Chocolate Cicadas and Mealworm Mints: Will FDA Spit Out Guidance for Edible Insects?

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Morgan Lewis - Well Done

The month of May was buzzing with good news for the edible insect industry, but this emerging food trend still faces regulatory uncertainty in the United States.

Early this month, the European Union approved dried yellow mealworm, the first insect to obtain marketing approval as a food under the bloc’s Novel Food Regulation. And across the pond, as billions of cicadas enjoy their moment in the sun, there has been a surge in consumer demand for edible insects in restaurants along the East Coast. Despite the western world’s bias against entomophagy (the practice of eating insects), these pro-insect developments, coupled with the growing body of research praising edible insects as a sustainable alternative source of protein, suggest that this emerging food trend may prove to last. Indeed, the global edible insects market is projected to reach $8 billion by 2030 (compared to just $112 million in 2019).

But as edible insects land on menus, gain consumer acceptance, and obtain approval in international markets, this new food frontier will benefit from insect-specific regulations.

Federal regulation of insects in human food has historically and primarily focused on regulating insects as “filth,” which may render the food adulterated under the Federal Food, Drug, and Cosmetic Act (FFDCA). However, existing food laws already provide an effective regulatory foundation for insects intended for human consumption. The FFDCA defines “food” as “articles used for food or drink for man” and “articles used for components of any such article.” This definition covers insects intended for human food, an interpretation that the US Food and Drug Administration (FDA) has consistently applied in informal communications.

For example, in a request for information about insects for human consumption, FDA wrote that “bugs/insects are considered food if that is the intended use,” subject to the regulatory requirements that all human food must meet. More specifically, the food product must be

  • clean and wholesome;
  • produced, packaged, stored, and transported under sanitary conditions and in compliance with current good manufacturing practices (cGMPs) for human food; and
  • properly labeled.

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

FDA may add to these insect-specific food requirements as the edible insect market grows and more information becomes available on hazards specific to insect consumption. Food safety concerns continue to be a fly in the ointment for entomophagy, and the lack of regulations or guidance will only exacerbate these issues.

For example, although the safety risks of eating insects depend on the species and production processes involved, biological hazards (e.g., bacteria, viruses, fungi, and parasites) and chemical hazards (e.g., mycotoxins, pesticides, heavy metals, antimicrobials, and other contaminants) may be present in insect stocks throughout the production chain.

Normally, any substance added to food is considered an “additive” and must be either generally recognized as safe (GRAS) or obtain pre-market approval as a food additive by FDA as safe for the ingredient’s intended use under prescribed conditions. An insect, insect part, or insect derivative added as an ingredient to food that is not GRAS or a food additive would be deemed unsafe and adulterated under the FFDCA.

However, the general food additive provisions are ill equipped to ensure the safety of edible insects as food. There are millions of insect species, each of which could require a separate FDA approval for use as a food additive and potentially overwhelm the agency’s capacity.

Like the Brood X cicadas, FDA’s regulation of insects for human food has been largely underground with its quiet and informal tolerance of insects intended for human consumption. The regulatory regime for food products generally offers some guidance for companies in this market, but affirmative and unambiguous recognition by FDA of insect products as a food or food component is a necessary first step in the effective regulation of edible insects. Absent clear guidance, companies in or entering the edible insect space should take care to follow all applicable regulations.

Associate Sophia Gaulkin contributed to this blog post.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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