Inspections, Compliance, Enforcement, and Criminal Investigations
Core Products Int'L Inc 8/18/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142
August 18, 2009
Via FED EX
RETURN RECEIPT REQUESTED
Core Products International, Inc.
808 Prospect Avenue
Osceola, Wisconsin 54020
Dear Mr. Mattison:
Refer to MIN 09 - 21
This letter is in reference to your firm's marketing of "Ibunex Topical Ibuprofen," a topical cream that is labeled as containing the active ingredients ibuprofen, glucosamine sulfate, chondroitin, and bromelain, 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.coreproducts.com
• "Ibunex is a topical formula that includes Ibuprofen with Glucosamine Sulfate, Chondroitin Sulfate, MSM and Bromelain. It should be considered a first offense during the acute phase for muscle and joint application. "
• "Ibunex is the first step for addressing soft tissue and joints."
• "Targets key ingredients into muscles and joints."
• "Apply directly to target areas of the back, neck, hips, extremity muscles and joints."
• "Liposomal Dermal Delivery Matrix. Liposomes are fatty droplets that encapsulate key ingredients and carry them to the target tissue where the lipids are naturally consumed making the ingredients bioavailable."
Based on these claims, "Ibunex Topical Ibuprofen" 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, "Ibunex Topical Ibuprofen" 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 "Ibunex Topical Ibuprofen" is labeled are being evaluated under the Tentative Final Monograph (TFM) issued on February 8, 1983, for a OTC External Analgesics. (48 Fed. Reg. 5852). The External Analgesics TFM did not include the ingredients ibuprofen, glucosamine sulfate, chondroitin, or bromelain, 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 "Ibunex Topical Ibuprofen."1 Additionally, we are not aware of a product with these ingredients, for topical application, to treat any of the conditions found in the labeling of "Ibunex Topical Ibuprofen," 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 "Ibunex Topical Ibuprofen." Thus, the current marketing of "Ibunex Topical Ibuprofen" 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.
We note that your "Liposomal Dermal Delivery Matrix" for "Ibunex Topical Ibuprofen" suggests a novel drug delivery system. FDA's regulations state that a drug may be considered a new drug because of the newness of its dosage form or the method or duration of administration or application suggested in its labeling (21 CFR § 310.3(h)(5)). Because such a delivery system is not generally recognized by experts to be safe and effective for any uses, "Ibunex Topical Ibuprofen" is a new drug under section 201(p) of the Act (21 U.S.C. § 321(p)), regardless of whether it would otherwise be subject to the OTC drug review, and its marketing in the U.S. without an approved new drug application violates sections 3O1(d) and 505(a) of the Act (21 U.S.C. §§ 331(d) and 355(a)).
Furthermore, "Ibunex Topical Ibuprofen" is misbranded under section 502(0) of the Act (21 U.S.C. § 352(0)) because it was 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)).
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 awarding 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 products 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, Minneapolis District Office, 250 Marquette Avenue, Suite 600, Minneapolis, MN 55401. Attention: Dr. Brian D. Garthwaite, Compliance Officer.
W. Charles Becoat
1 Although ibuprofen as an active ingredient was first approved by the Food and Drug Administration (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 lAAA TFM does not include the topical use of ibuprofen for any indication, nor does the lAAA TFM issued on November 16, 1988, (53 Fed. Reg. 46204) include glucosamine sulfate, chondroitin, or bromelain as active ingredients.