflammation”
• “Silver 1400 . . . Daily Detox [included in the Diabetes kit]: Candida overgrowth (caused by antibiotic medication . . . that kills good bacteria). Candida causes . . . high blood sugar. Silver kills Candida.”
• “Heart & Cardio [included in the Diabetes kit]: Multiple nutrients needed for Diabetics including . . . Chromium to improve insulin efficiency, CoQ10 . . . stabilizes blood sugar.”
• “Daily 89 Ingredients Multi Vitamin for Men and Women [included in the Diabetes kit]: 89 Vitamins, Minerals, Enzymes, Herbs & Fruits to nourish the pancreas in Diabetics. Plus the B vitamins that work best when taken together to . . . prevent neuropathology, atherosclerosis and needed for diabetic ulcer repair.”
• In addition, the name of your “Diabetes Kit” is an implied claim that the product is intended to mitigate, prevent, treat, diagnose, or cure diabetes.
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 https://www.facebook.com/GlennBurkettBeautyFitnessHealth/:
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. Helps with pain” [From September 1, 2020 Facebook Post directly above the Manuka CBD Silver Spray]
Joint Muscle & Back
• “Joint Muscle & Back provides a blend of natural anti-inflammatory nutrients . . .” [From July 29, 2020 Facebook Post within Infographic]
Daily 108
• “DAILY 108 . . . This daily multiple vitamin supports . . . backaches, osteoporosis, as well as anxiety, insomnia, restless leg/cramps” [From July 29, 2020 Facebook Post within Infographic]
Silver 1400ppm Colloidal Silver
• “Silver 1400ppm Colloidal Silver . . . Anti-Bacterial . . . Anti-Viral . . . Anti-Fungal . . .” [From July 29, 2020 Facebook Post within Infographic]
Colloidal Silver [an ingredient in your Colloidal Silver 1400 ppm Dropper, Colloidal Silver 1400ppm1400 Spray, Silver 750 Sinus Spray, and Silver Eye Drops products]
• “COVID-19 MUTATION will out smart the treatment. Glenn Burkett Is betting his life on Colloidal Silver to kill any mutations of COVID-19. . . . Understand that Prescription Drugs depress or destroy the immune system. [From June 13, 2020 Facebook Post.]
• “I believe in boosting the immune system with Colloidal Silver and not destroying it with ANTIBIOTICS and Steroids…NYTIMES.COM…Doctors Heavily Overprescribed Antibiotics Early in the Pandemic.” [From June 7, 2020 Facebook Post]
• “Silver uses for infection. Hypocrites used Silver for infection 500 BC . . . Doctors used Silver in Civil War in America to fight gonorrhea and in enemas to fight dysentery. In World War I Silver was used in wounds to fight infection. Dr. Collins at Harvard Medical has a protocol using Silver to make antibiotics 10 to 1,000 times more effective against infection.” [March 18, 2020 Facebook Post Showing Picture of “Silver 1400 ppm” Label]
• “The virus enters the body primarily through the nose. Also, it may get in through eyes and mouth . . . I use GLENN BURKETT SILVER to protect the nose, mouth and eyes from infection.” [March 15, 2020 Facebook Post]
Your social media website https://www.facebook.com/GlennBurkettBeautyFitnessHealth/ also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your Colloidal Silver 1400ppm1400pm Spray, Silver 750 Sinus Spray, and Daily 108 products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
• “I developed corona virus working at my job…I got Colloidal Dilver [sic] 1400 ppm, sinus spray 750 ppm, probiotic good bacteria and Daily 108 vitamins. I started feeling better after 3 days, Fever went down. The symptoms begin to subside” [May 21, 2020 Facebook Post]
Generally, a drug product is a “new drug” within the meaning of section 201(p) of the Act, 21 U.S.C. 321(p), unless it is generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an FDA-approved application, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for any of the above-mentioned products.
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). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your 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, Manuka CBD Silver Spray and Diabetes Kit products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. 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)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
Further, the Colloidal Silver 1400 ppm Dropper, Colloidal Silver 1400 Spray, Silver 750 Sinus Spray, and Silver Eye Drops products all contain colloidal silver as an active ingredient and are made available for purchase over-the-counter (OTC) without a prescription. Nonprescription drugs marketed without an approved application are subject to section 505G of the Act. Specifically, OTC colloidal silver drug products fall under section 505G(a)(5), because the Agency has established, in a final determination issued under 21 CFR part 330, according to that no colloidal silver-containing OTC drugs are generally recognized as safe and effective [21 CFR 310.548]. Further, 21 CFR 310.548 states that any OTC drug product containing colloidal silver ingredients “that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a new drug within the meaning of section 201(p) of [the Act] for which an approved application . . . is required for marketing” and that, in the absence of an approved application, “such product is also misbranded under section 502 of the [A]ct”Act [21 U.S.C. 352].
To the extent that your colloidal silver products are subject to section 505G, they are also misbranded under section 502(ee) of the Act.
Your Silver Eye Drops product is especially concerning from a public health perspective because ophthalmic drug products can pose serious risk of harm to humans if toxic substances are introduced directly into the eye because irreversible damage, including vision loss, can result.
In addition, your Silver 750 Sinus Spray product is especially concerning from a public health perspective because intranasal drug products may be rapidly absorbed through the highly vascularized nasal mucosa directly into systemic blood circulation, where they may exert undesirable systemic effects such as increased heart rate or elevated blood pressure. If toxic substances are introduced directly into the nose, harmful local effects such as bleeding, ulceration, or nasal septal perforation may occur.
Unapproved Animal Drug Products
We note that you also promote your Colloidal Silver 1400 ppm Dropper drugs for animal use. For example, your webpages https://glennburkettwellness.com and https://www.gb1com.com. In the “Suggested Use” section on the label depicted on your product page for your Colloidal Silver 1400 ppm Dropper product contains directions for pets and the front of the label contains an image of a dog and cat. New animal drugs that are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing are unsafe under section 512(a) of the Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction of adulterated drugs into interstate commerce is prohibited under section 301(a) of the Act [21 U.S.C. § 331(a)].
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be directed to the Food and Drug Administration, attention to: Mr. Ramon Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact, Ms. Pearl Lopina, Compliance Officer, at 407-475-4730 or via email at Pearl.lopina@fda.hhs.gov
Sincerely,
/S/
Ramon A. Hernandez
District Director | FDA San Juan District
Program Division Director
Office of Human and Animal Food Operations
East Division IV
____________________________
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Information on your website and social media account suggests that you may intend to market your Silver 750 Sinus Spray and Silver Eye Drops products as dietary supplements. For example, you display pictures of the labels of these products on your website that include “dietary supplement” on the label. However, these products do not meet the definition of a dietary supplement under 201(ff)(2)(A)(i) of the Act [21 U.S.C. § 321(ff)(2)(A)(i)]. The Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) as a product that is “intended for ingestion.” Your product page for Silver 750 Sinus Spray, includes a statement, “Suggested use: Place applicator in nostril, squeeze container and inhale.” Your product page for Silver Eye Drops includes a statement, “Silver Eye Drops,” and “Supports immune response to infection/dry eyes.” In addition, on your Facebook page, you include a video where you perform a hand gesture of applying your Silver Eye Drops product in the eye (see: https://www.facebook.com/GlennBurkettBeautyFitnessHealth/posts/2094433670606560).
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There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Content current as of:
02/15/2022
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages