Wellbeing subsidiary KGK Science and the International Probiotics Association (“IPA”) applauds FDA’s Commitment to Release NDI Draft Guidance Documents in the Near Future
VANCOUVER, British Columbia, June 09, 2022 (GLOBE NEWSWIRE) -- Wellbeing Digital Sciences Inc. (“Wellbeing” or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA: SQ2), subsidiary KGK Science Inc. applauds the efforts on the part of U.S. Food and Drug Administration (“FDA” or the “Agency”) to release the recent New Dietary Ingredient (“NDI”) enforcement draft guidance, which is part one of a multipart series of NDI guidance documents the FDA announced during a round table discussion at the IPA World Congress + Probiota Americas.
According to FDA, the recent enforcement discretion guidance on late submissions of NDI notifications, released on May 19, 2022, was in response to its commitment in the Fall of 2021 to update guidelines in 2022. Instead of releasing a single guidance document containing all issues for stakeholder notice and comment for a third time, FDA plans to release separate and smaller draft guidance with FDA’s thinking on each group of NDI topics.
IPA in conjunction with their U.S. Task Force Leader, Dr. Corey J. Hilmas, Chief Scientific Affairs and Regulatory Officer at KGK Science Inc., has initiated discussions with industry leaders to formally request a public meeting with the FDA to discuss issues that directly apply to probiotics. “Future draft guidance documents from the Agency on NDIs are critical to the probiotic industry and many of our KGK Science clients,” said Najla Guthrie, CEO of Wellbeing Digital Sciences.
“IPA has maintained a dialog with the Agency over the course of the prior two NDI draft guidance, and we anticipate many issues will remain unresolved in upcoming NDI guidance documents. Our issues and concerns are unique to probiotics, as we have stated in previous stakeholder comments, and IPA’s request for a formal probiotic public meeting is intended to ensure that FDA has all the information it needs to address these complex topics,” said George Paraskevakos, Executive Director of IPA.
“We believe a focused public meeting to address ongoing, unresolved issues related to probiotic NDIs, GMPs, labeling, and a host of other topics is long overdue. A public meeting would be a mutually beneficial process and dialog to have between the probiotic industry and the Agency over lingering issues that could not be resolved in any other format,” stated Dr. Corey J. Hilmas, KGK’s Chief Scientific Affairs and Regulatory Officer.
“IPA looks forward to continuing our dialog with the various heads of FDA responsible oversight of probiotics in a more formal setting in College Park, Maryland,” said Solange Henoud, VP Regulatory and Compliance at Lallemand Health Solutions and Chair of IPA Regulatory Committee.
For more information on the FDA Release Draft Guidance on NDI Enforcement Discretion please visit the U.S. Food & Drug Administration page.
ABOUT KGK SCIENCE
Subsidiary of Wellbeing Digital Sciences, KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging health care products. Founded in 1997, the business has successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. Furthermore, the company has produced over 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database and collected 10 million data points. For additional information, please visit kgkscience.com.
ABOUT WELLBEING DIGITAL SCIENCES
Wellbeing Digital Sciences Inc. is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical treatment solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research. Its mission is supported by a network of North American clinics that provide forward-thinking therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trials services to clients pursuing drug development. For additional information, please visit wellbeingdigital.co.
ABOUT INTERNATIONAL PROBIOTICS ASSOCIATION
The International Probiotics Association (IPA) is a global non-profit organization bringing together through its membership, the probiotic sector’s stakeholders including but not limited to academia, scientists, health care professionals, consumers, industry and regulators. The IPA’s mission is promoting the safe and efficacious use of probiotics throughout the world. Holding NGO status before Codex Alimentarius, the IPA is also recognized as the unified “Global Voice of Probiotics®” around the world. To learn more about IPA, visit https://internationalprobiotics.org/.
On behalf of: Najla Guthrie Chief Executive Officer WELLBEING DIGITAL SCIENCES
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