The U.S. Food and Drug Administration (FDA) recently sent warning letters to 17 companies that are “illegally selling” supplements that are marketed as preventing or curing Alzheimer’s disease. At the same time, recognizing that the use of supplements is widespread in the U.S., the agency also announced a plan for modernizing its regulation and oversight of dietary supplements.
Regarding the warning letters, FDA stated that many of the products were sold on websites and social media platforms, and “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.”
The agency also published a warning letter aimed at consumers on what to look out for. Much of the advice in the consumer warning letter revolves around identifying claims that seem too good to be true. Statements like: “You can even reverse mental decline associated with dementia or even Alzheimer’s in just a week” and “Supplements are used to cure Alzheimer’s disease.”
The consumer letter also notes, “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.”
The 17 companies sent warning letters are expected to respond within 15 days.
In his letter about the new policies, FDA Commissioner Scott Gottlieb wrote, “In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000—and possibly as many as 80,000 or even more—different products available to consumers.”
The new steps are designed to ensure a balance between “preserving consumers’ access to lawful supplements, while still upholding our solemn 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.”
The steps fall into communicating to the public concerns over any dietary supplement, making sure its regulatory framework has the flexibility to evaluate product safety while also promoting innovation, working closely with industry partners, developing new enforcement strategies, and working with the public to get feedback from dietary supplement stakeholders.
Gottlieb wrote, “The opportunity to strengthen the framework that governs dietary supplements couldn’t come at a more pivotal time. On the one hand, advances in science and the growth and development in the dietary supplement industry carries with it many new opportunities for consumers to improve their health. At the same time, the growth in the number of adulterated and misbranded products—including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks—creates new potential dangers.”
Steps being taken include developing a rapid-response tool to alert the public about questionable supplements; develop a regulatory framework for the submission of new dietary ingredient (NDI) notifications; creation of the Botanical Safety Consortium, a public-private partnership to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements; develop new enforcement strategies; and engage in public dialogue concerning whether more steps to modernize DSHEA are necessary.
Gottlieb concluded, “The steps outlined today highlight both where we are currently and where we look forward to moving toward. We are eager to continue our work with both our industry partners and dietary supplement consumers and will announce more upcoming ideas that we hope to roll out in the near future.”
美国食品药品监督管理局（Food and Drug Administration）（ FDA ）最近向17家“非法销售”用于预防或治疗老年痴呆症的补充剂的公司发出警告信。与此同时，该机构认识到营养补充剂的使用在美国非常普遍，并宣布了一项现代化饮食补充剂监管和监督的计划。
关于警示函， FDA 表示，许多产品都在网站和社交媒体平台上销售，并且“没有经过 FDA 的审查，也没有被证明对其声称治疗的疾病和健康状况进行安全有效的治疗。”
FDA 专员 Scott Gottlieb 在关于新政策的信中写道，“在国会通过《膳食补充剂健康和教育法》（ DSHEA ）25年来，改变了 FDA 监管膳食补充剂的权威的法律，膳食补充剂市场显著增长。曾经是一个价值40亿美元的行业，由大约4000种独特的产品组成，现在这个行业价值超过400亿美元，消费者可以获得的不同产品超过5万种，甚至可能多达8万种甚至更多。”
正在采取的步骤包括：开发快速反应工具，提醒公众注意有问题的补品；制定提交新的膳食配料通知的监管框架；建立植物安全联合会，建立公私伙伴关系，促进科学进步，评估植物成分和膳食补充剂混合物的安全性；制定新的执法战略；就是否有必要采取更多措施使 DSHEA 现代化开展公共对话。