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WARNING LETTER

September 11, 2023

RE: 663758

Dear Linda Axelrod:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://natoph.com/ in August 2023. The FDA has observed that your website offers “Women’s Tear Stimulation Dry Eye Drops,” “Allergy Desensitization Eye Drops,” “Ortho-K Thin (Daytime) Eye Drops,” “Ortho-K Thick (Night) Eye Drops,” “Tear Stimulation Forté Dry Eye Drops,” and “Cataract Eye Drops with Cineraria” 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 unapproved “Women’s Tear Stimulation Dry Eye Drops,” “Allergy Desensitization Eye Drops,” “Ortho-K Thin (Daytime) Eye Drops,” “Ortho-K Thick (Night) Eye Drops,” “Tear Stimulation Forté Dry Eye Drops,” and “Cataract Eye Drops with Cineraria” drug 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 “Women’s Tear Stimulation Dry Eye Drops,” “Allergy Desensitization Eye Drops,” “Ortho-K Thin (Daytime) Eye Drops,” “Ortho-K Thick (Night) Eye Drops,” “Tear Stimulation Forté Dry Eye Drops,” and “Cataract Eye Drops with Cineraria” 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 website https://natoph.com/ that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:

Women’s Tear Stimulation Dry Eye Drops
From the webpage https://natoph.com/product/womens-tear-stimulation-dry-eye-drops/:

• “Finally – Unique eye drops which stimulate the production of all three tear film layers while supporting the health of the cornea, conjunctiva and eyelid. Both formulas share five powerful broad spectrum ingredients which relieve symptoms caused from inflammation due to aqueous deficiency, including severe dryness such as with Sjogren’s Syndrome. Additionally, women experience more dry eye symptoms due to hormonal fluctuations so we added the two most commonly prescribed ingredients for these symptoms.”

Allergy Desensitization Eye Drops
From the webpage https://natoph.com/product/allergy-desensitization-eye-drops/:

• “Allergy Eye Drops stop allergy symptoms such as itching, burning, watering, edema and general ocular sensitivity.”

Ortho-K Thin (Daytime) Eye Drops and Ortho-K Thick (Night) Eye Drops
From the webpages https://natoph.com/product/ortho-k-thin-daytime-eye-drops/ and https://natoph.com/product/ortho-k-thick-night-eye-drops/:

• “These drops contain powerful ingredients to stimulate tear film production, counter-act irritation, halt allergies and reduce foreign body sensation . . . The clarifying ‘Thin Drop’ is preservative free and used as often as needed to alleviate dry, red, itchy, irritated eyes and is also OK with all contacts. The ‘Thick Drop’ reduces mechanical irritation.”
• “Both the Thin and Tick drops work similarly. . .. In addition, they contain Calendula, which is indicated for corneal health and vitality.”

Tear Stimulation Forté Dry Eye Drops
From the webpage https://natoph.com/product/tear-stimulation-forte-dry-eye-drops/:

• “Unique eye drops which stimulate the production of all three tear film layers while supporting the health of the cornea, conjunctiva and eyelid.”
• “‘Your drops are like miracle drugs for dry eye. I have had dry eyes ever since I moved to Phoenix in 1995. They have gotten progressively worse as I’ve gotten older and I am now 48. I would wake up in the middle of the night and find that my eyes would sting and burn. After using the Natural Ophthalmics drops for the past 6 months I have found that I no longer have the severe feeling that I would get in the middle of the night. Your drop has tremendously helped with reducing the severity of my dry condition.’”

Cataract Eye Drops with Cineraria
From the webpage https://natoph.com/product/cataract-crystalline-lens-eye-drops/:

• “These homeopathic drops trigger the transfer of oxygen and nutrients from the blood to the aqueous to nourish and detoxify the living tissue of the crystalline lens. Cineraria maritima has been used homeopathically for over 100 years to safely and effectively treat cataract.”
• “‘I have an 84 year old male patient who has been using your Cineraria eye drops for cataract. His vision has improved from 20/200 down to 20/60.’”

Your “Women’s Tear Stimulation Dry Eye Drops,” “Allergy Desensitization Eye Drops,” “Ortho-K Thin (Daytime) Eye Drops,” “Ortho-K Thick (Night) Eye Drops,” “Tear Stimulation Forté Dry Eye Drops,” and “Cataract Eye Drops with Cineraria” products 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 “Women’s Tear Stimulation Dry Eye Drops,” “Allergy Desensitization Eye Drops,” “Ortho-K Thin (Daytime) Eye Drops,” “Ortho-K Thick (Night) Eye Drops,” “Tear Stimulation Forté Dry Eye Drops,” and “Cataract Eye Drops with Cineraria.” 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).

We recognize that your “Women’s Tear Stimulation Dry Eye Drops,” “Allergy Desensitization Eye Drops,” “Ortho-K Thin (Daytime) Eye Drops,” “Ortho-K Thick (Night) Eye Drops,” “Tear Stimulation Forté Dry Eye Drops,” and “Cataract Eye Drops with Cineraria” products are labeled as homeopathic drugs 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 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 Drug and 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