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WARNING LETTER

September 11, 2023

RE: 663037

Dear Thomas Pominville:

As previously communicated to you in September 2022, your “Dryness Relief,” “Pink Eye Relief,”¹ “Allergy Eyes Relief,” “Red Eye Relief,” “Eye Strain Relief,” “Eye Lid Relief,” “Aging Eye Relief,” “Blur Relief,” “Floaters Relief,” “Twitching Relief,” and “Stye Relief” 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). Please refer to the warning letter issued to (b)(4), which we forwarded to you in our (b)(4) correspondence, as well as the FDA correspondence dated February 7, 2023 and addressed to TRP Company, Inc.’s legal counsel regarding the regulatory status of the above-listed products.²

This letter is to advise you that FDA reviewed TRP’s website at the Internet address https://www.thereliefproducts.com/ in July 2023 and observed that the above-listed products, in addition to a “Dryness Relief PF” product, are offered for sale in the United States. As further described below, based on our review we reiterate that the above-listed products, and the “Dryness Relief PF” product, are unapproved new drugs under section 505(a) of the FD&C Act, 21. U.S.C. 355(a), and the introduction or delivery for introduction into interstate commerce of unapproved new drugs violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d), 355(a).

Your unapproved ophthalmic 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 our July 2023 review of your product labeling, including on your website, your “Dryness Relief,” “Pink Eye Relief,” “Allergy Eyes Relief,” “Red Eye Relief,” “Eye Strain Relief,” “Eye Lid Relief,” “Aging Eye Relief,” “Blur Relief,” “Floaters Relief,” “Twitching Relief,” “Stye Relief,” and “Dryness Relief PF” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), 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 labeling claims that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:

Dryness Relief
From the webpage https://www.thereliefproducts.com/product/dryness-relief/:
• “Temporarily relieves extreme dryness, lack of tears, achy eyes, eyestrain, and redness”
• “[P]rovide temporary relief of . . . dry, irritated eyes”

Pink Eye Relief
From the webpage https://www.thereliefproducts.com/product/pinkeye-relief-eye-drops-regular/:
• “[F]ormulated to naturally address common pink eye symptoms . . . gently soothe all types of eye irritation including burning, grittiness, and overnight crusting of the eye”
• “Temporarily relieves redness, burning, crusting, and grittiness”

Allergy Eyes Relief
From the webpage https://www.thereliefproducts.com/product/allergy-eyes-relief-drops/:
• “[F]ormulated to temporarily alleviate acute, chronic, and seasonal eye allergy symptoms”
• “Temporarily relieves acute, chronic, and seasonal eye allergies, redness, burning, itchiness, and excessive watering”
• “[P]rovides temporary relief for symptoms such as excessive watering and itchy eyes, dry, red eyes, burning as well as acute and chronic allergies”

Red Eye Relief
From the webpage https://www.thereliefproducts.com/product/redeye-relief/:
• “Temporarily relieves redness, burning, and itching”
• “[F]ormulated to temporarily alleviate red eye symptoms . . . soothe red, irritated, and watering eyes”

Eye Strain Relief
From the webpage https://www.thereliefproducts.com/product/eye-strain-relief/:
• “[F]ormulated to temporarily alleviate eye strain symptoms . . . temporarily alleviate dry eyes, eye strain with headache, ocular fatigue, blurry vision”
• “Temporarily relieves eye fatigue and blurry vision”

Eye Lid Relief
From the webpage https://www.thereliefproducts.com/product/eye-lid-relief-pm/:
• “[F]ormulated to temporarily alleviate blepharitis symptoms . . . temporarily alleviate swollen, red lids, crusting lids, oily & sticky lids”

Aging Eye Relief
From the webpage https://www.thereliefproducts.com/product/agingeye-relief-drops/:
• “[T]emporarily alleviates . . . symptoms including eye floaters, blurry or cloudy vision, and ocular fatigue”
• “Temporarily relieves cloudy and blurry vision[,] Supports corneal and macular eye health”

Blur Relief
From the webpage https://www.thereliefproducts.com/product/blur-relief-eye-drops/:
• “[F]ormulated to temporarily alleviate blurred vision”
• “Temporarily relieves blurry vision, dry, red eyes, tired eyes, cloudy vision . . . and poor night vision”

Floaters Relief
From the webpage https://www.thereliefproducts.com/product/eye-floaters-relief/:
• “[F]ormulated to temporarily alleviate eye floaters and corneal opacities”
• “Temporarily [sic] relief from symptoms such as shapes and squiggly lines in vision, floaters, dark-dots and dust particles in your vision”

Twitching Relief
From the webpage https://www.thereliefproducts.com/product/eye-twitching-relief/:
• “[F]ormulated to temporarily alleviate eye twitching and spasms . . . provide temporary relief for symptoms such as twitching eyelids, spasms, quivering, irritation, sensitivity, eye strain, and tired eyes”

Stye Relief
From the webpage https://www.thereliefproducts.com/product/stye-relief-sterile-eye-ointment/:
• “[F]ormulated to naturally address common stye symptoms . . . provide soothing relief from symptoms such as inflammation, bumps on the eyelid, swollen lids, itching, burning, watering, and discomfort”
• “Temporarily relieves red, swollen bumps on the eye lid[,] alleviates swelling, burning, and watering”

Dryness Relief PF
From the webpage https://www.thereliefproducts.com/product/dryness-relief-pf-eye-drops/:
• “Temporarily relieves extreme dryness, lack of tears, achy eyes, eyestrain, and redness”

Your “Dryness Relief,” “Pink Eye Relief,” “Allergy Eyes Relief,” “Red Eye Relief,” “Eye Strain Relief,” “Eye Lid Relief,” “Aging Eye Relief,” “Blur Relief,” “Floaters Relief,” “Twitching Relief,” “Stye Relief,” and “Dryness Relief PF” 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 “Dryness Relief,” “Pink Eye Relief,” “Allergy Eyes Relief,” “Red Eye Relief,” “Eye Strain Relief,” “Eye Lid Relief,” “Aging Eye Relief,” “Blur Relief,” “Floaters Relief,” “Twitching Relief,” “Stye Relief,” and “Dryness Relief PF.” 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 “Dryness Relief,” “Pink Eye Relief,” “Allergy Eyes Relief,” “Red Eye Relief,” “Eye Strain Relief,” “Eye Lid Relief,” “Aging Eye Relief,” “Blur Relief,” “Floaters Relief,” “Twitching Relief,” “Stye Relief,” and “Dryness Relief PF” products are labeled as homeopathic drugs with active ingredients 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.

Additionally, TRP is responsible for ensuring that the drug products it distributes are not adulterated, notwithstanding that other entities are involved in the manufacture of such products, e.g., (b)(4). The significant violations of Current Good Manufacturing Practice (CGMP) requirements observed at (b)(4), with respect to its manufacture of TRP’s above-listed products, were documented in the Agency’s (b)(4) warning letter to (b)(4), which as noted above the Agency forwarded to TRP. Under section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B), drugs are deemed adulterated if they are not manufactured in conformance with CGMP. The CGMP violations identified at (b)(4) caused TRP’s drug products manufactured by (b)(4) to be adulterated.³ The introduction, delivery for introduction, or causing the introduction or delivery for introduction into interstate commerce of an adulterated drug is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Further, the receipt in interstate commerce of adulterated drugs, and the delivery or proffered delivery thereof, is a violation of section 301(c) of the FD&C Act, 21 U.S.C. 331(c).

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. In addition, please note that unapproved new drugs are subject to refusal of admission into the United States, and such products may be subject to detention without physical examination. For more information about detention without physical examination, see Import Alert 66-41.

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

cc:

Peter A. Arhangelsky, Esq.
Counsel for TRP Company
Emord & Associates
11808 Wolf Run Lane
Clifton, VA 21024
parhangelsky@emord.com

(b)(4)

____________________________

1 A review of your website and FDA records indicates that you offer different variations of your “Pink Eye Relief” product, i.e., “Pink Eye Relief PF” and “Pink Eye Relief PM.” Please be advised that the violations and safety concerns outlined above also apply to these products if introduced into interstate commerce.

2 (b)(4).

3 (b)(4).