Inspections, Compliance, Enforcement, and Criminal Investigations
Quasar Bio-Tech, Inc. dba Silver Bay LLC 12/9/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
December 9, 2011
Peter B. Nesbitt
Chief Executive Officer
Quasar Bio-Tech, Inc. dba Silver Bay LLC
1431 Tallevast Road
Sarasota, FL 34243
Dear Mr. Nesbitt:
During an inspection of your firm located in Sarasota, Floridaon February 2, 2011, through February 3, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures, the following models of light-emitting diode (LED) products: Baby Quasar; Quasar MD21 Infrared Heat Lamp (Quasar MD); and Quasar PowerPack (which includes the Baby Blue and Baby Quasar). 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.
During the inspection, FDA learned that your firm is promoting and marketing the Baby Quasar, Quasar MD and the Quasar Power Pack in the United States without the required marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Specifically, the Baby Quasar was cleared under (b)(4) as a prescription device with the following indications:“to emit energy in the red and IR region of the spectrum for the use in dermatology for the treatment of periorbital wrinkles.” However, you are marketing the device for over-the-counter (OTC) use and for other indications that represent a major change in the intended use of the device. For example, at the time of the inspection, your website (http://www.babyquasar.com) had the following claims:
“The Baby Quasar is designed with four wavelengths of natural light making it the most powerful and effective consumer device available today. Simply and thoughtfully designed for you, the individual who wants anti-aging or acne treatments all within the fun and convenience of your own home...”
“The Baby Quasar helps damaged cells to be replaced more promptly by increasing RNA and DNA synthesis.”
“The Baby Quasar helps to reduce pore size by regulating the amount of excess sebum being produced by your sebaceous glands.”
“The Baby Quasar decreases the flaws we would all like to be without, such as: acne, rosacea, blemishes, fine lines via sun damage, age spots, perinocular wrinkles, enlarged pores, skin laxity, coarse skin and translucent skin.”
Additionally, you are marketing the Baby Quasar with four wavelengths of light when it was only cleared for use at (b)(4) wavelengths (b)(4). For low level light devices, a change to the instructions for use and/or treatment parameters (wavelength, treatment area, power density, etc) could potentially affect the safety and effectiveness of the device.
The Quasar MD is cleared under (b)(4) as a prescription device with the following indications for use: “to emit energy in the infrared spectrum to topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.” However, you are marketing the device for over-the-counter use and for off-label indications that represent a major change in the intended use of the device. For example, your firm’s instruction manual for the Quasar MD states:
“Use the Quasar MD for…production of collagen.”
“As we age, our skin begins to change. It becomes less firm, loses color, pores may expand, and wrinkles form. Too much sun and smoking makes it worse. Research shows special red and infrared low-level laser light can stimulate the cells in your skin to become more active and help produce collagen, which is important for younger looking skin.”
Your firm’s website (http://www.babyquasar.com) also states:
“Built on revolutionary light technology, the Quasar MD emits a near infrared light that soothes and stimulates your skin, thereby…generating the production of new collagen.
Your website also claims that the Quasar MD is, “more powerful and 3x more effective than your prestigious Baby Quasar, you will be able to achieve professional quality spa results in half the time.” This statement represents a significant change in the indented use of the device because, unlike the Baby Quasar, the Quasar MD has not been cleared to treat dermatologic conditions.
Your website also promotes the “Quasar Power Pack”, which contains both the Baby Quasar and Baby Blue for use together. FDA has not cleared the use of the two light treatments together, which represents a major change in the intended use of each device For low level light devices, device specific clinical data is necessary for new indications for use/intended use unless there is sufficient data already available from the device in question to support the new indication/intended use. We currently do not have sufficient clinical data for the Quasar Power Pack. Your website (http://www.babyquasar.com) makes the following claims about the use of the Baby Blue and Baby Quasar together:
“In fact, clinical studies have shown that a combination of red (Baby Q) and blue (Baby Blue) light therapy works better than other acne treatments, is less costly, and has no side effects.”
“The Quasar Blue is intended for use in harmony with the Baby Quasar when treating Acne and blemishes.”
These changes to the intended use and technology of the Baby Quasar and Baby Blue cause these devices to be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), 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), for these devices, as changed. These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce them into commercial distribution with the changes discussed above, as required by section 510(k), 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(i) and (ii).
For devices 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 these 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 products may be legally marketed.
FDA previously advised you in a letter dated September 22, 2010, that many similar claims that you had made for your devices constituted changes in their intended uses requiring the submission and clearance of a new 510(k). Your firm did not respond to our letter.
Misbranded by Reference
Your devices are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), in that the labeling of the Quasar MD and Quasar Pro SP contains statements that are misleading under 21 C.F.R. § 807.97, because such statements create an impression of official approval of a device due to clearance of a premarket notification submission. Specifically, the labeling states:
“LED light therapy is FDA approved although specific devices may or may not have FDA approval.”
None of your devices were approved by FDA, but rather were determined to be substantially equivalent within the meaning of section 513(i)(1)(A) of the Act, 21 U.S.C. § 360c(i)(1)(A).
We received a response from you dated February 15, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm at the conclusion of the inspection. We reviewed your response and conclude that is not adequate because you stated that by April 1, 2011, your firm would review and correct all distributor websites and sales materials to ensure that all claims coincide with the appropriate FDA clearances. However, your website was reviewed on December 8, 2011[ip1] and it was determined that you had not removed violative claims from your website or revised your firm’s promotional materials.
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.
Please notify this office in writing within fifteen 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 firm’s response should be sent to: FDA’s Florida District Office, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. Refer to the Unique Identification Number (CMS case # 179355) when replying. If you have any questions about the contents of this letter, please contact Salvatore N. Randazzo, Compliance Officer at (407) 475-4712 or fax (407) 475-4769.
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. 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
Emma R. Singleton
Director, Florida District