Nutraceuticals World

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

EpiCor Postbiotic Receives ‘No Objection’ from FDA for GRAS Notification

The letter of no objection verifies the safety and tolerability of EpiCor as an ingredient in certain foods and beverages.

Mike Montemarano, Associate Editor 05.20.21

FDA’s Dr. Cara Welch Opening Speaker at the 9th AHPA Botanical Congress

The virtual event’s agenda will focus on the impact of COVID-19 on the botanicals industry.

Mike Montemarano, Associate Editor 04.15.21

BIO-CAT Microbials’ OPTI-BIOME Probiotic Strain Receives FDA 'Letter of No Objection' on GRAS Status

The letter came after testing, product certifications, claims substantiation, and regulatory support regarding Bacillus subtilis MB40.

Mike Montemarano, Associate Editor 04.14.21

AHPA Submits Comments to FDA on Proposed Traceability Rule

The association requested changes to the scope of herbs defined in the additional recordkeeping requirements.

Mike Montemarano, Associate Editor 03.02.21

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

Steven Tave to Leave FDA ODSP Director Position

With Dr. Cara Welch as acting ODSP director, Tave will go on to direct Strategic Planning and Operational Policy.

Mike Montemarano, Associate Editor 02.22.21

Breaking News | Cardiovascular Health | Certifications, Approvals & Patents | Probiotics & Prebiotics | Supplier Insights

Kaneka Gains FDA GRAS Status for Cardio Probiotic

Product is a clinically tested formulation of three strains that support healthy total cholesterol, LDL and HDL levels already in the normal range.

Sean Moloughney, Editor 02.15.21

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

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

Dietary Supplement Leaders Lament Pitfalls of FDA’s Approach to NDIs

Novel dietary ingredients often eschew a required approval process, and execs say this breeds adulteration, low-quality knockoffs, and possible health risks.

Online Exclusives By Mike Montemarano, Associate Editor 12.07.20

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

Cranberry Formulator Fruit d’Or Discusses New FDA Qualified Health Claim

The new qualification provides advantages to formulations containing whole cranberry fruit powder.

09.22.20

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

The Top 10 Ways to Avoid an FDA Warning Letter

This webinar on 9/16 will explore the top 10 CFR 21 cGMP reasons why dietary supplement brand owners, manufacturers and distributers are issued warning letters.

08.27.20

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

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

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

Breaking News | Packaging | Regulations | Regulatory News | World Markets

FDA to Add QR Code to Export Certificates for Food Beginning June 29

The “Certificate to a Foreign Government” and “Certificate of Exportability” will have the added security measure to ease export verification.

06.22.20

Breaking News | Dietary Supplements | Herbs & Botanicals | Industry & Market News | Regulations

CRN Files Citizen Petition Calling on FDA to Regulate CBD as a Legal Dietary Supplement

FDA can and should use its authority and discretion under the Food, Drug & Cosmetic Act to allow CBD to be marketed with necessary regulations and restrictions, CRN said.

06.19.20

FDA Temporarily Loosens Formulation, Vending Machine Regulations

It appears that the new policy will last throughout the COVID-19 public health emergency.

05.28.20

Breaking News | Dietary Supplements | Industry & Market News

FDA Issues Another Round of COVID-19 Claim Warning Letters

Companies selling vitamins, CBD, and unapproved drug products have been accused of claiming their products can remedy COVID-19.

05.27.20

Consumer Trends | Dietary Supplements | Healthcare Trends | Immune Function | Mood Health & Sleep

Navigating the Crisis Consumption Landscape

COVID-19 may have permanently changed how people approach their health and wellness.

By Mike Montemarano, Associate Editor 05.01.20

Breaking News | Herbs & Botanicals | Regulations | Regulatory News

FDA Warns CBD Companies to Discontinue Opioid-Related Claims

No CBD product has been approved for the treatment of opioid addiction, or for use as an opioid alternative.

04.23.20

Breaking News | Regulations | Regulatory News | World Markets

21 Additional Companies Accused of COVID-19 Scam Marketing

Purveyors of dietary supplements, IV 'therapies,' and ozone 'therapies' were accused by the FTC of purporting that their products could fight COVID-19.

04.23.20

Breaking News | Quality & Safety | Regulations | Regulatory News | Research

Oregon DOJ’s Decision on Health Claims Rule Postponed Following Critique

Dietary supplement manufacturers believe the new rule makes them vulnerable to 'baseless' lawsuits, and dilutes the expertise of federal actors.

Online Exclusives By Mike Montemarano, Associate Editor, Nutraceuticals World 04.22.20

Consumer Trends | Healthcare Trends | Healthy Aging | Immune Function

How the Coronavirus Reflects Our Values

The COVID-19 pandemic reveals more about society than we may otherwise have acknowledged. Some of it is heartening, some of it is sickening.

By Erik Goldman, Holistic Primary Care 04.20.20

Breaking News | Regulations | Regulatory News | World Markets

Coronavirus Supplement Scams Persist Across U.S. as FTC Announces Latest Offenders

The agency states that it has responded to more than 25 supplement companies promising a cure, treatment, or prevention of COVID-19.

04.17.20

FDA Deputy Commissioner Frank Yiannas Discusses State of Food Industry

In a Q&A session, the FDA official breaks down his takeaways amid the COVID-19 pandemic.

04.17.20

Will an EPA Drug Candidate Be Used to Treat COVID-19?

EPAspire, which contains EPA free fatty acids and sweet wormwood extract, is undergoing clinical trials as a possible treatment for COVID-19

04.16.20

Healthcare Trends | Herbs & Botanicals | Research

Five Cutting-Edge Cannabinoid Production Methods to Watch

Science continues to transform the cannabis industry.

By Andrea Holmes, PhD, Co-Founder & Chief Growth Officer, Precision Plant Molecules 04.09.20

The Gateway to Wellness

The gut holds keys to unlocking health on a whole host of fronts.

By Sean Moloughney, Editor, Nutraceuticals World 04.09.20

Dietary Supplements | Regulations

Radical Revamp for DSHEA or Common Sense Solutions?

These suggested regulatory updates could reward bold, innovative companies while also protecting consumers.

By Todd Harrison, Venable 04.09.20

Consumers Want Immune Support Now!

Interest has always been high but fears about coronavirus have amplified demand.

By Gregory Stephens, Windrose Partners, & Sheila Campbell, PhD, RD 04.09.20

Immune Function | Omega-3s | Research | Vitamins

In Response to Coronavirus, International Panel Discusses Role of Micronutrients in Immunity

With all other preventative measures in mind, some nutrition experts don't want to downplay the science backing micronutrients and immune function.

By Mike Montemarano, Associate Editor, Nutraceuticals World 04.09.20

PLT's Earthlight Receives Supplement Claims License

The mushroom-based ingredient can make licensed support claims on immune function, bone health, and general well-being in both adults and children in the Canadian marketplace.

04.08.20

FDA Continues Action Against Unapproved, Misbranded Products Related to Coronavirus

Dietary supplement industry urges continued aggressive prosecution against products promoted with illegal claims about prevention or treatment of COVID-19.

04.06.20

COVID-19 Supply Chain Disruption: A Point-In-Time Assessment

Here's what trade associations have reported regarding supply chain disruptions in the natural products world caused by COVID-19.

Online Exclusives By Mike Montemarano, Associate Editor, Nutraceuticals World 04.03.20

FDA to Conduct Remote Importer Inspections Virtually

Due to COVID-19, FDA announced that it will begin conducting its inspection activities electronically for the remainder of the public health emergency.

04.03.20

Cannabidiol & The Cassandra Conundrum

The gap between the scientific evidence and evangelical claims tsunami is vast.

By Anthony L. Almada, MSc, FISSN 04.02.20

Dietary Supplements | Herbs & Botanicals | Quality & Safety | Regulations | Testing

Positive Indicators: Selecting a Hemp Testing Lab

In an evolving marketplace with unique challenges, qualified labs can help confirm product safety and integrity.

By Jesse Miller, PhD, Director of Research & Development, Hemp Services, NSF International 04.02.20

Consumer Trends | Cosmeceuticals / Nutricosmetics | Herbs & Botanicals | Regulations

Opportunities in Hemp-Derived CBD

Sales of cannabidiol-based products have soared during the past year, and now formulators are rolling out CBD products designed to ease a variety of ailments.

By Virginia Lee, Brightfield Group 04.02.20

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