据美国食品药品管理局(FDA)消息,近日,美国FDA发布通告,否决一项关于维生素D的健康声称申请。
据了解,本次健康声称申请的内容为“摄取维生素D可减少多发性硬化症发生的风险”,由BurdockGroup代表拜耳公司提出。多发性硬化症是一种可损害人体中枢神经系统的慢性自身免疫性疾病。
美国FDA对申请材料进行评估认为,没有可靠的证据表明摄入维生素D会降低多发性硬化症的风险。
部分原文报道如下——
TheU.S.FoodandDrugAdministrationtodaydeniedarequestforuseofaqualifiedhealthclaimthatconsumptionofvitaminDmayreducetheriskofdevelopingmultiplesclerosis(MS),achronicautoimmunedisorderthatdamagesthebodyscentralnervoussystem.
TheFDAthoroughlyreviewedthe85publicationssubmittedbytheBurdockGrouponbehalfofBayer,aswellasallthepublicationscitedinthepetitionsappendix.Theagencyalsoconductedavastindependentliteraturereviewofhundredsofadditionalpublications.Throughthisrigorousassessment,theFDAdeterminedthatscientificconclusionscouldnotbedrawnabouttherelationshipbetweenvitaminDintakeandMSrisk.basedontheagencysreviewofthetotalityofpubliclyavailablescientificevidence,theFDAhasconcludedthatthereisnocredibleevidenceofarelationshipbetweenintakeofvitaminDandareducedriskofMS.
摘编自FDA
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