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FDA Is Not Looking to “Throw Out DSHEA,” Says ODSP’s Welch

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By Janet Poveromo

During the American Herbal Products Association’s (AHPA) 9th Botanical Congress held virtually on May 24,  Cara Welch, AHPAacting director of the Office of Dietary Supplements Programs (ODSP), U.S. Food and Drug Administration (FDA), told industry members that the FDA is not “looking to throw out DSHEA (Dietary Supplement Health and Education Act of 1994),” but may add to or adjust what is already there, she said.

Speaking on the FDA’s regulatory adjustment in response to COVID-19, Welch noted that FDA is committed to DSHEA’s “twin pillars:” preserving consumers’ access to safe high-quality and accurately labeled dietary supplements, while protecting consumers from dangerous and unlawful products.

Welch said that the ODSP was “mobilizing FDA’s response” due to the pandemic to identify fraudulent products and prosecute companies, allow for accommodations and flexibility where possible regarding serious adverse events reporting, and establish open communication. “In my opinion, FDA has done an excellent job in communicating about our expansive effort in response to COVID-19,” she said.

“It’s been a productive year,” Welch said, adding that the agency will continue to take action. While FDA in-person inspections took a hit as the agency shifted focus during the pandemic, Welch said they shifted focus to work that doesn’t require physical attendance at a facility. Among the initiatives, the agency developed a voluntary Remote Regulatory Assessment (RRA Program), which allows FDA to request records to review electronically and provide feedback. Welch stressed it is a voluntary assessment and not an official inspection.

According to AHPA, the Botanical Congress is held for the herbal industry to “explore issues directly impacting business.” The theme of the one-day event, Botanicals in the time of COVID-19, also included presentations on issues regarding supply chain, the expanded supplement marketplace, and the impact of COVID-19 on North American Traditional Healers.

For more information, visit www.ahpa.org.

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