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美國(guó)FDA否決一項(xiàng)關(guān)于維生素D的健康聲稱申請(qǐng)

觀察

2018年02月02日

據(jù)美國(guó)食品藥品管理局(FDA)消息,近日,美國(guó)FDA發(fā)布通告,否決一項(xiàng)關(guān)于維生素D的健康聲稱申請(qǐng)。

據(jù)了解,本次健康聲稱申請(qǐng)的內(nèi)容為“攝取維生素D可減少多發(fā)性硬化癥發(fā)生的風(fēng)險(xiǎn)”,由Burdock Group代表拜耳公司提出。多發(fā)性硬化癥是一種可損害人體中樞神經(jīng)系統(tǒng)的慢性自身免疫性疾病。   

美國(guó)FDA對(duì)申請(qǐng)材料進(jìn)行評(píng)估認(rèn)為,沒(méi)有可靠的證據(jù)表明攝入維生素D會(huì)降低多發(fā)性硬化癥的風(fēng)險(xiǎn)。   

部分原文報(bào)道如下:

The U.S. Food and Drug Administration today denied a request for use of a qualified health claim that consumption of vitamin D may reduce the risk of developing multiple sclerosis (MS), a chronic autoimmune disorder that damages the body's central nervous system.

The FDA thoroughly reviewed the 85 publications submitted by the Burdock Group on behalf of Bayer, as well as all the publications cited in the petition's appendix. The agency also conducted a vast independent literature review of hundreds of additional publications. Through this rigorous assessment, the FDA determined that scientific conclusions could not be drawn about the relationship between vitamin D intake and MS risk. based on the agency's review of the totality of publicly available scientific evidence, the FDA has concluded that there is no credible evidence of a relationship between intake of vitamin D and a reduced risk of MS.

(原標(biāo)題:美國(guó)否決一項(xiàng)關(guān)于維生素D的健康聲稱申請(qǐng))

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來(lái)源: 作者:高曉燕

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