自1994年起，美国法律将证明膳食补充剂掺假的举证责任交由政府，厂商无需事先向FDA证明产品安全或标签属实1。这种监管缺失导致市场急剧扩张，产品数量从当年的约4000种激增至如今FDA估计的多达10万种，年销售额也从约40亿美元飙升至近730亿美元，五分之三的成年人每月都在服用补充剂1。FDA膳食补充剂项目办公室主任Cara Welch表示：“在我们目前的权限下，FDA没有系统的方法知道市场上有哪些膳食补充剂、何时推出新产品或它们含有什么成分。”1
在缺乏有效监管的背景下，补充剂质量问题频发，尤其是软糖剂型因生产门槛降低而催生了大量贴牌品牌，但实际生产却集中在少数代工厂1。多项检测显示软糖补充剂标签剂量严重失准：Pieter Cohen团队购买25种褪黑素软糖产品进行检测，发现22种标签不准确，剂量范围为标签标示的74%至347%，其中一种完全不含褪黑素1。NOW Foods购买25种亚马逊上的维生素C软糖品牌进行检测，发现12种几乎检测不到维生素C，5种声称每颗含1000毫克以上但实际低于2毫克1。此外，FDA曾于2020年1月发布召回令，召回ABH Nature’s Products在2013年1月至2019年11月期间生产的所有膳食补充剂1。2021年11月，佐治亚州Norcross一家制造商因未声明含有牛奶，一次性召回涉及17个州、70多个品牌名的77种产品1。
在代工厂和私募公司层面，私募公司Highlander Partners于2017年开始收购软糖工厂，后于2021年8月以10亿美元将组装后的业务出售给Catalent1。Lonza的胶囊部门以约30亿美元出售给私募公司Lone Star Funds，Lonza保留40%1。IVC于2016年收购Perrigo整个美国维生素和补充剂业务，并于2019年以1.76亿美元收购GNC工厂1。在品牌端，Procter & Gamble以38亿美元现金收购Thorne；私募公司L Catterton于2023年10月以约6.8亿美元将Thorne私有化，34个月内获利约5.5倍1。Church & Dwight于2012年以6.5亿美元收购Vitafusion和L'il Critters，并于2025年12月出售这两个品牌，称其已萎缩至当年预期销售额的5%以下1。
在第三方检测方面，USP Verified目录列出16个品牌的159种已验证产品，而美国市场有8万至10万种产品；其中99种属于Nature Made，由日本制药公司Otsuka拥有1。ConsumerLab自1999年以来已检测来自1000多个品牌的7000多种产品；其2025年3月对22种复合维生素的评测中，7种未通过1。为此，文章建议消费者优先选择片剂或胶囊剂型，认准NSF或USP等第三方检测标志，并关注少数能够自主控制生产的品牌1。
Since 1994, U.S. law has placed the burden of proof on the government to demonstrate that dietary supplements are adulterated, meaning manufacturers are not required to prove their products are safe or that their labels are accurate before going to market 1. This regulatory framework has coincided with massive industry growth; while there were approximately 4,000 supplement products generating about $4 billion in annual sales in 1994, the FDA now estimates there could be up to 100,000 products on the market 1. Americans currently spend nearly $73 billion a year on these supplements, with three-fifths of adults taking them monthly 1. Highlighting the agency's limitations, Cara Welch, director of the FDA's Office of Dietary Supplement Programs, stated, "Under our current authorities, the FDA does not have a systematic way to know what dietary supplements are on the market, when new products are introduced, or what ingredients they contain" 1.
The lack of oversight has led to significant quality issues, particularly with gummy supplements which have lowered production barriers and spawned numerous white-label brands 1. A team led by Pieter Cohen purchased 25 melatonin gummy products and found that 22 had inaccurate labels, with dosages ranging from 74% to 347% of the stated amount, and one product contained no melatonin at all 1. Similarly, NOW Foods tested 25 vitamin C gummy brands from Amazon and discovered that 12 had virtually no detectable vitamin C, while five claimed to contain over 1,000 mg per gummy but actually had less than 2 mg 1. Consequently, the FDA has issued major recalls, including a January 2020 order recalling all dietary supplements manufactured by ABH Nature’s Products between January 2013 and November 2019 1. In November 2021, a manufacturer in Norcross, Georgia, recalled 77 products across 17 states and more than 70 brand names due to undeclared milk 1.
In 2017, private equity firm Highlander Partners began acquiring gummy factories, eventually selling the assembled business to Catalent for $1 billion in August 2021 1. Other major transactions include the sale of Lonza's capsule division to private equity firm Lone Star Funds for approximately $3 billion, with Lonza retaining a 40% stake 1. IVC acquired Perrigo's entire U.S. vitamin and supplement business in 2016 and bought GNC factories for $176 million in 2019 1. Church & Dwight purchased Vitafusion and L'il Critters for $650 million in 2012 but sold the two brands in December 2025, noting they had shrunk to less than 5% of their projected sales from that time 1. Additionally, Procter & Gamble acquired Thorne for $3.8 billion in cash, and private equity firm L Catterton took Thorne private for about $680 million in October 2023, yielding a roughly 5.5-fold profit in 34 months 1.
To navigate this largely unregulated market, the article recommends that consumers prioritize tablets or capsules and look for third-party testing marks such as NSF or USP 1. The USP Verified directory lists 159 verified products from 16 brands out of the 80,000 to 100,000 products on the U.S. market, with 99 of those verified products belonging to Nature Made, which is owned by the Japanese pharmaceutical company Otsuka 1. Meanwhile, ConsumerLab has tested over 7,000 products from more than 1,000 brands since 1999 1. In its March 2025 evaluation of 22 multivitamins, seven products failed to pass the testing 1. Additionally, the article names a few brands that maintain self-controlled production 1.
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