Bugger That! FSMA Regulators Prepare to Add Insects to the Menu

Kate McInnes
Senior Advisor: The Acheson Group

Alternative foods, and especially edible insects, are a growing global industry. In fact, 2.5 billion people currently consume insects today because they are super high in protein, have lower health risks, and cost much less to grow and process. Oh, and this market is expected to grow from $2.3B in 2021 to $9.5B by 2029 in North America alone.

Alternative foods are considered a "novel food", which means it’s not mainstream enough to have rigorous regulation (kind of like nutraceuticals). That said, many emerging and established alternative food manufacturers and growers are putting the effort in to be compliant (even though they technically don't need to be) because their buyers won't do business without proof of good food safety practices. Given the estimated growth of this market, it is only a matter of time before the FDA will add alternative foods to FSMA.

In our recent webinar, Exploring the Buzz: Opportunities and Challenges in the Rise of Alternative Foods, Kate McInnes, Senior Advisor at TAG, discusses the FSMA risk factors and areas of focus for manufacturers using insects and insect-based products in human food — known as entomophagy. In this blog, we’ll convince you why novel food regulations are soon to become a staple in FSMA and walk you through some of the risks that will need to be accounted for and documented to satisfy food safety regulations.

 Why...? The Advantages of Novel Foods

Why on Earth are people outside of fringe adventure food enthusiasts even considering this?

Health Benefits

Gram for gram, crickets have significantly more protein than beef, and outpace chicken, beef, and pork when it comes to calcium and the B vitamin riboflavin. They’re also a rich source of amino acids, polyunsaturated fatty acids (linked to reduced risk of heart disease), riboflavin, potassium, zinc, magnesium, copper, folate, biotin, and pantothenic acid.

Environmental Edge

Sustainability is at the forefront of the minds of both consumers and producers. Compared to cattle, crickets produce 80 times less methane — the greenhouse gas responsible for 30% of global warming. Raising livestock is also more resource-intensive in terms of land, feed, and water usage. For example, 100 gallons of water can be used to produce 238 grams of cricket protein compared to only 18 grams of chicken protein and only 6 grams of cow protein.

Economic Value

The cost of meat is on the rise due to inflation, demand, and other economic factors. Even eggs, which are historically one of the most affordable sources of animal-based protein, experienced soaring prices in recent years. In 2022, the Highly Pathogenic Avian Influenza outbreaks led to supply shortages that caused the price of eggs to soar to one of the most expensive sources of protein that year.

Okay, But Is Anyone Realistically Going To Eat This Stuff?

While the idea of mainstream consumers eating bugs may sound far-fetched, it’s worth reminding ourselves that it wasn’t too long ago that plant-based proteins were considered eccentric, and now health-based initiatives like Meat-free Mondays are becoming normalized in school and work cafeterias. In fact, a report by Bloomberg Intelligence projects explosive growth in the plant-based foods market from $29.4. billion in 2020 to a staggering $161.9 billion in 2030, which would comprise 7.7% of the global protein market.

While there is certainly an aesthetic difference between a veggie burger and a cricket burger, the rising trend of alternative protein sources indicates that this may not be a stigma held for long. Manufacturers are more than aware that the idea of eating insects can be hard to stomach, and are coming up with ways to integrate alternative foods into consumer products.

“You want to make it easier for individuals to make the choices that they would rather be making,” says Cortni Borgerson, an anthropology professor at Montclair State University in New Jersey, in a TIME feature on the rise of entomophagy.

By grinding the insects into a paste of flour, consumers can reap the health, environmental, and economic benefits of using insects as a source of protein and other nutrients — minus the cringe factor. Insect powders have been shown to be successfully used in baked goods and even burgers — in fact, you might not even know this but you’ve probably been eating bugs for years via red food coloring, carmine, commonly made from the crushed cochineal insect

What Does This Have To Do With FSMA

It’s only a matter of time before insects become a normalized part of healthy, sustainable, and economic diets. This not only means that regulating bodies will soon come knocking, but also that early adopters who are able to market and sell insect-infused products stand to gain a significant edge in the market — and have a major competitive advantage if they have FSMA certifications (e.g., BRC certification) and organized documentation to back up their products and services.

Think about the documentation issues many well-established F&B manufacturers have, and what that does to audits and food safety certifications. If you buy flour made from crickets to make high-protein baked goods, then you need to be FSMA compliant (this is where managing suppliers is a big deal). If you are aspiring to grow in the alternative food business, you need a digital plant management solution to track and trend potential opportunities and issues.


The biggest food safety risk in entomophagy comes from the rearing environment of farmed insects, particularly in controlling the food, water, substrate, and housing of the insects — and, importantly, documenting the controls in place sufficiently to satisfy the FDA’s Food Traceability Rule.

Biological hazards (such as pathogens, molds, yeasts, fungi, and parasites) and chemical hazards (like mycotoxins, enterotoxins, heavy metals, agricultural residues, drug residues, and allergens) are the most common culprits to enter rearing environments, and benefit from initiatives such as robust environmental monitoring programs and food allergen control programs.

Unlike with animal protein sources, it is not possible to remove the gut in almost all edible insects. This means that manufacturers need to have a complete understanding of the specific microbiota that are unique to their insect, and be well-informed of the inherent associated risks.

Insects belong to the same (arthropod) family as crustaceans, so those with crustacean and shellfish allergies are vulnerable due to contact with allergens such as tropomyosin and arginine kinase. There are 1,900 different species of insects consumed by humans, and must be evaluated individually to determine whether they have novel allergens specific to their species.

Being aware of the manufacturing environment is also important, which is where insects often come into contact with Listeria. Ensuring insects are washed properly before cooking helps to remove surface contamination, in addition to developing critical control points to eliminate concerns and building an accessible food safety training program for a diverse workforce to promote food safety culture within the manufacturing environment. Furthermore, these efforts should be sufficiently documented for both customers and potential future audits.

Ensure The Next Generation of Sustainable Protein Will Pass Regulatory Requirements

Want to learn more? Watch the webinar to dive into the details behind mitigating risks when manufacturing novel foods and download our free guide, The Finalized FDA Food Traceability Rule, to learn how you can apply best practices to document the steps you’ve taken to minimize food safety risks in novel foods.