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02-10-2009, 10:06 AM | #1 (permalink) |
Join Date: Jan 8 2009
Posts: 24
Rep Power: 0 | FDA and European Standards Reading Looking Fit it says... In our last article, we said the FDA’s response to the TAN Act contains an ominous warning that must not be ignored. Specifically, the FDA stated that the maximum allowable dose of 4 MED—which has been effectively used since 1986—is actually excessive and can be reduced to 1.3 or 1 MED without affecting tanners’ results. In addition, the FDA stated its intent to use research from international experts on the International Electrotechnical Commission (IEC) when considering any proposed changes to the sunlamp performance standard—which means that the FDA most likely intends to adopt the 0.3 W/m^2 European Union maximum-irradiance standard. Is anyone concerned by this and is the ITA powerful enough to stop it? |
02-11-2009, 10:40 AM | #4 (permalink) |
Join Date: Nov 13 2001 Location: MI
Posts: 861
Rep Power: 23 | Re: FDA and European Standards The FDA does not consider a higher MED for higher skin types. Rather they have been allowing four (4) 156 J/m² MEDs - or 624 J/m² max Te time as base tan ramps up to tolerate the full dose. No current limit on dose rate... just time based. But EU and AU both consider type 2 MED as 250 J/m², type 3 as 350 and type 4+ as 450. So probably FDA will do the same thing if and when they change the "rule". EU dose rate cap is low (0.30 W/m² Eeff) and AU is high (0.90 W/m²). Typical USA beds are in the ~0.7 W/m² range. Bottom line is the max time will be based on both dose rate and MED definitions. If the rate cap is low sesion times will usually be longer (depending on skin type). If the rate cap is higher sessions will usually be shorter. Exact schedules will have to be "worked out" once they (FDA) decide what they "want" given the above choices... or a variation of them. Fun, eh? |
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