WARNING LETTER
Thea Pharma, Inc.
MARCS-CMS 712416 —
July 09, 2025
Delivery Method:
Via Email
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Susan K. Benton
Recipient Title
President
Thea Pharma, Inc.
303 Wyman Street, Suite 205
Waltham
,
MA
02451
United States
(b)(6), (b)(7)(C)
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
July 9, 2025
RE: 712416
Dear Ms. Benton:
This letter is to advise you that on August 29, 2024 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address www.ivizia.com and your Amazon storefront at https://www.amazon.com/iVIZIA-Lubricant-Preservative-Free-Moisturizing-Friendly/dp/B09TD27BR5?th=1 where your IVIZIA sterile lubricant eye drops product is available for purchase in the United States without a prescription.
Based on our review, your IVIZIA sterile lubricant 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 sections 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 IVIZIA sterile lubricant eye drops 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 and your website 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:
IVIZIA sterile lubricant eye drops
“
Use
􀆒 For use as a lubricant to prevent further irritation or to relieve dryness of the eye” [from the Drug Facts panel on product carton labeling]
“iVIZIA for Dry Eyes . . . made with hydrating polymers, sodium hyaluronate, and trehalose, iVIZIA’s unique multi-moisturizing formula improves eye comfort during computer work . . .” [from your website https://www.ivizia.com/]
“Instant and long-lasting relief of dry eye symptoms for up to 8 hours…UNIQUE FORMULA…POVIDONE (active ingredient) …A hydrating polymer that significantly decreases dry eye discomfort…. made with revitalizing hyaluronic acid and trehalose…HYALURONIC ACID “HA” (inactive)…one of the most water-loving molecules…described as “nature’s moisturizer”. It can bind 1000 times its weight in water… TREHALOSE (inactive)… synthetized by plants such as the Rose of Jericho…can survive extreme dehydration thanks to trehalose.”[from your website under Product-Dry Eye Drops https://www.ivizia.com/ivizia-dry-eye-drops/ (last visited December 2024)]
“Scientifically formulated to moisturize and lubricate dry eyes…Hyaluronic Acid (enhancer)…can hold 1000x its weight in moisture…Trehalose (enhancer)…works with hyaluronic acid to resist drying longer.” [from the website directly linked from IVIZIA.com product page which direct consumers to purchase IVIZIA sterile lubricant eye drops without a prescription under the “BUY NOW” button https://www.amazon.com/iVIZIALubricant-Preservative-Free-Moisturizing-Friendly/dp/B09TCZRG1K?ref_=ast_sto_dp (last visited December 2024]
Unapproved New Drug Violations
Based on the above evidence of intended use, your IVIZIA sterile lubricant 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 IVIZIA sterile lubricant 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 IVIZIA sterile lubricant eye drops, 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 Over-the-Counter (OTC) monograph M018: Ophthalmic Drug Products for Over-the-Counter Human Use (hereinafter M018).
1
However, your IVIZIA sterile lubricant eye drops drug product does not conform to the conditions specified in M018 for the reasons described below.
Your IVIZIA sterile lubricant eye drops is a demulcent product formulated with several active ingredients that are not permitted for OTC monograph ophthalmic demulcent drug products. Specifically, according to your products labeling, your IVIZIA sterile lubricant eye drops is formulated with the active ingredients hyaluronic acid and trehalose.
However, hyaluronic acid and trehalose are not active ingredients permitted for ophthalmic demulcent drug products under M018. 21. We note that, although you identify these ingredients as inactive ingredients on the product label, statements on your website show that they are active ingredients because they are intended to furnish pharmacological activity for the treatment of a disease or condition
2
. Example of these statements include, “made with hydrating polymers, sodium hyaluronate, and trehalose, iVIZIA’s unique multi-moisturizing formula improves eye comfort during computer work . . .” Furthermore, claims such as “can hold 1000x its weight in moisture” and “nature’s moisturizer,” are associated with the ingredient hyaluronic acid and claims such as “can survive extreme dehydration thanks to trehalose,” and “works with hyaluronic acid to resist drying longer” are associated with the ingredient trehalose. Thus, these ingredients are active ingredients and, because they are not active ingredients permitted under M018.12, your IVIZIA sterile lubricant eye drops product does not conform with the conditions for lawful marketing of an OTC ophthalmic demulcent drug product as set forth in M018.
Thus, your IVIZIA sterile lubricant eye drops product does not comply with the applicable conditions specified in 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 IVIZIA sterile lubricant eye drops 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
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 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. Please include your firm name and the unique identifier “712416” in the subject line of the email.
Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling
Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
cc: Chrysoula Koukoutsis, Director, Global Regulatory Affairs, Vice President of Regulatory Affairs
___________________________
1
M018 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000023, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf.
2
See 21 CFR 201.66(b)(2), which defines an active ingredient as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.”
3
FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that IVISIA lubricant eye drops product is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling, nor has FDA determined this drug product to be GRASE pursuant to an order issued under section 505G(b).
Content current as of:
07/15/2025
Regulated Product(s)
Drugs
Over-the-Counter Drugs