Inspections, Compliance, Enforcement, and Criminal Investigations
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
WARNING LETTER NO. 2009-NOL-14
DELIVERY SIGNATURE REQUESTED
304 Dee Cee Court
White House, Tennessee 37188
This letter is in reference to your firm's marketing and distribution of "IBU-RELIEF 12," a topical cream labeled as containing the active ingredients arnica montana, ibuprofen, and methyl salicylate 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 the product observed on your website www.wonderlabs.com:
• "Homeopathic ... Professional Strength ... Pain Relieving Cream ... with Arnica Montana, Ibuprofen and Methyl Salicylate ...."
• "Get relief from inflamed tendons, ligaments, muscles and joints due to sports injuries, sprains, strains and bruises, as well as the pain of arthritis, backache, muscle spasms, bursitis, TMJ, heel spurs and gout. ..."
• "The cream absorbs directly into the area of pain. It contains homeopathic arnica to safely relieve pain and increase range of motion in the area of stiffness. IBU-Relief 12 contains ibuprofen and methyl salicylate ...."
The following is from the product label:
• "IBU-RELIEF 12 HOMEOPATHIC PROFESSIONAL STRENGTH ... PAIN RELIEVING CREAM WITH ARNICA MONTANA, IBUPROFEN AND METHYL
Based on these claims, "IBU-RELIEF 12" 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.
Moreover, based on the combination of active ingredients and the claims made for this product, "IBU-RELIEF 12" 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 "IBU-RELIEF 12" is labeled are being evaluated under the Tentative Final Monograph (TFM) 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 "IBU-RELIEF 12".2
The indications for inflammation, bursitis, "TMJ", heel spurs, and gout 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 "IBU-RELIEF 12", 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 "IBU-RELIEF 12" 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.
Furthermore, "IBU-RELIEF 12" is misbranded under Section 502(o) of the Act [21 USC 352(o)], because it is not manufactured, prepared, propagated, compounded or processed in an establishment duly registered under Section 510 of the Act [21 USC 352(o)], nor is it included in a list required by Section 510(j) of the Act [21 USC 360(j)].
We recognize the labeling for "IBU-RELIEF 12" identifies it as a homeopathic drug product. We acknowledge many homeopathic drugs 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 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 "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, 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 "IBU-RELIEF 12" 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 "IBU-RELIEF 12".
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 award 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 the 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. 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.
Your response should be sent to: Rebecca A. Asente, Compliance Officer, U.S. Food and Drug Administration at the above address.
H. Tyler Thornburg
New Orleans District
Page 4 - Wonder Laboratories, White House, TN