WARNING LETTER
DR Vitamins, LLC dba DR Vitamin Solutions
MARCS-CMS 663127 —
September 11, 2023
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Jonathan Formby
Recipient Title
President
DR Vitamins, LLC dba DR Vitamin Solutions
7804 Harwood Rd
North Richland Hills
,
TX
76180-5901
United States
info@drvitaminsolutions.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
September 11, 2023
RE: 663127
Dear Jonathan Formby:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.drvitaminsolutions.com in July 2023. We have also reviewed your social media websites at https://twitter.com/DRVitamins and www.facebook.com/DRVitamins; these websites direct consumers to your website www.drvitaminsolutions.com to purchase your products. The FDA has observed that your website offers “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” for sale in the United States.
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Additionally, we reviewed your product listings on your Amazon storefront at https://www.amazon.com/stores/DRVitaminSolutions/page/07F25A08-22FE-4E3D-8C74-5ACF57D4F83F where you have multiple listings of “Vision Clarity Eye Drops.” 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 “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” 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.
In addition, the drugs “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” are not properly listed with FDA causing them to be misbranded drugs under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introduction or delivery for introduction of such misbranded drug(s) into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Unapproved New Drug Violations
Based on a review of your websites, your “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” products 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 www.drvitaminsolutions.com, your social media websites, https://twitter.com/DRVitamins and www.facebook.com/DRVitamins, and Amazon storefront that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
On your product webpage for “Vision Clarity Eye Drops”:
• "Say Goodbye To Dry Eyes and Eye Irritations With Vision Clarity Eye Drops!”
• “[C]ontain heavily researched lubricants to help combat dry eye and other irritations.”
• Under “Dosage & Use”: “For use as a lubricant to prevent further irritation or to relieve dryness of the eye.”
• Customer review: “I used to use Bright Eyes III, but this brand seems to feel better when I put the drops in. I continue to see improvement with my cataracts!”
• Customer review: “Great product it really works, I can tell the difference. I recommend it, Beats having an unnecessary and expensive cataract surgery. My eyes are starting to clear up, almost no fogginess.”
• Customer review: “Just wanted you to know my fantastic results with your eye drops. I have been using them for almost a month now and the floaters in my eyes have disappeared. I feel my cataracts are much improved but I will know at my next vision appointment.”
• Customer review: “My mother wanted me to order Vision Clarity drops for her cataracts. Since I am placing my second order for an additional 6 boxes, I must tell you she is very happy. When I look at her eyes now it is amazing. She says she can see better than she has in years.”
On your product webpage for “Life Extension Brite Eyes III”:
• “The Brite Eyes III formula also contains the antioxidant N-acetyl-carnosine . . . Some experts think that carnosine has potential to support antioxidant activity which resists the presence of cataracts on the lens of the eye.”
• Under “Dosage & Use”: “For those with cataracts, glaucoma and other eye ailments, it is recommended to take 1 drop 4 times a day at various intervals morning, noon, evening and before bed.”
On your product webpage for “Can-C Eye Drops”:
• “By providing compounds like N-Acetyl-Carnosine (NAC), these Can-C Eye Drops are made to serve as your ultimate eye shield. As such, they may help to protect the eyes from damage in the form of free radicals, UV rays, and thereby, even cataracts.”
On your product webpage for “Longevity Science Visual Ocuity”:
• “[E]xpertly crafted to aid in the relief of dry, itchy eyes and other afflictions which might cause discomfort and limited vision.”
On your webpage https://www.drvitaminsolutions.com/blog/review-n-acetyl-carnosine-nac-eye-drops-2019/:
• “While Carnosine itself is a familiar amino acid compound with well-documented antioxidant properties, N-Acetyl-Carnosine (NAC) is a unique form of Carnosine with a very distinct intended usage. Over the past decade and a half, NAC eye drops
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have become an increasingly popular product for resisting and reversing cataracts in both pets and humans.”
On your webpage https://www.drvitaminsolutions.com/blog/benefits-n-acetyl-carnosine-drops-nac-eyes-especially-cataracts/:
• “N-Acetyl-Carnosine (NAC) drops can help. Especially with cataracts.”
• “There has been quite a bit of research with NAC, N-Acetyl-Carnosine drops especially for cataracts. Results from one study’s conclusion were very encouraging. ‘Topical NAC shows potential for the treatment and prevention of cataracts.’”
• “References:
o gov. Efficacy of N-acetyl-carnosine in treatment of cataracts.
o Dr. David Williams. Carnosine for Cataracts.”
On your webpage https://www.drvitaminsolutions.com/blog/nac-carnosine-eye-drops-and-eye-health/:
• “Eye drops with N-Acetyl-Carnosine (NAC) can be helpful for eye health. There was a 2-year study was done where one group got the NAC drops and one group did not. The group that had used the drops had improvement while the other group got worse. ‘Tolerability of NAC eye drops was good in almost all patients, with no reports of ocular or systemic adverse effects. Topical NAC shows potential for the treatment and prevention of cataracts.’”
• “These drops have been used for several eye health issues, but the most common use is for cataracts. NAC uses natural ingredients and the body’s main antioxidant glutathione to chip away at the damaged cells of the cataracts. The damaged cells are cleared away and healthy cells can be protected from further damage.”
On your social media websites at https://twitter.com/DRVitamins and www.facebook.com/DRVitamins:
• February 9, 2019 Twitter post: An image of the “Vision Clarity Eye Drops” with the text, “Carnosine, a cataracts worst nightmare.”
• July 11, 2019 Facebook video post: “Today, I would like to talk to you about our Vision Clarity Eye Drops. These are very popular and the key ingredient in them is N-Acetylcarnosine and they also have a lubricant. People use them for various health issues with their eyes, but the most popular by far is cataracts. We do not make any medical claims nor guarantees on any specific health issue, but we are very thankful that for over 10 years, people have been able to avoid having cataract surgery because they’ve used these drops. We suggest using 1 drop in each eye 4 times a day. It typically takes people on average of about 3 months to see a noticeable difference. And the best results usually take several months.”
• July 14, 2023 Facebook post: “Eye Health Bundle Pack . . . includes Can-C Eye Drops . . . ‘I have used these eye drops for many years. I have the the [sic] beginning of cataracts that have not progressed and my near sightedness has not gotten worse in over two years. I also find the drops are soothing to my eyes. I highly recommend this product.’”
On your Amazon product webpage for “Vision Clarity Eye Drops” at https://www.amazon.com/Carnosine-Lubricants-Hypromellose-Antioxidant-Lubricating/dp/B008J6QR8Q, you have an image that resembles an over-the-counter (OTC) drug facts label, and it displays Glycerin 1.0% and N-Acetylcarnosine (NAC) 1.0% as active ingredients. Furthermore, next to the OTC drug facts label, you include the claim, “clinically studied ingredients[:] cataracts[,] dry eyes[, and] floaters.”
Your “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” 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). Subject to 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 “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” products.
“Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” are marketed as ophthalmic demulcent (lubricant) drug products and are subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which 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 “OTC monograph drugs” – may be legally marketed if they meet applicable requirements. In particular, ophthalmic demulcent (lubricant) drug products are deemed to be GRASE and not a “new drug” if, among other things, they conform to the conditions of use set forth in the Over-the-Counter Monograph M018: Ophthalmic Drug Products for Over-the-Counter Human Use (hereinafter Monograph M018).
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However, your “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” do not conform to the conditions of use specified in Monograph M018 because these products are formulated with the active ingredient N-Acetyl-Carnosine (NAC), and labeled with indications to treat or prevent cataracts, neither of which are permitted under the final administrative order. Therefore, these products do not meet the requirements under section 505G.
We note that you list the NAC ingredient as an inactive ingredient or excipient on the label of your “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” products. However, your firm makes many therapeutic claims for NAC that cause it to be considered an active ingredient.
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For example, your website includes a blog post entitled, “The Benefits of N-Acetyl-Carnosine (NAC) for Your Eyes, Especially for Cataracts.” Many other examples of therapeutic claims related to NAC can be found in the various claims cited in this letter above which make it clear that NAC is intended to furnish pharmacological activity or other direct effect, including in the treatment of cataracts, and is thus an active ingredient. As previously stated, NAC is not a permitted active ingredient in Monograph M018 and treating or preventing cataracts is not a permitted indication in Monograph M018.
FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling. Moreover, there is no evident basis under the FD&C Act under which these products would be legally marketed without an approved application. Accordingly, these products are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).
Registration and Drug Listing Violations
Under section 510(j)(1) of the FD&C Act, 21 U.S.C. 360(j)(1), and 21 CFR 207.41, all drugs manufactured, prepared, propagated, compounded, or processed for U.S. commercial distribution must be listed with FDA. The drug products “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” are not properly listed with FDA.5 Therefore, these drug products are misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under 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 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.
Sincerely,
/S/
Jill Furman
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
_______________________
1
Your firm markets these ophthalmic products as containing N-acetylcarnosine (NAC).
2
You include a direct hyperlink to your “Vision Clarity Eye Drops” product webpage.
3
Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs", notably conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 CFR 330 prior to enactment of the CARES Act. In the case of OTC ophthalmic drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M018: Ophthalmic Drug Products for Over-the-Counter Human Use. (See Order ID OTC000023, available at FDA’s website OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/.)
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See e.g., 21 CFR 314.3(b) and 21 CFR 210.3(b)(7), which define 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 man.”
5
Your drug listing for “Vision Clarity Eye Drops” (NDC 71108-001-05) is inactive as of January 31, 2020. To date, FDA has not received an updated submission for the drug product “Vision Clarity Eye Drops” (NDC 71108-001-05).
Content current as of:
09/12/2023
Regulated Product(s)
Drugs