US patchwork of additive bans: Will food manufacturers be forced to come up with a different formulation for different states?

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Unsurprisingly, the current state of play in the US is causing deep concern in the food industry: especially for those producers that sell products across multiple states. It's turning into a quagmire to stay ahead of the latest regulatory developments and how they impact a product portfolio: do we reformulate or not, how will this affect prices, what are the risks, what are the consequences…

In October last year, California became the first state to prohibit the use of four food additives and since then, New York, Illinois, Missouri, Washington State, South Dakota and Pennsylvania have followed suit. Like a domino run gaining pace, states across the US are joining the brewing skirmish to wrest control of food additive regulation from the feds.

If passed, the new bills will take effect on January 1, 2027, and would end the sale, delivery, distribution, holding or offering for sale of foods containing any of the food additives, along with a raft of food dyes, in each state.

New York’s prohibition would take effect two years sooner in 2025.

With the so-called ‘patchwork of state-imposed additive bans’ placing the food industry on a knife edge, it’s not surprising many are turning to regulatory platform partners, such as RegASK, which uses AI to stay on top of the latest developments. Bakery&Snacks chatted to CEO Caroline Shleifer.

What is currently happening in the US?

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Pic: GettyImages/Jorgenmac (Jorgenmac/Getty Images/iStockphoto)

The situation is a bit unusual. We’ve seen the ban of four food additives [brominated vegetable oil (BVO), potassium bromate, propylparaben and Red 3] by California, followed by New York banning seven food additives [azodicarbonamide, BVO, butylated hydroxyanisole (BHA), potassium bromate, propylparaben, Red 3 and titanium dioxide], which will reverberate far beyond the state’s border.

We’re seeing a kind of a domino effect [Illinois, Missouri, Washington State, South Dakota, Pennysylvania] – and we’re talking about big states and those that are very important for manufacturers. So, those who are complying are puzzled about what’s coming next.

Do you believe the US Food and Drink Administration (FDA) has dropped the ball?

I don't think the FDA has dropped the ball, but it definitely doesn't have all the resources that would be required to follow all these aspects.

All of these additives – except BHA – are banned in Europe.

The first bill that is prohibiting the use of the seven in foods and drinks sold in New York, for example, will take effect in 2025, which is pretty soon for food manufacturers. The second bill would require companies to disclose to the State of New York when they add chemicals to food and drinks – even those typically self-determined with the GRAS (Generally Recognized as Safe) status.

Will it be challenging [for food manufacturers] to implement this in such a short time, and will it mean they will need to reformulate a product to comply nationwide or will there be different formulations depending on different states?

That’s hard to answer because we don’t know yet how these regulations will be enforced, but it’s likely to incentivize the FDA to catch up and potentially preclude the use of some of these chemicals nationwide,

It’s a pretty uncertain situation. The FDA does have a reputation of being a bit slow, but it is also restructuring – and with this year’s political elections, it’s really something that will need to be closely monitored.

What are the repercussions going forward for both the country and the food industry?

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Pic: GettyImages/bowie15

It’s going to be complex for manufacturers to make one product for, say, California and another for another state, so this is going to be a challenge.

Will this mean there’ll be less product innovation for a while? On the other side, there’s the accessibility to these products. And how are these regulations going to be enforced? How are they going to monitor what’s happening?

The responsibility will apparently be more on the manufacturer and the easy route would be to reformulate for the ‘most strict’ of regulations, but that will require a lot of work and could imply there could be a spike in terms of prices for the consumer.

There’s a positive advantage in the validation of the safety of ingredients, but it probably could slow innovation and mean higher prices. And let’s not forget the risk of class actions and lawsuits that could potentially start to arise. I would say the environment is definitely more uncertain than it was few years back.

Why do you think some of these additives were allowed for use in the US, yet banned elsewhere in the world?

In the US, there’s the GRAS principle (Generally Recognised as Safe), meaning if a manufacturer does the research and their studies show an ingredient is safe, the FDA doesn’t check unless there’s a problem later on or lawsuits.

The FDA has a more hands-off approach, whereas in Europe, you have the FSA (Food Standards Authority), which monitors everything around food safety and regularly revisits an ingredient or additive even if it has been approved, if there are more recent studies that show some negative impact to the health of consumers.

How do you see this scenario playing out?

It started with California, then New York, then Illinois followed, so we’re really starting to see the domino effect happening and it’s very likely that more states will enact their laws and regulations.

Some big companies may decide to challenge the states in court, but that will take time.

It’s really important to closely monitor what's happening as things are changing very fast.

How can RegASK help?

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Pic: GettyImages/NanoStockk (NanoStockk/Getty Images)

We’re an AI-driven platform that enables end-to-end intelligent regulatory intelligence and monitoring.

Because regulations are a moving target, it’s often challenging to stay ahead of the curve.

Our advanced AI technology immediately alerts you to any anticipated update to a regulation anywhere in the world. It’s not only in the US. Regulations vary from one country to another: different European countries have their own regulations and it’s the same for Asia.

When you want to launch a product in multiple countries, you need to be aware of how your formulation – and also your label – will be impacted or is compliant.

Most of our clients say they spend between 30% to 60% of their time trying to understand which regulations are applicable and making sure they’ve not missed anything. And they usually rely on Google, good sense or connections; and answers that come back on email or in SharePoint or Excel. This puts you at high risk of missing something important. And of course, if you miss something, then you are at risk of non-compliance, which means a risk of losing a shipment, having a product recall or worse, a lawsuit.

And by the time you’ve monitored how the regulations impact your product, another change might have happened.

The technology we’ve developed helps companies do this work with less effort by monitoring countries and product categories at the same time. We also leverage the ‘crowdsourced’ knowledge of our expert network to understand the impact, the level of risk, what to do to become or stay compliant and so forth.

We work with companies of all sizes – from large food manufacturers to smaller ingredient producers – to find a harmonized formulation or label that would work for several countries or across several states.

If you’re aware of the changes in advance, you can preempt them – and it can become a competitive advantage. We send notifications when a regulation that matches your interest changes or is likely to change. We also send you an outline on what has changed about the law and how it impacts you; and will even provide advisory on steps to take to address a potential lapse in product compliance.