Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
August 18, 2009
RETURN RECEIPT REQUESTED
Richard Savage, President
Meditrend, Inc. dba: Progena Professional Formulations
4820 Eubank Blvd., NE
Albuquerque, NM 87111
Dear Mr. Savage:
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)).
Following are examples of labeling claims for this product:
From your website: www.progena.com
- "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"
From the product's label:
- "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."
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the U.S. Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed.
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.
H. Thomas Warwick
Denver District Director
U.S. Food and Drug Administration
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.
2 Although ibuprofen as an active ingredient was first approved by FDA in 1974, that approval was for use as an internal analgesic available by prescription only. Oral dosage forms of ibuprofen were first available OTC in 1984. We note that on August 21, 2002, FDA proposed to amend the TFM for OTC internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include ibuprofen as a generally recognized safe and effective analgesic/antipyretic active ingredient for OTC use. (67 Fed. Reg. 54139). However, the proposal to amend the IAAA TFM does not include the topical use of ibuprofen for any indication, nor does the IAAA TFM issued on November 16, 1988 (53 Fed. Reg. 46204) include arnica montana as an active ingredient.
This page was posted on January 31, 2010.