2026-04-15T20:10:00-0400 / 哥伦比亚广播公司新闻
更新于：2026年4月15日 / 美国东部时间晚上8:49 / 美联社
美国食品药品监督管理局将于今年夏季召开会议，考虑放宽对六种以上多肽注射剂的限制。这类未获批准的疗法如今在健康博主、健身达人以及名人中广受欢迎。
周三公布的会议安排此前恰逢美国卫生部长小罗伯特·F·肯尼迪多次承诺放松对多肽类药物的监管。这类药物常被宣传为增肌、修复损伤或延缓衰老的快捷方式。相关宣称几乎没有研究作为支撑，且大多数多肽类药物尚未经过FDA的安全性审查。
肯尼迪曾谈及自己曾使用多肽治疗伤病。他的“让美国再次健康”运动的多位主要支持者都是这类药物的强力倡导者，其中包括自称“长寿专家”的加里·布雷卡，他通过自己的网站销售多款多肽配方产品。
FDA周三在一份联邦公告中表示，将在7月的会议上邀请外部顾问小组审查七种多肽药物，具体讨论是否应将它们列入药房可安全生产的物质清单。同时，该机构表示将很快把这些化学品从专为未获批高风险药物设置的限制性清单中移除。此次审议的多肽包括博主圈子里最受欢迎的几款产品，例如主打修复损伤和减轻炎症的BPC-157。
“‘狂野西部’即将变得更无序，”前FDA官员、现任公共利益科学中心主任彼得·卢里博士说道。卢里在采访中表示，允许未经临床试验的多肽类药物上市，对FDA数十年来的药物审核体系构成了“严重威胁”。
“如果现在有一条监管更宽松的上市途径，我看不出人们为什么还要走正规的药物审批流程，”他说道。
在乔·拜登总统任期内，FDA曾将近20种多肽列入联邦清单，禁止复合药房生产此类物质——复合药房是指调配制药公司未上市药品的企业。
当时，FDA的药房顾问委员会以压倒性票数表决认为，这些多肽不符合可安全复合的物质标准。FDA监管人员也表示赞同，并称这些物质“存在重大安全风险”，因为大多数多肽尚未在人体中进行过广泛测试。
参与当时决策的许多FDA顾问和内部工作人员现已离职。FDA的药房顾问委员会目前有多个空缺职位，肯尼迪可在7月的会议前完成任命。
肯尼迪在接受播客主持人乔·罗根采访时提前透露了周三的这一举措。两人此前多次谈论多肽类药物，并声称使用后获益良多。
“我是多肽的铁杆粉丝，”肯尼迪告诉罗根，“我自己用过，在治疗几处伤病时效果非常好。”
结合肯尼迪的表态，卢里表示，很难相信FDA会对这类药物进行真正的审查。
“所有人都知道卫生部长想要什么结果，”卢里说道，“我一刻也不相信，此事是对这些产品是否应被复合生产进行的诚实调查。”
美国复合药房联盟的斯科特·布伦纳表示，即将召开的会议将开启“漫长的程序”。他指出，即便顾问小组投票支持多肽类药物上市且FDA也同意，该机构仍需起草并公布相关修订规则。
多肽本质上是更复杂蛋白质的组成部分。在人体内，多肽会触发生长、代谢和修复所需的激素。
近年来，随着FDA批准用于治疗肥胖和糖尿病的GLP-1类药物大获成功，多肽类药物广为人知。其他获FDA批准的多肽还包括糖尿病患者使用的胰岛素，以及针对多种病症的激素类药物。
但许多在线推广的多肽从未获得批准，从技术上讲，作为药物进行营销是非法的。包括BPC-157和TB-500在内的多款多肽被国际体育当局列为违禁兴奋剂。
但这并未阻止它们在蓬勃发展的健康妙招和替代疗法市场中站稳脚跟。
“我认为这即将酿成一场灾难，”斯克里普斯研究转化研究所的埃里克·托波尔博士说道，他曾研究过相关问题，“这些多肽没有任何数据能证明其安全性和有效性。”
与此同时，一些膳食补充剂制造商已开始将多肽添加到胶囊、蛋白粉和软糖中。在最近一次FDA会议上，该行业主张扩大补充剂的联邦定义，允许在产品中使用多肽等新型成分。
FDA在2023年将多款注射用多肽列入限制性清单时，援引了包括癌症以及肝、肾、心脏问题在内的安全风险。
这引发了健康创业者、复合药房及其在华盛顿盟友的反对。
去年，包括阿拉巴马州共和党参议员汤米·图伯维尔在内的多名国会议员致信肯尼迪，要求解除对多肽生产的限制。
一些复合药房行业人士认为，FDA的限制催生了从中国和其他国家进口化学品的黑市，这些产品不受美国药品标准监管。
肯尼迪也呼应了这些担忧。
“在灰色市场，你根本不知道自己买到的是不是合格产品，”肯尼迪告诉罗根，“我们检测过的很多这类产品质量都非常、非常低劣。”
FDA will consider easing restrictions on peptides as RFK Jr. calls himself a “big fan”
2026-04-15T20:10:00-0400 / CBS News
Updated on: April 15, 2026 / 8:49 PM EDT / AP
The Food and Drug Administration will hold a meeting this summer to consider easing restrictions on more than a half dozen peptide injections, a group of unapproved therapies that have become popular among wellness influencers, fitness gurus and celebrities.
The meeting announcement Wednesday follows repeated pledges by Health Secretary Robert F. Kennedy Jr. to loosen regulations on peptides, which are often pitched as a quick way to build muscle, heal injuries or appear younger. There’s little research behind those claims, and most peptides have not been reviewed for safety by the FDA.
Kennedy has discussed using peptides for his own injuries. And some major supporters of his Make America Healthy Again movement are big proponents of them, including Gary Brecka, a self-described “longevity expert” who sells various peptide formulas through his website.
The FDA said in a federal notice Wednesday it will ask a panel of outside advisers to review seven peptides at a meeting in July, specifically whether they should be added to a list of substances that can be safely produced by pharmacies. In the meantime, the agency said it would soon remove the chemicals from a restrictive list reserved for unapproved, high-risk drugs. The peptides under discussion include some of the most popular among influencers, such as BPC-157, which is marketed to heal injuries and reduce inflammation.
“The Wild West is about to become wilder,” said Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest. In an interview, Lurie said allowing peptides on the market without clinical testing poses a “profound threat” to FDA’s decades-old system for vetting drugs.
“I don’t see why one would take the path of a proper drug approval if there is now this less rigorous, alternative path to market,” he said.
Under President Joe Biden, the FDA added nearly 20 peptides to the federal list of substances that should not be produced by compounding pharmacies — businesses that mix medications that aren’t available from drugmakers.
At the time, the FDA’s panel of pharmacy advisers voted overwhelmingly that the peptides did not meet the criteria for substances that can be safely compounded. And FDA regulators agreed, saying later that the substances “present significant safety risks,” because most have not been extensively tested in humans.
Many of the FDA advisers and internal staff who oversaw those decisions no longer work for the agency. The FDA’s pharmacy panel currently has a number of vacancies, which Kennedy could fill before the July meeting.
Kennedy previewed Wednesday’s move in an interview with podcast host Joe Rogan. Both men have repeatedly spoken about peptides and claimed to have benefited from their use.
“I’m a big fan of peptides,” Kennedy told Rogan. “I’ve used them myself and with really good effect on a couple of injuries.”
Given Kennedy’s statements, Lurie said it was doubtful the drugs would receive real scrutiny from FDA.
“Everybody knows the outcome that the secretary wants,” Lurie said. “I don’t believe for one moment that what’s going on here is an honest investigation of whether these products should be compounded.”
Scott Brunner of the Alliance for Pharmacy Compounding said the coming meeting will be the start of a “protracted process.” Even if the panel votes to make the peptides available, and FDA agrees, the agency will still have to draft and publish rules on the change, he noted.
Peptides are essentially the building blocks of more complex proteins. Inside the human body, peptides trigger hormones needed for growth, metabolism and healing.
In recent years, peptides have become widely known through the blockbuster success of GLP-1 medications, which the FDA has approved for treating obesity and diabetes. Other FDA-approved peptides include insulin for diabetics and hormone-based drugs for several medical conditions.
But many of the peptides promoted online have never been approved, making them technically illegal to market as drugs. Several peptides, such as BPC-157 and TB-500, are banned by international sports authorities as doping substances.
But that has not stopped them from gaining a foothold in the burgeoning marketplace for wellness hacks and alternative remedies.
“I think this is a disaster in the works,” said Dr. Eric Topol of Scripps Research Translational Institute, who has studied the issue. “These peptides have no data to support their safety and efficacy.”
Meanwhile, some dietary supplement makers have begun mixing peptides into capsules, protein powders and gummies. At a recent FDA meeting, the industry argued for expanding the federal definition of supplements to permit the use of newer ingredients like peptides in their products.
When the FDA added a number of injectable peptides to its list of restricted substances in 2023, it cited safety risks including cancer and liver, kidney and heart problems.
That triggered pushback from wellness entrepreneurs, compounding pharmacies and their allies in Washington.
Last year several members of Congress, including Republican Sen. Tommy Tuberville of Alabama, sent letters to Kennedy asking him to lift limits on peptide production.
Some in the compounding industry argue that FDA’s restrictions have given rise to an illicit market of imported chemicals from China and other countries, which are not subject to U.S. drug standards.
Kennedy has echoed those concerns.
“With the gray market you have no idea if you’re getting a good product,” Kennedy told Rogan. “And a lot of this stuff that we’ve looked at is just very, very substandard.”