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Analysis: Kudos to FDA's dietary supplements chief for sharing data

Josh Long, attorney and legal/regulatory affairs writer, Natural Products Insider
The regulator's transparency regarding dietary supplement-related actions provides all stakeholders a starting point for conversations.

During a recent event in New York City, the nation's top regulator of dietary supplements—Cara Welch, Ph.D.—presented data on FDA's compliance and enforcement activities.

While speaking June 29 at the 10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements, co-hosted by the American Conference Institute (ACI) and Council for Responsible Nutrition (CRN), Welch mentioned providing a review some years back on FDA's dietary supplement programmatic figures.

At the ACI-CRN conference, she provided a similar review that shared insights on various FDA activities from its inspections to enforcement actions.

"We have this information. We don't always share it," Welch, who directs the FDA's Office of Dietary Supplement Programs, said at the beginning of her June 29 presentation.

As a reporter who has been covering this industry for over a decade, I commend Welch for sharing the data and would encourage her to continue doing so at future events, including the one-day Dietary Supplement Regulatory Summit on July 21 in Washington, D.C. Simply put, industry representatives and other stakeholders cannot have fruitful conversations with the FDA about its regulations and enforcement activities without knowing what the FDA is doing.

Among the data Welch shared at the ACI-CRN conference specific to its dietary supplement operations:

  • The number of facility inspections in fiscal years 2017 through 2022 (mid-year figure)—In each of the fiscal years 2017, 2018 and 2019, the FDA conducted more than 500 inspections. In the wake of COVID-19, FDA inspections drastically declined to fewer than 300 in fiscal years 2020 and 2021.
  • The number of new dietary ingredient notifications (NDINs) that FDA has received and responded to since 1994 is 1,164.
  • Percentage of acknowledgement letters to NDINs in fiscal year 2018 was 35%; in 2019, 46%; 2020, 47%; and 2021, 60%.
  • The number of FDA warning letters in fiscal year 2017 was 70; 2018, 75;  2019, 57; 2020, 49; and 2021, 111.
  • Number of injunctions and seizures issued by fiscal year—In 2017, three injunctions, no seizures; 2018, four injunctions, no seizures; 2019, one injunction, two seizures; 2020, one injunction, no seizures; and 2021, three injunctions, one seizure.

By sharing this information, Welch is increasing the transparency of her office and helping to ensure stakeholders—regardless of their positions on the FDA's policies and enforcement practices—can cite the same set of "facts." Hopefully, that's something everyone can get behind.

Natural Products Insider logoThis piece originally appeared on Natural Products Insider, a New Hope Network sister website. Visit the site for information on ingredients, product development and regulatory issues

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