FDA WARNING_LETTER - Embryll Life Sciences, Inc. - October 24, 2023

The FDA issued a Warning Letter to Diana Rodriguez on October 4, 2023, regarding the marketing of Lanomax® for treating cataracts in animals. The FDA reviewed the firm's website, https://www.lanomax.com, in August and September 2023 and determined that Lanomax® is promoted and sold as a drug under section 201(g)(1) of the FD&C Act, intended for disease treatment or affecting animal body functions.

The product is cited as an unapproved new animal drug, violating section 301(a) of the FD&C Act, as it lacks FDA approval for safety and effectiveness. Currently, no FDA-approved eye drops exist for animal cataracts. The FDA noted that unproven treatments like Lanomax® could cause owners to delay appropriate veterinary care.

Lanomax® is also classified as a new animal drug under section 201(v) of the FD&C Act because it is not generally recognized as safe and effective by experts. To be legally marketed, new animal drugs require an approved or conditionally approved new animal drug application or index listing under sections 512, 571, and 572 of the FD&C Act. Since Lanomax® is not approved or indexed, it is deemed unsafe under section 512(a) and adulterated under section 501(a)(5