14 February 2019 - Deborah Wilkes
The Food and Drug Administration (FDA) plans to strengthen the regulation of dietary supplements in the US. The regulatory agency describes the move as "one of the most significant modernisations of dietary supplements regulation and oversight in more than 25 years".
FDA commissioner Scott Gottlieb pointed out the US dietary supplement market had grown significantly in the 25 years since the Dietary Supplement Health and Education Act (DSHEA) was introduced in 1994.
"Changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks," commented Gottlieb.
Announcing several steps to strengthen the regulation of dietary supplements, Gottlieb said the FDA wanted to achieve the "right balance" between preserving consumers' access to lawful supplements and protecting the public from unsafe and unlawful products.
Dietary supplements "play an important role in our lives as we strive to stay healthy", stressed Gottlieb, but the FDA had to protect Americans from the "potential dangers of products that don't meet the agency's standards for marketing".
Modernisation of DSHEA
Gottlieb said the FDA planned to "engage in a public dialogue" about the need for modernisation of DSHEA, and was interested in hearing ideas from stakeholders.
He noted that some stakeholders wanted to see dietary supplement exclusivity and add a product listing requirement.
"A mandatory listing requirement could provide significant benefits by improving transparency in the marketplace and promoting risk-based regulation," said Gottlieb, adding that it could also "help facilitate efficient enforcement of the law and establish new mechanisms to identify bad actors who put the public at risk and undermine consumer confidence in the entire industry".
Developing a rapid-response tool
In addition to the public dialogue, the FDA is working on new ways to communicate more quickly with the public when there are concerns about a dietary supplement. Gottlieb said the agency was developing a rapid-response tool to alert consumers and notify industry.
The FDA is also keen to ensure the regulatory framework is "flexible enough to adequately evaluate product safety while also promoting innovation". Gottlieb said the agency intended to update its compliance policy on new dietary ingredient (NDI) notifications and was planning a public meeting on responsible innovation in the dietary supplement industry.
In addition, the FDA is keen to continue working closely with industry partners. Gottlieb said the agency had created the Botanical Safety Consortium, a public-private partnership that brings together leading scientific minds from industry, academia and government to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements.
Developing new enforcement strategies is also high on the agenda. Gottlieb noted the agency had just sent 12 warning letters and five online advisory letters to companies illegally marketing products for Alzheimer's disease.
Dietary Supplement Working Group
Gottlieb noted that he had recently set up a Dietary Supplement Working Group within the FDA. He pointed out this was "led out of my office" and "comprised representatives from multiple centres and offices across the agency".
"I have tasked this group with taking a close look at our organisational structures, processes, procedures and practices in order to identify opportunities to modernise our oversight of dietary supplements," commented Gottlieb.
The US Council for Responsible Nutrition (CRN) urged the FDA to achieve "clarity on an approved list of pre-DSHEA dietary ingredients" and release "final NDI guidance that offers protection for innovation and research".
Clarify legal path for CBD
The industry association also called on the FDA to clarify the legal path to market for hemp-derived cannabidiol (CBD) as a food and a dietary supplement.
The US Consumer Healthcare Products Association (CHPA) said it looked forward to "collaborating with the FDA on proposals to enhance quality and promote informed decision-making as well as to discussing with the agency new policies that would promote innovation in the industry".
Gottlieb noted that the US dietary supplement industry had grown from a USD4 billion industry comprising about 4,000 unique products into an industry "worth more than USD40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers".
"The use of dietary supplements – such as vitamins, minerals or herbs – has become a routine part of the American lifestyle," commented Gottlieb, adding that "three out of every four American consumers take a dietary supplement on a regular basis".
"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," said Gottlieb. "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."
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