the GRAS is always greener

what a "loophole" looks like at the FDA and what happens when it disappears

Robert Kennedy Jr., our current Secretary of Health and Human Services, has aimed his sights at a litany of issues in our food system. Seed oils, food dyes, and ultra-processed foods are at the top of the list, and each of which fall under the GRAS framework in the FDA. Outside of the food founders and food lawyers that make up my subscriber base (hey friends 👋), it’s unlikely many folks know what GRAS, or “generally recognized as safe”, status is or where it’s come from. We’re going to check out its origins and why RFK is questioning its validity in the new FDA.

In a nutshell, an ingredient or “additive” needs premarket approval for it to enter the US food supply. The food needs to be on the GRAS list, otherwise, you can’t use it in mass produced food (though what’s eaten in your home kitchen stays in your home kitchen, ya filthy animal).

The Second World War created many technological advancements in food production when countries mobilized for conflict. Using processes other than canning to create whole meals required new and different ways to preserve food. The 1940’s were a boom in industrial chemistry whose blast zone gave us new chemical preservatives, emulsifiers and artificial colors and flavors to ensure troops were well-fed and ready to fight. The familiar smell and taste of home coming from a tin can was an incalculable morale boost for the trials of war. These technological advancements didn’t just serve wartime needs, they reshaped how food was produced and consumed at home.

As servicemen and women came back, they and their families found that these difficult years had conditioned them to liking rationed and shelf-stable meals. The first mass-produced frozen meal came out in 1953 by Swanson (still hanging on by a thread). The founder, Gerry Thomas, had 260 tons of frozen turkey sitting on railcars after Thanksgiving (talk about leftovers, am I right?). By using the double belt freezer, invented in 1925, Thomas and his bacteriologist, Betty Cronin, found how to make whole family meals in a tray and instruct consumers to heat them up to kill any harmful microbes. They began marketing them as “TV dinners” as more women entered the workforce and were no longer toiling in the kitchen to cook for their families.

Mass food production no longer had Uncle Sam as its sole buyer. With huge expenditures on food manufacturing equipment meant for soldiers, this industry had to target the civilian market. Supermarkets were new and they optimized for long shelf lives and ease of transportation, further requiring these new chemicals. Between changing consumer sentiments, a new and inclusive economic reality, and new one-stop food shops, consumer packaged goods became big business.

seed of doubt

Within the same decade, food scientists and nutritionists started questioning the safety of these food additives. While margarine had been around since the 1870’s, the process of partial hydrogenation in the 1910’s boomed during wartime and followed into this confluence of consumer habits and economic shifts. The issue was partial hydrogenation creates trans fats, and David Kritchevsky began linking these compounds to heart disease. The FDA had allowed scores of new artificial colors to be used in food, without checking their toxicity. Sulfites began being used as a mode of food preservation in wine and fruits causing asthma attacks and allergic reactions.

Something had to change.

In 1958, the Food Additives Amendment established the GRAS determination of foods. It allowed ingredients with a long history of safe use (like salt, etc.) or scientific consensus to bypass the FDA’s premarket approval process. The new framework enabled FDA scientists to investigate the toxicity of new additives and do longer term studies to see how they affect rat models. Some of these additives were banned and others were deemed safe and everyone lived happily ever after.

mowing down approval times

Not quite. The FDA was being overrun with food industry requests for new food additives that they swore were chill, but they still needed premarket approval. By 1997, it got to such a point that a new framework was made: the self-affirmed GRAS approval.

this is probably how it happened in DC

Oh baby - this is what get’s RFK’s blood boiling because the FDA has essentially gone back to a new form of the pre-1958 framework. The self-affirmed GRAS is what you expect it to be: companies conduct their own safety studies using independent expert panels and voluntarily submit a report to the FDA. After review, the agency will not confirm that you are on the GRAS list, but rather, does or doesn’t deny you from selling your products. Weird little turn of phrase there. The enemy of my enemy is my friend. Denying denial is acceptance.

fresh pastures of policy

RFK doesn’t seem to take umbrage with the idea of GRAS, just self-affirmed GRAS. I’ve worked on these types of applications in my previous jobs and it feels weird to have the reins in your hands as to whether you can sell your products or not. I need to repeat, that the FDA still does review these applications and it’s not simply cobbling together a one-sheeter on why you don’t think your new ingredient will kill someone. It requires money, time and knowledge of what to look out for to keep consumers safe. Killing consumers is bad for business and morally wrong.

At the same time, it’s a permeable roadblock to innovation, which has stalled (I wrote about this a few weeks back). New food sources that haven’t been in the food system, like species of fungal mycelium, cell-based meat, and others have to be rigorously tested before going into the marketplace. Venture capitalists won’t cut a check if you don’t have an eye towards getting this, but also know that some of their funds will be burnt up in animal toxicity studies. Eliminating this process and having to apply directly to the FDA for GRAS status will put us right back where we were in 1997. It’s not like we’re adding more government employees to this institution to make this older path more viable, but actively cutting many of them.

Eliminating the self-affirmed GRAS will be tough. Senators and many, many, many different organizations have sought to cut this statue from the agency, to no avail. As a business owner myself, I can’t help but wonder what would replace this effectively. As a slow food advocate and a consumer, I want to trust the brands and companies that are looking to shake up the industry and not question whether my smoothie is going to damage my organs and post up in a hospital bed. What makes this new push for its demise any more potentially successful? As RFK takes aim at self-affirmed GRAS, the bigger question remains: can we balance innovation and food safety without stalling progress or putting consumers at risk?