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
BioCentric Laboratories, Inc.
11023 W. Zephyr Street
Westminster, CO 80021
P.O. Box 1018
Brighton, CO 80601
This letter is in reference to your firm's marketing of "BioEntopic 15% Ibuprofen Creme," a topical cream that is labeled as containing the active ingredients ibuprofen, MSM, Arnica flower, and Devil's Claw Root, 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, including in the form of product "reviews" from previous purchasers, for this product:
From your website: www.bioentopic.com
- "Our 15% Ibuprofen Cream is an all-natural rich body moisturizing formula that includes MSM, Arnica flower and Devil's Claw Root for the most powerful synergistic complex available."
- "I ordered this product recently to use on my shoulder with bursitis, and it took the pain away ... This is also great on backaches ...."
- "I've used this cream for painful arthritic knees. Good pain relief - especially at night."
- "I bought this creme last week and have been using it to help with pain associated with prior ankle surgery ... The first time I used this product I felt relief within 5 minutes of applying it ...."
Based on these claims (including product "reviews" from previous purchasers), "BioEntopic 15% Ibuprofen Creme" 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, "BioEntopic 15% Ibuprofen Creme" 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 "BioEntopic 15% Ibuprofen Creme" 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 the ingredients ibuprofen, MSM, arnica flower, or devil's claw root, 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 "BioEntopic 15% Ibuprofen Creme." 1 Furthermore, indications for bursitis are not included in the External Analgesics TFM. 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 "BioEntopic 15% Ibuprofen Creme," 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 "BioEntopic 15% Ibuprofen Creme." Thus, the current marketing of "BioEntopic 15% Ibuprofen Creme" 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, "BioEntopic 15% Ibuprofen Creme" is misbranded under section 502(o) of the Act (21 U.S.C. § 352(o)) 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, Denver District Office, 6th & Kipling St., Building 20, Denver Federal Center, Denver, CO 80225-0087. Attention: William H. Sherer, Compliance Officer.
H. Thomas Warwick
Denver District Director
U.S. Food and Drug Administration
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 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 MSM, arnica flower or devil's claw root as active ingredients.
This page was posted on January 31, 2010.