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Posts tagged ‘FDA’

Just because it’s sweet and sticky doesn’t mean it’s ‘honey’

honey

Honey mixed with sugar might be sweet, but it is not “‘honey’, says the US Food and Drug Administration. – freegreatpicture.com

 

US FDA: If it’s not pure honey, then it’s not honey; product must be labelled as a ‘blend’

Honey mixed with sugar might be sweet, but it is not “honey”. Food companies and other producers that add sweeteners to honey have to alert consumers by labelling their products as a “blend”, the US Food and Drug Administration said on April 7.

Only manufacturers that do not add sugar, corn syrup or other sweeteners should label their products as pure “honey”, the FDA said in draft guidelines posted online.

The proposal aims “to advise the regulated food industry on the proper labelling of honey and honey products to help ensure that honey and honey products are not adulterated or misbranded,” the agency wrote.

Americans consume more than 400 million pounds (181 million kilos) of honey each year, according to US government and industry estimates. But just 149 million pounds (67.5 million kilos) were produced in the United States last year, US Department of Agriculture data showed.

To feed America’s sweet tooth, much honey is imported, and US producers are worried about cheap substitutes.

Pure honey is generally more expensive than those mixed with corn syrup and traditional sugar, and prices reached a record high of US$2.12 a pound (RM15.20 a kilo) last year, according to the USDA.

The FDA’s review follows a petition from the American Beekeeping Federation and several other related groups seeking a standard US definition for the natural sweetener to promote fair trade.

While the agency rejected their request, it said it was willing to look at labelling.

The FDA inspected imported honey to see whether it had been “adulterated” with corn or cane sugars. In recent decades, it detained honey containing such substitutes from countries such as Brazil and Mexico, according to the agency.

Manufacturers have 60 days to comment on the proposal before final guidelines are issued. Even then, however, guidelines are not mandatory. – Reuters

Watch this video on the honey hunters of Malaysia.

 

Here’s Sir David Attenborough studying giant honey bees in Malaysia.

via Just because it’s sweet and sticky doesn’t mean it’s ‘honey’ – News | The Star Online.

F.D.A. Rule Could Open Generic Drug Makers to Suits

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Karen Bartlett of New Hampshire took a generic prescription, harming her skin and eyesight.

The Food and Drug Administration on Wednesday signaled its intention to permit generic drug makers to make changes to their safety labels, a move that could open the door to lawsuits against generic drug companies for the first time since a Supreme Court decision barred such suits two years ago.

Consumer advocates applauded the development, calling it a necessary fix for a system that they say is unfair to patients who take generic medicines.

“It’s common sense,” said Dr. Sidney M. Wolfe, a senior adviser to the Health Research Group at Public Citizen, which in 2011 petitioned the F.D.A. to pass just such a rule. “It will obviously end this situation where people are being harmed physically and yet, although they are harmed, they have no right to go into court and get redress for serious damages.”

Dozens of lawsuits against generic drug manufacturers have been dismissed since 2011, when the Supreme Court ruled that because the generic companies must, by law, use the same label warnings as their brand name counterparts they cannot be sued for failing to alert patients about the risks of taking their drugs. Last month, the Supreme Court ruled — on similar grounds — that patients also may not sue generic drug makers by claiming that the drug was defectively designed.

The F.D.A.’s intentions came in the form of a bureaucratic step in which the agency must notify the Office of Management and Budget of its plans to publish a proposed new rule. In a summary posted Wednesday on the budget office’s Web site, the F.D.A. said the proposed rule would “create parity” between generic and brand-name drug makers with respect to how they update their labels — the lengthy list of a drug’s uses, dosages and risks.

Under the current system, brand-name manufacturers can change the label if they receive important new information about their drug. If the F.D.A. agrees that the label change is necessary, the generic manufacturers of the drug must also change their labels. The rule change could also allow generic manufacturers to change their labels if they became aware of safety concerns, which could make them liable if a court were to find they failed to warn patients about potential harms.

“It is a first step toward acknowledging that there is a problem with the current system,” said Michael Johnson, a lawyer who represented Gladys Mensing, one of the patients who sued generic drug companies in the 2011 Supreme Court case, Pliva v. Mensing. “It doesn’t make sense to have one set of rules for the name brand and another set of rules for the generics.”

Sandy Walsh, an F.D.A. spokeswoman, noted that the agency had said before that it was considering such a rule change. “It is premature to cite what changes in the regulations might be,” she said in an e-mail. “Discussions are under way.”

The Generic Pharmaceutical Association, an industry group, declined to comment on Wednesday. In the past, generic drug companies have argued against such a change, saying that it could create a chaotic situation in which several different labels existed for the same drug.

Jay Lefkowitz, the lawyer who represented the generic drug makers in both Supreme Court cases, said in an e-mail, “We will obviously look very carefully at whatever the F.D.A. proposes, if in fact it ends up proposing any change at all.”

via F.D.A. Rule Could Open Generic Drug Makers to Suits – NYTimes.com.

FDA缩减监测预算:美国食品安全问题恶化

许多美国人,特别是那些低收入人群,每年由于食用受污染的食物而引发死亡的案例不在少数。然而,政府和民间似乎仍然存在一种普遍的看法,即国家食品安全标准是一流的。

据《华盛顿邮报》报道,美国人对自己国家的食品安全标准的信心是如此强大,以致于在2011年众议院通过投票决定削减美国食品和药物管理局(FDA)的食品安全监管预算。他们的理由是:“我们的食品体系99%是安全的。”

疾控中心估计,每年大约有4800万人感染食源性疾病,大约12万8千人住院,约3000左右的人死于与食物相关的疾病。

去年,美国有37例水果和蔬菜回收事例,而在2005年,只有两例。最近,连著名的Trader Joe’s都宣布召回巴伦西亚奶油咸花生酱,因为该产品感染了沙门氏菌。

《彭博市场》杂志最近的一份报告显示,现在食品安全现状很糟糕。 FDA一直没有能够做出足够的检查,以确保食品的安全消费。彭博社报道说,2011年该机构只是针对“0.6%的国内食品和仅仅0.4%的进口商”进行检查。食品工业雇佣了第三方审计员,其任务是确保食品是安全的。而这个审计机构是盈利性机构,通常不做必要的检查。”

据《彭博市场》杂志报告, IEH实验室及咨询集团所有者,美国食品和药物管理局代表Samadpour为了说明审计机构不负责任,盲目地站在食品工业一边时,用了一个夸张、讽刺的比喻说,如果你要在食物里加老鼠药时,审计人员会问“加够了吗?”大多数审计机构不会问“为什么要往食物里加毒药呢?”

2011年奥巴马总统签署了《食品安全现代化法案》,但是该法案到目前为止仍没有得到实施。

《审计和检查是远远不够的》这项研究的主要作者道格·鲍威尔对“彭博市场”杂志说,“人们需要转变观念,要认真地对待食品安全。通过审计机构监管是远远不够的。”

医药日报发布

政府警告:镇痛药物可待因对一些儿童是致命的

By Lucy

     一些儿童服用处方止痛药可待因后,可能会发生致命的换气过度,联邦监管机构对三个孩子的死亡案件进行调查发现,其中一个孩子是由服药后出现的严重呼吸问题致死。

可待因过量的症状,包括不寻常的嗜睡,兴奋或难以被唤醒,嘴唇或嘴发蓝,烦躁且呼吸困难。如果家长发现这些症状,应该停止给孩子可待因,并立即就医。

美国食品和药物管理局(FDA)在一份声明中说,孩子们服用了一剂可卡因(过量),以缓解他们手术后的不适(切除扁桃体或淋巴腺来治疗阻塞性睡眠呼吸暂停的手术)。FDA说,家长和监护者需要知道这些警告标志,因为孩子们服用的可待因过量了。

FDA在一份声明中说,可待因过量的症状,包括不寻常的嗜睡,兴奋或难以被唤醒,嘴唇或嘴发蓝,烦躁且呼吸困难。如果家长发现这些症状,应该停止给孩子可待因,并立即就医。

FDA还表示,作为在短时间内的急需品,医生在开含可待因的处方药时,只能给最低有效剂量。

止痛药在体内被肝脏转化成吗啡,但一些人服用可待因的副作用风险更大,因为他们的肝脏转化成吗啡的速度远远超过其他人。FDA说, 证据表明, 服用可待因后死亡的三个孩子都属于超快代谢型。

服用止痛药后,血液中这些“超快代谢型”吗啡,更可能成为危险的“高于正常值”杀手, 因此,有更大的风险患危及生命的呼吸问题。

根据FDA统计,1%至7%的人属于超快代谢型。但对某些特定民族来说更普遍,100个人中有28个人属于超快代谢型。

FDA药物评价和研究中心麻醉,镇痛和成瘾产品部主任Rappaport博士在新闻发布会上说,“目前FDA正在调查不良事件报告并审查其他相关信息,确定是否有更多儿童因意外服用过量可待因导致死亡的病例。”

医药日报发布

FDA禁止含BPA材料的婴儿奶瓶和鸭嘴杯

美国联邦监管机构周二表示,婴儿奶瓶和鸭嘴杯将不再含有双酚A(即BPA)。妈妈们可以放心喂养孩子。

去年十月,因为安全问题,美国化工行业的主要协会,美国化学理事会(ACC)就已经放弃这种化学物品用于工业制造水瓶和鸭嘴杯。7月17日,他们再次要求禁止婴儿产品中使用这种化学物质。

过去的研究发现,BPA与某些类型的癌症,糖尿病,生殖异常和心脏病的风险增加有关。

FDA发言人艾伦·柯蒂斯在一份声明中说,“消费者可以放心,这些产品不含有BPA,”并补充说,监管决定必须建立在这个瓶子行业逐步淘汰的化学物质的基础上。该机构将继续支持BPA应用在装食物的产品安全性。

ACC的要求支持FDA正式禁止这个化学物质,可能有助于降低消费群体的负面宣传,因为对健康的关注,最终导致禁止BPA用于其他类型的包装。

一些国会议员已经推出了一些法案,要求禁止在全国所有的罐头食品,瓶装水和食品容器的中使用BPA。然而,化学品制造商仍然维护用于强化塑料制品的有机化合物,认为在所有食品和饮料的用途是安全的。

这种化学物质在水瓶,CD,牙科密封剂等所有东西里面都能找到。一些研究人员表示,从验证化学品的啮齿动物和其他动物的试验中得知,摄入BPA可以影响婴幼儿的生殖和神经系统。

然而,据美联社报道,FDA一再表示,老鼠和其他哺乳动物的结果不能等同于人类,联邦政府已花费数千万美元对此进行研究,以评估该化学品对人类的健康影响。

据美联社,在约90%美国人的尿液中有这种化学物质的痕迹,这主要是因为BPA会从瓶子和罐头渗到食品和饮料中。20世纪50年代以来,BPA已被用于制造密封罐头食品,以防止污染和腐烂变质。

医药日报所有

防曬霜使用學問多

即使是最勤快誠心的防曬霜使用者也可能會搞錯用法。

這是因為﹐對女性來說﹐防曬可絕非僅僅是選擇SPF值那麼簡單。底霜或有色保濕霜中的防曬成分不足以每日保護皮膚。而化妝品中的防曬成分多數只提供對一種紫外線的保護﹐且彩妝若上得不徹底或不夠頻繁就無法滿足防曬需要。

F. Martin Ramin for The Wall Street Journal
但護膚品的SPF值只顯示了它防護導致曬傷的中波紫外線(UVB)而不是長波紫外線(UVA)的能力﹐長波紫外線能更深入地穿透皮膚並導致早衰。

儘管皮膚科醫生建議每天擦防曬霜﹐但多數人都不會這樣做。紐約威爾康奈爾醫學院(Weill Cornell Medical College)的皮膚病學臨床教授尼爾•薩迪克(Neil Sadick)說﹐五個人中大約只有一個人堅持每日按正確方法塗抹防曬霜。

他說﹐“即使我的病人使用帶防曬成分的化妝品﹐我也會告訴他們沒有得到充分保護。”

美 國食品和藥物管理局(Food and Drug Administration﹐簡稱FDA)發佈了有關防曬產品的新指引﹐旨在通過更多測試以及防曬產品(包括含防曬成分的化妝品)上更清晰的標注來保護 消費者遠離皮膚癌。該指引從6月18日起生效﹐但過時產品下架仍需時日。

據皮膚癌基金會(Skin Cancer Foundation)的統計﹐在美國每年有200多萬人被診斷為皮膚癌。黑色素瘤──最危險的皮膚癌──在美國多數年齡群中的發病率持續上升。根據梅奧 診所(Mayo Clinic)最近的一項研究﹐1970年至2009年﹐18歲至39歲的美國女性中黑色素瘤的發病率增加了八倍。該研究指出﹐年輕女性使用日光浴床可能 是導致發病率上升的原因之一。

在匹茲堡(Pittsburgh)從事廣告業的加布麗埃 勒•博根(Gabrielle Bogan)今年24歲﹐她十幾歲時每月曬10次日光浴﹐但當她發現頭皮上長了兩顆痣時便停止了。這兩顆痣不是惡性的﹐但她從那以後就開始使用SPF值為 45的防曬霜﹐作為日常護膚的一部分。博根說﹐“我喜歡這款[防曬霜]﹐因為它的SPF值較高。”

但護膚品的SPF值只顯示了它防護導致 曬傷的中波紫外線(UVB)而不是長波紫外線(UVA)的能力﹐長波紫外線能更深入地穿透皮膚並導致早衰。(兩種紫外線都會導致皮膚癌。)例如﹐使用 SPF值50的人曬很久太陽也不會被灼傷。“他們認為自己得到保護了﹐但卻受到了UVA的無聲傷害。”新澤西州巴斯金里奇(Basking Ridge)斯隆-凱特琳癌症中心(Memorial Sloan-Kettering Cancer Center)的皮膚病外科和皮膚病學總監斯蒂芬•王(Steven Q. Wang)說。

通過新的FDA測試的防曬產品現在將在產品SPF值後註明“廣譜”﹐以表明其對兩類紫外線均有效。皮膚病學家推薦每天使用SPF值至少為15的廣譜防曬霜。抗UVA成分非常重要﹐因為家裡、辦公室或汽車上的窗玻璃通常只能阻擋UVB而阻擋不了UVA。

強生公司(Johnson & Johnson)日用消費品部(旗下產品包括廣受歡迎的露得清(Neutrogena)皮膚護理產品)皮膚護理創新副總裁柯蒂斯•科爾(Curtis Cole)說﹐在化妝品或保濕霜中加入防曬成分是種挑戰。

科爾博士說﹐“配方設計師必須做許多額外工作﹐以瞭解它們的質感﹐使它們仍然‘受消費者喜愛’。”

科 爾博士說﹐氧化鋅和二氧化鈦──通常被稱為物理防曬霜──提供了物理屏障﹐但如果配方錯誤﹐可能會留下白色殘留物。所謂的化學防曬霜是油質的──在多數護 膚品中這並非理想性質。而且﹐科爾博士說﹐底霜或有色保濕霜中的色素可能會干擾護膚品的抗曬穩定性﹐即暴露於陽光下時保持有效的能力。

旗 下包括美寶蓮(Maybelline)品牌的歐萊雅(美國)(L’Oreal USA)的皮膚護理和防曬研究與創新部副總裁安東尼•波坦(Anthony Potin)稱﹐歐萊雅在其少數產品中加入了更多紫外線過濾成分﹐以符合新的FDA指引。該公司還開發了一批專門與新指引接軌的防曬產品。配方與包裝符合 新指引要求的歐萊雅Paris Sublime Sun在2月份上市。

薩迪克博士說﹐人們應每天在臉部、耳部、頸部、手部和其他裸露皮膚上擦一層相當於一小烈酒杯量的防曬霜。

包括歐萊雅、露得清、嬌韻詩(Clarins)和香奈兒(Chanel)在內的化妝品品牌正在推銷更清透、專為彩妝打底而設計﹐且比傳統防曬霜顏色更淺、水分更少的新型液體防曬霜。

皮 膚癌基金會資深副總裁、紐約大學朗格尼醫療中心(NYU Langone Medical Center)臨床皮膚病學教授德博拉•薩爾諾夫(Deborah Sarnoff)說﹐人們的防曬霜用量通常只有推薦用量的1/3至1/2。結果﹐他們獲得的防護效果也只有1/3至1/2──SPF值30一下變成了 SPF值15甚或SPF值10。

由於這一原因﹐露得清的產品SPF值比多數化妝品公司的產品都高。科爾博士說﹐“即使用戶抹得很少﹐仍足以起到保護效果。”

基於認為高於50的SPF值增加的保護效果甚微的研究﹐FDA正考慮提議將SPF指數的上限定為“50+”。露得清稱﹐該公司發佈的研究結論與之不同。

對於另一個極端──SPF值非常低的護膚品──FDA也已制定了下限。沒有通過廣譜測試或SPF值等於或低於14的護膚品將需要標明警示語﹐包括﹐“經證明本產品僅有助於防止曬傷而非皮膚癌或皮膚早衰。”

男性也應該每日塗防曬霜﹐尤其是那些謝頂或脫發的男性﹐因為他們可能有更多皮膚暴露在陽光的直接照射下。

潤唇膏的SPF值至少為15也很重要﹐尤其是對男性而言﹔女性從啞光唇彩中獲得了部分保護。薩爾諾夫博士建議特別注意下唇﹐因為這裡通常是受到最多日曬的。

由於FDA的新指引﹐多數防曬霜品牌都必須徹底檢查其包裝。產品必須帶有“藥品說明”標簽﹐這明顯類似於非處方鎮痛藥﹐其中要列出有效成分、用途和警告。FDA指引還要求在小容器上使用特定字號和字體。

克里斯汀•迪奧香水公司(Christian Dior Perfumes)市場營銷、教育與活動部資深副總裁莉薩•霍金斯(Lisa Hawkins)說﹐“很難以美觀的形式滿足這個要求。尤其是在奢侈品包裝上。”

產品行銷全球的迪奧正在生產專為美國設計的包裝﹐霍金斯稱其“成本昂貴且設計複雜”。該公司還在考慮減少在美國的供貨量。

Elizabeth Holmes

華爾街日報中文版

Blood Clot Warning Added to Yaz and Other Newer Birth Control Pills

Harrison Eastwood / Getty Images

 

Yaz, Yasmin and other newer birth control pills will soon be bearing warning labels that detail the potential risk of blood clot risks, the U.S. Food and Drug Administration (FDA) announced on Tuesday.

The FDA is updating the labels based on recent studies that suggest that birth control pills containing drospirenone, a synthetic version of the female hormone progesterone, have a slightly increased risk of blood clots, compared with older birth control pills.

The new labels will note that some studies have found as high as a threefold increase in the risk of blood clots with drospirenone-containing pills, and will include a summary of a previous FDA-funded study on the risk, officials said in a statement.

However, the overall risk of blood clots on either newer or older birth control pills is still very low. In its statement, the FDA put the risk into perspective:

The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period…For example: If 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot.

Popular birth control brands Beyaz, Safyral, Yasmin and Yaz will all receive the updated labels, but the FDA says women already using them shouldn’t worry and should “continue taking their pills as directed unless told otherwise by their healthcare professional.”

The FDA does suggest that women educate themselves on symptoms of blood clots, including persistent leg pain, severe chest pain and sudden shortness of breath. If women experience these symptoms, they should call their doctor right away.

Read More : Time

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