There are three ways ingredients get to be legally used in food in the US. Those pathways are governed by the FDA, and they are unsettling.
As food innovators, you are formulating nutritious, simple foods that people want. You bring them real food in a convenient way. How do you know a new natural ingredient you are using is safe?
Let’s look at the pathways to clearing a food ingredient and if we have learned anything since the rash of recalls and food borne illness outbreaks last year.
Some background: Our 2021 - 2022 food safety record was so bad, FDA commissioner Robert Califf hired the Reagan Udall Foundation to tell us that the human food part (the F in FDA) needs an overhaul – which no one disagrees. Here’s a poll:
All we know is that we will be getting someone who will head human foods, but so far, nothing.
Case study: Remember Daily Harvest? I wrote about their French Lentil & Leek Crumble which caused hundreds of people to fall ill (see quick summary here). What was then speculation has been confirmed that an ingredient (tara flour), which is not approved by the FDA, and sounds similar to a different ingredient (tara gum) that has legal status for use in food, was the culprit. The close-sounding ingredient went through an exception called GRAS status (Generally Recognized as Safe) with the FDA.
So that’s it. GRAS status will save us! But will it? Wait, what is GRAS?
GRAS is one of the three ways ingredients get to be legally used in food, none of which are great. The three ways are:
1. FDA Approval – is a rigorous process which involves scientific review and time for public comments. It can take years and costs a lot of money. In the past 20 years, only 10 new food additives have been approved through this process.
2. GRAS Status – is an exception from FDA approval. It means that a substance can be generally recognized as safe if qualified among experts with scientific training and experience to evaluate its safety. In the past 20 years over 500 food additives have achieved GRAS status.
3. Prior Sanction – refers to substances that were approved for use in food before the 1958 Food Additives Amendment.
Clearly GRAS is the most common method for new food ingredients to enter the market, but here’s the thing – it’s optional to convene a GRAS panel and it’s also optional to submit findings to the FDA for evaluation. Furthermore, of the companies that do submit findings, the FDA’s evaluation response can take up to a year, meanwhile a manufacturer can market the product which can end up in food.
As an example, Anderson Advanced Ingredients has been marketing FiberSmart, a low glycemic sweetener used in a multitude of products, since 2015, but only recently received recognition by the FDA as GRAS. !!!
Said in another way: An ingredient can be marketed and used in food as GRAS with no FDA evaluation. Let that sink in.
The takeaway: As is the case so often in entrepreneurship, you need to “trust but verify” everything about your business, including new ingredients.
The additional due diligence in quality assurance you may want to do involves answering for these questions:
· How long has the ingredient been in circulation?
· Who else is using it?
· Does the intended use of the ingredient match how you will be using it?
· Have there been any outbreaks or recalls? (check FDA database)
As always, talk to a food safety professional before launching new products or working with new ingredients. The EAS website is a good place to learn more, and they have consultants to help you along the way.
All my best,
Jennifer
NEWS
When it goes right and when it goes wrong with two meals cos.
The news on Tattooed Chef was not surprising to me. They raised on a SPAC and went on an acquisition spree. This is immensely difficult for even big CPG. On the other hand Kevin’s skyrocketed right under our nose. Their secret? I can’t say for sure but I bet it included focus, execution, and a value prop in clean, sous vide meals otherwise not found in refrigerated.
“Many marketers are flummoxed by shoppers ‘trading down’ to store brands. But, very often in our data, we find that the reason a shopper might opt for store brands is actually not due to the reason most assume: low prices. Rather, many shoppers – in this highly verbal mindstate – simply perceive that store brands dispense with the puffery, and simply state in plain language “what this is” (peanut butter, sauce, tea, and so on).”
