False starting in the stevia race
Stevia is hot. We all know this. Over the past year, it has had industry, analysts, and even consumers buzzing.
This is great; the potential is there, and it promises to benefit all. But over the past few months, people have been getting itchy feet and this has led to some players spilling into the market prematurely.
Notably, the heavy-weights out there – Coca-Cola and PepsiCo – are still waiting patiently at the starting line. What is making them hold back, and why are others ignoring it?
The ‘race’ started in May last year, when we all learnt that Cargill and Coke were developing a new natural sweetener derived from the South American herb stevia. For the next ten months or so, interest gathered in a healthy and civilized fashion.
Supply chains were put in place, ingredient firms set up production, and finished product manufacturers contemplated formulation changes. As we reported back in November, industry was quite simply positioning itself to ride the new wave.
The one drawback was – and remains – the regulatory situation: Stevia is not yet approved for use as a food additive in the two major western markets, Europe and the United States.
In the US, everyone was waiting for Cargill to make the first move and petition the Food and Drug Administration (FDA) for approval. With the path paved, this would have made the journey much smoother and much cheaper for the smaller firms following behind.
But Cargill and Coke were not in the same kind of rush as everyone else. They were going ahead with their product launch in markets where stevia already had approval, such as Japan, Brazil and China, while working through the steps for regulatory approval in other markets, including the US.
This time, though, not everyone decided to wait along with them. In June, Arizona-based Wisdom Natural Brands announced that it had self-affirmed its version of Stevia – Sweet Leaf – as GRAS (generally recognized as safe). This month, another US ingredient firm, Blue California, is expected to announce its stevia sweetener is also self-affirmed GRAS.
In theory, GRAS self-affirmation is a perfectly legitimate route to take. Companies need to conduct all relevant safety tests that prove an ingredient is safe for use in foods and drinks. This is a costly and time-consuming process, and is not taken lightly by anyone because product lines and reputations are at stake.
Nevertheless, many, many food and drink companies are not willing to make the commitment to reformulate unless an ingredient has received FDA GRAS approval.
This doesn’t mean that self-affirmation is any less thorough; it is simply a strategy to ensure all risk factors have been minimized and there is little chance of damage to a firm’s brands or bottom line if FDA comes up with any objections.
FDA affirmation is, of course, more time consuming. The agency says it will respond within 180 days of receiving a notification, but industry has learnt this is an optimistic estimate.
Right now, though, we need to work with what we have, even if it means a little patience.
As it happens, the only two companies to have filed stevia GRAS notifications with FDA are Cargill and Whole Earth Sweetener Company, which is working with PepsiCo to bring the PureVia stevia brand to market.
Coke and Pepsi have too much at stake to rush to market prematurely, and so have resigned to waiting for all the regulatory steps to be completed before making any more moves.
Trying to work around regulations will also do no one any favors. A soda brand sweetened with stevia and labeled a dietary supplement (stevia is currently approved as a supplement in the US) last month blasted that it “leads Coke and Pepsi by a full year in the race to release a soda sweetened with stevia”. The drink – Zevia – is marketed as a ‘carbonated stevia supplement’.
However, regardless of what it says on the label, FDA will also look at the intended use of a product if it falls under its radar. Last year the agency sent a warning letter to Hain Celestial Group, saying its Celestial Zingers To Go tea and drink mixes, which contained stevia, were "adulterated", as they were conventional food items marketed as dietary supplements.
Stevia must not be viewed as a ‘race’ to market, because someone could soon be caught out with a false start. The best way forward is to keep those positions at the ready, and watch the heavy-weights. As the Greeks say, ‘If you’re in too much of a rush, you’ll trip up.’
LorraineHeller is editor of NutraIngredients-USA.com and is a specialist writer on food industry issues. With an international focus, she has lived and worked in the UK, Cyprus and France.
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