Update: On May 29th, 2014, FDA finalized an order to reclassify sunlamp products from Class I devices to Class II devices requiring pre-market 510(k) submissions. For more information, please see the Tanning website. President, Indoor Tanning Association, Inc. 2025 M St., NW, Suite 800 The Food and Drug Administration (FDA) is aware that some tanning salon owners are removing the original ultraviolet (UV)-emitting tanning lamps from their tanning beds/booths and replacing them with lamps that emit red light. These salon owners are then selling sessions in the red-light units with a range of indications and promotional claims, including ones pertaining to: Ultraviolet tanning beds/booths/lamps meet FDA’s definition of “device” and “electronic product” at sections 201(h) and 531 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Tanning lamps are subject to an electronic product performance standard, and are generally 510(k)-exempt. See 21 CFR 878.4635, part 1010 and 1040.20.
Replacing the original ultraviolet lamps with lamps that emit red light and are intended for uses such as those listed above creates a new type of product that is also a “device” and an “electronic product” under the FD&C Act. Exposure to red light has been scientifically shown and is understood by consumers to affect skin structure, for example by reducing wrinkles for months after treatment, which may be the result of new collagen formation or reorganization, or repair of elastin damage. Claims such as those listed above would cause the product to meet one or both of the “device” definitions at sections 201(h)(2) and (3) of the FD&C Act. Red lights intended for uses such as those listed above would not fall under 21 CFR 878.4635, and would not be 510(k)-exempt (they also would not fall under 21 CFR 1040.20, but would be subject to the regulations generally applicable to electronic products at parts 1000 - 1005). Unless and until such device receives 510(k) clearance or premarket approval from FDA, it would be an adulterated and misbranded device that may not be marketed for sale.
Red light therapy systems intended for uses such as those described above may fall under 21 CFR 878.4810, 878.5400, or 890.5500, depending on the technology and the claims made. For devices that fall within one of these classification regulations, the proper application to file is the 510(k) or “Premarket Notification.” FDA requests the Indoor Tanning Association’s assistance in getting this message out to its members. FDA is also communicating this message to state radiation control programs. Some states have expressed concern about this practice to FDA and have already taken action on their own. Some useful links to the FDA website relevant to this issue are shown below: The instructions on how to submit a Premarket Notification application can be found at Device Advice: Premarket Notification (510k). The sunlamp regulations and other resources can be found at Sunlamps and Sunlamp Products (Tanning Beds/Booths): Laws, Regulations & Standards. Questions about the requirements for clearance of red light devices may be directed to Richard Felten in the Office of Device Evaluation, CDRH, 10903 New Hampshire Avenue, WO-66, Silver Spring, Maryland 20993 or by email at Richard.Felten@fda.hhs.gov.
Questions about FDA radiation control requirements for electronic products may be directed to Sharon Miller in the Magnetic Resonance and Electronic Products Branch, Office of In Vitro Diagnostics and Radiological Health, CDRH, 10903 New Hampshire Avenue, WO-66, Silver Spring, Maryland 20993 or by email at SharonA.Miller@fda.hhs.gov. Center for Devices and Radiological HealthTanning Bed TipsTanning BoothSun TanningTanning SecretsTanning ProductsSkin Care ProductsTanning SalonsSkin CancerLung CancerForwardTanning In A Tanning Bed 101: For Beginners That Have Never Tanned Before Tanning SuppliesBed CleanerStickers, Eyeware Tan Incorporated Tan ASZ U offers all brands of sun tan lotion and indoor tanning lotion products at a big discount. In addition, we now offer an easy-to-use shopping cart system to make purchasing our sun tan lotion and tanning products and supplies a very quick, easy, and effortless process. We look forward to serving all of your needs by offering a huge selection of suntan lotion and suntan oil as
well as other indoor tanning bed lotion products and supplies. Copyright 2017 Tanning Lotion Warehouse.A salon or spa may provide a range of services from personal care to cosmetic care. Before opening your business, consider which type of services you would like to offer. Some common types of spa/salon businesses are: This guide focuses on operating an independent spa or salon. For information on buying a franchise, visit The Canadian Franchise Association online or call 1-800-665-4232. When you start a business there are several things to consider before you can sell your product or service. Most businesses in Ontario need to complete a minimum of three basic steps: Our business start-up guide will give you more information on these steps and other basic requirements for starting a business in Ontario. Your business may need licences and permits from the federal, provincial and municipal levels of government. In addition to the information you will find in this guide, you can use the Canada Business Permits and Licenses Search, powered by BizPaL, to find licences and regulations that may affect your business.
You can also contact us to speak to someone about starting your business. Permits and licences search Some common licences, permits and regulations that may apply to starting your spa or salon include: When your business uses recorded music, you are responsible for obtaining the right licence(s) for that use. The Copyright Board of Canada works with individual copyright collective societies who provide music licensing. Contact the following two organizations for more information. If you have legal questions, contact a lawyer who deals with business regulations. The Law Society of Upper Canada's Law Society Referral Service may be able to assist you in finding a lawyer or paralegal, based on your needs. Law Society Referral Service Depending on your location and the type of products or services being offered, federal, provincial and/or municipal business taxes may apply. If you sell goods and services in Ontario, you may need a business number to collect and remit the Harmonized Sales Tax (HST).