Category Archives: Business

Industry Experience on Regulation

I sent a questionnaire to a dozen or so leading entomophagy companies in North America (the questions are listed in this post).

The responses received were overall positive. Not all parties responded and some responses were limited due to the confidential nature of the topic.

Key take a ways:

  • Regulators, including state and local agencies, are aware that the companies are producing insect containing food products.
  • Producers are demonstrating that the insects used are wholesome and that the food is being produced using Good Manufacturing Practices (GMPs).
  • Food safety information in the form of a GRAS dossier has not been required by regulators.
  • Allergen risk is being communicated.
  • Consumers are informed that their products contain insects.
  • No one is aware of efforts to limit used of insects as food.

What Is Really Happening With Edible Insect Regulation?

Regulations have been a gray area for insect businesses and investors so it’s an issue that needs to be understood.

I’ve broken it down to two possible scenarios.

One is that companies have not being pressed by regulators about edible insects. Entomophagy is not a risk and is not considered a regulatory concern that is different than any other agricultural product or prepared food.

Second is that companies are managing regulation internally. If they are questioned by regulators, they are addressing them directly. Regulation may be an issue that companies are actively addressing but are not openly sharing.

I have not seen much activity on websites or in the press about regulation except that it is a potential issue. The IFT Annual Meeting has a technical session on edible insects and one of the speakers segment is called ‘Regulatory Issues, Concerns, and Status of Insect Based Foods and Ingredients’. (I’ll be there!)

Regulation is an issue but what’s really happening? My thoughts here.

I put together a questionnaire to help find out the current state of regulatory affairs with edible insects.

Please send me comments on the following questions or leave comments on the blog. It would be very helpful to the industry.

I have also sent the questionnaire to a few of the leading groups for entomophagy in North America. Once I get some feedback Ill post a regulatory snap shot.

  • Do you own, rent, or outsource (contract manufacture) the facility where you make your product?
  • If you use outside manufacturing or a commercial kitchen how did you convince them to allow you to process insect foods or were they open to it?
  • Do you deal directly with any local, state or federal regulatory agencies? Which ones?
  • How do regulatory agencies feel about you using insects as food? Do they know about it?
  • Are you aware of any directed efforts to limit or disallow the use of insects in foods? Could be from regulatory bodies, lobbyist or other activists.
  • How do you demonstrate that the insects you are using are safe for human consumption? Have you been asked by any regulators?
  • Have you ever been audited by a third party organization?
  • Do you take any special precautions on the packaging to inform consumers that the products contain insects?
  • How much extra resources are required because you are producing insect containing foods compared to other foods in the same category.
  • Is there a threshold for flavor/taste that determines how much you can add? Insect type, preparation and application.
  • It’s important to understand how entomophagy could affect the population at large (this how the FDA looks at potential issues). What are your sales volumes and estimated growth?

Edible Insects are Awsome… What can you do to help?

Edible insect are great. But there is still more work to be done. The availability is limited to mostly mail order and the variety is lacking too. There is a lot of potential for new and creative entomophagy products. Cost is also high.

A note before I get into the main point of this post – Entomophagy start ups aren’t just about the selling of foods that are or contain insects. They are Lifestyle BRANDS. What you choose to eat says a lot about who you are. By choosing edible insects you are making a statement that you care about the environment, animal welfare, and your health.

What can you do?

  • Create demand… by buying more edible insects. Two parts to this. One is consuming processed edible insect products like Hopper Granola Crunch. Second is using more edible insect ingredients in cooking. There are now a few options for cricket flour and also frozen whole crickets (my preferred way to buy insects). Cost will go way down with companies producing higher volumes of product and variety will go up.
  • Get your swag on! You are what you eat. You are what you wear too. How better to start a conversation about food choices than to wear edible insect gear. In essence, you are doing guerrilla marketing for the start ups and yourself. Its a win win. If you missed the perks from Exo‘s kick starter campaign, its not too late to get a T-shirt on their website. (its an affiliate link… I just want to make it easy for you to get awesome swag)
  • Tweet and Re-Tweet. Edible insect companies are constantly posting great stuff on the web.

Tweet this article!

Post this link: http://wp.me/p4fIin-3v

How to get a contract manufacturer for edible insect products.

thinking from microsoft

Microsoft Office

Let’s face it. Most people aren’t that interested in eating insects. If I extrapolate, most contract manufacturers (co-packers) won’t be that interested in making insect products like cricket bars or cricket soups.

Part of the reason is that they just won’t have the same passion for entomophagy. Entomophagy is considered innovative in western cultures and some people just don’t see the value in it. Secondly, and probably a bigger factor, is that adding a new type of food ingredient in a food facility is a business risk. People connect insects with filth and uncleanliness so their other co-packing customers might balk at the idea of sharing production equipment with crickets or meal worms. Insects are considered allergenic. So would other products sharing production equipment need an allergen warning such as “made in a facility that also process insects”? Another issue is that the regulatory framework is unclear. Insects as food is not specifically mention anywhere in anywhere in US regulations besides the part on action defect levels. A contract manufacture that you find suitable to work with probably has a successful business. Why would they want to do anything to jeopardize business model?

The first step when talking to a contract manufacturer is to explain the benefits of insects as food.There are a lot of great reasons to get into the entomophagy business. This is a home run.

Secondly, be prepared with counter points in case your co-packer has objections. Below are some talking points to appease potential co-packers (Mostly applicable to the US but can be transferable for other regions).

  • Insects are already in products. Ingredients like dates, peanut butter, chocolate and cinnamon have insect parts in them. Insects are an unavoidable and inherent in some ingredients.
  • Insect cross contamination poses no inherent health risk. The amount from cross contamination would be less that the levels listed in the Defect Levels Handbook. Good manufacturing essentially eliminates cross contamination.
  • Disclosure to other co-packer customers is not necessary as it does not affect their product. (Given that the facility/equipment is well maintained).
  • A manufacturing warning is not needed. This is based on the assessment that the amount of insects from cross contamination would be negligible compared the action defect level.
  • The likelihood of the product being recalled is very low. I wrote a blog post about this Read it here.
  • State that the insects being used are food grade. Have documents available indicating that they have been farmed in compliance with FD&C Act Chapter IV: Food and processed in compliance with CFR Title 21 Food
  • Minimally process insects can be considered a ‘raw agricultural product’ and there for do not need a GRAS determination. There is a grey area consisting of whole foods that does not get the same scrutiny that additives do.
  • As back up, also have information specifically related to making a GRAS determination. Don’t forget, GRAS substances do not require pre-market approval.
  • Also mention that regulatory agencies do not consider edible insects a priority. They have much more pressing concerns. Most likely, edible insect businesses will fly under the radar for a while.

I hope this helps.

Microsoft Office

Microsoft Office

Please reach out to me if you have any questions. I would love to help.

Insect food allergens are a bigger issue than previously thought

Potential insect allergens may cause the FDA to disagree with a GRAS determination. This premise means that an ingredient being added to food that is an allergen, like whey protein concentrate, would not be allowed. How is whey powder allowed as a food ingredient? I feel like I am missing part of the puzzle. But let’s not get into this for now.

There are a lot of food products that contain potentially fatal allergens. Regulators feel the danger is well managed by requiring allergen containing products to state that they contain allergens. The allergens that cause reactions are also well known to consumers. A person with a milk allergen knows that they can’t consume dairy products and they know to look at the ingredients and/or allergen statement to find out if the food is OK. We don’t have this luxury for insects. People don’t know that insects can cause a reaction and they don’t know if they will be affected if they eat insects.

Im making the assumption that some people are allergic to insects. Not all insects may be allergenic. Very few people may be allergic but we just don’t know. Protein sequencing can determine if proteins present in crickets, for example, are known allergens. The Food Allergy Research and Resource Program has an online database and other resources. While the technical information may be helpful, for now, a practical approach to addressing the issue is needed.

Proposal for Insect Allergen Communication.

Whether insects are being added to processed foods, sold as an agricultural product or used in restaurant dishes; a common platform for communicating the allergen risk can benefit entomophagy.

A visual to communicate risk:

  • Can be used on product packaging, posters and more.

Insect Allergen Warning Entomophagy

A source for more information:

Link to website about allergens

What allergens are in insects?

Who may be affected by insect allergens?

How do I find out if I am allergic?

What do I do if I have a reaction?

(I cant answers these at this time. Go to http://www.foodallergy.org/ for general Food allergies information)

 Not yet!

I don’t think we need to take these step yet. A strong warning may scare people from trying insects for the first time. However, this approach is an option to prevent regulator objection. This option could also be presented if and when any regulatory bodies object. Take a look at how the FDA addressed Added Caffeine in Gum. A potentially dangerous food ingredient (caffeine) was added to a food where it is not normally present (gum). A regulatory objection will probably start as a negotiation and not a new law.

I recommend a label explicitly stating that insects are an allergen, then providing more information about who is likely susceptible:

ALLERGY WARNING: Contains Insects (people who are allergic to shellfish may also be allergic to insects)

Food Recalls – Can this happen to entomophagy products?

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.

Allergies and Insects

Bee AllergenInsects can cause an allergic reaction in people. Generally speaking, one mechanism is through a food consumption, secondly is through environmental exposure.

What does the FDA think about food allergens?

The FDA’s primary concern with regard to food allergens are the ‘Big 8’. They are Milk, Eggs, Fish, Crustacean shellfish, Tree nuts, Peanuts, Wheat and, Soybeans. These foods account for over 90% of food allergic reactions. There are over 160 foods that can cause allergies but these 8 are the only ones that require labeling by law. People allergic the shells may see cross reactivity to insects. The prevalence of shellfish allergy in the United States is around 2%. The majority of the population can consume insects without significant risk of an allergic reaction. I do recommend voluntary allergen labeling for packaged insect products. Consumer education will help general acceptance of insects as food.

Environmental insect matter can cause allergy symptoms. Skin contact and dust inhalation can have adverse effects on people farming and post-harvest processing of insects. Fecal matter and dried insect parts can become airborne and subsequently be inhaled. Sensitization can occur from repeat exposure. Issues with worker related environmental allergens would involve the Occupational Safety and Health Administration (OSHA). I am curious to know if insect farmers that currently produce high volumes have come across this issue.

What should we do about insect allergens?

  • Regularly clean farming facilities including the farming equipment and other building surfaces to remove dust and particulate matter.
  • Monitor the health of insect farmers for development of allergic sensitization. Use personal protective equipment such as mask and googles when appropriate.
  • Limit dispersal of fine particulates when making insect flour through engineering controls.
  • Label insect containing food products with an allergen statement such as ‘People allergic to shell fish may also be allergic to insects’.