GRAS Questions: Why Should I Invest in a GRAS when Everyone is Already Selling My Ingredient?
“Why should I invest in a GRAS when everyone is already selling my ingredient?” Well, to be frank – it’s the law. “Any substance that is...
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Burdock Group
Jul 14, 20197 min read
Reading the Cannabis Leaves: Predicting the Future of CBD in Food and Dietary Supplements
On May 31st, 2019 a panel of ten FDA officials, including the acting Commissioner, Dr. Ned Sharpless, sat for hours listening to over 100...
Burdock Group Consultants
Sep 6, 20183 min read
Dietary Supplements Containing Pure or Highly Concentrated Caffeine – Potential Adulteration
In response to the increase in caffeinated dietary supplements in the marketplace and public health risks associated with oral intakes of...
Burdock Group Consultants
Jul 10, 20183 min read
Phytonutrients Beneficial Food Components, but Safety Testing Still Necessary
The term “phytonutrient” is defined in the Merriam-Webster dictionary as “a bioactive plant-derived compound (such as resveratrol)...
Burdock Group Consultants
Jun 5, 20188 min read
Can a Food Be a Drug and a Supplement?
“Let food be thy medicine and medicine be thy food” — Hippocrates of Cos (ca.460 BC – ca. 370 BC) The Drug-Like Properties of Foods Many...
Burdock Group Consultants
May 1, 20184 min read
“Informed Decision Making” a Priority for Responsible Stakeholders in Dietary Supplement
The University of Mississippi (Ole Miss) is the home to the National Center for Natural Products Research (NCNPR), a division of the...
Burdock Group Consultants
May 1, 201810 min read
FDA’s Hostile Take-Over of GRAS, Part III: It Started Earlier Than We Think
You would think any application of the GRAS1 process would be a legitimate pathway to federal compliance unless expressly prohibited by...
Burdock Group
Apr 3, 201811 min read
Modernization of Cosmetics Regulation Act of 2018
The cosmetics industry has been largely self-regulating since passage of the Food, Drug, and Cosmetic Act of 1938; however, the proposed...
Burdock Group Consultants
Apr 3, 20184 min read
“Natural” Ingredients in Dietary Supplements for Sports Nutrition: Unfounded Assumption of Safety
In 2016, sports nutrition dietary supplements sales in the United States (U.S.) totaled $5.7 billion dollars, which was approximately...
Burdock Group Consultants
Mar 6, 20186 min read
FDA’s Hostile Take-Over of GRAS, Part II: FDA’s Assault on Legitimacy of GRAS Expert Pan
The week of November 13, 2017, is notable because FDA released two documents relating to guidance for conclusions of GRAS1 status and...
Burdock Group Consultants
Feb 6, 20185 min read
“Self”-GRAS in AAFCO’s Official Publication a Win-Win
A newsletter article published in the Burdock Advisor a year ago1 described an existential threat to the AAFCO system of approval of Feed...
Burdock Group Consultants
Feb 6, 20184 min read
FSMA Key Requirements: Food Safety Plans and Preventive Controls Qualified Individuals
In case you were not already overwhelmed with the acronyms used in the food industry and associated regulations, the Food Safety...
Burdock Group Consultants
Jan 9, 20185 min read
Filing a Citizen Petition to FDA: How It Works and What It Can Accomplish
Is there a regulation or order related to food that you would like the U.S. Food and Drug Administration (FDA) to issue, amend or revoke?...
Burdock Group Consultants
Dec 5, 201710 min read
Is This FDA’s Hostile Take-Over of GRAS or Is It Simply Establishing Some Ground Rules?
Quantity & Quality of Evidence The first, “Regulatory Framework,” brings up some interesting issues, if not in a slightly overbearing...
Burdock Group Consultants
Oct 10, 20174 min read
What data will FDA consider as evidence that a substance is a pre-DSHEA dietary ingredient?
On Oct.3, 2017, the Food and Drug Administration (FDA) held a public meeting to discuss the development of a list of substances that were...
Burdock Group Consultants
Sep 7, 20173 min read
Burdock Group’s Work With BioTech Startup Captozyme Results in Successful GRAS Determination o
After working with the Burdock Group to recently obtain a successful self-contained GRAS (Generally Recognized As Safe) determination for...
Burdock Group Consultants
Sep 7, 20171 min read
Why Is 2017 a Better Year for Dietary Supplements Than 1997?
For FDA, 2017 marks another year that the agency continues to endanger the consumer by demanding such a high threshold for NDIN filing.
Burdock Group Consultants
Aug 1, 20175 min read
Don’t Build Me a Cadillac: All I Want Is a Ford
The above dialogue is a common one in consulting and usually refers to an opinion on the safe use of an ingredient, or a GRAS...
Burdock Group Consultants
Jul 11, 20174 min read
“Clean” Labels Must Also Mean Safe Foods
Food and color manufacturers need to fully characterize the ingredients they are producing to ensure that the end product is safe.
Burdock Group Consultants
Mar 21, 20171 min read
Petfood Forum 2017: Speaking Engagement Teaser on ‘The FDA GRAS Final Rule: Impacts on Getting
To be compliant with federal law, an ingredient added to food (including pet food) must be approved by FDA for its intended use as a food...
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