Chocolate Cicadas and Mealworm Mints: Will FDA Spit Out Steerage for Edible Bugs? | Morgan Lewis – Effectively Achieved


May was full of good news for the edible insect industry, but this emerging food trend is still facing regulatory uncertainties in the US.

Earlier this month, the European Union approved the dried yellow mealworm, the first insect to receive marketing approval as a food under the block’s Novel Food Regulation. And across the pond, consumer demand for edible insects in east coast restaurants has increased as billions of cicadas enjoy their moment in the sun. Despite the Western world’s prejudices against entomophagy (the practice of eating insects), these insect-friendly developments, coupled with the growing body of research promoting edible insects as a sustainable alternative source of protein, suggests that this emerging food trend will be permanent could prove. In fact, the global edible insect market is projected to reach $ 8 billion by 2030 (up from just $ 112 million in 2019).

However, as edible insects end up on menus, gain consumer acceptance and enter international markets, this new food frontier will benefit from insect-specific regulations.

The federal regulation of insects in human food has historically and primarily focused on the regulation of insects as “dirt”, which can adulterate the food according to the Federal Law on Food, Drugs and Cosmetics (FFDCA). However, existing food laws already provide an effective regulatory basis for insects intended for human consumption. The FFDCA defines “food” as “articles used in food or drink made for human beings” and “articles used in components of such article”. This definition includes insects intended for human consumption, an interpretation that the United States Food and Drug Administration (FDA) has consistently applied in informal communications.

For example, in a request for information on insects for human consumption, the FDA wrote that “Insects / insects are considered food if that is the intended use,” subject to the legal requirements that all human food must meet. In particular, the food product must be

  • clean and healthy;
  • manufactured, packaged, stored and transported under hygienic conditions and in accordance with current good manufacturing practices (cGMPs) for human food; and
  • properly labeled.

In addition to general food regulations, the FDA stated that insects for human consumption must have been raised specifically for human consumption. For example, insects cannot be “made wild” (collected in the wild).

The FDA may add to these insect-specific food requirements as the edible insect market grows and more information becomes available on the hazards specific to insect consumption. Food safety concerns remain a problem in the ointment for entomophagy, and the lack of regulation or guidance will only make these problems worse.

Although the safety risks of eating insects depend on the species and production processes involved, examples include biological hazards (e.g. bacteria, viruses, fungi, and parasites) and chemical hazards (e.g. mycotoxins, pesticides, heavy metals, antimicrobials, and others ) significant contaminants) can be present in insect populations along the entire production chain.

Typically, any substance added to food is considered an “additive” and must either be generally recognized as safe (GRAS) or approved by the FDA as safe for the intended use of the ingredient under prescribed conditions prior to placing on the market. An insect, part of an insect or an insect derivative that is added as an ingredient to foods that are not GRAS or a food additive is considered unsafe and adulterated under the FFDCA.

However, the general rules on food additives are ill-designed to ensure the safety of edible insects as food. There are millions of insect species, each requiring separate FDA approval for use as a food additive and potentially overwhelming the agency’s capacity.

As with the Brood X leafhoppers, the FDA’s regulation of insects for human consumption has been largely underground, as insects intended for human consumption are quietly and informally tolerated. The Food Products Regulatory System generally provides some guidance to companies in this marketplace, but the FDA’s positive and unambiguous recognition of insect products as a food or food component is a necessary first step in effective edible insect regulation. Without clear instructions, businesses in or entering the edible insect room should be careful to comply with all applicable regulations.

Associate Sophia Gaulkin contributed to this blog post.

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