Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm369286
Timestamp: 2018-12-10 17:42:21
Document Index: 779782338

Matched Legal Cases: ['§ 352', '§ 331', '§ 353', '§ 344', '§ 352', '§ 201']

Medtech Products, Inc. 9/19/13
This letter is to advise you that the United States Food and Drug Administration (FDA) has recently reviewed your firm’s labeling and marketing information for the drug product, “Murine Ear Drops for Earache Relief.” Based on our review, the product is in violation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). As described in more detail below, this product is misbranded under sections 502 and 503 [21 U.S.C. §§ 352 and 353] and in violation of section 301 of the FD&C Act [21 U.S.C. § 331].
The product name, “Murine Ear Drops for Earache Relief”
“Chamomilla HPUS 10x......calmative, pain reliever”
“Mercurius solubilis HPUS 15x......anti-inflammatory”
“Relieves pain, soothes, and calms”
“Provides temporary relief from earache (ear pain) in adults and children . . .”
Although marketed to consumers as an over-the-counter (OTC) drug, Murine Ear Drops for Earache Relief is a prescription drug under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. Section 503(b)(1) of the FD&C Act [21 U.S.C. 353 (b)(1)] identifies criteria for determining the prescription status of a product. The product listed above is a prescription drug within the meaning of section 503(b)(1) of the FD&C Act because it is intended to treat diseases that require diagnosis and treatment by a physician or is intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. Ear pain (earache) is not a currently recognized OTC indication in the final monograph for topical otic products (21 C.F.R. § 344) or in any approved OTC new drug application.[1] OTC treatment is inappropriate for ear pain because consumers cannot distinguish its symptoms from those of more serious disorders of the ear or adjacent tissues which are not amenable to OTC treatment and which can lead to serious injury if not accurately diagnosed and treated by a licensed healthcare professional.
Murine Ear Drops for Earache Relief is also misbranded within the meaning of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352 (f)(1)] in that its labeling fails to bear adequate directions for use as that term is defined in 21 C.F.R. § 201.5. The indication for which the product listed above is labeled and marketed, i.e., treatment of ear pain or inflammation, is not appropriate for OTC use. If an indication requires the supervision of a practitioner licensed to prescribe drugs, adequate directions for use cannot be written for an OTC drug product for that indication.
Address your reply to the U.S. Food and Drug Administration; Attn: LCDR Frank Verni, RpH; 158-15 Liberty Avenue; Jamaica, NY 11433. You may reach LCDR Verni at (718) 662-5702 if you have any questions about this matter.
Medtech Products, Inc. - Close Out Letter 11/6/14