FDA to strengthen dietary supplement oversight, reevaluate existing regulation and DSHEA law

February 11, 2019

U.S. Food and Drug Administration Commissioner Scott Gottlieb, MD, has announced new efforts by the agency to reform FDA’s oversight of dietary supplements. The commissioner expressed in his statement the concern that the immense growth of the dietary supplement market since the passage of the primary law governing supplements, the Dietary Supplement Health and Education Act (DSHEA), 25 years ago may have outpaced the evolution of FDA’s policies and hindered the agency’s capacity to manage emerging risks from bad actors.

“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,” stated 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.”

Gottlieb had hinted back in December that FDA would be reevaluating dietary supplement oversight when he announced the agency’s formation of a new Dietary Supplement Working Group. Now, the commissioner says the agency is opening discussions about the possibility of changes to supplement laws.

Whether or not any changes are made to existing dietary supplement regulations remains to be seen, but FDA has effectively opened communication on that front. Said Gottlieb: “We’ll engage a public dialogue around whether additional steps to modernize DSHEA are necessary. We’ve heard from stakeholders who want to open such a dialogue. 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. We believe there may be opportunities to modernize DSHEA for the future, while preserving the law’s essential balance.”

The main goals of FDA’s new plan, says Gottlieb, are to protect the public through more effective communication about adulterated products on the market, effectively evaluate the safety of dietary supplement products without hindering innovation, and develop new enforcement strategies. While the announcement was short on details, Gottlieb did outline several important steps that FDA will take to meet its policy goals.

For example, in its efforts to improve communication with consumers, FDA is developing a new rapid-response tool to alert the public of what products and ingredients to avoid. In the meantime, however, FDA has kicked off its new efforts by sending out 12 warning letters and five online advisory letters to companies selling dietary supplements with unsubstantiated claims that their products prevent, treat, or cure Alzheimer’s disease, as well as other health conditions. This demonstrates the agency’s commitment to enforce its policies and protect the public from adulterated products or those making unsubstantiated claims.

FDA also wants to encourage the submission of more New Dietary Ingredient (NDI) notifications. Gottlieb said the agency is continuing to develop guidance for NDI notifications and that it is planning to update its compliance policy regarding NDIs. FDA will be holding a public meeting to receive feedback from industry stakeholders. “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,” said the commissioner.

Another major part of Gottlieb’s announcement was FDA’s formation of a Botanical Safety Consortium, a public-private partnership combining scientists from the industry, academia, and government to promote advances in evaluating the safety of botanical ingredients and mixtures for dietary 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,” says Gottlieb. The ultimate goal of the consortium is to help FDA keep up with the technological advancements of the dietary supplement industry.

Educational organization the American Botanical Council (ABC; Austin, TX), said that its own chief science officer, Dr. Stefan Gafner, is now a member of the Botanical Safety Consortium’s steering committee. The Council for Responsible Nutrition’s (CRN; Washington, DC) said its senior vice president of scientific and regulatory affairs, Duffy MacKay, ND, is also a member of the committee.

ABC noted: “The consortium, a private-public partnership which was formed in September 2018, is tasked to develop new, non-animal assays to evaluate the safety of dietary ingredients in the areas of liver toxicity, genotoxicity, reproductive and developmental toxicity, cardiotoxicity, and systems toxicity. The development and validation of these assays are intended to help industry members avoid having to perform animal studies, and to put tools at their disposal that are more predictive about the safety of ingredients than some of the currently used tests.”

Gottlieb also hinted at the potential that FDA will eventually enact a mandatory dietary supplement product listing in its efforts to modernize DSHEA. “[A mandatory listing requirement] 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,” said Gottlieb. “We’re interested in hearing other ideas our stakeholders may have, and not just those limited to changes to the law, so we can go about the task of regulating this space in a way that reflects where the industry is today and continue to safeguard consumers’ ability to access safe, compliant dietary supplements for the next 25 years.”

In large part, Gottlieb used the announcement to express a willingness to work with and listen to industry stakeholders in FDA’s efforts to ensure what he called a “flexible” regulatory framework that allows the agency to “adequately evaluate product safety while also promoting innovation.”

Initial response to Gottlieb’s announcement from industry trade groups was generally supportive, with industry leaders likely reserving judgement until there are more facts. Trade groups such as the Natural Products Association (NPA; Washington, DC) and CRN encouraged FDA to continue focusing on increasing enforcement of bad actors.

“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,” said Steve Mister, CRN president and CEO, in a press release. “We welcome additional enforcement actions to bring to justice those who would cynically trade on the halo effect of responsible industry to make a quick buck while ignoring the safety and health of consumers. We again call on Congressional appropriators to allocate to FDA the funding required to adequately police this important and growing regulatory beat and for FDA and other federal entities to follow through on tough enforcement.”

Daniel Fabricant, PhD, president and CEO of NPA, also welcomed greater enforcement to root out bad actors, but defended the safety of the dietary supplement industry. “We look forward to working with FDA on modernization, but what consumers need is action,” said Fabricant in a press release. “We encourage the FDA to use the current tools it has at its disposal to protect consumers from companies selling illegal products masquerading as nutritional supplements. The U.S. 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."

Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD), underlined the importance of protecting consumer safety as well as consumer access to supplements.

He said: “As we celebrate in 2019 the 25th anniversary of the passage of DSHEA, AHPA shares Commissioner Gottlieb’s vision, as articulated in today’s press release, of finding the right balance between preserving consumers’ access to lawful supplements, while also protecting the public from unsafe and unlawful products and holding accountable companies that are not in compliance with the law. AHPA has previously communicated specific suggestions for regulatory improvements to FDA and we look forward to a robust and transparent discussion on how best to serve Americans who include supplement products in their families’ healthcare choices.”

The American Botanical Council shared its thoughts in a member advisory, stating: “ABC welcomes the efforts by the FDA to help enhance product quality and to remove adulterated and illegal products from the market.”

Update: This story was updated on 2/14/19 to include comments from AHPA and ABC.