Tag Archives: gras

By Jennifer Allen

Like most people, you probably know that the FDA regulates food. But did you know that it also regulates food packaging? That’s because chemicals in packaging could migrate into our food under certain conditions. FDA defines a “food contact substance” at CFR 21, 170.3(e)(3) as “any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.” This definition includes substances used in food packaging.

Generally speaking, regardless of the type of packaging involved or the specific component of that packaging, manufacturers are presumed to be following current good manufacturing practices. And, if no limit is specified, the quantity of any substance used in the packaging must not exceed the amount absolutely necessary to achieve the desired result. Provided the manufacturer adheres to those basic requirements, then it has a few different options for the type of materials it may use.

One option the manufacturer has is to use a material or component that is generally recognized as safe for use in food packaging (“GRAS”) under CFR 21, part 186, or that is used in accordance with a prior sanction or approval. Examples of GRAS substances include clay and Japan wax.

Or the manufacturer may use specific materials already approved by FDA. In CFR 21, parts 175, 176, and 177, the FDA has authorized the use of different types of adhesives/coatings, paper and paperboard, and polymers, respectively. Each of those types of product must be used in accordance with the strict conditions set forth in those parts. For example, synthetic paraffin is approved for use as a coating, but under CFR 21, 175.250, there are strict technical requirements for the congealing point, oil content, and absorptivity of the substance.

Alternatively, a manufacturer may submit a premarket notification for a food contact substance under CFR 21, 170.100-106, known more colloquially as an FCN. Unlike substances approved for use by all under the sections above, a substance approved via an FCN is only approved for use by the manufacturer that submitted the FCN, and only under the precise conditions of use set forth in the FCN. If another manufacturer wants to use the exact same substance in the exact same manner, it must nevertheless submit its own FCN.

Finally, under CFR 21, 170.39, manufacturers may seek an exemption for a particular substance that migrates from the food-packaging material into the food at minimal levels if they can show that the substance 1) has not been shown to be a carcinogen, and there is no reason to suspect it may be carcinogenic; 2) presents no other health and safety concerns; 3) has no technical effect on the food; and 4) has no significant adverse impact on the environment.

A word about per- and poly-fluoroalkyl substances, more commonly referred to as PFAS. PFAS are used in certain types of disposable dishware and in non-stick cookware. It is PFAS that allow you to enjoy that greasy piece of fried chicken on a paper plate without the grease soaking through the plate onto your clothes. But in recent years, PFAS have come under attack. That’s because the evidence suggests that these substances build up in the human body and in our water and soil, and may be harmful to human health and to the environment. Certain PFAS are currently approved for use by the FDA, but with mounting pressure from various stakeholders, that is rapidly changing.

April 17, 2025

Beltway Beat

Health Groups Urge FDA: Target Toxins, Preserve Safe Food Ingredients

By Food Safety Tech Staff

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The paper was developed in response to HHS Secretary Robert F. Kennedy, Jr.’s March 10 directive to the FDA to explore eliminating the “self-affirmed” Generally Recognized as Safe (GRAS) pathway, which allows companies to determine food ingredient safety without FDA review.

The white paper advocates for an alternative to the total elimination of the ‘Self-GRAS’ pathway, focusing instead on eliminating the most hazardous chemicals while preserving access to safe, beneficial ingredients. The paper and further background materials can be found here.

ANH’s white paper has been endorsed by a range of groups, including the Global Wellness Forum, the Organic Consumers Association, and the National Foundation for Integrative Medicine, with more groups continuing to sign on. It was also sent to RFK, Jr. and various members of relevant FDA and HHS committees, encouraging them to incorporate this common-sense plan into GRAS reform.

“We support Secretary Kennedy’s intention to remove the most toxic substances from our food supply,” said Jonathan Emord, J.D., ANH General Counsel and co-author of the white paper. However, the government should avoid complete elimination of Self-GRAS, which would create a massive regulatory bottleneck, potentially removing thousands of safe ingredients from the market along with those that are unsafe.”

The authors emphasize that their targeted approach is particularly well-suited to the current reality of reduced resources at the Department of Health and Human Services. “By focusing regulatory scrutiny on the small subset of ingredients with demonstrated safety concerns rather than attempting to review all 10,000+ self-affirmed ingredients, this strategy allows the FDA to efficiently protect public health even with limited staff and resources,” the white paper explains.

According to ANH, the GRAS designation was established under the Food Additive Amendment of 1958 to exempt well-established, demonstrably safe food ingredients from the FDA’s rigorous pre-market approval process. Companies have used this pathway to introduce ingredients into the food supply, including colors, preservatives, technological additives, and chemicals, most of which have not been thoroughly reviewed for safety or reassessed after decades of use. While these concerns are valid, the Self-GRAS pathway remains vital for introducing safe, innovative products without unnecessary regulatory burdens.

ANH’s proposed reforms draw important contrasts with the European regulatory approach to food additives, where only about 400 ingredients are currently permitted. The paper argues this may be overly cautious, potentially depriving consumers of healthy options.

“Our white paper defines a strategy for balanced GRAS reform while avoiding the EU model of extensive regulatory overreach in favor of freedom of choice,” said Robert Verkerk, Ph.D., ANH’s Executive & Scientific Director and white paper co-author.

The white paper proposes several key reforms:

Targeted Approach to Unsafe Ingredients: Prioritize the removal of specific unsafe ingredients rather than requiring re-evaluation of all 10,000+ self-affirmed GRAS substances. The paper identifies potassium bromate, propylparaben, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), sodium benzoate, and brominated vegetable oil (BVO) as examples of additives that may be injurious due to their chronic toxicity.
Public Transparency Register: Create a comprehensive online database of all GRAS determinations, enhancing accountability and consumer information. This would complement the FDA’s recently announced Chemical Contaminants Transparency Tool.
Tiered Risk/Benefit Assessment: Implement a four-tier system that calibrates evidence requirements based on an ingredient’s history of use and safety profile. Substances with at least 30 years of safe use would face minimal requirements, while those with evidence of potential toxicity would require more robust safety data.
“Safe Harbor” for Time-Tested Ingredients: Create a pathway for ingredients with a documented history of safe use for over 60 years, predating the 1958 Food Additive Amendment. These would be officially recognized by the FDA as “historically safe.”
Appropriate Warning Requirements: When specific populations may be vulnerable to otherwise safe ingredients, warnings rather than outright bans should be required. The FDA would recognize such warnings as creating a presumption of safety for the ingredient.

March 11, 2025

Beltway Beat

RFK Jr Moves to Eliminate GRAS and Synthetic Dyes

By Food Safety Tech Staff

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HHS Secretary Robert F. Kennedy Jr. directed the acting FDA commissioner, to take steps to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway. According the HHS website, this will enhance the FDA’s oversight of ingredients considered to be GRAS.

“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” said Secretary Kennedy. “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”

Eliminating the self-affirmation process would require companies seeking to introduce new ingredients in foods to publicly notify the FDA of their intended use of such ingredients, along with underlying safety data, before they are introduced in the food supply.

“The FDA is committed to further safeguarding the food supply by ensuring the appropriate review of ingredients and substances that come into contact with food,” said Acting FDA Commissioner Sara Brenner, M.D., M.P.H. “The FDA will continue to follow our authorities and leverage our resources to protect the health of consumers to ensure that food is a vehicle for wellness.”

The statement said, HHS is committed to working with Congress to explore ways legislation can completely close the GRAS loophole.

Synthetic Dyes DOA

On Monday, in his first meeting with top executives from PepsiCo, W.K. Kellogg, General Mills and other large companies, Secretary Kennedy bluntly told them that a top priority would be eliminating artificial dyes from the nation’s food supply according to a NY Times article.

In a letter to it’s members, Melissa Hockstad the Consumer Brands Association’s President wrote “Decision time is imminent” According to the letter, Mr. Kennedy also warned food companies that they should anticipate significant change as a result of his quest for “getting the worst ingredients out” of food. And while Mr. Kennedy said in the meeting that he wanted to work with the industry, he also “made clear his intention to take action unless the industry is willing to be proactive with solutions,” according to the Hockstad letter.

June 18, 2019

Seaweed-Based DNA Barcodes Trace Food Throughout Supply Chain

By Food Safety Tech Staff

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Having the ability to apply barcodes directly to food could change the game of food traceability. One company has developed a patented technology that involves applying a DNA barcode directly to raw materials and finished product to enable traceability of a product throughout the entire supply chain.

Last month SafeTraces, Inc. was granted a U.S. Patent for a new method that encodes and decodes digital information to and from DNA strands. Called safeTracers, these seaweed-based DNA barcodes have been deemed generally recognized as safe (GRAS) by FDA, are non-GMO and Kosher, and can be applied to all food and beverage products, according to SafeTraces. The DNA barcodes were initially developed for low margin industries such as fresh produce, and bulk foods and grains. The safeTracers are generated via the company’s IoT miniDART solution, which creates a unique batch for each lot of product. They are directly applied to food during processing, giving the food item or batch of commodity food a unique tag that contains traceability information.

This technology could be fill a critical piece of the puzzle during a recall, as information about a product could be accessed within minutes.

August 12, 2016

FDA Issues Final Rule on GRAS

By Food Safety Tech Staff

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Today FDA issued the final rule, “Substances Generally Recognized as Safe” (GRAS). The rule outlines what kind of scientific evidence can be used to demonstrate safety, along with the role of publications in assessing whether scientific evidence of safety is “generally available and accepted”, according to an FDA release. “The GRAS criteria require that the safe use of ingredients in human and animal food be widely recognized by the appropriate qualified experts.”

GRAS substances are not subject to FDA premarket approval but must meet the same safety standards as approved food additives. The agency “strongly encourages” companies to tell FDA of GRAS conclusions through the notification procedure found in the final rule, because the procedure provides the agency with important food safety monitoring information. The document will be published on the Federal Register on Wednesday, August 17.

Jim Lassiter, president and COO of Ingredient Identity

September 1, 2015

Will FSMA Push Ingredients into a New Era of Scrutiny?

By Maria Fontanazza

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In June FDA officially deemed the use of partially hydrogenated oils (PHOs) as unsafe, or technically, not generally recognized as safe (GRAS). The use of PHOs has been debated for more than a decade, and as a result of FDA’s latest ruling on PHOs, food processors must remove these ingredients from their products within three years.

From preservatives to artificial sweeteners to natural flavors, the list of ingredients that go into processed foods can be quite extensive. Consumers are becoming more vigilant about what they put into their bodies, and FSMA will give FDA the authority to act immediately in instances related to safety. Does this mean that some ingredients could be in danger? The answer is yes, according to Jim Lassiter, president and COO of Ingredient Identity. “[Ingredients] are products that you literally take inside your body, and there is nothing more personal than that,” says Lassiter. Combine this simple yet fundamental fact with consumer awareness and the entrance of FSMA, and food and beverage manufacturers may be entering a new era of scrutiny.

Food Safety Tech: From an ingredients perspective, what challenges are the industry facing?

Jim Lassiter: Implementation of FSMA. Although it’s being implemented at a slower pace than Congress desired, and I believe slower than [FDA’s] original intent, that pace is accelerating. And while the increase in challenges related to the composition and manufacturing of products will be significant, FSMA will be an overall benefit to consumer confidence.

Consumer confidence. Whether the issue is bioengineered foods or disclosure of bioengineered foods through the business of trans fats, or just the general composition and healthful nature of foods. Slowly but surely, increasing consumer awareness of food choices and diet will have a significant impact. Regardless of the type of product, this is going to be universal and will increasingly play a role in decisions that food companies make during product development.

The unknowns. We don’t know what is coming around the corner, whether it’s positive or negative. A lot of effort is being extended within the food sector to discover the next big thing—whether it’s probiotics or prebiotics; addressing product reformulation in light of the elimination of trans fat [requirement]; or something that strikes out of the blue. That is always the most challenging aspect of the ingredients industry. Foods themselves, regardless of what country you are in, are cultural in nature; they are the most personal consumer good that you can obtain. As a result, our awareness as an industry of what we do to products must bear both of those pieces in mind. We have to recognize the cultural nature of food and simultaneously recognize the personal nature of products. As a result, we won’t necessarily have insights into the great unknown or the next big thing, but at least we will have the perspective necessary to deal with any unknowns as we move forward.

FST: In the coming year, what overall effect will FSMA have on food and beverage manufacturers related to ingredients themselves?

Lassiter: From an ingredients perspective, what’s going to happen is simple and straightforward. FSMA grants FDA the broad authority to assist and act in instances where there are issues with safety. That is, however, still nebulously defined and interpreted. So, there’s potential for FDA to suddenly make a determination that an ingredient is not safe or [that it] poses some degree of safety risk. FSMA authorizes FDA to take immediate action rather than [submit] a new process notification, etc. They will also have the authority to take immediate action in the case of violations of good manufacturing practices if the perception can be tied to any aspect of safety. FSMA stands for safety; that is the hinge point on which all of this occurs.

For example, with the revised good manufacturing practice for the manufacturing of food products coming out and the full implementation of HACCP across all food categories, it’s conceivable that FDA will take immediate action on inspection deficiencies in the food manufacturing realm. I think that’s one of the big issues. I don’t want to make it sound like the boogey man is out there, but it is a very real possibility. Ingredients themselves can suddenly be identified as unsafe. I don’t see that necessarily being a very radical reaction. The potential impact is more likely to be broad, but I suspect that at some point in time, there will be an ingredient that pops up out of a FSMA ruling that will suddenly be declared to be unsafe and [consequently] removed from market.

Second, I think the implementation of HACCP across all food categories will have notable impact, initially through common regulatory action (i.e., via inspection deficiencies reports, which are very common in terms of dietary supplement manufacturer inspections). I think you’ll see those becoming increasingly common in food manufacturing operations, because of the implementation of HACCP more broadly. The first round will be more likely for increased regulatory activity in food manufacturing inspections. If that message is not received and implemented rapidly, then the extension of FSMA is that [FDA] can shut down the plant without any due process whatsoever. That looms as part of the implementation. In terms of ingredients, you’re likely to see [some] that folks may not have previously thought about [as unsafe] identified as potentially hazardous. I’m not sure in what area it will occur, but I’m fairly confident that it will happen at some point in time.

Part II of Food Safety Tech’s conversation with Jim Lassiter takes a closer look at GRAS self declarations and the areas of confusion among companies.

Does your product contain PHOs? FDA says they're not GRAS.

June 16, 2015

Partially Hydrogenated Oils Not GRAS, Says FDA

By Maria Fontanazza

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FDA has made it official. The main source of artificial trans fat in processed foods, partially hydrogenated oils (PHOs), are not generally recognized as safe (GRAS) for use in human food. The agency is giving food manufacturers three years to comply. Companies can either reformulate products without PHOs and/or petition FDA to allow specific uses.

FDA is defining PHOs as “fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value greater than four”.

“This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, in an FDA press release. Manufacturers have been required to indicate the presence of trans fats on product labeling since 2006. The agency estimates that between 2003 and 2012, consumption of trans fat decreased by nearly 78%, and attributes this drop to labeling requirements and consumer awareness. For the past decade, the Institute of Medicine has recommended limiting trans fat consumption.

“The FDA’s action on this major source of artificial trans fat demonstrates the agency’s commitment to the heart health of all Americans,” stated Stephen Ostroff, M.D, acting commissioner of FDA. “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”

After issuing its notice in November 2013 that PHOs were not GRAS, FDA received more than 6000 comments in response to this tentative determination. According to the Federal Register notice, the majority of comments from industry, trade associations, advocacy groups, health professionals, and government stakeholders were in favor of FDA’s tentative determination. Those who expressed dissent cited the agency’s scientific analysis as well as its potential effect on trade, taxes, and the potential that it could lead to bans on other substances; some provided alternatives to dealing with the issue of trans fat in food.

March 30, 2015

Standards for Animal Food Ingredients

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The U.S. Food and Drug Administration has announced a strategy to establish ingredient definitions and standards for animal food in order to increase transparency and affirm the safety of the animal food supply, as required by the Food and Drug Administration Amendments Act (FDAAA) of 2007.

As part of the strategy, FDA will review the list of animal food ingredient definitions used by industry and state regulators, which is contained in Association of American Feed Control Officials’ (AAFCO) Official Publication. AAFCO is a voluntary membership organization that includes regulatory officials of U.S. state and federal government agencies. AAFCO provides a forum for these regulatory officials to provide guidance and recommendations to ensure that the regulation of animal feeds is as uniform as possible from state to state.

The Official Publication includes FDA-approved food additives and ingredients that are generally recognized as safe (GRAS), as well as AAFCO-established definitions for other ingredients. The FDA intends to align AAFCO ingredient listings with the agency’s regulatory process and requirements.

The agency has identified the following steps for animal food ingredients:

FDA intends to publish a proposed rule establishing as the agency’s standards and definitions for animal food ingredients the AAFCO definitions for those ingredients that are recognized as GRAS or approved by the agency as food additives. This proposed rule will be open for public comment, and the agency will consider those comments before issuing a final rule.
FDA scientists will evaluate the remaining animal food ingredients listed in the AAFCO Official Publication that are currently not FDA-approved food additives or regcognized as GRAS.
- In cases where the scientific literature supports a GRAS determination, the FDA will publish the supporting information in the Federal Register for public comment before affirming the ingredient as GRAS.
- In cases where the data and information support a finding that the ingredient meets the food additive approval standard, the FDA intends to approve the ingredient as a food additive.
- In cases where the FDA does not currently have data to make a GRAS determination or to approve the ingredient as a food additive, the agency will require manufacturers of these ingredients to submit a food additive petition in order to allow continued legal use of the product in animal food.

Although animal food ingredient definitions and standards generally do not vary widely across the industry, and consumers can be confident in their accuracy, FDA’s strategy will formalize definitions and standards to meet federal laws and regulations.

The agency intends to work closely with industry during this transition to minimize disruption to animal food production and ensure transparency and clarity for both manufacturers and the public.

Synthetic Dyes DOA

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