Delivery Method: Via Email Product: Drugs Recipient:
Recipient Name
Clint Worley, COO
Covalent Medical
24600 Millstream Drive, Ste 410
Aldie, VA 20105
United States
CWORLEY@focusvitamins.com Issuing Office: Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
July 9, 2025
RE: 695839
Dear Mr. Worley:
This letter is to advise you that on September 27, 2024 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address, www.focusvitamins.com, where your FOCUS PI Post-Injection Eye Drops product is available for purchase in the United States without a prescription. We also reviewed your social media sites on Instagram (https://www.instagram.com/focus_vitamins/) and Facebook (https://www.facebook.com/focusvitamins), both of which direct consumers to your website to purchase your product(s).
Based on our review, your FOCUS PI Post-Injection Eye Drops product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). In addition, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.
Unapproved New Drug and Misbranded Drug Violations
Your FOCUS PI Post-Injection Eye Drops product is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.
Examples of claims from the product labeling, your website, and your social media posts that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:
“FOCUS PI … Post-Injection Eye Drops”
“Long Lasting Relief, Clinically proven to lubricate, hydrate, & relieve the eyes from irritation” [from PDP on product carton labeling]
“Use ▪ For use as a lubricant to prevent further irritation or to relieve dryness of the eye” [from Drug Facts panel on product carton labeling]
“Designed for Post-injection Irritation Relief” [from your website https://focusvitamins.com/products/focus-pi (last visited September 2024)]
“Focus PI (Post-injection) eye drops provide relief from irritation associated with eye injections. As the first product of its kind, Focus Vitamins and founding ophthalmologists formulated Focus PI to help soothe any eye discomfort patients might experience, including irritation and dry eye symptoms after eye injections.” [from your website https://focusvitamins.com/products/focus-pi (last visited September 2024)]
“Focus PI is formulated and safe for use immediately after eye injections and/or during the following days when your eyes are irritated.” [from your website under FAQS: When should I use Focus PI? https://focusvitamins.com/products/focus-pi (last visited September 2024)]
“If you get eye injections, Focus PI is for you! Focus PI are post-injection eye drops that are clinically proven to lubricate, hydrate, & relieve the eyes from irritation that comes after ocular injections.” [from Instagram post with 2 likes on January 23, 2023 https://www.instagram.com/p/Cn0P_CpMZJM/ (last visited September 2024)]
“Searching for post-injection relief for your eyes? Focus PI eye drops are clinically proven to lubricate, hydrate, and relieve the eyes from irritation following ocular injections. Shop now…” [from Facebook post on August 15, 2023 https://www.facebook.com/focusvitamins (last visited September 2024)]
Unapproved New Drug Violations
Based on the above evidence of intended use, your FOCUS PI Post-Injection Eye Drops product is intended for use as an ophthalmic demulcent (lubricant) drug product. As described below, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. 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 section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for your FOCUS PI Post-Injection Eye Drops drug product.
Your drug product is marketed as an ophthalmic demulcent drug product and is subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which generally governs nonprescription drugs marketed without an approved application. Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements. With respect to nonprescription ophthalmic drug products, such as your FOCUS PI Post-Injection Eye Drops drug product, in order to be GRASE and not a new drug, the product must, among other things, conform to the conditions in the applicable OTC monograph, here OTC Monograph M018: Ophthalmic Drug Products for Over-the-Counter Human Use (hereinafter M018).1 However, your FOCUS PI Post-Injection Eye Drops drug product does not conform to the conditions specified in M018 for the reasons described below.
Specifically, the statements made in your product labeling on your website and social media sites include claims for relief of post-injection irritation, which are not permitted indications for ophthalmic demulcent drug products in monograph M018.2
Thus, your FOCUS PI Post-Injection Eye Drops drug product does not comply with the applicable conditions specified in Monograph M018 and has not otherwise been found GRASE.3 Accordingly, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which this product would be legally marketed without an approved application. Because there is no approved application in effect for this product, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
Misbranded Drug Violations
Additionally, your FOCUS PI Post-Injection Eye Drops drug product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your product(s). 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 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 product(s) 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 15 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. Please include your firm name and the unique identifier “695839” in the subject line of your email.
Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
_____________________________
1 M018 reflects the monograph conditions as set forth in the relevant final order(s) established and in effect under section 505G; see Order ID OTC000023, available at FDA’s website OTC Monographs@FDA.
2 Under M018.60, “Labeling of ophthalmic demulcent drug products”, the permitted indications are listed in M018.60(b).
3 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that the FOCUS PI Post-Injection Eye Drops drug product is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b) of the FD&C Act.
