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WARNING LETTER

October 04, 2023

Re: 668858

Dear Diana Rodriguez:

This letter concerns your firm’s marketing of an unapproved new animal drug product, Lanomax®, for the treatment of cataracts in animals. The United States Food and Drug Administration (FDA) has reviewed your website at the internet address https://www.lanomax.com in August and September 2023 and has determined that you promote and offer this product for sale there.

Based on our review of your website at the internet address https://www.lanomax.com, your Lanomax® product is a drug under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)], because this product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal. This product is an unapproved new animal drug and introducing or delivering this product for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

Currently there are no FDA-approved eye drops for use in animals that are labeled for treating, preventing, mitigating, or curing cataracts. Your product, which claims to treat this condition, has not been determined by FDA to be safe and effective. Your unproven treatment could cause animal owners to forgo or delay appropriate veterinary care.

You can find the FD&C Act and FDA regulations through links on FDA’s homepage at www.fda.gov.

Examples of claims FDA observed on your website and product labeling that show the intended use of your Lanomax® product include, but are not limited to the following:

From your home website titled “LANOMAX®” at the URL https://www.lanomax.com/:

• “Lanomax® is the only eye drop on the planet currently that has a real therapeutic effect on cataracts.”
• “…in the case of incipient, immature, and mature cataracts, if you administer two vials of Lanomax® eye drops to one eye for six weeks, you will see visible improvements compared to the untreated eye.”
• “…there are dramatic cases where a visible effect is even noticed within a short period of 1-2 weeks after beginning to administer Lanomax®.”

From your webpage titled “LANOMAX®” at the URL https://www.lanomax.com/retail/index.php/lanomax.html:

• “Lanomax® can cure cataracts in the form of eye drops alone…”
• “Lanomax® uses ThruDelivery®, an innovative drug delivery system built using the latest advanced nanotechnology…It is because of this ThruDelivery® system that Lanomax® is the only eye drop on the planet to show a real therapeutic effect on cataracts.”
• “Currently, this amazing lanosterol delivery system is only found in Lanomax® eye drops.”
• “Lanomax® has an excellent therapeutic effect on incipient, immature, and mature cataracts.”
• “The therapeutic effect of Lanomax® varies greatly depending on the type of cataract and the degree of its progression.”
• “Sometimes there are dramatic cases where a visible effect can even be noticed within a short period of 1-2 weeks beginning to administer Lanomax®.”

From your webpage titled “FAQ” at the URL https://www.lanomax.com/retail/index.php/faq.html:

• “Can Lanomax® be used for animals such as birds, minks or horses? Lanomax® can be used for cataracts that occur in all kinds of animals.”
• “Can I use Lanomax® for animals with diabetes? Lanomax® is safe for use on animals with age-related diseases, including diabetes.”
• “Can Lanomax® be used on animals with glaucoma? Does it increase the intraocular pressure? Lanomax® is safe for use on animals with glaucoma; it will not affect the intraocular pressure.”
• “Do I need a prescription and veterinarian involved to use Lanomax®? No, Lanomax® does not require consulting a veterinarian or getting a prescription.”
• “During the use of Lanomax®, the cataracts split into multiple fragments. What causes this? It is a desirable phenomenon to see the protein aggregation (the cause of cataract) is dissolving. This is nothing to be alarmed about and you should continue the treatment.”
• “Must I continue to use Lanomax® after the cataracts are completely cured? … you may want to continue to use a low dose of Lanomax® as a preventative measure against the recurrence of cataracts.”

On your webpage titled “Reviews” at the URL https://www.lanomax.com/retail/index.php/reviews.html:

• "…I found out about Lanomax…the progression has stopped and his eyes have remained stable every [sic] since…”
• "…was completely blind due to diabetic cataracts. Thanks to Lanomax, his cataracts are dissolving and he can see again…”
• "…I'm writing to tell you your lanomax eye drops helped my dogs [sic] vision immensely…”
• "Just want you to know that Lanomax is helping…He can see something out of his cataract eye [sic] that is not hyper mature.”
• "…has severe cataract on his left eye. We have applied Lanomax on both eyes…We think Lanomax is also helping the right eye from developing cataract."
• "Lanomax works well and my dog's vision has improved…”
• "To all who have cataract animals!! This product truly works…”

This product is a new animal drug under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. This product is not approved or index listed by FDA, and therefore, the product is unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited under 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 product. 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 the requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and/or injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address 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 cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. 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.

Please direct your response to U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov. Please include “CMS Case 668858” in the subject line of
your email.

Sincerely,
/S/

Neal Bataller, ME, DVM
Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine

Cc: media@embryll.com
support@lanomax.com