Regulatory News

Packaging | Quality & Safety | Regulations | Regulatory News | World Markets

‘Made in USA’ Labeling: FTC Rule Intended to Act on Claims Violations

Final rule designed to provide clarity on U.S.-origin claims, and deter bad actors without imposing new burdens on marketers.

Online Exclusives By Mike Montemarano, Associate Editor 08.23.21

NPA Submits Citizen Petition for NAC’s Inclusion as Dietary Supplement Ingredient

While the amino acid has been featured in dietary supplements for decades, FDA objects to its use due to the fact that it was sold as a drug.

08.18.21

Herbs & Botanicals | Quality & Safety | Regulations | Regulatory News

FDA Rejects Two New Dietary Ingredient Notifications for CBD

The decision likely means the agency will not approve future NDIs for CBD barring a directive from Congress.

Online Exclusives By Mike Montemarano, Associate Editor 08.13.21

Trade Associations Request Additional 2022 Funding for FDA's ODSP

AHPA, CHPA, CRN, and UNPA all endorsed stronger support for the FDA’s enforcement arm specific to dietary supplements.

Mike Montemarano, Associate Editor 06.07.21

CRN Files Citizen Petition Regarding FDA’s Objection to NAC Supplements

FDA raised objections to the use of N-acetylcysteine in supplements in Dec. 2020, and since, Amazon has pulled all NAC-containing products from its platform.

Mike Montemarano, Associate Editor 06.02.21

Breaking News | Quality & Safety | Regulations | Regulatory News

U.S. Marshals Seize $1.3 Million Worth of Kratom in Florida

Agency considers Mitragyna speciosa a new dietary ingredient for which there is inadequate information to assure it doesn’t present significant risks.

Sean Moloughney, Editor 05.25.21

Legislation to Create Regulatory Pathways for CBD Use in Foods and Supplements Introduced

The bipartisan legislation, the Hemp Access and Consumer Safety Act of 2021, was introduced by Senators Ron Wyden, Jeff Merkley (both D-OR) and Rand Paul (R-KY)

Mike Montemarano, Associate Editor 05.19.21

CRN Calls on Congress to Make Clarification in Defining 'Dietary Supplement'

The proposed modifications will expand FDA’s authority over products which are not currently supplements, but are marketed as such.

Mike Montemarano, Associate Editor 04.28.21

6th Annual Dietary Supplements Regulatory Summit Scheduled for July 13

The virtual symposium will feature top FDA officials, including acting director Dr. Cara Welch, as well as industry experts.

Mike Montemarano, Associate Editor 04.14.21

First Day Life Shuts Down Children's Behavioral, Cognitive Health Claims Following Challenge

Several claims and consumer testimonials claimed that a multivitamin supplement could improve children’s behavioral issues such as hyperactivity and tantrums.

Mike Montemarano, Associate Editor 04.08.21

Deerland Probiotic DE111 Gains Health Claims Approval in Australia and New Zealand

Company noted this is the first Bacillus subtilis probiotic to attain food-health relationship claims in the region.

Sean Moloughney, Editor 04.06.21

Folium Biosciences Submits Novel Food Application for CBD in U.K.

The application seeks FSA validation for the company’s broad-spectrum CBD oil.

Mike Montemarano, Associate Editor 03.16.21

FTC Finalizes First Administrative Actions Against CBD Marketing Claims

The crackdown, known as CBDeceit, targeted six CBD companies making deceptive disease treatment claims about their products.

Mike Montemarano, Associate Editor 03.08.21

NY Federal Judge Enters Permanent Injunction Against Dietary Supplement Manufacturer

Confidence USA was found to have violated the FD&C Act, and has been ordered to stop production until coming into compliance with GMPs.

Mike Montemarano, Associate Editor 03.04.21

New FDA Traceability Rule Appears to Omit Dietary Supplement Manufacturers

While the agency has not specifically confirmed it, dietary supplements were not mentioned in a list of manufacturers required to enhance traceability measures.

Mike Montemarano, Associate Editor 02.25.21

House Resolution Calls for CDC and FDA to Back Vitamin D for COVID-19

U.S. Representative Glenn Grothman (R-WI) believes the agencies should further communications and investigations on the risks of vitamin D deficiency.

Mike Montemarano, Associate Editor 02.22.21

Omega-3s Recommended in Australian Pregnancy Guidelines Update

This recommendation was approved by the National health and Medical Research Council for the national 2020-2025 guidelines.

Mike Montemarano, Associate Editor 02.11.21

Schrader-Griffith Bill to Regulate CBD Re-Introduced to 117th Congress

Trade associations reaffirmed support for the legislation, which would establish a clear pathway to market for hemp extracts.

Mike Montemarano, Associate Editor 02.08.21

AHPA Requests FDA Take a New Approach on Produce Regulation Affecting Herbs

Many herbs are subject to the same requirements as vegetables which are eaten raw.

01.14.21

Physicians Committee Calls on USDA to Retract Latest Dietary Guidelines for Americans

The non-profit health organization believes research linking animal products to cancer risk was overlooked.

01.08.21

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‘Made in USA’ Labeling: FTC Rule Intended to Act on Claims Violations

NPA Submits Citizen Petition for NAC’s Inclusion as Dietary Supplement Ingredient

FDA Rejects Two New Dietary Ingredient Notifications for CBD

Trade Associations Request Additional 2022 Funding for FDA's ODSP

CRN Files Citizen Petition Regarding FDA’s Objection to NAC Supplements

U.S. Marshals Seize $1.3 Million Worth of Kratom in Florida

Legislation to Create Regulatory Pathways for CBD Use in Foods and Supplements Introduced

CRN Calls on Congress to Make Clarification in Defining 'Dietary Supplement'

6th Annual Dietary Supplements Regulatory Summit Scheduled for July 13

First Day Life Shuts Down Children's Behavioral, Cognitive Health Claims Following Challenge

Deerland Probiotic DE111 Gains Health Claims Approval in Australia and New Zealand

Folium Biosciences Submits Novel Food Application for CBD in U.K.

FTC Finalizes First Administrative Actions Against CBD Marketing Claims

NY Federal Judge Enters Permanent Injunction Against Dietary Supplement Manufacturer

New FDA Traceability Rule Appears to Omit Dietary Supplement Manufacturers

House Resolution Calls for CDC and FDA to Back Vitamin D for COVID-19

Omega-3s Recommended in Australian Pregnancy Guidelines Update

Schrader-Griffith Bill to Regulate CBD Re-Introduced to 117th Congress

AHPA Requests FDA Take a New Approach on Produce Regulation Affecting Herbs

Physicians Committee Calls on USDA to Retract Latest Dietary Guidelines for Americans

September 2021

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