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Posts tagged ‘FDA’

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


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


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

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 –





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?”





By Lucy






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。


















F. Martin Ramin for The Wall Street Journal

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。


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。


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﹐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。



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。







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。”


Elizabeth Holmes


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

Exciting developments

source : The Star



美國消費者權益團體「公共利益科學中心」發表聲明,指出可口可樂、百事可樂等飲料含高量致癌物質4-甲基咪唑(4-methylimidazole,簡稱 4-MEI),這種色素添加物會在動物身上造成腫瘤,因而要求政府下令禁用。但美國食品暨藥物管理局發言人 (FDA)表示,每天至少要喝1000罐可樂,才會達到在老鼠實驗中致癌的劑量,消費者並無立即危險。


「公共利益科學中心」 (CSPI)公布的研究報告指出,包括可口可樂、百事可樂、健怡可樂、健怡百事可樂、Dr Pepper等可樂均含用來形成飲料焦糖顏色的4-MEI。


CSPI上個月向FDA陳情,建議禁止使用大多數可樂均含的亞硫酸銨色素,以免數以百萬計的民眾曝露於致癌物質。CSPI 估計,可口可樂和百事可樂所含4-MEI在美國造成約1萬5000 人罹患癌症。該組織指出,一罐可口可樂含有145微克4-MEI,百事可樂含量約一半,而加州政府規定4-MEI含量超過29微克即需加註警語。




FDA發言人卡拉斯以電子郵件答覆彭博社記者查詢時強調,老鼠致癌實驗使用的劑量相當於消費者在一天之內喝下1000 罐以上的可樂,因此FDA沒有理由相信可樂對民眾有立即危險,但已在檢討CSPI的陳情。









出處 : 聯合晚報

FDA: J&J delayed reporting insulin pump problems

By Linda A. Johnson, Associated Press

TRENTON, N.J. – Federal regulators have warned Johnson & Johnson that it could face fines and other sanctions for selling faulty insulin pumps and delaying disclosures of serious injuries to diabetics who were using its OneTouch Ping and 2020 pumps.

The Food and Drug Administration ordered the Animas Corp. unit of J&J (JNJ) to explain why it kept selling pumps known to fail and also to submit a plan to rectify a failure to promptly report cases in which its device might have caused or contributed to death or serious injury.

In a Dec. 27 warning letter posted online by the FDA Tuesday, the agency wrote to Animas and J&J CEO Bill Weldon that inspectors found Animas, which is based in West Chester, Pa., never reported on one complaint about serious patient injury and delayed reporting on two others. Those patients were hospitalized with dangerously high blood sugar, respiratory failure and coma, and a life-threatening complication called diabetic ketoacidosis, caused by a lack of insulin to break down blood sugar.

nsulin pumps, which are about the size of a cellphone, automatically inject small amounts of insulin through a tiny needle under the skin throughout the day to keep diabetics’ blood sugar at a safe level. Patients program the device to inject additional insulin right before a meal or snack, according to the amount of carbohydrates about to be eaten.

Animas spokeswoman Caroline Pavis said in an interview that the company did not report the three patient incidents to FDA as required within 30 days because each involved patients not using the pumps according to directions. In one case, she said, the patient ignored an alarm signaling the cap had come off the insulin cartridge inside the device, preventing insulin from being pumped into the body. She said Animas will now report all patient complaints promptly.

The problems follow a string of nearly 30 product recalls announced by New Brunswick, N.J.-based Johnson & Johnson from September 2009 through last month. They have included millions of bottles of Tylenol, Motrin and other nonprescription medicines for children and adults, prescription drugs for seizures and HIV, faulty hip implants and contact lenses that stung the eyes. Reasons for the recalls ranged from contamination with metal shards and glass particles to nauseating odors and inaccurate levels of active drug ingredients.

“Any company can have one of these things pop up and smack them, and you can have a bad coincidence when two of them come and smack you three weeks apart. But it’s not bad luck when you have” this many, said Erik Gordon, a professor and analyst at the University of Michigan’s Ross School of Business. “The amazing thing is that Bill Weldon still has a job.”

The recalls cost J&J $900 million in 2010 alone in lost revenue from products not being in stores, plus millions more for factory upgrades and legal expenses. The FDA and Congress have been investigating the handling of the manufacturing problems and the recalls by a company that stresses in its corporate credo its responsibility to the doctors, patients and parents who use its products.

J&J has said there have been no reports of serious patient harm from the recalled products, although it’s now being sued by a couple alleging their toddler died from taking a “super dose” of defective Children’s Tylenol.

In a separate issue with the Animas insulin pumps, some pump keypads for controlling how much insulin is injected were deteriorating prematurely, leading to failures.

“We decided to go with a new keypad because it’s more durable,” Pavis said.

But while Animas was lining up the new keypad supplier, it was still selling the older ones. The FDA demanded documents about the company’s decision to do that.

David Rosen, a former FDA staff member who’s now an attorney at Foley & Lardner advising clients on FDA regulatory issues, said companies must continuously evaluate a product’s safety over its life span.

“A company the size of J&J should have infrastructure in place to process, review and classify complaints, because they could be indicative of a larger issue with the product,” he said. “It’s a little disconcerting that they didn’t have their act together in that regard.”

The FDA’s warning letter states that the initial Animas response to the problems cited in the August inspection report was not adequate. Pavis said Animas hopes to respond before the Jan. 20 deadline.

The letter states that if the company doesn’t promptly correct the violations, it could face seizure, injunction, and fines, and could be denied future contracts from federal agencies. Pavis could not say how much business Animas does with government Medicare and Medicaid programs.

On Wednesday, Johnson & Johnson shares fell 7 cents to close at $65.13.

Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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