Department of Health and Human Services
|Public Health Service
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
August 18, 2009
DELIVERY SIGNATURE REQUESTED
Progressive Emu, Inc.
232 Oxmoor Circle, Suite 1013
Birmingham, Alabama 35209
This letter is in reference to your firm's marketing of "Emuprofen," a topical cream labeled as containing the active ingredients ibuprofen and emu oil and sold over-the-counter (OTC) without a prescription. The labeling for this product contains therapeutic claims causing the product to be a drug, as defined by Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 321(g)].
The following are examples of labeling claims for this product observed on your website www.emuprofen.com:
- "Emuprofen combines Emu oil with Ibuprofen, MSM, Glucosamine and a blend of natural anti-inflammatory botanicals to bring you an incredibly powerful topical pain cream...."
- " ... alternative to oral NSAIDS for numerous conditions, including arthritis, lower back pain, tendonitis, shin splints, shoulder and neck pain, ankle sprains, knee pain, foot pain, plantar fasciitis, carpel tunnel syndrome, and tennis elbow ...."
- "We use only Certified Fully Refined Emu Oil in the production of Emuprofen and have had wonderful results for athletes experiencing problems with tennis elbow, muscle pain, muscle inflammation, tendonitis, and shin splints ...."
- "Emuprofen is a topical ibuprofen cream that has the same ingredients as oral medication, but it does not cause the side effects that sometimes come with the oral medication ...."
Based on these claims, "Emuprofen" is a drug under Section 201 (g)(1)(B) of the Act [21 USC 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 USC 321(g)(1)(C)], because it is intended to affect the structure or function of the body.
In addition, based on the active ingredients and the claims made for this product, "Emuprofen" is a new drug within the meaning of Section 201 (p) of the Act [21 USC 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 "Emuprofen" 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 and emu oil, and these ingredients were not evaluated as part of the OTC drug review for any external use, including any of the indications found in the labeling for "Emuprofen" 1.
The indications for tennis elbow, muscle inflammation, tendonitis, and shin splints 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 "Emuprofen" having been available in the U.S. market as an OTC drug, on or before December 4, 1975. Therefore this product is not subject to the OTC drug review. The current marketing of "Emuprofen" violates Sections 301(d) and 505(a) of the Act [21 USC 331 (a) and 355(a)], because it is a new drug and it is not the subject of an approved new drug application.
Also, "Emuprofen" is misbranded under Section 502(o) of the Act [21 USC 352(o)], because it was not manufactured, prepared, propagated, compounded or processed in an establishment duly registered under Section 510 of the Act [21 USC 360(b)], nor is it included in a list required by Section 510(j) of the Act [21 USC 360(j)].
The above violations are not meant to be an all-inclusive statement of violations existing in connection with your product. It is your responsibility to ensure your firm complies with all requirements of federal law and FDA regulations.
A description of the new drug approval process and other requirements can be found on FDA's website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions regarding this process should be directed to the 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 above and prevent future recurrence. Failure to do so may result in enforcement 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.
Please notify this office, in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct violations noted above and to assure similar violations do not occur. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed. Furthermore, please advise this office of the actions you will take to address product already distributed. 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.
Your response should be sent to: Rebecca A. Asente, Compliance Officer, U.S. Food and Drug Administration at the address above.
H. Tyler Thornburg
New Orleans District
1. Although ibuprofen as an active ingredient was first approved by FDA in 1974, the approval was for use as an internal analgesic available by prescription only. We note, 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.
This page was posted on January 31, 2010.