WARNING LETTER
Trew Balance
MARCS-CMS 709880 —
August 25, 2025
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Sheelah Golliglee
Recipient Title
President
Trew Balance
11200 W. Michigan Ave. Suite #3
Youngtown
,
AZ
85363
United States
youngtownclinic@gmail.com
info@trewbalance.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
August 25, 2025
7558 W. Thunderbird Rd. Suite 1-489
Peoria, AZ 85381
RE: 709880
Dear Sheelah Golliglee:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://trewbalance.com/ in May 2025. The FDA has observed that your website offers “Trew Vision CBD 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 “Trew Vision CBD Eye Drops” 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 this product bypasses some of the body’s natural defenses.
Based on a review of your website, your “Trew Vision CBD 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://trewbalance.com/, that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:
On your “Trew Vision CBD Eye Drops” product page https://trewbalance.com/product/trew-vision-cbdeye-drops/:
“Protects from macular degeneration
Reduces the risk of diabetic retinopathy
Protects against computer radiation exposure
Acts as an optic nerve tonic to protect the eyes
Great antibacterial and antiseptic properties
Reduces stress and fatigue
Excellent eye drops for relaxation
Protects from glaucoma
Helps in treating pink eye
Helps in treating sore eyes”
Your “Trew Vision CBD 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 section 505(a) of the FD&C Act, 21 U.S.C. 355(a). There is no FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for this product. 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).
We recognize that your “Trew Vision CBD Eye Drops” is labeled as a homeopathic drug with active ingredient(s) measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.
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 product is 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 “709880” 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
Content current as of:
09/02/2025
Regulated Product(s)
Drugs