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FDA to overhaul oversight of dietary supplements, curb ‘potentially dangerous products’

The Food and Drug Administration plans to strengthen its oversight of the dietary supplement market in what Commissioner Scott Gottlieb called “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.”

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The agency is developing a new “rapid-response tool” to alert the public to avoid buying products that may contain unlawful or potentially dangerous ingredients, the agency said in a press release Monday.

The dietary supplement industry is worth over $40 billion and the choices for consumers have skyrocketed from 4,000 products to 80,000 in the past 25 years, the agency said.

“As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver,” said Gottlieb.

The agency is also looking to update its compliance policies with new dietary ingredient notifications, or NDIs, which requires manufacturers to alert the FDA of any ingredients that weren’t sold in the U.S. before 1994.

“An effective NDI notification process represents the FDA’s only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources,” said Gottlieb.

It’s also creating the Botanical Safety Consortium, a partnership between the public and private sectors, to evaluate 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,” said Gottlieb.

It also is hoping to make enforcement processes easier, which allows employees to issue warnings to companies and consumers.

The FDA rolled out part of its plan Monday morning when it sent warning letters to 17 companies for “illegally selling” products that claim to treat Alzheimer’s disease.

“I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks,” said Gottlieb. “To continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products.”

The FDA said it will continue to roll out plans in the next few months and that it plans to open communication up to the public and stakeholders.