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4kodiak/iStock Unreleased via Getty Images The FDA has issued a warning letter to Amazon.com (NASDAQ:AMZN) for the distribution of products that violate federal laws set forth by the Food, Drug, and Cosmetic Act. An investigation by the FDA revealed that products labeled as energy-enhancing supplements or dietary supplements on Amazon's site contained undisclosed and potentially dangerous active pharmaceutical ingredients, including sildenafil and tadalafil, as confirmed by laboratory analyses.
4kodiak/iStock未通过盖蒂图片发布FDA已向亚马逊(Amazon.com)(纳斯达克:AMZN)发出警告信,警告其分销违反《食品、药品和化妆品法》规定的联邦法律的产品。FDA的一项调查显示,亚马逊网站上标记为增强能量补充剂或膳食补充剂的产品含有未公开且潜在危险的活性药物成分,包括西地那非和他达拉非,实验室分析证实了这一点。
The FDA said in the letter that, 'Surprisingly, the labeling for these products does not include some important ingredients. Specifically, sildenafil and tadalafil, powerful phosphodiesterase type-5 inhibitors, are the active ingredients in widely prescribed drugs for erectile dysfunction—Viagra and Cialis.' 'The danger of these undisclosed ingredients lies in their potential interaction with nitrates commonly found in medications like nitroglycerin.
FDA在信中表示,“令人惊讶的是,这些产品的标签中没有包含一些重要成分。具体来说,西地那非和他达拉非是一种强大的5型磷酸二酯酶抑制剂,是治疗勃起功能障碍的广泛处方药伟哥和夏利的活性成分这些未公开成分的危险在于它们与硝酸甘油等药物中常见的硝酸盐的潜在相互作用。
Consumers with diabetes, high blood pressure, or heart disease often take nitrates. This combination can lead to highly dangerous drops in blood pressure. The failure to disclose these ingredients in the products’ labeling renders them misbranded under Section 502(a) of the FD&C Act,' the FDA stated in the letter.
患有糖尿病、高血压或心脏病的消费者经常服用硝酸盐。这种组合会导致非常危险的血压下降。美国食品和药物管理局在信中表示,未能在产品标签中披露这些成分,导致其根据《食品和药品管理法》第502(a)条被贴错标签。
Further introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), and 355(a) and introducing or delivering for introduction into interstate commerce a food that is prohibited under section 301(ll) of the FD&C Act, the FDA added.
美国食品和药物管理局补充说,根据《食品和药物管理法》第301(a)、301(d)和505(a)节、《美国法典》第21卷第331(a)、331(d)和355(a)节的规定,禁止进一步引入或交付这些产品以引入州际商业,并禁止引入或交付《食品和药物管理法》第301(ll)节禁止的食品以引入州际商业。
In a letter addressed to CEO Andrew Jassy dated December 20th, the FDA has requested a response within fifteen working days from the date of receipt of this letter. More o.
在12月20日写给首席执行官安德鲁·贾西(AndrewJassy)的一封信中,美国食品和药物管理局(FDA)要求在收到这封信之日起十五个工作日内做出回应。更多o。