Burdock Group

MAHA Successes May Depend on Manufacturers' Negligence. The Answer: SUSTAINABLE GRAS™

The Burdock Group AdvisorThe MAHA Strategy Report for Make Our Children Healthy Again (The-MAHA-Strategy-WH.pdf) is a mandate to weed out the possible causes of chronic disease(s) in children; for...

Schedule Initial Consultation Online | Burdock Group

Burdock Group Consultants is a leading authority in food safety and regulatory compliance, offering tailored solutions across diverse industries. Our expertise and commitment to staying informed...

US Focus on Regulatory Pathways for Dietary Ingredients and Types of Claims

The session will explore key topics such as regulatory agencies, product categories and definitions, labeling, claims, and requirements for new dietary ingredients. Attendees will also gain clarity...

The Origin of a Regulation

What Can Happen at FDA?

Prescription Diets for Animals

Given below, is FDA's capsule summary of the section of the Orphan Drug Act that describes medical food for humans. A medical food for humans is appropriate for individuals who cannot tolerate...

Notify That GRAS or Not?

How does GRAS Notification compare to GRAS self-affirmation, self-GRAS and FDA GRAS and GRAS Affirmed, the latter two of which are provided

Part III - Getting to a GRAS – The Process of Compiling a GRAS Dossier [1]

This is the third in a series of articles describing the steps necessary to produce a maximally optimal GRAS dossier.

Part II - Getting to a GRAS – The Process of Compiling a GRAS Dossier [1]

This is the second in a series of articles describing the steps necessary to produce a maximally optimal GRAS dossier.

Part I - Getting to a GRAS – The Process of Compiling a GRAS Dossier [1]

This is the first in a series of articles describing the steps necessary to produce a maximally optimal GRAS dossier. Part 1- The Substance IntroductionThis article is the first of three articles on...

Burdock Group announces the appointment of Dr. Erik Hedrick, Ph.D., to the position of Executive...

I am pleased to announce the appointment of Dr. Erik Hedrick, Ph.D., as the new Executive Vice President of Burdock Group. In this role, Dr. Hedrick will oversee safety and regulatory compliance...

AAFCO’S Slow Motion Trainwreck Continues to be Propelled by Naivete and Hope

Last Wednesday, I received a very upbeat email from AAFCO celebrating CVM having issued its final guidance (GFI 293) [allowing] animal feed and pet food manufacturers to continue using ingredients...

Post-Market Assessment of Chemicals in Food - Perspectives and Where to Go from Here?

Introduction: FDA has already taken some foods off the market.On Wednesday September 25th, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) held a public meeting discussing their proposed...

International Regulations on Dietary Supplements: Challenges and Opportunities

An aging population has increasingly become a global phenomenon, not just in developed countries, but also among emerging regions.1 The shift to an elderly population adds to healthcare burdens, but...

GRAS: Meeting the Burden of Persuasion

In the process of compiling a GRAS dossier, often so much emphasis is placed on showcasing the safety data that communicating the rationale behind the conclusion of safety becomes an afterthought....

The Elements for a Successful Generally Recognized as Safe (GRAS)

What makes for a successful Generally Recognized as Safe (GRAS) determination?

THE END OF THE CVM/AAFCO MOU – THE SLOW MOTION TRAINWRECK

CVM’s announcement that the memorandum of understanding (MOU) between CVM and AAFCO would not be renewed should not be a surprise to anyone,