The head of FDA on Monday announced a goal to implement “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.”
A quarter century after Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA), the industry has thrived with tens of billions of dollars in annual sales, the majority of U.S. adults taking supplements and an estimated 80,000 products on the U.S. market.
But in a lengthy statement revealing plans to strengthen the agency’s regulation of dietary supplements, FDA Commissioner Scott Gottlieb, M.D., expressed concern that changes in the supplement market may have outpaced the evolution of the agency’s policies and capacity to manage emerging risks.
“To continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products,” Gottlieb said. “Toward these goals, the FDA is committing to new priorities when it comes to our oversight of dietary supplements at the same time that we carefully evaluate what more we can do to meet the challenge of effectively overseeing the dietary supplement market while still preserving the balance struck by DSHEA.”
Alerting public to dangerous ingredients, encouraging new dietary ingredient notifications
The commissioner announced several steps to advance FDA’s policy goals, including novel ways to communicate more readily when the agency is concerned that an ingredient marketed in supplements is unlawful and potentially dangerous.
“We’re developing a new rapid-response tool to alert the public, so consumers can avoid buying or using products with that ingredient, and to notify responsible industry participants to avoid making or selling them,” he disclosed.
Second, Gottlieb suggested FDA is working to encourage the submission of new dietary ingredient (NDI) notifications. For years, FDA officials have emphasized the notification process represents the agency’s only opportunity to evaluate new ingredients in supplements before they are placed on the market.
Over the years, FDA has objected to the majority of NDI notifications due to safety concerns and for other reasons, including incomplete filings. Meanwhile, distributors and manufacturers are suspected of dodging their statutory obligations because there are typically just dozens of NDI notifications each year.
Since 2011, FDA has issued two “draft” guidance documents governing the notification process. Industry sources have complained the agency has too broadly interpreted what constitutes an NDI and that the notification system fails to give companies proper incentives to innovate.
Gottlieb revealed plans to issue more guidance and modernize its approach to NDI notifications.
“We’re continuing to develop guidance for preparing NDI notifications to ensure FDA can thoroughly review the safety of these ingredients,” he said. “In conjunction with this effort, we’re planning to update our compliance policy regarding NDIs.”
The commissioner plans to hold a public meeting in the spring concerning “responsible innovation” in an industry with more than US$40 billion in annual sales.
“I expect the feedback received during this meeting will be essential as we move to modernize our approach toward NDIs,” the commissioner said. “We’ll look to address other challenges that may act as barriers to dietary supplement innovation and safety, including issues such as what the right incentives might be for establishing dietary supplement exclusivity, and the scope of permitted dietary ingredients.”
Opening discussion on modernizing DSHEA
The commissioner also announced plans to start a public dialogue over modernizing DSHEA a quarter century after its passage, and he said his agency has heard from stakeholders who want to open such talks.
“While the FDA is committed to leveraging its existing resources and authorities to the fullest extent possible, we believe there may be value in a broader public conversation about whether certain changes to the law might be helpful,” he said. “We believe there may be opportunities to modernize DSHEA for the future, while preserving the law’s essential balance.”
For example, some stakeholders have supported the idea of a mandatory product registry. Currently, supplement companies can register their products with voluntary systems that have been established, including a label database maintained by the Office of Dietary Supplements within the National Institutes of Health; and a product registry called the Supplement OWL (Online Wellness Library) launched by the Council for Responsible Nutrition (CRN), a trade association representing the dietary supplement industry.
The law does not mandate registration of dietary supplement products, making it exceedingly difficult for FDA to track the growing number of products on the market.
“A mandatory listing requirement could provide significant benefits by facilitating efficient enforcement of the law and establishing new mechanisms to identify bad actors who put the public at risk and undermine consumer confidence in the entire industry,” Gottlieb said.
The commissioner said he is interested in hearing from stakeholders beyond changes to the law so that his agency can regulate the industry in a manner that reflects its current state while continuing to protect consumers’ access to supplements that are safe and compliant with the law.
For example, he asked about the feasibility of creating a product listing system that makes it easier for FDA “to take swift action against illegitimate and dangerous products, such as products that are tainted with drug ingredients?"
“And is it possible to do this without disrupting the balance struck by DSHEA, and without imposing any significant new burdens on responsible firms?” the commissioner asked. “The answer to these questions may very well be yes. And if that’s the case, these are absolutely things that we should be talking about.”
The 25th anniversary of DSHEA's passage "is an excellent time to examine processes aimed at ensuring that the products consumers purchase are safe and carry claims backed by evidence, as well as ways to promote innovation in the industry," said the Consumer Healthcare Products Association (CHPA), which represents manufacturers and marketers of over-the-counter medicines and dietary supplements, in a statement. "This important announcement by FDA highlights the need for balance between continued access to products that promote a healthy lifestyle, fostering research on new, innovative ingredients, and making sure that marketed products are accurately labeled and are safe for use."
Protecting public health, public-private partnership
The commissioner said his agency will continue to take steps to protect the public health and develop new enforcement strategies to protect consumers. He highlighted a batch of 12 warning letters and five online advisory letters made public and sent to companies whose products are allegedly being marketed as unapproved new drugs. Many of the products are marketed as dietary supplements, and they feature claims to cure, treat or prevent Alzheimer’s disease and other serious conditions, including cancer and diabetes, Gottlieb said.
“We’re already making our internal processes more efficient for taking enforcement action when products claiming to be supplements contain unlawful ingredients, including drug ingredients,” the commissioner said.
For example, he cited:
- new guidance in April 2018 and subsequent warning letters in June to protect consumers from dietary supplement products marketed in bulk and containing pure and highly concentrated caffeine;
- a warning to consumers to refrain from purchasing Rhino male enhancement products that contain active ingredients in FDA-approved prescription drugs; and
- warnings to companies for making unproven claims that their products containing a substance known as tianeptine treat opioid use disorder.
“We’ve also been active with compliance and enforcement efforts against firms that have shown persistent inability to comply with the current good manufacturing practice requirements for dietary supplements,” Gottlieb said.
Steve Mister, president and CEO of CRN, said he appreciated the commissioner’s commitment to modernize FDA’s oversight of dietary supplements.
“His statement shares our vision to further develop the thriving, innovative and safe marketplace for dietary supplements that, as he so eloquently states, play an important role as ‘we strive to stay healthy,’ and have ‘become a routine part of the American lifestyle,’” Mister said in a statement. “We also applaud Dr. Gottlieb’s enthusiasm for rooting out bad actors who put consumers at risk by spiking products with unapproved ingredients or drugs and commend the enforcement actions initiated today to address this critical problem.”
Mister called on lawmakers in Congress to allocate sufficient funds to FDA to police the supplement industry and for FDA and other federal agencies “to follow through on tough enforcement.”
Gottlieb’s announcements were not limited to agency actions. He revealed the creation of a public-private partnership involving scientific experts from academic, industry and government. He said the Botanical Safety Consortium will promote advances in assessing the safety of botanical ingredients and mixtures in supplements.
“This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness we share with consumers and other stakeholders,” Gottlieb said.