FDA Update by ODSP Director Steven Tave Presented at 7th Annual AHPA Botanical Congress

FDA Update by ODSP Director Steven Tave Presented at 7th Annual AHPA Botanical Congress

Tave outlines collaborations between FDA and supplement industry to ensure consumer safety

Published: Thursday, November 15, 2018

The American Herbal Products Association’s (AHPA’s) 7th Annual Botanical Congress featured a Food and Drug Administration (FDA) update by Steven Tave, FDA’s Director of the Office of Dietary Supplement Programs (ODSP), who highlighted recent collaborations between the responsible supplement industry and FDA toward the shared goal of a well-regulated dietary supplement market.

Tave was one of more than 20 industry experts who presented on Nov. 10 at AHPA’s Botanical Congress, a unique, annual event that convenes leading herbal industry veterans to discuss issues impacting the herbal product and herbal supplement industries. The event is held in Las Vegas as part of the SupplySide West tradeshow.

“One of the things I have really come to appreciate since I’ve been in this job is the enormous amount of common ground between our goals at FDA and the goals of the responsible participants in the dietary supplement industry,” Tave said in a video prepared for the event. “Anyone who is paying attention can’t help but see that responsible dietary supplement firms today are looking for ways not just to comply with the law’s requirements, but to set higher standards for themselves and to hold the entire industry to those standards.”

He outlined several areas where FDA and the supplement industry have recently cooperated to further ODSP’s top three priorities:

  • Safety: Protecting consumers from harmful products
  • Product integrity: Ensuring product identity and quality
  • Informed decision-making: Enabling consumers and health care providers to be well informed about supplement products

Safety

Tave stressed that an effective New Dietary Ingredient (NDI) notification process represents is FDA’s only opportunity to evaluate new ingredients before they hit the market, making a robust NDI notification process an integral part of the Dietary Supplement Health and Education Act (DSHEA) framework. He could not provide a timeline for revised or final guidance, but assured the audience that FDA is grappling with some of the more complicated sections of the guidance while working to make progress on less complicated issues. Two areas FDA is currently investigating are the development of an authoritative pre-DSHEA or “old” dietary ingredient list and a “master file” process.

Tave said that FDA is thinking about ways to help firms see the value in a good NDI notification and would be transparent as it works to finalize NDI guidance. FDA’s goal is to ensure that notifications are only submitted for ingredients that require a notification and that NDI notifications are well prepared and contain all required information, he said.

“This is an area where industry-provided training and collaboration can also be helpful and I know that AHPA has been a leader in providing education and analysis regarding the NDI notification process,” he said.

Product Integrity

Product integrity comes down to tainted products and current good manufacturing practices (cGMP), according to Tave.

“When we find [tainted] products, we work quickly to remove them from the market and to alert consumers to their dangers,” Tave said. “I know that AHPA has been a strong advocate in support of FDA’s efforts to address this issue, and that reflects positively on both AHPA’s leadership and its membership as a voice of responsible industry.”

Tave noted that illegal, drug-spiked products are not a new issue and that they simultaneously put consumers in dangers and tarnish the reputation of the responsible industry.

“We’re still spending a lot of time and resources trying to track these products down in order to take them off the market,” he said. “We’re long overdue for a candid dialogue about what might be done differently to enable us to find and remove these illegitimate products more quickly and efficiently.”

Tave also indicated that FDA would like to see better industry-wide compliance rates with cGMP requirements for dietary supplements, but acknowledged that many firms are, for the most part, getting it right.

“They’re making the investment and they’ve shown a commitment to doing what it takes to deliver a quality product to their customers,” he said. “It’s a product, in many ways, of the industry-led efforts to promote compliance, including through education and training.”

Tave added that compliance will only get more challenging with implementation of the Food Safety Modernization Act (FSMA) and that FDA is looking for ways to enhance educational and training resources.

He also highlighted FDA’s recent program alignment initiative to reorganize FDA’s field activities which historically had a been organized based primarily on geography and have moved to a commodity-based alignment.

“Inspections will be assigned to FDA staff based on their expertise and not just based on where they happen to be stationed,” he said. “As changes are implemented over time it should increase both the efficiency of our inspections and field activities.”

Informed decision-making

Ensuring consumers aren’t misled by products making unlawful and unfounded disease claims is another important priority for FDA, Tave said. At the same time, FDA wants to make it easier for responsible firms to communicate reliable information to their consumers.

“The vision is to level the playing field for responsible firms like yours,” Tave said. “Our shared challenge, going forward, is to figure out what it will take to make that vision a reality. I look forward to collaborating with AHPA and its members toward this goal.”

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