bgs final report_spa and wellness industry

It is believed this is because it is driven by

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Unformatted text preview: lable at: Radio Singapore International (2005). [Online Standards & Ethics – Miss Jacqueline Le Sueur Soul is integrity. Something that came up time and time again during the two days is the fear that the industry lacks integrity. It is believed this is because it is driven by operators who are focused primarily on revenues, and not so concerned about the wellbeing of guests or staff. Eg: lack of responsibility in 8 marketing, menu and product claims: over-promising, under-delivering. While the importance of profit is recognised, our industry in particular must ‘walk its talk’ to maintain its relevance to consumers and have long term growth. Appendix B Ear Candles - FDA Regulation and Position: Vasant G. Malshet, Ph.D., DABT, Toxicologist, Ear, Nose, and Throat Device Branch, Center for Devices and Radiological Health, US Food & Drug Administration Source: s.cfm?renderforprint=1& An independent clinical study of ear candle use conducted by Daniel R. Seely, M.D. of the Spokane ENT Clinic, Spokane, WA (Laryngoscope 1996;106:1226-9) identified 21 ear injuries resulting from ear candle use in a survey of 122 otolaryngologists. The study concluded that ear candles have no benefit in the management of cerumen problems and may, in fact, result in serious injury. Injuries such as burns of the pinna and external auditory canal, partial or complete occlusions of the ear canal with candle wax, and tympanic membrane perforation were identified in the epidemiological survey. FDA became concerned about the safety issues with ear candles after receiving reports of patient injury caused by the ear candling procedure. Although there are proponents who argue in favor of the use of ear candles, FDA is unaware of any controlled studies or other scientific evidence that support the safety and effectiveness of these devices for any of the purported claims or intended uses as contained in the labeling. Based on the growing concern associated with the manufacture, marketing, and use of ear candles, FDA has undertaken several successful regulatory actions including product seizures and injunctions since 1996. These actions were based, in part, upon violations of the Food, Drug and Cosmetic Act which pose an imminent danger to health. Specifically, the devices were considered to be misbranded in accordance with Section 502(j) of the Act because: Ear candles are dangerous to health when used in the manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling. FDA considers these devices to be dangerous because the use of a lit candle in proximity to the face carries a significant risk of potentially severe burns to the skin/hair, ear canal, tympanic membrane, and middle ear structures. The labeling was deemed to be false or misleading [section 502(a)], in that there is no valid scientific evidence to support the efficacy of the intended uses. The label of the “device fails to bear adequate...
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This document was uploaded on 01/14/2014.

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