The letter advised that the United States Food and Drug Administration (FDA) reviewed Homeolab’s labeling and marketing information for the drug product, “Kids Relief Earache” and found it to be in violation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
The flase and misleading representations include:
“Ferrum phosphoricum 30X……inflammation and fever”
“Belladonna 30X……throbbing pain and inflammation
“Pyrogenium 30X……infection and fever”
“Relieve mild to severe ear pain”
“Soothe throbbing pain & pressure”
Based on these claims, the product is a drug as defined by section 201(g)(1)(B) and (C) of the FD&C Act [21 U.S.C. § 321(g)(1)(B) and (C)], because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, and/or intended to affect the structure or any function of the body.
Although marketed to consumers as an over-the-counter (OTC) drug, Kids Relief Earache 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 any final monograph or in any approved OTC new drug application. 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.
Because this product is subject to 503(b)(1) of the FD&C Act, the product is misbranded under section 503(b)(4) of the FD&C Act [21 U.S.C. § 353(b)(4)] in that the label fails to bear the symbol, “Rx only.”
Kids Relief Earache 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.
The FDA also found the drug misbranded within the meaning of section 502(a) of the FD&C Act [21 U.S.C. 352 (a)] in that its labeling is false or misleading because it represents the product as suitable for use by consumers to treat a condition which the Agency has found not appropriate for OTC drug treatment, and because it encourages OTC treatment for ear pain, but fails to distinguish among conditions that manifest with ear pain and that can lead to serious injury if not accurately diagnosed and treated by a licensed physician.
Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. The FDA acknowledged that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)” (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed. Thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. One of those conditions is compliance with section 503(b) of the FD&C Act. Under the CPG, only homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed over-the-counter (OTC). Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.
The FDA ordered the company to take prompt action to correct the violations cited in the letter.