Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
May 1, 2014
WL# 19 – 14
Dr. Barry J. Kaplan, President and Owner
Dr. Joel Kaplan, Inc.
1220 Rosecrans St., Ste. 128
San Diego, CA 92106-2674
Dear Dr. Kaplan:
During an inspection of your firm located in San Diego, California, conducted from June 19th, 2013 through July 17th, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm operates as a manufacturer of the MegaVac System, an external penile rigidity device, from a retail store location. Your firm also markets and sells medical devices and dietary supplements from your website www.drjoelkaplan.com. We note that your website www.getbiggertoday.com also redirects to the aforementioned website. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), the MegaVac System is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We did not receive a response from you concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm on 07/17/2013. Noted violations include, but are not limited to, the following:
1. Failure to adequately maintain device history records as required by 21 CFR 820.184. Your firm has no device history records associated with the repacking of MegaVac pumps.
2. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a). For example, your firm has not established a complaint handling procedure for the medical devices you manufacture and distribute.
Our review of the inspection and your firm’s websites (www.getbigger.com and www.drjoelkaplan.com) determined that the MegaVac System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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) for the device as described and marketed. The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
Specifically, the MegaVac System was cleared under K974196 with the following indications: to create and maintain penile erection in impotent men. However, your firm is marketing the device for penis enlargement, length and correction of penile curvature, which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval.
Examples include, but are not be limited to:
- “Our products bring permanent and safe Penis Enlargement and help resolve Erectile Dysfunction.”
- “mild curvature of the penis may also be corrected…”
- “vacuum pumps are effectively used for post-surgical enlargement and will reverse the effects of penile shrinkage due to aging”
- “our products bring permanent and safe Penis Enlargement”
- “Gain 1-3 inches permanently…”
- “…increase girth by 25%”
- “Dr. Kaplan’s Penis Pumps are the most successful natural strategy for penis enlargement…”
- “The Deluxe Hand Pump…for permanent increase in penis length, penis girth, and scrotal enlargement”
- “Dr. Kaplan’s Pump Systems: “Correct Curvature”
The above claims exceed the limitations of the regulation and the special controls guidance document for an external penile rigidity device and would require a new 510(k) submission.
Your firm also stated these devices are “FDA Approved”. The reference to “FDA Approved” implies that this device received an official approval based upon the 510(k) clearance. Such statements are misleading because these devices are deemed to be substantially equivalent and are not approved by the FDA.
FDA also determined that your firm manufactures the Clitoris Enhancement System. Clitoris Enhancement System devices are Class II devices and are regulated under 21 CFR 884.5970. A review of our records reveals that your firm has not received 510(k) clearance before offering this device for sale. Therefore, the Clitoris Enhancement System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device 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) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our office requests that Dr. Joel Kaplan Inc. immediately cease activities that result in the misbranding or adulteration of the MegaVac System and Clitoris Enhancement System, such as the commercial distribution of the devices for the uses discussed above.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected. A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.
In addition, in the Pharmacy section of your firm’s website at www.drjoelkaplan.com, your Original Penis Enlargement Pills (Vascular Dilator), Penis Enlargement Pills (Yohimbe Free), Tribulis Terrestris (Natural Viagra Alternative), and Male Booster (Natural Cialis Alternative) products are promoted as “nutritional supplements” alongside Dr. Joel Kaplan’s Official Pump Systems. You make unsubstantiated medical and structure/function claims for these “nutritional supplement” products.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
Irvine, CA 92612
If you have any questions about the content of this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at 949-608-2918 or firstname.lastname@example.org.
Alonza E. Cruse, Director
Los Angeles District
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence