WARNING LETTER
Belmont Eyecare LLC
MARCS-CMS 670186 —
December 01, 2023
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Golie Keovan
Recipient Title
CEO
Belmont Eyecare LLC
3110 W. Belmont Ave., Unit 1E
Chicago
,
IL
60618
United States
Belmonteyecare3110@gmail.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
December 1, 2023
RE: 670186
Dear Golie Keovan:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet addresses https://www.chicagoashlandeyecare.com/ in October 2023. The FDA has observed that your website offers “Colloidal Silver Eye Drops,” “MSM Eye Drops,” “Organic Daytime Oil Eye Drops,” “Organic Daytime Oil Eye Drops Small,” “Organic Evening Oil Eye Drops,” and “Organic Evening Oil Eye Drops Small” for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Your “Colloidal Silver Eye Drops,” “MSM Eye Drops,” “Organic Daytime Oil Eye Drops,” “Organic Daytime Oil Eye Drops Small,” “Organic Evening Oil Eye Drops,” and “Organic Evening Oil Eye Drops Small” products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.
Based on a review of your website, your “Colloidal Silver Eye Drops,” “MSM Eye Drops,” “Organic Daytime Oil Eye Drops,” “Organic Daytime Oil Eye Drops Small,” “Organic Evening Oil Eye Drops,” and “Organic Evening Oil Eye Drops Small” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples of claims from your product labeling, including on your website https://www.chicagoashlandeyecare.com/, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
Colloidal Silver Eye Drops
“Colloidal Silver is an all natural anti-bacterial, anti-viral and anti-fungal solution that is a safer alternative to antibiotics and will not cause future bacterial resistance. Colloidal Silver had been used in medicine as an antiseptic for centuries and as a cure-all anti-microbial for everything from tuberculosis, herpes, staph and yeast infections.”
“Our 500 ppm Colloidal Silver Eye Drops are the highest potency available eye drop for ocular infections. Research suggests it works by attaching to proteins on the cell walls of microorganisms, damaging their cell membranes . . . . Can also be used to control sinus infections.”
MSM Eye Drops
“MSM Eye Drops are a natural anti-inflammatory and an alternative to steroid drops (which can elevate intraocular pressure.)”
“When MSM (a sulfur-based compound) is applied into the eye, the antioxidant sulfur plus vitamin C aids in pushing out metabolicwaste [sic] away from ocular tissues of the cornea, intraocular lens and the retina to minimize free radical damage.”
“[A]pply MSM eye drops topically [and] these nutrients will be able to go the extra mile because of the improved cellular permeability. The retina has one of the highest metabolic needs in the body, and the macula actually has the highest metabolic need of the retina. In Macular Degeneration, there is a nutrient starvation going on in the macula.”
“○ For Ocular Repair”
Organic Daytime Oil Eye Drops, Organic Daytime Oil Eye Drops Small, Organic Evening Oil Eye Drops, Organic Evening Oil Eye Drops Small
“Naturally improve dry-eye symptoms by reducing tear evaporation, encouraging lipid production, and adding a protective layer of fatty acids over the eyes to lock in moisture.”
“These drops have the highest lipid concentration indicated for dry, itchy or irritated eyes, cataracts, allergy symptoms, and post lasik [sic] surgery. The drops contains [sic] a range of powerful fatty acids and other antioxidants that can benefit your eyes, with additional antibacterial, antifungal and antiviral support.”
Your “Colloidal Silver Eye Drops,” “MSM Eye Drops,” “Organic Daytime Oil Eye Drops,” “Organic Daytime Oil Eye Drops Small,” “Organic Evening Oil Eye Drops,” and “Organic Evening Oil Eye Drops Small” are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for “Colloidal Silver Eye Drops,” “MSM Eye Drops,” “Organic Daytime Oil Eye Drops,” “Organic Daytime Oil Eye Drops Small,” “Organic Evening Oil Eye Drops,” and “Organic Evening Oil Eye Drops Small.” Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
The violations cited in this letter are 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 fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.
Sincerely,
/S/
Jill Furman
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Content current as of:
12/05/2023
Regulated Product(s)
Drugs