WARNING LETTER
OcluMed LLC
MARCS-CMS 663525 —
September 11, 2023
Delivery Method:
Via Email
Product:
Drugs
Recipient:
OcluMed LLC
401 Commerce Drive Suite 201
Fort Washington
,
PA
19034
United States
info@oclumed.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
September 11, 2023
AgentOf LLC
1280 Stillwater Drive
Miami Beach, FL 33141
RE: 663525
Dear OcluMed LLC:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://oclumed.com/ in July 2023. The FDA has observed that your website offers “OcluMed Nutritional/Lubricant Eye Drops” (hereinafter referred to as “OcluMed Eye Drops”) for sale in the United States. Based on our review, this product is an unapproved new drug 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 this product 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 unapproved “OcluMed Eye Drops” drug product is 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 “OcluMed Eye Drops” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is 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 website https://oclumed.com/ that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:
On the webpage https://oclumed.com/:
“Now OcluMed is thinking outside the contact lenses aisle, with a scientifically proven formula designed with a potent blend of antioxidants to . . . prevent or improve cataracts . . . OcluMed is an effective solution for cataracts . . .”
The webpage https://oclumed.com/ also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your product for the cure, mitigation, treatment or prevention of disease. Examples of such testimonials include:
o “‘After taking the drops 3 times per day for almost 2 months…my surgeon stated that the cataract was down to a trace’”
o “‘I use the drops 1X a day in each eye. I went to my ophthalmologist and was concerned as I had not been to him in three years. I thought my cataracts would be worse. To my surprise, the cataracts were not worse, in fact, they had not progressed at all! Needless to say, I feel that my regime is working well and OcluMed drops are certainly a part of that.’”
o “‘I am very encouraged with my vision improvement with OcluMed eye drops. Prior to discovering these drops I was doomed to losing my vision, since I was diagnosed with macular degeneration and the beginning of cataracts . . . For the past 8 months I have religiously utilized a daily regimen of vitamins and OcluMed drops with extremely positive results.’”
o “‘I have been using Oclumed since at least 9/29/2013. It essentially helped to reverse the cataract condition in both of my eyes’”
On the webpage https://oclumed.com/pages/about-us:
“When cataracts cloud your vision, they stand between you and so many things you love to see and do. Proven over 80% effective at stabilizing and improving clarity when used over time, OcluMed is a powerful, natural approach to offsetting the effects of cataracts—delaying or eliminating the need for surgery. Its systems method of improving vision and treating senile cataracts is claimed in our pending patents and its efficacy and superiority is supported by our treatment results, which distinguishes our eye drop from other previous attempts to reduce oxidative damage in the eye that allows the eye to repair the cataract.”
“Care for your eyes by making OcluMed part of your daily routine. Its patented system works on all aspects of eye health, from helping to slow or repair damage, to improving clarity and keeping cataracts surgery at bay.”
Your “OcluMed Eye Drops” is not generally recognized as safe and effective (GRASE) for its above referenced uses and, therefore, this product is a “new drug” 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 “OcluMed Eye Drops.” Accordingly, the introduction or delivery for introduction into interstate commerce of this product 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 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 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:
09/12/2023
Regulated Product(s)
Drugs