美國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。
美國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。
美國食品藥物管理局（FDA）11日宣布計劃加強監督營養補品市場，為逾25年來重大修法行動之一。FDA正在開發一種快速反應工具，可提醒民眾避免購買含有違法或潛在危險成分的產品，並向17家非法宣稱其補品可治療阿滋海默症的業者發出警告函。
FDA警告，營養補品爆炸性成長，導致未列明成分的補品激增，功效誇大不實或誤導情事頻傳，為消費者帶來風險。美國營養補品市場的規模超過400億美元，過去25年消費者可選擇的產品也從4,000種暴增至8萬種。
連結：FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease（美國FDA公告）
The U.S. Food and Drug Administration today posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions. These products, which are often sold on websites and social media platforms, have not been reviewed by the FDA and are not proven safe and effective to treat the diseases and health conditions they claim to treat. These products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.
“Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases like Alzheimer’s. Alzheimer’s is a challenging disease that, unfortunately, has no cure. Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease, or worse as some fraudulent treatments can cause serious or even fatal injuries. Simply put, health fraud scams prey on vulnerable populations, waste money and often delay proper medical care – and we will continue to take action to protect patients and caregivers from misleading, unproven products,” said FDA Commissioner Scott Gottlieb, M.D. “Today’s actions are part of the FDA’s larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago. That law sought to achieve the right balance between preserving consumers’ access to lawful supplements, promoting innovation in these products, while upholding our obligation to protect the public from unsafe and unlawful products and holding accountable those actors who are unable or unwilling to comply with the requirements of the law. Our newest policy efforts will seize the game-changing opportunity to further strengthen the regulatory framework overseeing dietary supplements and will hone in on important steps to both promote industry innovation while upholding the safety of these products as part of our overall commitment to protecting public health.”
小編評：外國的月亮沒有比較嚴，強調業者自主管制的美國保健食品界也是一堆亂象。