This isn't new. It is just the United States re-introduction of the They Fit condoms, including the same letter-number sizing system system, that was used when They Fit was first introduced to the US about 15 years ago. The original They Fit brand was withdrawn from the market in the USA years ago, because the German-owned supplier in Malaysia got blacklisted by the US FDA after failing quality inspections three times in a row. (Curiously, they received an award for exemplary quality from European medical device regulators at this same time.) They Fit was allowed to liquidate their inventory already imported to the USA to existing customers only, but was prohibited from importing additional condoms from that factory, or seeking new customers. I bought out their stock of my size, and one other (U22 and Z22, as I recall), about 600 total. Presumably, they have a new supplier...
It actually took a lot of legal wrangling to be able to sell the original They Fit, or any special sized condoms, in the USA in the first place. FDA has specifications for condoms (developed for FDA by an organization called ASTM) which lists the maximum permissible size (actually width), and ordinarily larger ones cannot be sold here. (In the USA, condoms are by law considered medical devices, and are therefore subject to full control by FDA, just like drugs, etc.) The regulation was circumvented by having a dick-measuring process, and by using size codes that were not obviously related to the size. (Hence the crazy letter-number combinations). There originally was actually a patent on this method of circumventing the FDA regulation, which I believe has now expired, and may explain why the product has resurfaced.
The argument implied by FDA was that men, being vain creatures, would assume that they must have a big dick and buy XXXXL if given the chance, even though they did not fit at all and would therefore not work correctly. Thus there was a maximum size limit which, given the elasticity of the rubber, etc, would not fail on most of the population, based on the dick-size analysis by ASTM. However, I believe the real issue is that some Washington bureaucrat was deathly afraid to admit that some men might actually have a bigger dick than he did.
