Inspections, Compliance, Enforcement, and Criminal Investigations
Wal-Med, Inc. 30-Apr-07
Department of Health and Human Services
Public Health Service
April 30, 2007
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 07-13
Nancy F. O'Farrell, President
Wallace O'Farrell Marketing, Inc.
aka, Wal-Med, Inc.
11302 164th Street East
Puyallup, Washington 98374
Dear Ms. O'Farrell:
During an inspection of your firm located in Puyallup, Washington, on November 15, 2006, through December 14, 2006, an investigator from the United States Food and Drug Administration(FDA) determined that your firm manufactures the vaginal lubricants FemGlide, Slippery Stuff, and HerGel, which are intended to be used as patient lubricants and/or accessories to condoms. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Our inspection revealed that these devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(13), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). These devices are also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce these devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency, 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your devices is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The labeling for Lice-Out and Lice-Trap also contain therapeutic claims that cause the products to be drugs, as defined by section 20 1 (g) of the Act, 21 U.S.C. 321 (g).
Following are examples of labeling claims for these products:
"Ingredients: Water (Aqua), Polyoxyethylene, Methylparaben, Sodium carbomer"
"Louse & Nit Removal Gel"
"Non-toxic, no harmful or dangerous pesticides. Safe, gentle enough to use on eyebrows or pubic hair, water-based formula captures and immobilizes lice while loosening their eggs (nits), making them easier to remove with our fine toothed Lice-Trap" precision comb."
"Ingredients: Deionized (purified) water, Polyoxyethylene, methyl-paraben, Sodiumcarbomer"
"The 'Original' Gel Immobilizing Louse and Nit Removal System!"
"Non-toxic, no harmful or dangerous pesticides. FDA Registered, safe, gentle, water based formula captures and immobilizes lice making them and the eggs (nits) easier to remove with our fine toothed LiceOut precision comb..."
"When LiceOut is applied liberally to wet hair, it coats lice with a suffocating layer of gel that immobilizes the pests and shuts off their airways, creating a state of 'sham' death."
These claims indicate that Lice-Trap and LiceOut are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man. The disease, in this instance, is pediculosis. Claims such as these represent and suggest that the intended use of these products is to have a direct effect on lice, that are the cause of disease, pediculosis. Accordingly, as noted above, Lice-Trap and LiceOut are drugs under section 201(g)(1)(C) of the Act, 21 U.S.C. 321(g). Moreover, because there is no evidence that Lice-Trap and LiceOut are generally recognized as safe and effective for these claimed indications, and we are unaware of any topical preparation indicated for lice removal that is formulated as Lice-Trap and LiceOut that have been marketed in the U.S. on or before December 4, 1975, the products are new drugs as defined by section 201(p) of the Act, 21 U.S.C. 321 (p)).
Under section 505(a) of the Act, 21 U.S.C. 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Section 301(d) of the Act, U.S.C. 33 l(d), makes the introduction or delivery for introduction into interstate commerce of any article that violates section 505 a prohibited act. There are no FDA approved applications for these products and your distribution of these products in interstate commerce violates sections 505(a) and 301(d) of the Act.
Further, Lice-Trap and LiceOut are subject to the final monograph covering pediculide drug products for over-the-counter (OTC) human use [21 CFR 358] because the claims on the labeling of the products state that the products will mitigate and treat lice. Under 21 CFR Part 358, the only acceptable active ingredients in pediculicide products are pyrethrum extract combined with piperonyl butoxide.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts
Please notify this office in writing within fifteen (15) working days from the date you receive this
letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Lisa M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about the content of this letter please contact: Lisa M. Althar at (425) 483-4940.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Charles M. Breen