Source: https://www.casewatch.net/fdawarning/prod/2009/meditrend.shtml
Timestamp: 2019-04-24 01:52:20+00:00

Document:
This letter is in reference to your firm's marketing and distribution of "IbuPRO-10 Plus," a topical cream that is labeled as containing the active ingredients ibuprofen and arnica montana and is sold over-the-counter (OTC) without a prescription. The labeling for this product contains therapeutic claims that cause the product to be a drug, as defined by section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(g)).
"For the temporary relief of minor aches & pains due to: Sprains & Strains, Rheumatic & Muscular Pain, Arthritis and Backache"
"Homeopathic, Fragrance-Free, Non-Greasy, Topical Analgesic Cream . . . Reduces Pain, Swelling and Inflammation . . . Well Tolerated with No Gastrointestinal Side Effects"
"Pain Relief for Acute & Chronic Conditions"
"Homeopathic . . . Topical Analgesic Cream . . . ."
Based on these claims, "IbuPRO-10 Plus" is a drug under section 201(g)(1)(B) of the Act (21 U.S.C. § 321(g)(1)(B)), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man and under section 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)C)), because it is intended to affect the structure or function of the body.
Moreover, based on the combination of active ingredients and the claims made for this product, "IbuPRO-10 Plus" is a new drug within the meaning of section 201(p) of the Act (21 U.S.C. § 321(p)), because it is not generally recognized as safe and effective for its labeled uses. Drug products intended for indications such as those for which "IbuPRO-10 Plus" is labeled are being evaluated under the Tentative Final Monograph (TFM) issued on February 8, 1983 for OTC External Analgesics. (48 Fed. Reg. 5852). The External Analgesics TFM did not include either the ingredient ibuprofen or the ingredient arnica montana, 1 nor were these ingredients evaluated as part of the OTC drug review for any external use, including any of the indications found in the labeling for "IbuPRO-10 Plus" 2 Furthermore, we are not aware of a product with these ingredients, for topical application, to treat any of the conditions found in the labeling of "IbuPRO-10 Plus," having been available in the U.S. market as an OTC drug on or before the inception of the OTC drug review. Accordingly, this product is not subject to the OTC drug review. There is no approved new drug application for "IbuPRO-10 Plus." Thus, the current marketing of "IbuPRO-10 Plus" violates sections 301(d) and 505(a) of the Act (21 U.S.C. §§ 331(d) and 355(a)) because it is a new drug and it is not the subject of an approved new drug application.
Furthermore, "IbuPRO-10 Plus" is misbranded under section 502(o) of the Act (21 U.S.C. § 352(o)) because it is not manufactured, prepared, propagated, compounded or processed in an establishment duly registered under section 510 of the Act, (21 U.S.C. § 360), nor is it included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
We recognize that the labeling for "IbuPRO-10 Plus" identifies it as a homeopathic drug product. We acknowledge that many homeopathic drug products are manufactured and distributed without FDA approval under enforcement policies set out in FDA's Compliance Policy Guide entitled, "Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)" (the CPG). The CPG defines a homeopathic drug as: "Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements." The CPG additionally states that "Drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products."
Although arnica montana is an established homeopathic active ingredient included in the HPUS, ibuprofen is not a recognized active ingredient in the HPUS or any of its addenda or supplements. Furthermore, to our knowledge, ibuprofen is not listed in any recognized materia medica containing information on the preparation of homeopathic medicines. Therefore, ibuprofen is not a homeopathic ingredient, and "IbuPRO-10 Plus" is not considered a homeopathic drug product under the CPG. Accordingly, the policies set forth in the CPG for the marketing of homeopathic drug products do not apply to "IbuPRO-10 Plus."
Additionally, if another firm manufactures the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the U.S. Food and Drug Administration, Denver District Office, 6th & Kipling Street, Building 20, Denver Federal Center, Denver, Colorado 80225, Attention: William H. Sherer, Compliance Officer.
1 We acknowledge that homeopathic drug products were excluded from the OTC drug review. 37 F.R. 9464, 9466 (May 11, 1972). However, as discussed below, the Food and Drug Administration (FDA) does not consider "IbuPRO-10 Plus" to be a homeopathic drug product.

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