Insect Protein: What are the Food Safety and Regulatory Challenges?
Updated: Feb 4, 2022
Traditionally, Americans have used livestock and dairy products as the primary sources of dietary protein. However, current popular dietary trends in American culture have focused on novel sources of protein to replace traditional sources. This shift in emphasis raises new questions on the safety of these non-traditionally sourced proteins.
While there is currently a variety of novel protein sources available (e.g., microalgae, seaweed, duckweed, rapeseed, peas, brown rice, soybean, hemp, chia seed, and flaxseed), one that is attracting much attention is the insect. As foreign as it may seem to some, insects have a long history of dietary use in many world cultures and, although in limited situations, insects have been introduced to the American culinary culture. However, there has been an increasing interest in using insects as protein replacements to traditional sources, apparently originating from ethical questions surrounding the use of animals as food, health-related concerns, and economic reasons. The interest in new sources may also be fueled by the continued idea that, due to increased protein demand in a growing global population, a shortage in available protein will lead to a further dependence on alternative protein sources.
Questions on protein availability and quality have been around since the 1950s, under the idea of the “World Protein Gap” (seen as a cause of health issues in the Third World)., Insects are considered a sustainable source of protein and are assumed to have the ability to fill the increasing demand for protein. This sustainable protein source may become important as the global population reaches nine billion and current protein sources become more costly to produce. According to the United Nations (UN), 80% of the world’s countries already use insects as a food source.
Insects may have safety-in-use in select parts of the world, but having a wide variety of insects available and varying methods for preparation makes evaluating the safety of the overall foodstuff difficult. In the United States, there are a number of factors that should be taken into consideration when evaluating the safety of using insects as a food ingredient, including that a food ingredient must be determined safe under conditions of use.
Options are available for determining the safety of a food ingredient used in the United States. The Food, Drug, and Cosmetic (FD&C) Act (through the 1958 Food Additive Amendment) provides that the process for evaluating the safety of a food ingredient is either through a food additive petition (FAP) or a generally recognized as safe (GRAS) determination. While the requirements for proceeding with a FAP or a GRAS determination are almost identical, a food ingredient with robust and publically available safety evaluation or a history of safe consumption is a good candidate for a GRAS determination.
There are a variety of insects that have been used in and for food around the globe (e.g., locust, ant, grasshopper, mealworm, cricket, silkworm, and beetle). In the United States, the cricket appears to be the most popular choice, as indicated by the number of news stories on their current availability as a food. Crickets are currently found for sale as a whole, cooked food or in a powder form (also referred to as cricket flour).
In addition to selecting an insect that will be both safe and accepted by the consumer, an evaluation should be conducted to ensure that the insect is not contaminated. This contamination can exist in two forms: microorganism and toxicant contamination.
Insects are susceptible to microbial contamination (e.g., bacteria, fungi, and mycotoxins), as their nutrient content make them a good host for pathogens under certain conditions. This may impact the consumer (specifically in the event that uncooked insects are ingested) and also may cause food spoilage. A claim has been made that insect pathogens are taxonomically different than those that affect humans and, thus, can be regarded as harmless; however, in order to verify this claim, testing would be required on any insect source that was going to be used as a food ingredient, especially because some parasites (e.g., the dwarf tapeworm) may infect people that have ingested an infected insect, such as a beetle or mealworm.
Toxicant contamination of the insects is also a safety aspect that should be considered. This can arise from the area where it is being raised or what it is fed in the diet. Insects have the ability to uptake and concentrate substances from their environment or feed. Because of this bioaccumulation, these substances could potentially be passed on to the consumer. Evidence has indicated that it is possible for insects to have concentrations of chemicals that exceed levels that are typically acceptable for food consumption.15 Further, autonomic defense mechanisms may also produce toxins that could be harmful if consumed.
Beyond what would be considered good agricultural practices, safety evaluations addressing physical hazards should also be conducted. Consuming grasshoppers and locusts with their legs still attached (including large spines on the legs) has resulted in impaction within the gut wall.13 Additionally, insects used as a food ingredient should also be evaluated for potential allergenicity, as individuals that have allergic reactions to crustaceans (e.g., shrimp and lobster) may also react in a similar manner to insects.
Proponents of using insects as a meal source/protein replacement claim that it has twice the protein of beef, contains all nine essential amino acids, has five times the magnesium of beef, and twice the iron. While these may sound great for the consumer, a safety evaluation should be conducted to ensure that consuming these nutrients, or any other substance from the insect, at higher levels are not harmful to health (just because your body requires a substance for normal function does not mean that it reacts positively when it has more). Further, the safety evaluation should identify all substances that will change in significant amount as compared to traditional protein sources (e.g., beef, pork, and poultry). It is important to remember that, in order for a food ingredient to be GRAS, it must be safe under its intended use and in accordance with federal rules and regulations.
Typically the FDA is the arbiter of items used as food. In this case, the FDA has been apathetic when addressing the use of insects as a food; substantive information is lacking. In responses to entomophagy inquiries, FDA responds by first referencing Section 201(f) of the FD&C Act and states that, per this section of the Act, bugs/insects are considered food if they are to be used for food or as components of food. However, this section of the Act does not specifically mention insects. The referenced section (and subsequent sections) delineate between the definitions of a food, a drug, and a cosmetic for purposes of the Act. In fact, a review of relevant and available FDA documents finds an absence of the word “insect” beyond adulteration with defects (in this instance, commodities with a maximum allowable amount of insect filth).
The FDA response19 continues to indicate that, usually, a food must be clean and wholesome, must use sanitary conditions for production, packaging, and transportation and, must following proper labeling requirements per Section 403 of the Act, including the scientific name of the insect. Additionally, insects being raised for humans (specifically, as insects intended for ingestion by animals or for pet food may not be used for humans) must be processed following current good manufacturing practices, the insects cannot be wildcrafted, and must be shown to be wholesome. However, missing from the FDA response is that, under FDA interpretation of the Act via Code of Federal Regulations (CFR), if these insects are food and are going to be used as a “food additive”, they must undergo a safety evaluation for their intended use. Based on available information, it is clear that insects are used as food ingredients, and thus, insect-based food ingredients either must be determined GRAS or must be a food additive through the FAP. For example, the moment that the insect is altered from its raw form (e.g., crickets cooked and ground into a powder for use in cookies or protein bars), the insect becomes a food ingredient. This important and relevant information is missing from the FDA’s inquiry response and should be addressed by the manufacturer or processor using insects as food ingredients.
As insects become the increasingly accepted as a protein source in the United States, there will be questions as to their safe use as a food. Additionally, as more insect-based ingredients enter the market, FDA may be forced to acknowledge that they must be either determined GRAS or evaluated as a food additive. A manufacturer that enters this market must be aware of the hurdles that exist, the issues that should be addressed, and the importance of obtaining a GRAS determination for any insect food ingredient.
 The gap that could exist between supply and demand for animal protein in developing countries.
 Carpenter, K.J. (1986) .The History of Enthusiasm for Protein. Journal of Nutrition. American Institute of Nutrition. 116(7): 1364-70.
The method used by these sellers to establish the safety of their cricket products, if any, are unclear.
 Either a chemical (e.g., pesticide or polychlorinated biphenyl) or a heavy metal.
 United Nations (2013). Edible insects: Future prospects for food and feed security. http://www.fao.org/docrep/018/i3253e/i3253e.pdf
 van der Spiegel, M., Noordam, M.Y., et al. (2013). Safety of Novel Protein Sources (Insects, Microalgae, Seaweed, Duckweed, and Rapeseed) and Legislative Aspects for Their Application in Food and Feed Production. Comprehensive Reviews in Food Science and Food Safety. 12(6): 662-678.
 Eating insects as food.
 21 USC 321
 From presentation by Dr. George Ziobro (FDA Center for Food Safety and Applied Nutrition)
at Institute of Food technologists (IFT) 2015: Regulatory Issues, Concerns, and Status of Insect Based Foods and Ingredients. Chicago, IL.
 21 USC 343
 Collected in the wild.
 21 CFR §170
 Based on products that are currently available for sale.