The Environmental Working Group (EWG) recently raised concerns about chemicals being added to foods through the “self-affirmed GRAS” process without FDA review. This has raised alarms among consumer groups and the media. While EWG raises a legitimate concern, the level of alarm seems greater than the evidence warrants.
EWG published two reports, and it is the second one that is suddenly getting media attention. But one point in EWG’s original article deserves clarification. It blurred together the original FDA GRAS list and the modern self-affirmed GRAS process. They are not the same thing.
Their second list of 111 additives removed ingredients that are already on the GRAS list (CFR – Code of Federal Regulations Title 21). Those substances have in fact gone through FDA review. The full GRAS process remains in place. The self-affirmed GRAS process is, essentially, a shortcut.
Wait, what is GRAS?
GRAS stands for “Generally Recognized as Safe.”
Congress created the GRAS exemption because many familiar food ingredients—salt, vinegar, culinary spices, apples, ground beef, and countless others—have long histories of safe use. These ingredients do not have to go through the same approval process required for new food additives. Over time, the GRAS pathway has increasingly been used for new ingredients.
Here’s the important point:
A company may, on its own, determine that an ingredient is GRAS based on publicly available scientific evidence and the opinion of qualified experts. This is the “self-affirmed GRAS” process. It is not required to ask FDA for permission before marketing that ingredient. However, many companies voluntarily submit a GRAS Notice to FDA asking the agency to review their conclusion. Whether a company does so is at the heart of the current controversy.
The pet food connection
EWG’s report focuses on the human food industry, but many of the same regulations apply to animal food. In some ways, the animal pathway is more stringent. Pet food ingredients do not enter the market through today’s self-affirmed GRAS pathway. They must either go through AAFCO’s ingredient definition process, or be added to its Common Food lndex (which is gradually being assembled).
Now, before we go any further, let me explain why I’m writing about this.
Since 1999, I’ve served as an advisor to the Association of American Feed Control Officials (AAFCO) and have been a member of its Pet Food Committee, Ingredient Definitions Committee, and numerous working groups. I’ve worked with FDA scientists and regulators on many issues—sometimes agreeing with them, sometimes arguing.
I’ve spent more than 25 years sitting at the AAFCO table, debating ingredient definitions and pet food regulations with FDA scientists, state regulators, and representatives of the pet food industry. Sometimes I agreed with them. Sometimes I argued vigorously against them. It’s a good system where all viewpoints are welcomed, heard, and debated.
That doesn’t mean the system is perfect. It certainly isn’t. But I understand the process from the inside, without relying on the rhetoric of either critics or the pet food industry.
With that perspective in mind, let’s take a closer look at what “self-affirmed GRAS” really means, what it doesn’t, and what it means for your cat.
Does FDA review GRAS ingredients?
Yes and no.
If a company does submit a GRAS Notice, FDA scientists may spend months reviewing it. The review may include manufacturing methods, toxicology, nutritional value, ingredient efficacy for the intended use, target species, proposed use levels, and the supporting scientific literature. The FDA scientists who review these submissions are neither anti-industry nor pro-industry. Their job is simply to evaluate whether the evidence supports the conclusion.
If FDA agrees that the evidence appears adequate, it issues a “no questions” letter. This is typically viewed as a green light, although legally it is not an approval. FDA is stating that it has no questions about the company’s conclusion based on the information provided. It generally also provides its reasoning.
If FDA disagrees, it says so—in great detail. But that does not necessarily stop a company from marketing the ingredient.
No matter what process an ingredient goes through before entering the market, it must still meet the same legal standard for safety: a “reasonable certainty of no harm.”
A tale of two additives
Recently I looked at two FDA animal food GRAS letters that illustrate how the system actually works.
The first involved a marine microalgae oil proposed as a source of omega-3 fatty acids (EPA and DHA) for cat food.
FDA reviewed the manufacturing process, production organism, contaminants, nutritional value, bioavailability, and a 41-week gestation-lactation-growth study in cats. The agency noted limitations in the available literature—including the lack of long-term safety data—but ultimately concluded that it had no questions regarding the company’s GRAS determination for the proposed use level.
The second involved alpha lipoic acid for adult dog food. This one… did not go so well.
FDA concluded that the submitted evidence did not provide a sufficient basis for a GRAS determination. The agency criticized the relevance of several studies, found the efficacy data inadequate, questioned the reliability of the pivotal safety study, noted the lack of reproductive safety assurance, and pointed out that some of the proposed claims would classify the ingredient as a new animal drug rather than a food ingredient.
Nevertheless, that company currently includes alpha-lipoic acid in some of its foods. How can this be? There are a few possibilities. The company may have generated additional evidence and made its own GRAS self-affirmation without re-submitting it to FDA. Legally, that’s possible. Alternatively, the ingredient could possibly be used under some other regulatory basis.
The problem I have with it is that many people feed the same dog food to both their dogs and cats, and many cats like to sneak dog food when they get a chance. Alpha-lipoic acid is toxic to cats, although at the inclusion level present in the dog food, it is not a significant risk. However, there remains the possibility that chronic feeding could pose a health risk to a cat over time.
One more wrinkle
When an ingredient receives a no questions letter (or even a full approval) from FDA, that status applies only to that ingredient as produced or utilized by that company. It is not allowed for another company to piggy-back on that status for its own use.
So, who’s right?
EWG is correct that companies are not legally required to submit GRAS determinations to FDA. That means some ingredients may enter the marketplace without any FDA review.
However, it is incorrect to say that FDA never analyzes GRAS determinations.
Hundreds of ingredients for both human and animal food are already included in the Code of Federal Regulations. This includes preservatives such as BHA and BHT (which were specifically flagged by EWG in its first report). Both were approved by FDA and added to the very first GRAS list in 1959. They also have AAFCO ingredient definitions dating back decades, thereby permitting their use in pet food. They did not sneak in through the modern self-affirmation process.
When companies voluntarily submit notices, FDA’s reviews can be detailed, scientifically rigorous, and sometimes highly critical—as the alpha-lipoic acid letter clearly demonstrates.
The fundamental issue
The real policy question is whether companies should be allowed to market newly self-affirmed GRAS ingredients without first submitting them to FDA, as is currently the case.
I believe it would be best to require mandatory FDA notification for all self-affirmed GRAS ingredients. Companies could still assemble their own scientific dossiers, but every new determination would receive at least an initial FDA review before entering the marketplace. That would increase transparency—and safety—without eliminating the GRAS pathway itself.
Unsurprisingly, the food industry sees the issue differently. Industry groups generally support a single national, science-based regulatory system administered by FDA rather than a patchwork of differing state laws. They argue that additional notification requirements could increase costs, slow innovation, and create regulatory uncertainty.
In response to the EWG report, FDA initiated active post-market safety reassessments, emphasizing some of the ingredients flagged by EWG. This is a good thing, if perhaps a bit too little, too late. But any action toward more transparency and better science is a welcome step.
EWG argues that the current system allows too much to occur outside public view. The lack of transparency means we have no way to know whether every self-affirmed GRAS determination is supported by the same level of scientific scrutiny that FDA would provide.
That is the danger EWG has highlighted. I don’t believe it is as severe as the headlines imply. FDA retains the authority to challenge a company’s GRAS determination and take enforcement action when appropriate. Nevertheless, greater transparency would strengthen consumer confidence in the system—a goal we can all support.