Odsp

ODSP’s Welch: NDIN 'guidances are not enforceable'

22-Apr-2024 By Danielle Masterson

FDA’s director of the Office of Dietary Supplement Programs (ODSP), Cara Welch, PhD, stopped by SupplySide East to present an overview of the agency’s FY23 activities related to dietary supplements and FY24 plans as well as an update on the pending Human...

ODSP’s Cara Welch talks FDA priorities and resources in evolved market

15-Sep-2023 By Asia Sherman

The National Institutes of Health kicked off its annual Office of Dietary Supplements Seminar Series this week with a presentation by Dr. Cara Welch on how the Food and Drug Administration (FDA) regulates the dietary supplement marketplace.

Sens. Durbin & Blumenthal express concerns over proposed changes to FDA's Supplement Office

26-Aug-2023 By Stephen Daniells

Two of the dietary supplement industry’s most vocal critics in Congress – Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) – have written to the FDA to express concerns about proposed changes to the Office of Dietary Supplement Programs (ODSP).

AHPA’s McGuffin: We oppose the reorganization of FDA’s food and supplements program

17-Jul-2023 By Stephen Daniells

The Board of the American Herbal Products Association will oppose FDA proposals to reorganize its dietary supplements program into a new Office of Food Chemical Safety, Dietary Supplements, and Innovation.

UNPA’s Israelsen: ‘Dietary supplements are not food additives - full stop’

10-Jul-2023 By Stephen Daniells

FDA’s recent proposal to relocate the Office of Dietary Supplement Programs (ODSP) to a new Office of Food Chemical Safety, Dietary Supplements, and Innovation, is disturbing, says UNPA’s Loren Israelsen.

NPA’s Fabricant on FDA reorg, HSAs/FSAs, Master Files, NMN and more

07-Jul-2023 By Stephen Daniells

From a proposed reorganization of the Food & Drug Administration to progress (or not) on the NMN situation, there’s a lot going on in the dietary supplements industry. We caught up with Daniel Fabricant, PhD, president and CEO of the Natural Products...

FDA proposes relocation of Office of Dietary Supplement Programs, industry reacts

06-Jul-2023 By Asia Sherman

The dietary supplement industry is expressing concern over a proposed update to a Food and Drug Administration (FDA) reorganization that would relocate the current Office of Dietary Supplement Programs (ODSP) to a new office under its “Risk Management...

ODSP’s director on NDIs, MPL, and NMN

27-Apr-2023 By Danielle Masterson

NutraIngredients-USA caught up with Cara Welch, PhD, Director of FDA's Office of Dietary Supplement Programs. Welch talked inspections, made the case for MPL and hinted NDI guidance is on the way.

Top 8 takeaways from Regulatory Summit

26-Jul-2022 By Danielle Masterson

This year’s Dietary Supplement Regulatory Summit in Washington, DC, featured updates and insights from top FDA officials, including the Office of Dietary Supplement Programs along with top stakeholders and industry experts. Here are a few key takeaways...

Part 1

FDA’s Cara Welch on RRAs & third-party audits: 'We’re staring at a backlog of inspections'

27-Jun-2022 By Stephen Daniells

The head of the FDA’s Office of Dietary Supplement Programs suspects that remote regulatory assessments (RRAs) will continue even as regular facility inspections resume post-COVID, as the agency seeks to get a good picture of the compliance status of...

CRN’s Mister on NAC: ‘This isn’t a one ingredient issue’

14-Mar-2022 By Stephen Daniells

As the uncertainty around the regulatory status of NAC (N-acetyl cysteine) continues, it is important the industry doesn’t lose this for the precedent it sets for other potential ingredients, said CRN’s Steve Mister.

Cara Welch named permanent director of ODSP at FDA

11-Mar-2022 By Stephen Daniells

The US Food and Drug Administration has announced that Dr Cara Welch will be the new permanent director of its Office of Dietary Supplement Programs. The announcement was welcomed by industry trade groups.

Democratic Senators request $3.75 million increase in ODSP budget

13-Jul-2021 By Stephen Daniells

Five Democratic Senators have cosigned a letter the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies asking for a significant increase for the budget for the Office of Dietary Supplement...