Nutraceuticals World

Dietary Supplements | Functional Foods & Beverages | Quality & Safety | Regulations

Cybersecurity Risks Discussed at Roundtable on Remote Regulatory Assessments

Information-sharing at voluntary, remote inspections can be valuable, but must guard against cyber threats.

Online Exclusives By Mike Montemarano, Associate Editor 07.14.21

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

Consumer Trends | Dietary Supplements | Herbs & Botanicals | Regulations

Untapped Potential: CBD Food & Supplement Market Still in Regulatory Limbo

Without a federal regulatory framework for hemp-derived CBD dietary supplements, stakeholders across the value chain are feeling the effects.

By Sean Moloughney, Editor 04.01.21

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

Nutrition Industry Reacts to 2020-2025 Dietary Guidelines for Americans

Trade associations highlighted concerns with the federal recommendations for daily nutritional intakes, which will be standard until 2025.

Online Exclusives By Mike Montemarano, Associate Editor 01.08.21

FTC Takes Action on CBD Claims, Issuing Penalties

CRN voiced support for the enforcement action, and reminded observers about the need for a legal pathway to market.

12.18.20

FDA Warns Against Male Enhancement and Weight Loss Products Sold Online

The agency reported on a list of nearly 50 products which contain potentially dangerous drug ingredients.

12.18.20

Breaking News | Dietary Supplements | Regulations | Regulatory News | World Markets

CRN Responds to FDA Position on NAC Supplements, New HHS Guidelines

FDA currently prohibits the use of NAC as a dietary supplement, and is concerned about a proposal for HHS to review certain regulations or let them expire.

12.07.20

Breaking News | Dietary Supplements | Regulations | Regulatory News | World Markets

Regulatory Harmonization Set to Boost Supplement Market in ASEAN Region

Cooperation on shared desire to ensure high levels of product safety and quality opens up new opportunities for the region.

11.30.20

Breaking News | Dietary Supplements | Quality & Safety | Regulations | Regulatory News

FDA’s Steven Tave Discusses Bridging Gaps Between Regulation and Enforcement

The director of the agency’s Dietary Supplements Program pointed to tangible options for better regulating the industry.

Online Exclusives10.22.20

National Advertising Division Refers Company to FTC Over Dramatic Weight Loss Claims

Leptitox, marketed as an appetite suppressant and weight loss product, had claims that were challenged by the Council for Responsible Nutrition.

10.02.20

Breaking News | Contract Manufacturing | Regulations | Regulatory News

FDA ‘Won’t Focus’ on Enforcement of New Label Requirements For Small Companies

Manufacturers told the agency they would need additional time in light of COVID-19 challenges.

09.21.20

Breaking News | Contract Manufacturing | Quality & Safety | Regulations | Regulatory News

FDA Proposes Rule to Expand Food Traceability

Certain types of foods would be subject to new record-keeping requirements.

09.21.20

FDA Rejects New Dietary Ingredient Bid for Oleandrin

The agency expressed significant concerns about the safety of this compound, which is currently being investigated as a new drug.

09.09.20

Despite Optimism from Other Trade Groups, NPA Rejects New CBD Proposals

The trade organization believes that a proposed bill falls short by failing to establish a safe level of daily consumption.

09.08.20

Supplement and Hemp Industry Trade Associations Applaud Proposed CBD Legislation

The industry has called on Congress to provide FDA statutory authority to regulate hemp and hemp-derived CBD since the passage of the 2018 Farm Bill.

09.08.20

Herbs & Botanicals | Regulations | World Markets

CBD Regulatory Status Update in Europe

Investing in a novel food application for hemp extracts or CBD derived from hemp is a risky proposition at present.

By Joerg Gruenwald, analyze & realize ag 09.08.20

Breaking News | Regulations | Regulatory News

Groups Request More Time to Meet New Food and Supplement Labeling Rules

FDA previously gave companies with $10 million or more in annual sales an additional year to meet the revised nutrition labeling regulation.

08.25.20

USDA Publishes Proposed Rule to Expand National Organic Program

The new proposed regulations would increase oversight and enforcement of the production, handling, and sale of organic products.

08.20.20

Breaking News | Medical Nutrition | Quality & Safety | Regulations | Regulatory News

Colloidal Silver Promoter Charged with Making Fraudulent COVID-19 Health Claims

According to the FDA, SilveryGuy was participating in the Amazon Associates program, and is not the first participant to allegedly market products in this way.

08.19.20

AHPA Supports USDA Proposal to Allow Pullulan in Organic-Labeled Products

The proposed allowance applies to pullulan's use in tablets and capsules of dietary supplements.

08.12.20

Breaking News | Dietary Supplements | Regulations | Regulatory News

Senator Introduces Bill to Expand Health Savings, Flexible Spending Accounts for Supplements

The legislation is a ‘common-sense solution that will save patients and taxpayers money,’ according to NPA’s Dan Fabricant.

08.10.20

Breaking News | Dietary Supplements | Industry & Market News | Regulations | Regulatory News

CRN’s Virtual ‘Supplement Advocacy Send-In’ Encouraged Safe Industry Advocacy

With the Capitol closed, the online event served to drive industry speakers to contact representatives virtually.

08.06.20

Potential MA, NY Bans on Weight Loss, Muscle Building Supplements Spark Industry Backlash

State bills proposed in Massachusetts and New York would be the first to place popular bulking and cutting ingredients under lock-and-key from minors if passed.

07.31.20

Breaking News | Dietary Supplements | Industry & Market News | Regulations | Regulatory News

FDA Warns Companies To Stop Making Hangover Claims

The agency stated that no dietary supplement can serve as a substitute to a health problem that can only be solved by moderate or no drinking.

07.30.20

FDA Publishes Blueprint for New Era of Food Safety

The policy initiative, which was announced in 2019, will leverage new technology to improve food safety practices.

07.28.20

FDA Announces Qualified Health Claim for Certain Cranberry Products

A handful of clinical trials have yielded evidence that cranberry ingredients may prevent recurrent UTIs in healthy women.

07.22.20

Industry & Market News | Quality & Safety | Regulations | Regulatory News | Testing

NPA Requests FDA Take More Action Against Adulteration

The trade group requested particularly that FDA begin issuing import alerts for supplements and expand participation in the group’s quality assurance program.

07.21.20

Balchem Discusses Choline in the USDA’s DGAC Report

Based on a committee report, it is apparent that the 2020-2025 Dietary Guidelines for Americans will see an increased focus on choline supplementation.

07.20.20

USDA Posts 2020 Dietary Guidelines Committee Report

The scientific overview will inform federal policymakers on dietary recommendations for the next five years.

Online Exclusives By Mike Montemarano, Associate Editor 07.17.20

FTC Orders 'Thrive' Supplement Marketer to Stop Making COVID-19 Health Claims

While the FTC has sent more than 275 warning letters surrounding these claims, the case against the marketer represents the first related court order.

07.13.20

FDA Intends to Resume On-Site Domestic Inspections

Beginning July 20, the FDA is expected to resume pre-announced, prioritized inspections depending on COVID-19 trajectory data and state policy.

07.13.20

Breaking News | Consumer Trends | Dietary Supplements | Industry & Market News | Regulatory News

AHPA, Member Companies Share Concerns About USPS Financial Stability

Like many other CPG categories, herbal product and other dietary supplement companies rely heavily on mail delivery.

Online Exclusives By Mike Montemarano , Associate Editor 07.13.20

Are Americans Widely Deficient in Nutrients Known to Benefit Immune Support?

Data analyzed by NHANES points to major population percentages deficient in major vitamins.

06.25.20

State Officials Criticize FDA Over Inaction on CBD Regulatory Pathway

During a webinar hosted by Natural Products Association, officials from Virginia and Louisiana questioned reports that progress was being made on the federal regulatory level.

06.25.20

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