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FDA提醒欺诈性的和未批准的流感相关产品

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药士
发表于 2018-3-7 08:41:08 | 显示全部楼层 |阅读模式

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FDA warns of fraudulent and unapproved flu products

March 2, 2018
As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency is reminding consumers to be wary of unapproved products claiming to prevent, treat or cure influenza, or flu. This year’s severe flu season raises new concerns about the potential for consumers to be lured into buying unproven flu treatments, and even worse, buying counterfeit antivirals online from websites that appear to be legitimate online pharmacies.
“This year the flu has been widespread, impacting millions of patients across the country, and leading to a new record number of flu-related hospitalizations,” said FDA Commissioner Scott Gottlieb, M.D. “We understand the toll this year’s flu season has taken on peoples’ lives. As the flu continues to make people sick — and even cause deaths — unscrupulous actors may also be taking advantage of unsuspecting consumers by promoting their fraudulent products that have not been reviewed by the FDA to be safe and effective. The FDA is warning consumers to be alert, and try and steer clear of fraudulent flu products, which may be found online or in retail stores. We’re advising consumers on some of the telltale signs to look for when trying to spot flu products that may be fraudulent. All of us must also continue to be diligent in doing our part to prevent the spread of flu however possible. People who are sick with flu-like symptoms and those who are at high risk of serious flu complications should see a health care professional as soon as possible to see if they should be treated with antiviral drugs.”
Consumers should be aware that there are no legally marketed over-the-counter (OTC) drugs to prevent or cure the flu. However, there are legal OTC products to reduce fever and to relieve muscle aches, congestion and other symptoms typically associated with the flu. Products sold online are fraudulent if they claim to prevent, treat or cure the flu, and have not been evaluated by the FDA for that intended use.
These flu claims may indicate that an OTC product is fraudulent:
  • reduces severity and length of the flu;
  • boosts your immunity naturally without a flu shot;
  • safe and effective alternative to the flu vaccine;
  • prevents catching the flu;
  • effective treatment for the flu;
  • faster recovery from the flu; or
  • supports your body's natural immune defenses to fight off the flu.
Health fraud scams waste money, lead to delays in getting a proper diagnosis and treatment, and may even lead to more serious injuries or death. The FDA routinely warns the public about health scams and has recently taken action against companies promoting and selling unproven treatments for cancer, opioid addiction and other illnesses. However, there are numerous unapproved and potentially unsafe products that continue to be sold directly to consumers in part because companies or individuals can move their marketing operations to new websites.
Online pharmacies present another opportunity for scammers to take advantage of unsuspecting consumers. Online pharmacies may claim to sell prescription antiviral drugs, such as Tamiflu, at reduced prices or without a prescription. The FDA advises consumers to avoid purchasing products making such claims.
Beware of online pharmacies that:
  • allow you to buy prescription medicine without a prescription from your health care provider;
  • do not have a U.S. state-licensed pharmacist available to answer your questions;
  • offer very low prices that seem too good to be true; or
  • are located outside of the U.S. or ship worldwide.
These pharmacies often sell medicines that can be dangerous because they may:
  • have too much or too little of the active ingredient you need to treat your disease or condition;
  • not contain the right active ingredient; or
  • contain wrong or other harmful ingredients.
Legitimate online pharmacies exist, but so do many websites that look like professional and legitimate pharmacies, but are actually fraudulent. The FDA recommends consumers buy prescription drugs from their local pharmacy or only through an online pharmacy that requires a valid prescription from a doctor or other authorized health care professional and is licensed by the state board of pharmacy (or equivalent state agency) where the patient is located.
The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



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药士
 楼主| 发表于 2018-3-7 08:56:14 | 显示全部楼层
本帖最后由 beiwei5du 于 2018-3-7 08:59 编辑

京都念慈庵)川贝枇杷膏在美国是按照膳食补充剂(保健品),甚至连OTC也称不上!是没有审核其安全和有效性的。那么这个FDA的alert是否有含沙射影的功能能????

Because the syrup is classified as a supplement, the country's Food and Drug Administration (FDA) doesn't inspect it for safety or effects. The FDA has suggested that people consult their doctors instead.

https://news.cgtn.com/news/794d6a4d35677a6333566d54/share_p.html




然后看到很多关于这个所谓“神药”的宣传,其中包括CCTV(不想说CCTV专业性了),我个人甚至认为,这就是自欺欺人的自海,无良商家的炒作而已!!
https://mp.weixin.qq.com/s?timestamp=1520382758&src=3&ver=1&signature=lmP1sNehdsx4NOENnJ0vEsPZ-vcf2VXtsRYuF5Iu9ovUQAUrctNBF2JkozhI-dd4YX4JIbQGXHW42EerfCyrss-iOX1niuffnF30*CEMNOBS6OhGdf6Wcit9B46HRrJlhsJTQSYFXYNCLklCLx6yI0PZYErVZBnBScTwlMepWpk=

点评

这跟前一阵CFDA给那个眼药水神药的处理方式类似哈  详情 回复 发表于 2018-3-7 23:04
枇杷膏缓解咳嗽症状还是很有效的,但用于流感就呵呵了。既然那么有效,又游离于FDA监管,自然FDA就不开森啦,发个alert也是很正常的。  发表于 2018-3-7 09:51
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药士
发表于 2018-3-7 09:15:19 | 显示全部楼层
beiwei5du 发表于 2018-3-7 08:56
(京都念慈庵)川贝枇杷膏在美国是按照膳食补充剂(保健品),甚至连OTC也称不上!是没有审核 ...

保健品本来就是打擦边球的产品,由于含有水果及一些中草药,肯定会有一些功效,说句难听的很多中药饮片就草药。而保健品这种,你让企业去申请批文吗,有监管部门和法规不?FDA眼红当然是因为在美国市场卖得太火的缘故,既然美国人都说有功效,FDA自然要问问这个“神药”的安全性和归属。

点评

fda为什么眼红,FDA并不会涉及商业层面的问题,本身你属于保健品,没有评估安全性和有效性,站在维护公众健康的层面,自然会做一些警示。但是如果你保健品声称预防,治疗治愈,缓解等等作用,那么FDA就要给你急!.  发表于 2018-3-7 09:52
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药生
发表于 2018-3-7 09:18:35 | 显示全部楼层
那种软文不就是利用了一些人心中廉价“爱国情操”吗?
眼里,耳朵里就喜欢听一些好的
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药生
发表于 2018-3-7 09:40:51 | 显示全部楼层
是否是针对中药产品?
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药士
 楼主| 发表于 2018-3-7 10:08:01 | 显示全部楼层
本帖最后由 beiwei5du 于 2018-3-7 10:12 编辑

@radiopharm 确实如你所说,川贝枇杷膏仅仅是一个解表,也就是临时性缓解轻度不适和口腔和喉咙疼痛之类的,这个很多药品产品都可以做到,跟是否治愈流感没有半毛关系(至少没有数据证明)!

NIN JIOM PEI PA KOA
Dosage form: syrup
Ingredients: ELM 650mg in 5mL
Labeler: NIN JIOM MEDICINE MANUFACTORY (HK) LTD
NDC Code: 57708-888
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Product Facts(如果是药品的话,一般这里会显示为drug facts)


King to Nin Jiom Pei Pa Koa is a pleasant tasting natural herbal based liquid especially formulated for relief of minor discomfort and to protect irritated areas in sore mouth and sore throat.
Pei Pa Koa contains No Alcohol, artificial flavors, colors, or preservatives.


INDICATIONS
For the temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

DIRECTIONS: Adults and Children 2 years of age and older: 2 teaspoonfuls every 2 hours as needed or as directed by a doctor or dentist.
Children under 2 years of age: Consult a doctor or dentist.

WARNINGSIf
sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. If you are pregnant or nursing a baby seek the advice of a health professional before using this product. Keep this and all drugs out of the reach of children.
Keep this and all drugs out of the reach of children.


Active:Elm Bark 650 mg per teaspoon.


In a Sucrose Syrup and Honey base of herbal extracts consisting of:loquat leaf, fritillary, balloon flower root, snakegourd seed, sand root, senega root, tuckahoe, licorice root, ginger root, five flavored seed, and peppermint.


For the temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.


Product Label







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药徒
发表于 2018-3-7 23:04:20 | 显示全部楼层
beiwei5du 发表于 2018-3-7 08:56
(京都念慈庵)川贝枇杷膏在美国是按照膳食补充剂(保健品),甚至连OTC也称不上!是没有审核 ...

这跟前一阵CFDA给那个眼药水神药的处理方式类似哈
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