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NJ Labs Underscores Importance of TOC Water Testing Analysis for Cosmetic, Nutraceutical and Pharmaceutical Products

by Shari Barbanel | August 22, 2022

A flood of warning letters from the FDA (U.S. Food and Drug Administration) on water system suitability could pull the plug on the production of food, beverage, cosmetic, nutraceutical, and over-the-counter (OTC) or pharmaceutical products if companies are not conducting total organic carbon (TOC) water testing analysis on a regular basis, reports NJ Labs (New Brunswick, NJ). ...

FDA’s Long-sought Guidance on NAC Follows NPA’s Lawsuit and Citizen’s Petition

by Shari Barbanel | August 10, 2022

Following a Citizen’s petition and lawsuit filed by the Natural Products Association (NPA) against the U.S. Food and Drug Administration (FDA) for a dietary supplement issued enforcement discretion for N-Acetyl-Cysteine (NAC) has resulted in the agency issuing final guidance. “This is a big win but it is bittersweet for sure. Although it was NPA’s leadership ...

CRN President Issues MPL Update to Members

by Shari Barbanel | August 10, 2022

In an open letter to members, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), updated the CRN community on the status of the association’s effort to create a dietary supplement registry at the U.S. Food and Drug Administration (FDA). In the letter, Mister reassured members that CRN would continue to advocate ...

NPA, CRN Respond to Research Showing Supplements With Banned Ingredients are Still on the Market

by Shari Barbanel | August 2, 2022

A study recently published in JAMA by Pieter A. Cohen, MD; Bharathi Avula, PhD; and Kumar Katragunta, PhD, et al, has found that supplements with banned ingredients are still on the market despite the companies having received warning letters from the U.S. Food and Drug Administration (FDA). The study stated that “Some dietary supplements are adulterated ...

Senator Burr Takes Position Against Including Dietary Supplement Provisions in FDA User Fee Bill Package

by Shari Barbanel | July 25, 2022

On July 14, Senator Richard Burr (R-NC), the ranking member of the Senate HELP Committee and a central negotiator in the conference proceedings, introduced a clean reauthorization of FDA User Fee Programs (U.S. Food and Drug Administration), which does not include controversial dietary supplement provisions. Senator Burr cited concerns over the Senate’s ability to pass ...

ProTab Labs Offers Solutions for Infant Formula Producers Facing Crisis

by Shari Barbanel | June 22, 2022

To tackle the infant formula crisis, producers can rely on Southern California supplement solutions contract manufacturer ProTab Laboratories to blend custom premixes and produce and package infant formula with a rapid turnaround time, the company stated. “ProTab is in the perfect position as a supplement solution manufacturer and packager to prioritize infant formula production with safety and ...

NPA Responds to Report of Increased, Unintentional Pediatric Melatonin Ingestion

by Shari Barbanel | June 8, 2022

Over the past decade and particularly since the beginning of the COVID-19 pandemic, the use of melatonin supplements to address sleep issues has increased significantly by both adults and children. On Thursday, June 3, the Centers for Disease Control and Prevention (CDC) released a 10-year study that found a sharp increase in the use of ...

Durbin, Braun Introduce Legislation to Mandate Product Listings for Dietary Supplements

by Shari Barbanel | May 4, 2022

U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Mike Braun (R-IN) introduced the Dietary Supplement Listing Act of 2022, bipartisan legislation to require dietary supplement manufacturers to list their products with the U.S. Food and Drug Administration (FDA). The Dietary Supplement Listing Act of 2022 would require companies to provide FDA with vital information about their ...

CRN Dismisses FDA Response on N-acetyl-cysteine (NAC)

by Shari Barbanel | April 6, 2022

The Council for Responsible Nutrition (CRN) on March 31 denounced the U.S. Food and Drug Administration’s (FDA) decision regarding the legal status of n-acetyl-cysteine (NAC) as a dietary ingredient. “CRN is extremely disappointed and unconvinced by FDA’s response today that it has chosen to deny CRN’s citizen’s petition while holding out the possibility that it may open ...

NPA Says Mandatory Product Listing is a “Non-Starter” and Amounts to “Pre-Market Approval”

by Shari Barbanel | April 6, 2022

The Natural Products Association (NPA) has issued a statement on the President’s FY 2023 Budget Request to Congress regarding the section on the U.S. Food and Drug Administration (FDA). “FDA’s proposal to include mandatory product listing in their FY23 budget request is a non-starter,” said Dr. Daniel Fabricant, the association’s president and CEO. “Year after ...

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