Regulatory

The three color additives are Galdieria extract blue, Butterfly pea flower extract, and calcium phosphate.

CRN recently updated the safe intake level for magnesium supplements to 500 mg per day for healthy adults which was previously recommended at 400 mg per day.

Gary Callahan goes through the five most common GMP violations dietary supplement manufacturers run into based on warning letters from FDA.

FDA announces plans to remove the petroleum-based dyes from the US food supply.

HHS and FDA consider major changes amid legal and industry pushback.

Nutritional Outlook interviews Steve Mister, president and CEO of the Council for Responsible Nutrition about the drastic changes at HHS and proposed changes to the self-affirmed GRAS pathway.

The 2-HOBA ingredient, Hobamine, was recently issued a NPN by Health Canada and may help with protecting and fighting against oxidative damage caused by free radicals.

Quicksilver Scientific recently obtained their NSF/ANSI 455-2 Dietary Supplement GMP Certification ensuring their products follow proper protocols.

According to the announcement, the restructuring will save taxpayers $1.8 billion per year by reducing the workforce by 10,000 full-time employees and consolidating the department’s 28 divisions into 15 new divisions.

In the supplemental submission CRN urged FDA to reexamine and correct its interpretation of the drug preclusion clause rather than provide justification for its interpretation

On March 10, the DOJ and the defendant filed a stipulation to dismiss with prejudice the lawsuit in which each party agrees “to be responsible for its own costs and fees and agrees that no party shall be responsible to any other party for any fines, costs, fees, or penalties arising from this case.”

U.S. Department of Health and Human Services (HHS) Secretary, Robert F. Kennedy Jr., is directing the acting U.S. Food and Drug Administration’s (FDA) acting commissioner to explore rulemaking that would eliminate the independent conclusion of GRAS provision.

What do the new "healthy" label claim definitions mean for consumers and food brands?

The deputy commissioner has been overseeing the reorganization of the FDA's Human Foods Program. He resigned on Monday following the firing of 89 staff members by the Trump Administration.

The new label would complement the Nutrition Label, making important nutrition information readily available for consumers.

The new certification program seeks to support compliance, safety, and quality in worldwide supply chains.

FDA contends that the color additive is safe for humans but is legally obligated by the Delaney Clause of the FD&C act to revoke authorization as research shows the Red No. 3 induces cancer in rats.

The Clean Label Project released a new report where they announced findings of lead and cadmium in protein powders.

The updated criteria for the claim include limits to certain nutrients, and identified foods that are consistent with Dietary Guidelines.

According to the announcement, the authorization is also exclusive to AIDP and its partner company and licensee, ThreoTech, meaning that they are the only parties that can market magnesium L-threonate in the EU for a period of five years.

Monellin is a novel sweet protein found in the fruit of the West African shrub, Dioscoreophyllum cumminsii (serendipity berry).

The U.S. Senate Committee on Agriculture, Nutrition, & Forestry has introduced the Rural Prosperity and Food Security Act, which will serve as the Senate’s draft for the 2024 Farm Bill.

NXT USA has announced that the patented ingredient TamaFlex has been officially registered as a Food with Functional Claim (FFC) in Japan by the Consumer Affairs Agency (CAA).

According to a statement from ODS director, Stefan M. Pasiakos, PhD, the strategic plan outlines three primary goals: advance research, expand capacity, and foster stewardship.

The court has granted a joint motion for stay filed by NPA and FDA, pending the agency's decision on the citizen petition asking FDA to reverse its stance on NMN's status as a dietary ingredient.

The Global Organization for EPA and DHA Omega-3s’ vice president of regulatory and scientific affairs talks about recent class actions and why they are without merit.

In his CRN Convergence '24 conference presentation, Brian Yam of Blue Ocean Regulatory Inc. discussed how brands can last in Amazon’s marketplace.

What does the current regulatory landscape look like and how will the 2024 Farm Bill change things for hemp as a supplement in the near future?