Scott Gottlieb, M.D., resigning FDA Commissioner, revealed plans of strengthening the agency’s dietary supplements regulations. He expressed concern about FDA policies and abilities to manage risks that may emerge with the changes in the industry.

The head of the FDA announced a goal this month to regulate modern dietary supplements. Resigning FDA commissioner, Gottlieb, raised concern that changes in the supplement market have exceeded the level of security provided by the agency’s policies. A quarter of a century after the Dietary Supplement Health and Education Act of 1994 (DSHEA), was passed by Congress, the industry experienced extraordinary growth. The majority of adults are now taking supplements. Annual sales have reached a new peak, earning tens of billions of dollars.

But new plans were revealed that entails a different approach to regulating these products. According to Gottlieb, public health requirements need to be strengthened and made to be more modern to fulfill their obligations to the public. He also states that the FDA will commit to their priority concerning the oversight of supplements. They will also evaluate more ways to oversee the dietary supplement market. Most importantly, the FDA plans on educating and alerting the public about dangerous ingredients that may be contained in these supplements. They will also encourage new dietary ingredient notifications.

New FDA Announcement: Modernize Dietary Supplement Regulations

The commissioner announced, “We’re developing a new rapid-response tool to alert the public, so consumers can avoid buying or using products with that ingredient and notify responsible industry participants to avoid making or selling them.” Gottlieb talked about multiple ways to help the FDA advance their policy goals. He also brought up how they will use new and more effective ways of communicating when ingredients for dietary supplements are unlawful due to dangerous effects it could have on the public. One of Gottlieb’s goals is to alert the public to help customers avoid dangerous products. He would also like to notify manufacturers and distributors of safety concerns because they are known to ignore NDI notifications as there are usually dozens of notifications sent out each year. The commissioner also added, “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.”

Gottlieb is fighting for a requirement to make a mandatory listing. He discussed how mandatory listing would have significant benefits for the public. He states, “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.” He is interested in hearing from more stakeholders so that his agency can accurately represent their current clients and the current state of the supplement industry. Some stakeholders have already expressed interest in a mandatory product listing system. Gottlieb states that a listing system will make it easier for the FDA to take effective action against dangerous products.

President and CEO of CRN, Steve Mister, has said that he appreciates Gottlieb’s efforts to modernize the supplement industry. Mister calls on Congress to take action and provide funds to the FDA so that they can make the required action to address critical problems in the dietary supplement market.

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