Colleen Kavanagh of ZEGO Foods provides a somewhat scary look at what the recent relaxation of FDA food regulation guidelines could mean to food production and safety for individuals with dietary needs.

Colleen Kavanagh ZEGO Foods FDAThis spring, the U.S. Food and Drug Administration (FDA), which oversees U.S. food regulations, announced temporary flexibility policy regarding certain labeling requirements for foods for humans during the COVID-19 pandemic.

Colleen Kavanagh is the founder of ZEGO Foods, a food manufacturer that makes superfood-based products, has quality standards — and tests — for more than 400 agricultural pesticides and toxins in the ingredients of the food her company provides. ZEGO’s manufacturing facility is also free from the top 13 allergens — peanut, tree nuts, milk (dairy), soy, egg, fish, shellfish, mollusks, sesame, lupin, sulfites, mustard, wheat — and no corn or corn derivatives are used on equipment, packaging or processing aids.

I recently chatted with Colleen about what the new FDA guidelines could mean for food production and safety for individuals with dietary needs.

When I first met you over the phone years ago, we talked about one of your passions — pesticides in our food. Colleen, people can potentially have allergies to these pesticides in non-organic foods, correct?

Yes. We also double check on some pesticides that can drift into organic crops, especially heavy metals, which aren’t covered under the “organic” label. Crops like chocolate, protein powder, and rice can be high in certain heavy metals. So our philosophy is that well-nourished people are better to themselves, better to the people around them, and better stewards of the earth. And you can’t be your best self if you don’t know if there’s something in your food that could be harming you.

Now the U.S. FDA has issued a new policy due to COVID-19 to allow flexibility in labeling on packaged foods. This is really a potential harmful issue for people with food allergies, especially those who don’t have allergies to the top eight allergens. It says, “FDA announces temporary flexibility policy regarding certain labeling requirements for foods, for humans during COVID-19 pandemic.” (See the document here.)

What does that say to you, a food manufacturer who is really keen on labeling?

It’s so frustrating. We weren’t where we needed to be, but we were moving in the right direction on food labeling with the passage of the Food Allergen Protection Act. We also have been trying to push the industry further to worry not just about allergens, but also letting people know about the toxic residue that can be on food. This guidance is definitely a diversion from that.

Even if we weren’t an allergy-free company that’s primarily focused on transparency, I would not want this to be allowed because I want people to have confidence in U.S. foods. For example, if you export your foods to another country, they may worry that you’ve adulterated your foods during COVID because of this new guidance, and they may be less likely to choose a U.S. company to fill a slot in their store or their company. I don’t also think it gives you any legal protection as a company. My counsel said, “I would not advise you to rely on this guidance. It’s poorly written. And it’s not a guarantee that you’re not liable.”

I am an advocate for transparency in the food and beverage we serve at meetings. When we get back to meeting in person, the catering companies and the chefs at convention and conference centers need to be transparent about their food safety practices. And if they can’t rely on the companies producing the food and beverages they’re buying to be transparent, how can they then be transparent to their customers? And how does it affect restaurants?

I’m not an expert on restaurant regulations, but from what I understand, I don’t think this is an issue for them. Another document for restaurants came out at the same time that allows restaurants to take food that was labeled for them and resell it to consumers, even though it doesn’t have an official nutrition label on it. It still has to have allergen labeling and an accurate ingredient list. They also let manufacturers who have prebought ingredients that restaurants aren’t ordering now to sell those things to consumers without the retail labeling.

The policy that’s more of concern actually allows you to make substitutions with an inaccurate label.

That’s just scary. What can a consumer do? 

The most important thing to do right now is file a comment on the guidance, and include your name, since it’s more meaningful that way. Looking at the comments, some people are concerned that this affects the top eight allergens. It doesn’t: those are still protected. You can’t swap in an allergen if it’s in the U.S. list of top eight.

That’s good to know. Are you seeing good comments from your other food manufacturers?

No, no, not at all, and I should be. Wherever you sit in the food chain, it’s important to comment because they’re going to take those concerns very seriously if the food industry says, “We don’t want this flexibility — this is bad for us. It’s shaking consumer confidence — people aren’t going to trust our products.” We’re going to start fielding phone calls from food allergy families saying, “Hey, have you made any changes? Because I heard that this is now allowed.”

To be clear, ZEGO is not going to make any changes. But if you’re swapping out ingredients, you don’t just do that in secret. You have to document everything in an internal tracking system.

What kind of products are going to be so hard to come by that they actually have to make substitutions?

I have not heard of anything as of yet. I’m concerned that this administration put out this guidance that they want manufacturers as much flexibility in their regulatory process as possible. So every agency was tasked with finding where can they provide flexibility.

Think about the child nutrition school lunch laws, where they all of a sudden gave flexibility on meeting a deadline for improving nutrition standards, when 90% of schools had already done it. Nobody was really asking for it. They just wanted to show that they were pro-business. I don’t know that there were actually any companies asking for this.

It also is so poorly written that it doesn’t seem like whoever wrote it really even understood what they were doing. For example, one comment says, “Does not define what a valid COVID-19 disruption in the supply chain is.” So if you normally buy strawberries and strawberry prices are going really high for reasons mainly unrelated to COVID, you could switch to some other, cheaper berry that someone might have an allergy to and call it a COVID emergency. It’s self-policing.

For example, We use sacha inchi protein, because it’s the highest quality protein powder available. So companies, even if they use a teeny tiny amount, can put it on their label. We offer a bag that is just sacha inchi seed protein so you know exactly what you’re getting. But if someone has a blend, they could just swap out that sacha inchi seed with pea protein, cause it’s cheaper, and not tell anybody. And you’re paying a premium price for a product that isn’t delivering what it says it’s supposed to be delivering.

That just seems so screwed up.

It is. And this is an industry that is historically fraught with fraud — back in the old days, they would shave broom handles in with the shaved Parmesan cheese in Italy to make it go further and cut their costs. Adulteration happens all the time. It’s a huge, very fragmented industry, and you can’t just rely on people being good people.

The FDA guidance also does not require companies making off-label substitutions to notify consumers in any way, even on their websites. 

Yeah. It’s not required at all. Which is crazy because we have time to do social media posts to reach our consumers when we can’t actually do demos, have food shows, and really meet them. How is it that we don’t have time to put a little banner across our product page?

It’s just an unnecessary amount of lack of disclosure that is sowing so much fear in consumers and really undermining the trust that people have in our food system in the U.S.

The FDA also is not approving or tracking changes, let alone keeping a master database of all product changes. 

This is a problem. Companies wouldn’t have to put anything on their Amazon page, and anything that’s scanned using a UPC code is not going to be associated with a lot number. You need both pieces of information. This has to be handled like you would a recall — this is name of this product. This is a UPC code. These are the days it was produced. And this is a lot code number. The reason that we need the FDA to have the master list is that it’s unreasonable and unsafe to expect consumers to check every single product on each product website, every time they want to buy something.

They need to be able to have a master list so if they go to the grocery store and they’re like, “Oh shoot, I didn’t check to see if chef Boyardee SpaghettiOs has made any changes,” they should just be able to go to one place to check that and the 14 other things they need to buy. The FDA is not acting as a helpful partner with the food industry or with consumers with this.

There’s very little policing on any of the food laws, to be honest. So, adding in this extra flexibility is sort of crazy.

And one other thing. There are three different issues that they talk about: omissions, reductions, and substitutions. I have no problem if people need to reduce or omit something temporarily — it’s the substitution piece that’s the big concern.

If you’re going to substitute almonds for peanut butter, they can’t touch that, right?

They can’t touch that, but they could, for example, substitute mangoes for blueberries.

And lots of people are allergic to mangoes, so that could cause allergic reactions and people wouldn’t know why. More than 170 foods cause allergic reactions. And people are also allergic to food derivatives —I was talking to somebody who is allergic to about half of the artificial sweeteners that are out there but not the other half. Under this guidance, companies could say switch to a different sweetener without notifying anyone and she would have an allergic reaction to it.

And sometimes it’s the way it’s processed that causes problems for some people, like my daughter who can’t have tapioca but she can have yams. Something about the processing could make her sick.

Chefs at convention or conference centers, though they’re probably not buying a lot of food right now, need to be commenting as well?

Everyone does.

What you said a few minutes ago about restaurants not wanting to change their labels because it’s already printed scares me. Cause they’ve already printed it on. I get that they don’t want to waste the plastic, but they should put a notice on their main website, or at least on Amazon, if that’s a big seller for you.

Right — really any third-party platform that you’re using to sell your product. But even that is difficult: for example, while we control of all of our sales on third-party platforms, some companies have third-party sellers on third-party platforms, so there might be somebody selling a Clif Bar on Amazon and it’s not Clif Bar.

Let’s say you make an oat-based bar that has nuts and fruit in it. And you need to swap out your fruit on one of them. Tell the stores, “We want to just substitute this other flavor that we already have in circulation.” So now they carry a different SKU and they can swap it back when the other SKU is back. So if you can’t get blueberries, don’t swap out the blueberries with something else — just get rid of that SKU until you can get blueberries again.

Colleen, you run your business being very transparent about what you’re doing and the food you’re producing — do you see more companies doing this? 

I think that most companies will try not to make substitutions, if for no other reason that the liability involved if someone gets hurt by their product.

I definitely recommend that everyone reads the FDA temporary policy regarding certain food-labeling requirements during COVID. They’re saying that food manufacturers can change and omit ingredients without communicating that to the FDA or to consumers. And this is really scary for people who have dietary restrictions.

Tell us a little bit about where they can get your food — they know you can trust you!

You can go to our website,, as well as Amazon. ZEGO makes breakfast and snack foods that are designed to be nourishing regardless of your special diet — they are free of the top 14 allergens, gluten-free, and we also test for the 400-plus pesticides, herbicides, and some cases, heavy metals.

And 90% of our ingredients come from the U.S. Because the supply chain is shorter, we know the co-op farms we buy from. Purity tastes great. Give them a try!

Do you sell wholesale to chefs at convention centers?

We sell wholesale and also for events. We were kind of a darling of the corporate campus because we are so allergy- and diabetic-friendly — we meet so many needs. So when chefs get requests for people with allergies, ZEGO is kind of an easy go-to because our stuff is always delicious and it’s always clean.

We are very easy to buy direct from, and we love working with people.

Our mission of bringing more transparency to the food system so that people can be their best selves is directly tied with how big and prominent the company can get. If we can show other companies that ZEGO is successful because people are demanding and valuing transparency, they will start to imitate what we’re doing. And that’s when we really start to move the needle.

If we can get consumer demand going, we can turn this industry around pretty quickly.

LISTEN to the interview with Colleen to learn more and hear directly from her about how to know what’s in the food you serve on the Eating at a Meeting Podcast: