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Thai FDA investigates bra claimed to help enlarge breast.
(From Thai Press Reports)
Section: General News - The Food and Drug Administration (FDA) is to review a 'breast-enlarging' bra's specifications to see if it warrants an import ban, after the importer claimed the agency had declared the device safe, the Nation reports.
Pakdee Phosiri, FDA secretary-general, said the bureau in June last year classified the bra as a Level I device 'under general control", meaning the product does not require FDA authorisation.
This, however, did not guarantee the product was safe, nor its quality, as the importer, Venus Technology Ltd, claimed in its advertisements, Pakdee said. He added that the FDA clearly stated that it prohibited Venus Technology from making such claims in its advertising without first obtaining FDA approval.
This would require the agency's medical products committee to review the device's specifications for it to be reclassified. If the product was deemed not to fulfil the maker's claims, importation to the Kingdom could be denied, Pakdee said.
The FDA would then ask the Thai Pharmaceutical Manufacturers Association, a ...
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