As we all know, a food recall is bad PR. What reasons do recalls take place and who initiates recalls?

Most recalls are initiated by the manufacturer. The top two reasons foods are recalled are for undeclared allergens (ex. milk) and pathogens (ex. salmonella). Any product that violates the Code of Federal Regulations (CFR) or the Federal Food, Drug, and Cosmetic Act (FD&C Act) should be recalled.

The FDA states that they hear about a problem a variety of ways:

• A company discovers a problem and contacts FDA.
• FDA inspects a manufacturing facility and determines the potential for a recall.
• FDA receives reports of health problems through various reporting systems.
• The Centers for Disease Control and Prevention (CDC) contacts FDA.

Up until fairly recently, the FDA did not have the authority to mandate a recall. They now have the authority to mandate a recall with the passing of the Food Safety Modernization Act (FSMA).  From Food Safety News: FDA Reports Only One Use of Mandatory Recall Authority To Date . The FDA would first request a recall, and if matters are not sufficiently handled, the FDA would then mandate a recall. It seems unlikely that edible insect products would get to this stage. My understanding is that the FDA can also proactively send a desist letter for products before they get to market.

A recall request is a more likely scenario. Here is what the Regulatory Procedures Manual says about requesting a recall:

“An FDA request that a firm recall a product is ordinarily reserved for urgent situations. The request is directed to the firm that has primary responsibility for the manufacture or marketing of the product when the responsible firm does not undertake a product recall on its own initiative. FDA requested recalls are most often classified as Class I. Generally, before FDA formally requests recall action, the agency will have evidence capable of supporting legal action, i.e.seizure. Exceptions include situations where there exists a real or potential danger to health, or in emergency circumstances such as outbreak of disease involving epidemiological findings. The completion of either a firm initiated or FDA requested recall does not preclude FDA from taking further regulatory action against a responsible firm.”

Recall classes from FDA website:

Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.

Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.

If insect products were to be recalled just for having insects, my understanding is that it would be a class III. There is not evidence to supports that farmed insects pose a “slight threat of a serious nature”. Insect products could have a Class I designation if they are contaminated with pathogens etc.

One situation where edible insect products could be subject to recall is by not meeting GRAS criteria. If a GRAS determination is deemed not valid, then the products would be in violation of manufacturing laws. This scenario can happen when the FDA (in partnership with state regulatory agencies) inspects a manufacturing facility. I recommend that firms have at least some documentation that supports a GRAS determination be internally filed. So if inspectors question the safety of using insects as food, the firm will have information detailing its safety, and hopefully prevent an escalation of a safety issue/ recall/ facility shutdown.

Where are we at now?

• The FDA is marginally aware that insects are being introduced into the food supply
• The volume at which insects are being consumed is very low
• Manufacturers that use insects have a GRAS dossier available upon regulatory inspection?
• The FDA’s risk assessment of insect containing foods (without other hazards) would result in low risk and therefore not a priority to the FDA when considering a proactive recall

What else do we need to consider?

• There may be ways for regulatory agencies to prevent manufacturing/marketing of products before they get to a recall stage.

• State and local rules vary state to state and may also cause, unaccounted  for, road blocks.