The US Food and Drug Administration has announced plans for “one of the most significant modernizations of dietary supplement regulation and oversight” since the enactment of the Dietary Supplement Health and Education Act (DSHEA) 25 years ago.
Over that period the US dietary supplement industry has grown to be worth over $40 billion, while the choices for consumers have skyrocketed from 4,000 products to 80,000.
Among proposals outlined last week by FDA’s Commissioner Scott Gottlieb include:
• Developing a new “rapid-response tool” to alert the public to avoid buying products that may contain unlawful or potentially dangerous ingredients.
• Updated compliance policies, including new dietary ingredient notifications, or NDIs, which require manufacturers to alert the FDA of any ingredients that weren’t sold in the US before 1994.
• A new mandatory ingredients listing requirement under DSHEA that “could provide significant benefits by improving transparency in the marketplace”.
In a statement on the FDA website, Gottlieb adds: “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.”
Consumer groups have given a cautious welcome to the FDA’s plans. Sandra Eskin, head of the food safety project at Pew Charitable Trusts, told the Washington Post. “The commissioner’s statement is the first time in 25 years that FDA’s leadership has publicly committed to taking meaningful steps to improve dietary supplement oversight”. But the Center for Science in the Public Interest argues that more still needs to be done, and that “the FDA is hampered by a terrible law and drastically limited resources within that there’s only so much you can do.”
“(the FDA should focus on using the) current tools it has at its disposal to protect consumers from companies selling illegal products masquerading as nutritional supplements”
Responding to the FDA’s announcement, US trade body the Natural Products Association (NPA) said: “We look forward to working with FDA on modernization, but what consumers need is action”.
But the NPA says it the FDA should focus on using the “current tools it has at its disposal to protect consumers from companies selling illegal products masquerading as nutritional supplements. It added: “The US has the safest nutritional supplements in the world because of collaborative efforts between our industry and federal regulators, and we are confident that collaboration will continue.”