Evidence, Regulations, and Low Calorie Sweeteners: How Does Your Food Become FDA Approved?

How on earth do I trust chemicals in my food?!

I’ve mentioned before that, even as a fully trained working scientist, I was scared of some of the things in the food supply. Weren’t there… chemicals?! I’ve struggled with chronic illness myself and there was so much information online that said the food supply made me sick. If you want to read more about that, I’ve gone into it a lot before in this piece, but to sum it up?

I got the worst headache of my life, I was scared that something in the food was causing it, and eventually correct medical treatment helped me be a lot less scared. But I’d be lying if I didn’t say I wasn’t at least a little nervous when I started working as an analytical chemist at a pesticide company. I’d read bad things on the internet.

But… life is made of chemicals, and knowledge is better than fear. Harder, but better. If microscopic amounts of pesticides on my apples had made me sick before, you should have expected something to happen to me the moment I walked into work my first day, but here I am, feeling the same. I realized how tightly regulated the industry was from having to submit my analysis of pesticides to the Environmental Protection Agency (EPA). If I designed a new method to analyze a substance, it had to be reproducible by any other chemist, whether it was in our other facility down the street or another lab around the world that read and wanted to check our results. If our formulations chemists produced a new product, it was tested and analyzed for stability, toxicity, and any possible breakdown.

I worked in a system that made it purposefully difficult to get a new substance to market, and that’s a good thing. I also left that job knowing that before anything in the food supply hits the market, it’s much safer than the average consumer believes it to be.

What’s all the testing for?

From my experience working in industry labs and writing independently on low calorie sweeteners, I could be confident that sucralose- and all LCSs- are heavily tested. Obviously what I tested for in a pesticide lab was different, but both types of labs submitted federally mandated testing, both conducted testing under GLP conditions, and there were hundreds of safety tests required to get to market for anyone under these strict regulations. Just like at my labs, the researchers who performed the tests to better understand sucralose adhered to these standards and presumably care about the health and safety of their loved ones who could consume it. My personal experience makes the evidence I read as debunker-in-chief at SciBabe all the more compelling to me.

So what testing standards does the food industry follow? They quite literally throw the book at it, i.e. the FDA Redbook. It’s a long read, but if you’re curious, make a lot of popcorn, it’s all publicly available. In order to get any food additive to market, they have to go through a process called the Food Additive Petition (and proving once again that I’m apparently twelve, I laughed my ass off when I found out this is abbreviated FAP – as an analytical chemist, don’t even ask how I’ve seen ‘analytical standards’ abbreviated). The sucralose FAP was approved many years after its submission, which should serve as an indicator of the amount of time taken to critically review all the submitted data. In 1998, FDA approved sucralose for use in fifteen common types of food products, including beverages, baked goods, canned fruits, etc. Sixteen months later, based on further research, FDA approved sucralose as a general purpose sweetener, which means FDA found it to be a safe and suitable for any sweetening purpose.

To understand the process of FDA approval of substances like sucralose, you’ll have to wade through some common toxicology acronyms like ADME, NOAEL and ADI. Though sometimes confused with the latest supplements Gwyneth Paltrow is dosing out via enema, they’re terms we use to characterize the potential effects of any substance expected to be consumed. What do they mean, how do we determine them, and what implications do they have for you as a consumer?

ADME: Absorption, Distribution, Metabolism, and Elimination

ADME is the lifeblood of any toxicological analysis. Do you want to know if a substance breaks down at all when it’s metabolized? This is part of the ADME analysis. Do you want to know if any of the substance remains in the body, how long it remains, and if it remains in a way that’s possibly harmful? ADME. Does the chemical break down in the body in ways that it did not break down in stability testing? ADME. This is the testing that really tells you if the substance is or is not safe in real world conditions in the body. Originally used for drug testing and expanded to cover a variety of substances including food additives, the summary of this is that the substance has to go from point A (ingestion) to point B (don’t make me draw a diagram), without causing any biological mischief in between. This includes checking if the substance is broken down in the digestive tract, liver, kidneys, absorbed into the bloodstream, and even if any potential metabolites are dangerous.

NOAEL: No Observed Adverse Effect Level

This is one of many measures determined when assessing the toxicity of a substance. There are a few measurements that people familiar with my writing may have seen by now. This list includes:

ED50: Effective dose for 50% of the population

LD50: Lethal dose for 50% of the population

TD50: Toxic dose for 50% of the population

LOAEL: Lowest observed adverse effect level

LOEL: Lowest observed effect level

ADI: Acceptable daily intake

These terms can have different meanings for different substances. For instance, in the case of a pesticide, the effective dose for a pest is also the lethal dose. However, a safe and effective pesticide needs to be applied to multiple systems sometimes. A well-designed pesticide has to be below the NOAEL for humans, crops, animals (for flea control) and possibly other non-target organisms while still reaching the ED50 for the target pest. In the case of an antibiotic, the ED50 has to be lethal for the target bacteria and safely below the TD50 for the human (or other animal) ingesting it. Often people take medications that are above the LOAEL, as many medications have side effects, but this is not the case with food additives as we’ll see.

ADI: Acceptable Daily Intake

There are a few things to consider when determining acceptable daily intake (ADI) for any food additive. For something like a low calorie sweetener, the ADI is typically derived from the NOAEL, found from studies conducted over a lifetime of consumption. The ADI is a factor of 1/100th the NOAEL. Let’s look at what this translates to in real life.

Low calorie sweeteners tend to have a quality of packing much more sweetening potency by weight compared to their carb endowed counterparts. Because of this, most of the content of a packet of sucralose is actually common bulking food ingredients (it gives the 12 mg of sucralose per packet a workable texture and volume, making the sweetener easier to use). When you read that the ADI is 5 mg/kg bw/d, it may seem either low (or like it’s in another language), but it translates to 340 mg of sucralose for a 150lb person. That’s about 28 packets of Splenda daily. Remember, that’s 1/100th of the amount that produces any known adverse effects, and that’s what the FDA approves for ADI.

Who seriously has 28 packets of sweetener per day every day?!

So after being evaluated for benchmarks like these amongst a huge battery of tests (really, you should check out the FDA Redbook), a food additive can be formally confirmed as safe for use, or in the case of some sweeteners, granted Generally Recognized As Safe (GRAS) status.

GRAS is a fairly misunderstood term, so let’s walk through the process the way we did when I was in school. Hum it with me…

I’m just a… low calorie sweetener?

How do you go from lab notebook to GRAS? When I was chemisting it was a lot of late nights, some swearing, and an occasional call to IT for another printer jam (“yes, Chad, I tried turning it off”). Mostly, there’s a lot of science.

GRAS status sounds like bureaucrat talk for, “this thing is scary and will make you grow a third nipple but we can’t really tell you.” What’s the big difference between passing through FAP and GRAS? In addition to demonstrating safety from passing myriad required tests, a substance accrues a long history of safe usage by consumers and gains consensus among food experts as safe before attaining GRAS status. At this point stevia and erythritol are both GRAS sweeteners. GRAS doesn’t denote that something is just kinda not scary. It means there’s expert consensus that it’s safe.

This isn’t to say that the process is perfect or that the FDA regulations have the market sorted. As with food colorants, sometimes food additives are removed from market in the event that incrementally safer classes are developed. In the case of partially hydrogenated oils, we’ve seen the rare case of a substance’s GRAS status revoked. However, that does show that when there’s clear evidence of harm, products are removed from market.

So I should just trust everything on the market unquestioningly?

I’m encouraging you to ask questions and read up on all the studies and testing I’ve posted about. The arguments that ‘nature is better’ or that our parents’ generation had healthier food is specious considering we’re living longer lives with a class of food that’s been through much more testing and is, by and large, less toxic than ever before. We have more options to balance a healthy and flavorful diet than ever before. Though a lot of the knowledge about the food supply can seem overwhelming, it also means there are evidence based answers if you ask experts for them.

Don’t panic, ask some questions, and I’ll give you my honest answers. Life is chemicals, and that’s just fine. Anyone who tells you different is selling something.

 

-SciBabe

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About SciBabe 76 Articles
Yvette d'Entremont, aka SciBabe, is a chemist and writer living in the San Francisco Bay area with her husband and their pets. With her addiction to crocheting and baking she's sure she would have made a great housewife if it wasn't for her potty mouth.

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