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FDA Appoints New Head

by Shari Barbanel | February 29, 2016

It was confirmed that Robert M. Califf, MD, MACC, is the new U.S. Food and Drug Administration’s (FDA) commissioner of food and drugs. As the top official of the FDA, Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health, the ...

Registrar Corp Introduces FDA Compliance Monitor

by Shari Barbanel | January 12, 2016

The U.S. Food and Drug Administration (FDA) recently finalized two new rules that require food facilities and importers of food and beverages to monitor and document the compliance status of each supplier, “including FDA warning letters or import alerts relating to the safety of food and other FDA compliance actions.” The two new rules, the Preventive ...

FDA Updates Webpages to Reduce Confusion Between Legal Supplements and Illegal Drug-Spiked Products

by Shari Barbanel | December 7, 2015

The U.S. Food and Drug Administration (FDA) recently updated language on several pages of its website to more accurately describe illegal, drug-spike products and to remove references to these as dietary supplements after the American Herbal Products Association (AHPA) requested the changes. FDA usually uses terms such as “marketed as dietary supplements” or “masquerading as ...

FDA Determines GE Salmon Safe

by Shari Barbanel | November 30, 2015

“After an exhaustive and rigorous scientific review, FDA [Food and Drug Administration] has arrived at the decision that AquAdvantage salmon is as safe to eat as any non-genetically engineered (GE) Atlantic salmon, and also as nutritious,” the FDA report stated. The FDA scientists evaluated data submitted by the manufacturer, AquaBounty Technologies, and other peer-reviewed data, ...

NPA Welcomes FDA Process to Define “Natural”

by Shari Barbanel | November 19, 2015

The Natural Products Association (NPA) responded to recent steps taken by the U.S. Food and Drug Administration (FDA) to define the term “natural” on food labels. “It’s about time that natural be defined by experts and no Madison Avenue ad executives,” said Dan Fabricant, PhD, executive director and CEO of the NPA. “NPA strongly supports ...

Ingredion Incorporated Submits Health Claim to FDA

by Corinne Anderson | September 21, 2015

Ingredion Incorporated (Westchester, IL) submitted a health claim petition to the FDA (Food and Drug Administration) for the reduction of risk for type 2 diabetes with resistant starch from high-amylose corn. Clinical studies conducted by academic institutions and research organizations on high-amylose corn resistant starch type 2 (RS2) over the years, have generated considerable scientific ...

Company Owner Pleads Guilty to Adulterating Supplements

by Shari Barbanel | December 29, 2014

The owner and president of a dietary supplement manufacturing company in Flanders, NJ, pleaded guilty to conspiracy to commit wire fraud in relation to a scheme in which he directed the sale of diluted and adulterated dietary ingredients and supplements sold by his company, U.S. Attorney Paul J. Fishman announced. Barry Steinlight, 69, of Hackettstown, ...

Supplement Caucus Co-Chair Rep. Pallone Now On Key House Committee

by Angela Santoriello | November 21, 2014

Rep. Frank Pallone Jr. (D-NJ), the co-chair of the Congressional Dietary Supplement Caucus, narrowly beat out Rep. Anna Eshoo (D-CA) to replace vocal supplement industry critic Rep. Henry Waxman (D-CA) as the ranking Democrat on the House Energy and Commerce Committee, reported the American Herbal Products Association (AHPA). Among the committee’s broad jurisdiction are several ...

CRN Launches Tool to Help Industry Monitor GMP Violations

by Angela Santoriello | November 17, 2014

The Council for Responsible Nutrition (CRN) announced a free online tool that compiles FDA warning letters sent to dietary supplement companies into a searchable database to help industry achieve better regulatory compliance. The database can be used to evaluate FDA’s warning letter allegations of good manufacturing practices (GMPs) violations, products making impermissible claims, and products ...

Gaia Herbs Presents ID Validation Program at USP Workshop

by Angela Santoriello | October 30, 2014

Gaia Herbs (Brevard, NC) was the only natural products industry representative invited to present at a U.S. Pharmacopeial Convention (USP) workshop hosted last week at the agency’s national headquarters in Rockville, MD, reported the company. The event, titled “DNA Methods for Quality Control of Botanical Products,” was co-organized by several other government departments including the ...

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