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成分違規、宣傳不實… 500億補品市場 FDA將嚴管


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02/12/2019

成分違規、宣傳不實… 500億補品市場 FDA將嚴管

FDA11日發布警告,提醒消費者注意市面上售出的營養保健補充品宣稱有助阿茲海默症,完全不實。(取自FDA視頻)

設在馬里蘭州的 FDA總部。(美聯社) 在11日發布警告,提醒消費者注意市面上售出的營養保健補充品宣稱有助阿茲海默症,完全不實。(取自FDA視頻)


Watch Out for False Promises About So-Called Alzheimer’s Cures

Published on Feb 11, 2019

WARNING! Beware of unproven Alzheimer’s treatments like these! They may not work and may pose a danger to individuals taking them. There isn’t a cure for Alzheimer’s yet. But early diagnosis and treatment with FDA approved drugs may help slow it down. Talk to your doctor or healthcare provider, and read this Consumer Update to learn more: https://www.fda.gov/ForConsumers/Cons...


聯邦食品暨藥物管理局(FDA)11日宣布,將對美國銷售額500億元的營養補品市場,加強監管一年;該局警告,營養補品的爆炸性成長,使得未列明成分的補品激增,養身功效誇大不實或誤導情事頻傳,為消費者帶來風險。


華盛頓郵報報導,FDA指出,本月初已向銷售數十種補品的公司,發出12封警告函及五封建議信,因為這些補品含有未核准藥物,或不法宣傳其補品可治療阿茲海默症等重症。



    
   
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跟不上變化 將進行25年來最大修法

FDA局長戈特利布(Scott Gottlieb)說,該局擬修改政策,此舉將是1994年「膳食補充品健康教育法」(Dietary Supplement Health and Education Act)立法以來,25年來最重大的修法行動;該法認為補品是安全的,除非有證據證明它不安全。

戈特利布說,多數補品廠商有責任感,但補品市場的大幅擴展,讓「不良分子」滲入,銷售危害人命或功效誇大不實的產品,「我擔心,補品市場的瞬息萬變,已讓我們的政策和管理風險的能力跟不上腳步。」

根據1994年法律,補品所受規範與食品相同,因此上市前不須經過核可,其安全及成效,不似藥品須經檢驗核准;自該法實施後,補品種類4000種,每年銷售額40億元,至今擴展為8萬種產品,每年銷售額500億元。

FDA雖不須在補品上市前核准檢驗,但將不安全產品自市場撤下,卻是該局的職責。


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一旦發現違法、危險 將迅速反應

FDA指出,每四個美國人有三人定期使用補品,年紀較長者,每五人有四人使用補品;至於兒童,每三人有一人使用補品。

戈特利布說,他打算採取「平衡的做法」,一方面改進其安全,減少不實宣傳,一方面鼓勵業者革新;例如,該局計畫建立迅捷反應的利器,一旦發現補品含有違法和危險成分,可迅速向公眾發布警告;該局打算改進含有偉哥等處方藥成分的補品的處理程序。

戈特利布表示,將檢討有關新膳食補品成分的法規,確保新成分能改進產品;他承諾,將舉行公聽討論此事及其他問題。至於引起激辯的補品廠商強制登記問題,戈特利布認為有助於市場透明化,但可能須經立法通過。


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衛生官員和公衛專家愈來愈關切補品的不安全成分,去年10月加州公共衛生廳發表的一項分析,在746種膳食補品中發現未獲核准並可能危害健康的藥物,幾乎所有補品都宣傳能增強性能力、減肥或刺激肌肉成長。這些藥物包括西地那非(sildenafil,偉哥的活性成分)及刺激肌肉成長的類固醇(steroids)。去年秋天,FDA警告消費者避免使用含有西地那非的男性延時持久藥「Rhino」,聲稱接獲舉報,有民眾使用後出現胸痛、嚴重頭疼及勃起不消的症狀。

已退休的聯邦大法官歐康納罹患有阿茲海默症。(美聯社)

FDA在11日發布警告,提醒消費者注意市面上售出的營養保健補充品宣稱有助阿茲海默症,完全不實。(Getty Images)






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02/12/2019

Watch Out for False Promises About So-Called Alzheimer’s Cures

Chances are, you know someone with Alzheimer’s disease or a related dementia involving memory loss. That’s due in part to the fact that as our older population grows, so does the number of people facing serious cognitive and related health issues.

Not surprisingly, this demographic change has been accompanied by a growth in the number of marketers who prey on this population, pitching products that make unproven claims that they can prevent, treat, delay, or even cure Alzheimer’s disease.

These purported miracle cures are sold primarily on the Internet. They are often, though not always, falsely labeled as dietary supplements. Regardless of their form, these products fly in the face of true science. What these companies are selling is the false hope that there is an effective treatment or cure.

At best, the products offered by these scam artists will have no effect on the patient; at worst they may pose a danger to a patient who takes them. Not only will they not do what they claim, the ingredients in these products may interact with, and potentially interfere with, essential medications. Furthermore, these products have not been evaluated by the U.S. Food and Drug Administration (FDA) for safety and effectiveness. These products are a waste of money and may also delay consumers from receiving the necessary care and support for their illness.



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Look Out For Unproven Claims about Alzheimer’s Treatments


Remember the saying, “if it seems too good to be true, it probably is?” Unfortunately, when faced with a serious health issue, even the most rational person can be led to believe implausible claims. Indeed, that’s what companies selling fake treatments count on.

One of best ways to protect yourself from fake treatments is to ask whether the claim seems too promising and if it contradicts what you’ve heard from reputable sources about treatments for Alzheimer’s disease. Companies selling unproven Alzheimer’s treatments often include a range of unsupported and expansive claims about the supposed healing powers of their products. These includes statements such as:

  • “You can even reverse mental decline associated with dementia or even Alzheimer’s in just a week;”
  • “Clinically shown to help disease of the brain such as Alzheimer’s and even dementia;”
  • “Supplements are used to cure Alzheimer’s disease;”
  • “can … reduce the risk of Alzheimer’s by half;”
  • “May have a role in preventing the progression of Alzheimer’s;” and
  • “Clinically shown to help disease of the brain such as Alzheimer’s and even dementia.”

Another red flag is that many of the claims made by these companies about the supposedly curative powers of their products are often not limited to Alzheimer’s disease. Consumers should steer clear of products that claim to cure or treat a broad range of unrelated diseases.

For instance, the FDA sent a warning letter to a company selling one product marketed as a dietary supplement that the company claimed “may help alleviate the neurodegenerative effects of Alzheimer’s disease and Parkinson’s,” and also claimed it was successful in “Relieving pain associated with rheumatism, back ache and arthritis; Can help fight off colds and flu; Can help with blood sugar management; Can help stabilize high blood pressure; [and] Help fight off bacterial infections.”





How to Protect Yourself


Here are some other ways to protect yourself and others from fake Alzheimer’s treatments:

  • Question any product that also claims to be a “scientific breakthrough.” Companies marketing these products take advantage of people when they are most vulnerable and often looking for a miracle cure.
  • Always check with your doctor or health care professional before buying or using any over-the-counter product, including those labeled as dietary supplements.

A great deal of scientific research is being conducted on Alzheimer’s disease, but at this point, no cure or treatment have been shown to stop or reverse the progression of the disease. Several prescription drugs have been approved by the FDA to treat people who have been diagnosed with Alzheimer’s disease. Most medicines work best for people in the early or middle stages of Alzheimer’s, and can slow down some symptoms, such as memory loss, for a time. But none of these medications stops the disease itself.

Treatment development and FDA-approval requires clinical research and testing to ensure that any new drugs are both effective and safe. For patients interested in accessing investigational drugs, there are legal ways to do so, such as by taking part in clinical trials.

FDA Protects Consumers from Companies Selling Unapproved New Drugs

The FDA takes action against companies marketing unapproved new drugs that claim to prevent, diagnose, treat or cure Alzheimer’s disease and a number of other diseases and health conditions.

The FDA issues warning letters to advise the companies to change or remove claims about their products that render the products misbranded or otherwise illegally marketed, and if the companies don’t comply, the FDA may take further legal action to prevent the products from reaching consumers.

To learn more about the illegal marketing of certain products claiming to treat Alzheimer’s and related diseases, visit www.fda.gov/alzheimershealthfraud. If you know of a product or supplement (other than approved drugs) being advertised or sold as treatment for Alzheimer’s or other diseases, you can report it on FDA’s website here.

The FDA has issued warning letters and online advisory letters regarding several of these misleading products. Photos of these products are available on FDA’s Flickr photostream












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