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GRAS Questions: Why Should I Invest in a GRAS when Everyone is Already Selling My Ingredient?

Aug 3, 2019
3 min

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 intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a

Reading the Cannabis Leaves: Predicting the Future of CBD in Food and Dietary Supplements

Jul 14, 2019
7 min

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 presentations from a variety of viewpoints on the topic of cannabis and CBD. This public hearing was assembled quickly1 in response to growing pressure from stakeholders, the public, and lawmakers for some direction from FDA. Throughout the hearing, the FDA asked numerous pointed questions which, provided some insight into the shape of pote

Dietary Supplements Containing Pure or Highly Concentrated Caffeine – Potential Adulteration

burdockgroupconsul

Sep 6, 2018
3 min

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 caffeine, the Food and Drug Administration (FDA) released guidance to industry regarding products containing pure or highly concentrated caffeine. The caffeine guidance document describes multiple circumstances under which FDA may deem pure or highly concentrated caffeine-containing dietary supplements to be adulterated under Section 402(f)

Phytonutrients Beneficial Food Components, but Safety Testing Still Necessary

burdockgroupconsul

Jul 10, 2018
3 min

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) associated with positive health effects.” However, the U.S. Food and Drug Administration (FDA) has not officially recognized or defined the term, phytonutrient. In fact, while the U.S. Food, Drug and Cosmetic (FD&C) Act refers to the need and labeling of “nutrients” multiple times, the term “nutrient” was never officially defined. It is beneficial

Can a Food Be a Drug and a Supplement?

burdockgroupconsul

Jun 5, 2018
8 min

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 foods have drug-like properties. For example, foods with vitamin C (such as citrus fruit) can cure scurvy, the dreaded disease of 17th Century sailors; likewise, seafood can cure (thyroid) goiters because seafood represents a unique source of iodine; most obviously, food can cure malnutrition and starvation and protein-containing foods are a

“Informed Decision Making” a Priority for Responsible Stakeholders in Dietary Supplement

burdockgroupconsul

May 1, 2018
4 min

“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 School of Pharmacy that is funded and recognized as a Center of Excellence by the Food and Drug Administration (FDA). As part of their partnership with FDA, the NCNPR hosts the annual International Conference on the Science of Botanicals (ICSB), which draws government officials, academia, industry, trade associations, scientists, physicians, pha

FDA’s Hostile Take-Over of GRAS, Part III: It Started Earlier Than We Think

burdockgroupconsul

May 1, 2018
10 min

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 statute (e.g., color additives, dietary supplements) or by regulation (e.g., 21CFR2§184.1(b)(2));3 the latter of which requires a food additive petition (FAP) be filed for any additional use, use levels or changes to the manufacturing process of an otherwise GRAS affirmed substance.4 So far, so good for many food ingredients, until you get to

Modernization of Cosmetics Regulation Act of 2018

burdockgroupconsul

Apr 3, 2018
11 min

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 Modernization of Cosmetics Regulation Act (MCRA) of 2018, will change the standards of cosmetics production and safety to that approximating food ingredients — a move that may be very costly and disruptive for some cosmetics companies. So, what is the history of cosmetics regulation and what can we expect from the MCRA? A Short History of Co

“Natural” Ingredients in Dietary Supplements for Sports Nutrition: Unfounded Assumption of Safety

burdockgroupconsul

Apr 3, 2018
4 min

“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 13 percent of total dietary supplement sales ($41.16 billion).1 For sports nutrition dietary supplements, athletes are demanding “natural” products with “clean” labels, presuming that “natural” products with “clean” labels and ingredient lists are safe. From where is consumers’, and even manufacturers’, unfounded assumption of safety for these

FDA’s Hostile Take-Over of GRAS, Part II: FDA’s Assault on Legitimacy of GRAS Expert Pan

burdockgroupconsul

Mar 6, 2018
6 min

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 draft guidance for conduct of GRAS Expert Panels.2 Both of these documents revise and expand on “Substances Generally Recognized as Safe: Final Rule” (81 FR 54869, August 17, 2016). In December, our newsletter discussed the guideline for Regulatory Framework,3 this month we will discuss draft guidance for the conduct of GRAS Expert Panels (GEP)

“Self”-GRAS in AAFCO’s Official Publication a Win-Win

burdockgroupconsul

Feb 6, 2018
5 min

“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 Ingredient Definitions (FID). The threat arose as a result of the FDA’s Center for Veterinary Medicine (CVM) determination that an FID does not confer federal compliance. According to CVM, as many as 500 ingredients in AAFCO’s Official Publication (OP) may be affected. Today’s article also describes a pathway for AAFCO to survive another th

FSMA Key Requirements: Food Safety Plans and Preventive Controls Qualified Individuals

burdockgroupconsul

Feb 6, 2018
4 min

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 Modernization Act (FSMA) of 2011 and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR 117)1 sparked a whole new set of alphabet soup, including FSMA, FSS, FSP, PCQI, PC, PRP, TAN and many more. Learning the acronyms, some of which are defined herein, will likely be fairly

Filing a Citizen Petition to FDA: How It Works and What It Can Accomplish

burdockgroupconsul

Jan 9, 2018
5 min

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? Or is there another form of administrative action you think FDA should take or refrain from taking? Recently, FDA has issued several new or revised regulations and guidance documents which impact the food industry, such as revisions to food labeling (nutrition and supplement facts panels) (21 CFR 101.108(c)), current good manufacturing prac

Is This FDA’s Hostile Take-Over of GRAS or Is It Simply Establishing Some Ground Rules?

burdockgroupconsul

Dec 5, 2017
10 min

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 manner ─ more like warnings than counseling by an elder. For example, in the Introduction section there were several (sharp) bullet points reminding the reader of his/her responsibilities, including statements that FDA is releasing this guidance to: “Remind you that a GRAS conclusion based upon scientific procedures requires the same quantity a

burdockgroupconsul

Oct 10, 2017
4 min

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 in use as dietary ingredients prior to the passing of the Dietary Supplement Health and Education Act (DSHEA).1 Under DSHEA, ingredients which were marketed in the United States (U.S.) as a dietary ingredient (in or as a dietary supplement) before Oct. 15, 1994. These are considered pre-DSHEA dietary ingredients, also commonly referred to a

Burdock Group’s Work With BioTech Startup Captozyme Results in Successful GRAS Determination o

burdockgroupconsul

Sep 7, 2017
3 min

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 its oxalate-reducing enzyme, biotechnology company Captozyme licensed the rights for commercialization to Entring LLC, which will make it available for purchase this fall as a food ingredient. Consumers seeking a low-oxalate diet can add the virtually tasteless, odorless powder to a variety of oxalate-packed foods and beverages to help redu

burdockgroupconsul

Sep 7, 2017
1 min

Why Is 2017 a Better Year for Dietary Supplements Than 1997?

Looking at industry, 2017 is a better year than 1997 for dietary supplements, as industry has matured from a plethora of cowboys (with some notable exceptions), to a self-policing industry that has embraced GMPs and transparency with the Supplement Owl. For FDA, 2017 marks another year that the agency continues to endanger the consumer by demanding such a high threshold for NDIN filing acceptance that many producers have simply gone to market, hoping to stay under the FDA rad

Don’t Build Me a Cadillac: All I Want Is a Ford

burdockgroupconsul

Aug 1, 2017
5 min

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 determination. The manufacturer has a new ingredient that he intends to add to food or use as a dietary supplement, but doesn’t have the depth of bench on his staff to generate a supportable opinion on safety. He needs the documentation in case the unthinkable happens — the FDA, FSIS or a third-party auditor asks for his supporting documentation on the

“Clean” Labels Must Also Mean Safe Foods

burdockgroupconsul

Jul 11, 2017
4 min

“Clean” Labels Must Also Mean Safe Foods

There has recently been an increased interest in cooking, as evidenced by the increase in the number of televised cooking shows, internet articles on cooking shortcuts and books describing the unique personal connections people have with the art of cooking. The interest in cooking has also increased the consumer’s desire to understand more about the ingredients that go into made-from-scratch food, or processed food. At the same time, consumers in this complex technological er

burdockgroupconsul

Mar 21, 2017
1 min

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 additive if the ingredient has not been determined generally recognized as safe (GRAS) for its intended use by experts in the field of food safety. Once the safety testing data is complete, food additive approvals can take 2-4 years; whereas a GRAS determination may only take six months for the same ingredient. FDA recently released its Fin

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