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Novel Food Ingredient

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Taimie L. Bryant uses the lens of a particular innovative plant-based food company’s decision to test a novel food ingredient on animals as a means of considering more generally whether any food producer has rational legal reasons for testing on animals.

Image courtesy of interviewee. March 8, 2024

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This video video discusses the motivations behind animal testing by innovative food companies, particularly contrasting two companies: Beyond Meat and Impossible Foods. The speaker initially sought to understand why new companies would test on animals when others, including long-established brands, do not. They explored reasons such as perceived marketing advantages, FDA regulations, and liability concerns, ultimately finding that FDA rules do not mandate animal testing.

Comparing Beyond Meat, which achieved success without animal testing, to Impossible Foods, which conducted animal tests for a novel ingredient, the speaker highlights different approaches to safety assessments. The FDA allows companies to self-assess the safety of new food ingredients, creating room for controversy over potential conflicts of interest.

The research focuses on consumer perceptions of animal testing, revealing that most consumers prefer products not tested on animals, regardless of their knowledge of testing methods. Participants indicated a desire for labeling related to animal testing.

The article concludes with a call for collaboration between consumer safety and animal protection organizations, emphasizing the need for alternative testing methods that do not harm animals. It advocates for more reliable, non-animal testing approaches and urges consumer organizations to push for transparency regarding animal testing practices in food production. The speaker expresses hope that this research will be valuable in promoting animal welfare and consumer safety.

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X-TIMESTAMP-MAP:LOCAL=00:00:00.000,MPEGTS=900000

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I became interested in the question of why a new,

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extremely innovative food company would

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do testing on animals when other companies

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that have been long established and other new

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and innovative companies were not testing on animals.

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So I wanted to know if this, the, the new companies

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that test on animals were doing so

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because they thought it would give

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them a marketing advantage.

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Did they think that the FDA rules required it?

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Were they trying to avoid liability at the state level,

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consumer protection type, litigation?

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What was going on that we would see this difference between

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and among the companies?

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So I started with what the companies said,

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and the company said that, FDA rules

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required animal testing.

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But when I looked very deeply into that question, I learned

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that FDA rules do not require animal testing.

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And so I needed to look further about

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what the motivations could be.

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Now, the study takes into account two different companies

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to contrast them and contextualize the research I was doing.

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One is the Company Beyond Meat, which came out with this

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replica of a hamburger, Patty

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in 2015.

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It did so without, doing any testing on animals

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and fully met FDA requirements.

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The product was received very well by consumers.

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It even had the mouth feel flavor

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and bleeding properties of a real hamburger patty.

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Um, in 2016, impossible Foods came out with

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a burger called Impossible Burger, which

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unlike Beyond Meat's product, involve some animal testing

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because it had a novel genetically modified,

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organ organism in the, production process.

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They couldn't get the bleeding property

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without modifying genetically a yeast

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that could feed on beet root to produce that red color.

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And it also gave a distinctive taste that would be more like

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Hamburger Patty.

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So,

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the Beyond Meat Burger did not involve animal testing

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because it did not involve a novel food ingredient.

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So it could pass FDA requirements very easily

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because there was no novel food ingredient

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that needed to be tested.

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But impossible foods needed to assess the safety

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of this ingredient that they were using, which was novel.

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Alright, so FDA rules require that,

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such a novel food additive be assessed for safety.

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And if the,

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scientific community agrees that it is a safe product,

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the company doesn't even have to notify FDA,

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they can just put it on the market.

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They don't have to go through any approval process

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before point of sale.

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However, impossible Foods thought

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that there would be an advantage to getting what is called

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a no questions letter from the FDA

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and A No questions letter says in effect

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that this company has submitted this assessment of safety

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of a particular product.

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And we agree that with the process they used,

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they have established, sufficiently

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that the ingredient is safe.

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The FDA doesn't repeat any of the work,

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it just reviews the work that's been done.

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Now, let's say that Impossible Foods submitted

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the request for review

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and a no questions letter to be issued.

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And the FDA said, you know what?

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We don't think that the work

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that you did actually supports your claim

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that it's a safe product.

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We, we, we can't tell that from this, then

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the Impossible Foods would've had the opportunity

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to just simply withdraw their petition

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and put this product on the market anyway,

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because there's no requirement to get FDA approval.

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They could also have negotiated with FDA in order

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to work out a test protocol

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that could meet FDA requirements.

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Instead, what Impossible Foods did when they,

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got a little bit of pushback from FDA was to decide

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to do animal testing,

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and they, subcontracted that to

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a product testing company.

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And that product testing company tends

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to use animal-based tests.

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And FDA guidelines allow for such tests,

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and that would be the fastest way to get

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that product to market.

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So, if the testing company had a suite

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of non-animal tests

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or Impossible Foods had worked

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with an organization like peta, which maintains a division

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of scientists to help companies meet the requirement

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of safety assessment without testing on animals.

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If they had done those either of those things,

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they could have avoided animal testing.

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But that could take some time if they are going to go

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through an organization with scientists

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to help them negotiate with FDA as to what would be okay,

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and working with a test product testing company

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that has animals already in cages

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and is able to do this work more quickly.

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And the tests are covered by FDA guidelines as guidelines,

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not requirements, then Impossible Foods could get their

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product to market much more quickly.

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In 1958, when the Food Drug

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and Cosmetic Act, FDCA was amended,

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there was a new requirement placed on FDA to assess

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the safety of particular types of additives to food

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and novel food ingredients.

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That is, they haven't been consumed

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by consumers regularly up to that point, fell into the class

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of substances that FDA needed to review.

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Well, it turns out there are a lot of them.

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There are a lot of these chemicals.

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They were, there were already a lot when the law

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was, amended.

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And now in the context of GMO foods,

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we're seeing even more,

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novel food ingredients coming into, the marketplace.

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And so if FDA had to do all of those assessments themselves,

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we would see the need for great expansion of the FDA at,

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at considerable cost and at considerable time.

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So what the FDA ultimately decided to do

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and finalized this role in 2016, was

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to allow companies to voluntarily notify FDA

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of their having done the safety assessment

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that is FDA wouldn't do the assessment.

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A company would be responsible for doing the assessment.

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And if they wanted their ingredient to be listed so

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that others could learn about the fact that it had gone

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through a safety assessment process,

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then the company could contact FDA

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and request that no questions letter that I mentioned.

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They didn't have to do that.

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FDA left it totally up to companies to make these decisions.

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Now this created some controversy.

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And so there was pushback both in lawsuits

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and also with proposed legislation to require FDA

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to do these assessments themselves

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because it seemed to many people inappropriate

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for the companies wanting to sell these products

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to be the ones doing the safety assessment.

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And the fear was that companies might take shortcuts

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and might use tests that were

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less reliable simply because they were faster.

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Okay? So FDA issues this, these guidelines

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for this kind of assessment in something

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called the Red Book.

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The most recent version of the Red Book is in,

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came out in 2000.

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And this version of the Red Book states clearly

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that animal tests are not required

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and states clearly that the science

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of doing safety assessments should be reflected in

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how companies actually do these things.

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And as science evolves

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and more techniques are developed,

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they should be used if they provide more reliable results.

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At the same time, the guidelines for each of the types

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of assessments that are necessary,

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the these guidelines will give an example

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that is an animal-based test.

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So if a company wants to most quickly move

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through the process, they might gravitate towards using one

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of those tests because

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after all the FDA has mentioned it as an example.

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So only a company

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that can readily find an alternative test that

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meets the same safety assessment rigor,

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that the FDA requires,

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only in those cases would accompany be likely

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to choose a different kind of test.

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Okay, so that raises a question of

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how reliable animal tests are.

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And now we have,

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because of the developments of alternative test methods,

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not just in this country, but in Europe for example,

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we have a variety of methods.

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And not only is animal welfare implicated,

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but consumer safety is at issue

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because many of those non-animal tests

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lack the validity, the scientific validity

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of the non-animal tests.

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So in those cases where that situation exists,

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consumers receive a less safe product

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if the company relies on animal testing

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because their subcontractor safety assessment company uses

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animal testing or

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because they really want just very quickly to get

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through the process and don't wanna have to negotiate

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with FDA about whether a particular non-animal

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test meets their standard.

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Now, organizations like peta, it's not the only organization

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that does this kind of work regularly meet

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with FDA evaluators of these notifications

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that companies set.

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And so these organiza organizations are actually,

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educating FDA officials about what could be acceptable

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as a safety as assess assessment measure.

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Um, so there is progress FDA looks at

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that learns about these things,

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but it's a time consuming process. So

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If a company that has no obligation to notify FDA at all

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simply uses a test that appears in the guidelines, they will

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shortcut the process, the length of time it takes in order

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to get a product to market.

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So FDA guidelines clearly state

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that animal testing is not required,

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and that was confirmed in subsequent litigation.

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There is room for optimism

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that the culture at FDA will change

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because in 2022,

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a law was passed called the FDA Mod Modernization Act

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2.0, which removes

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FDA's prior mandate to test

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new pharmaceutical drugs on animals.

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They might still be used if the company

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and FDA think that that is state of the art for assessing,

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the pharmaceutical in question,

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but they need not if the company shows that another method

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will provide the type of rigor that the safety assessment

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or the dosage standardization assessment requires.

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So part of what's happening as a culture in companies

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that they use,

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product safety assessment companies not in-house,

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and those assessment companies may not have within their

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repertoire a number of alternative tests

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and instead rely on animal tests.

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Another piece of this is the culture at FDA, which is used

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to receiving these kinds

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of notifications based on animal tests.

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So companies can look for

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non-animal testing options.

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They can also work with FDA to change the relationship

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between FDA's assessment of animal

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based testing and non-animal based testing options.

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They can also look to Congress to try to, change this

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configuration of, test expectations.

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I think since they're only guidelines at this point,

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I thought that one thing that might be animating a company's

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decision to do animal testing was concern about

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consumer safety laws at the state level.

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Up to this point, I've been talking about federal laws.

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So would there be any incentive stemming from concern about

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consumer or originating litigation at the state

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level at this point?

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These kinds of questions about food safety are addressed

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by the FDA.

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Under federal laws.

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There are many of these law,

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there are at least three of these laws.

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And tellingly, they preempt state law.

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So somebody, a consumer who eats, a,

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a burger with a novel food ingredient in it and,

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and then feels ill

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and thinks it's attributable to the manufacturer,

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having used a novel food ingredient, may want

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to sue under federal law,

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but doesn't have standing, doesn't have the legal ability

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to sue under federal law

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because the FDA is the one

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that has enforcement power, not consumers.

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So the most that someone can do is file a complaint

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with FDA, that they have been harmed by this product.

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But even that route is problematic

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because they're going to have to show causation.

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And if somebody consumes that burger, the evidence

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will pass through the digestive track

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and really not be available for review most likely.

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So even in the few instances where there's

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a a, a place where consumers can seek relief,

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either because they go to the FDA with a complaint or

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because there's a little window

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of opportunity in those federal laws,

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they are still gonna come up against this hurdle of having

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to show that this product

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and this ingredient in this product

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resulted in the injury they're complaining about.

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And this turns out to be extraordinarily difficult.

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So we don't see any litigation really.

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We've seen one case about, an ingredient in popcorn

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microwave, popcorn diacetyl, which has been shown

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to injure people if they're exposed to it heavily

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and over a long period of time, which is the case with

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employees who work in microwave popcorn companies.

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So ultimately, there's a consumer who consumes a lot

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of microwave popcorn, develops,

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lung problems similar to those of employees in popcorn,

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microwave, popcorn companies,

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and the court when finding that the plaintiff

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could go forward, set based that on the epidemiological,

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the human based evidence from those employees

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in microwave.

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Popcorn companies did not rely on animal testing.

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So that's the only case I could find.

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And scholars in the field are seeing,

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we don't see this litigation

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because causation is a huge problem.

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So given this scenario, given this landscape, a company

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would be irrationally risk averse to, to

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test on animals to avoid a lawsuit,

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that just is not going to happen.

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And so suppose, suppose they are that risk averse.

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Um, how would a court look at this kind of

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evidence based on animals?

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Well, we just don't have this kind of evidence about food,

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but we do have it about pharmaceuticals.

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So we do have litigation about

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companies using animal testing in order to

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assess the efficacy of a drug to assess the safety

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of a drug, those kinds of, of of tests.

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And we find courts thinking, why are you,

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why are you testing on animals who are not like humans

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in all relevant respects?

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And you are giving animals massive doses that don't

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replicate the amount that a human would be taking in?

18:47.265 --> 18:49.445
And why are you putting this in front

18:49.445 --> 18:53.605
of us when there is viable epidemiological evidence

18:54.755 --> 18:57.885
available that does not support,

18:58.155 --> 19:00.165
your claim about safety?

19:00.985 --> 19:04.885
It could go the other way that, you know, somebody may want

19:04.885 --> 19:08.045
to use animal tests to show that the company

19:08.795 --> 19:10.325
avoided a responsibility,

19:10.905 --> 19:15.245
but courts are not very receptive to animal testing

19:16.185 --> 19:19.845
if the test doesn't take into account

19:20.655 --> 19:22.245
these kinds of variables.

19:22.465 --> 19:25.725
The differences between the species used and the human,

19:26.425 --> 19:30.605
and also fails to fully consider epidemiological data,

19:30.735 --> 19:32.765
which doesn't rely on animals at all.

19:33.625 --> 19:37.405
So if you are irrationally risk averse as a company

19:37.865 --> 19:41.645
and you decide to do animal testing despite the low,

19:41.825 --> 19:44.925
extraordinarily low probability of litigation,

19:45.825 --> 19:49.005
you are likely to be in a situation with a court saying,

19:49.445 --> 19:50.645
I don't like your evidence.

19:51.065 --> 19:52.925
I'm not going to accept your evidence.

19:53.385 --> 19:56.245
So I could find no reason for a company

19:56.625 --> 19:58.325
to be doing animal testing

19:58.665 --> 20:01.325
to avoid a problem at the state law level.

20:01.975 --> 20:04.045
Third piece of my project was

20:04.145 --> 20:08.205
to consider whether there was a marketing advantage that is,

20:08.255 --> 20:11.165
would consum would consumers believe

20:11.195 --> 20:12.845
that a product was safer

20:12.875 --> 20:15.005
because it had been tested on animals?

20:15.745 --> 20:18.925
So I wanted to know consumers perspectives

20:19.535 --> 20:23.325
about animal testing in, in these contexts,

20:23.385 --> 20:27.885
but I narrowed it to the question of animal testing

20:28.705 --> 20:32.525
on novel food ingredients in plant-based burgers.

20:33.205 --> 20:34.245
I chose burgers

20:34.245 --> 20:39.045
because as our survey indicated, 98% of those people

20:39.265 --> 20:43.165
who participated in the study did eat burgers, right?

20:43.665 --> 20:47.325
Um, it was a demographically representative sample.

20:48.025 --> 20:52.365
Uh, almost all, participants eat meat.

20:53.225 --> 20:55.245
And that was fine.

20:55.345 --> 20:57.685
We did not wait the vegetarians

20:57.745 --> 20:59.765
or vegan participants in this,

21:00.035 --> 21:03.805
because my thinking was that the company

21:04.585 --> 21:08.365
was thinking, these are meat eaters we're trying to get over

21:08.385 --> 21:09.805
to plant-based burgers.

21:10.015 --> 21:13.205
We're doing that by making the burger taste just like a

21:13.215 --> 21:14.285
meat-based burger.

21:15.105 --> 21:17.605
And so these people eat meat.

21:17.605 --> 21:19.805
They're not gonna care about testing on animals.

21:20.145 --> 21:22.205
If they did care about testing on animals,

21:22.205 --> 21:23.765
they'd be vegetarian or vegan.

21:24.585 --> 21:29.085
And so, I wanted to test this hypothesis

21:29.085 --> 21:31.565
that a company might be working under, which is

21:31.595 --> 21:33.245
that meat eaters don't care.

21:33.625 --> 21:36.605
So it was a demographically representative sample

21:37.155 --> 21:38.205
with pretesting.

21:38.425 --> 21:41.885
We learned that we, with the particular instrument we used,

21:41.885 --> 21:46.805
that we could get a statistically valid survey if we did it

21:46.805 --> 21:51.405
with, maybe 300, but we doubled that for 600 people.

21:52.145 --> 21:57.045
And what we presented to them was three choices of burgers.

21:57.545 --> 21:58.765
In one of them.

21:59.585 --> 22:03.685
The, novel ingredient was tested on animals,

22:03.705 --> 22:05.325
the animals experienced pain.

22:06.185 --> 22:09.785
And the second example was

22:10.645 --> 22:12.945
the novel ingredient was tested on animals.

22:12.965 --> 22:14.985
The animals did not experience pain.

22:15.525 --> 22:18.545
And the third example was a burger produced by a company

22:18.545 --> 22:20.265
that said, I'm not testing on animals.

22:21.935 --> 22:25.065
Some of the study participants

22:26.355 --> 22:30.365
were asked, does the FDA require testing on animals?

22:30.825 --> 22:32.405
And most people did not know.

22:33.545 --> 22:37.205
Um, we asked some of the participants

22:37.205 --> 22:40.165
because we wanted to see the effect of knowledge

22:40.185 --> 22:41.965
of animal test methods.

22:43.155 --> 22:44.735
We asked some of them, do you know

22:44.735 --> 22:47.295
what animal tests are typically like?

22:47.795 --> 22:50.015
And with some of them, the question set

22:50.495 --> 22:51.615
educated them about it.

22:52.195 --> 22:56.255
And what we found was that across the board, no matter

22:56.255 --> 22:59.095
what they knew about the FDA, no matter

22:59.165 --> 23:01.575
what they knew about animal testing methods,

23:02.085 --> 23:03.655
they didn't like animal testing.

23:04.565 --> 23:07.775
They consistently,

23:08.115 --> 23:11.215
at a statistically significant level chose

23:11.915 --> 23:14.735
the burgers whose ingredients were not tested

23:15.315 --> 23:16.775
at all on animals.

23:17.895 --> 23:21.055
I, I guess as the researcher, I was very uncomfortable

23:21.085 --> 23:23.455
with the option of testing on animals,

23:23.635 --> 23:25.055
but they experience no pain.

23:25.605 --> 23:27.095
That is just not how it works.

23:27.995 --> 23:30.975
Animal testing necessarily involves suffering

23:31.115 --> 23:32.455
of various kinds.

23:32.965 --> 23:36.775
However, I really wanted to see if

23:36.775 --> 23:40.295
that would make a difference if the humane treatment aspect

23:40.295 --> 23:41.295
would make a difference.

23:41.355 --> 23:45.925
And it didn't. What surprised me was that,

23:47.195 --> 23:51.485
many people, the, the majority, the strong majority

23:51.585 --> 23:55.325
of people, well over 70%

23:55.835 --> 23:58.765
said they didn't care if the company

23:59.665 --> 24:03.205
or its subcontractors for ingredients

24:03.205 --> 24:04.725
or whatever had done the testing,

24:05.435 --> 24:07.125
they thought it should be on the label.

24:07.945 --> 24:10.925
So going forward, one of the takeaways from the study,

24:11.385 --> 24:15.445
not the only one, but one of the takeaways is that companies

24:16.065 --> 24:19.685
should put on their labels whether they have tested on

24:19.715 --> 24:22.405
animals or not, because it is relevant

24:22.425 --> 24:23.885
to the consuming public.

24:24.945 --> 24:29.045
One of the conclusions I reached as a result of this,

24:29.235 --> 24:33.745
work was that consumer safety

24:34.415 --> 24:38.025
organizations should be concerned about

24:39.305 --> 24:42.285
the implications of less reliable

24:42.975 --> 24:46.565
tests being used for toxicity assessments,

24:47.235 --> 24:49.725
allergenicity assessments, for example,

24:50.625 --> 24:55.085
and should be on the side of animal protection organizations

24:55.915 --> 24:59.005
seeking to reduce reliance on animals

24:59.585 --> 25:03.645
in context in which really there is no nothing to be gained

25:04.425 --> 25:06.005
by involving animals.

25:06.545 --> 25:07.885
And animals suffer

25:08.545 --> 25:12.165
so tremendously from being used in this way.

25:12.865 --> 25:16.165
So here we have the possibility of a productive alliance

25:16.715 --> 25:21.205
that stands the public in better stead than they have been

25:21.395 --> 25:24.645
because they will get more reliable products.

25:25.105 --> 25:26.605
And a very large majority

25:26.625 --> 25:30.245
of the American public when asked in various surveys,

25:30.785 --> 25:32.485
really supports animal welfare.

25:32.705 --> 25:35.285
Animal protections really cares about

25:35.795 --> 25:39.405
whether there is unnecessary testing on animals.

25:40.225 --> 25:45.205
And so the alliance that's possible, between these types

25:45.205 --> 25:50.085
of organizations strikes me as an underutilized opportunity

25:50.305 --> 25:53.525
to benefit both animals to consumers.

25:54.755 --> 25:58.725
Another takeaway is the need for,

25:59.435 --> 26:03.485
evolution to be pushed a little bit in the direction

26:03.585 --> 26:06.885
of using non-animal based testing.

26:07.865 --> 26:11.845
Now we have all of these kinds of methods of assessing

26:12.785 --> 26:15.085
the different kinds of things we want to assess

26:15.635 --> 26:19.125
without involving inflicting suffering on animals.

26:19.785 --> 26:22.365
And since we have that our laws,

26:22.505 --> 26:25.605
our requirements should actually be,

26:26.125 --> 26:27.325
adjusted to account for that.

26:27.705 --> 26:30.485
So one of the suggestions I make is that the FDA

26:31.945 --> 26:36.445
not require negotiation about the alternative tests,

26:37.265 --> 26:42.045
but require showing that an animal test is the state

26:42.045 --> 26:44.325
of the art for that type of chemical.

26:45.265 --> 26:49.085
So more safe harbors that are non-animal tests,

26:49.605 --> 26:51.925
I think should appear in the Red book, the guidelines.

26:52.825 --> 26:57.805
And I think Congress could expand its footprint in this

26:57.805 --> 27:00.445
area beyond the,

27:01.525 --> 27:06.205
FDA modernization Act 2.0 by including this type

27:06.205 --> 27:10.405
of testing as well as the what that law covers,

27:10.615 --> 27:14.565
which is testing of, pharmaceutical products.

27:15.425 --> 27:20.405
So the final takeaway that means a lot to me as somebody

27:20.625 --> 27:21.725
who works in this field

27:21.785 --> 27:24.245
and cares about animals is the need

27:24.245 --> 27:28.125
for animal protection organizations to stand up

27:28.125 --> 27:32.445
and tell people this product involves animal testing.

27:33.795 --> 27:37.655
But what we saw in the cases that I'm describing now,

27:39.165 --> 27:42.855
what we saw, what we heard was silence from most

27:42.855 --> 27:44.215
of those organizations

27:44.605 --> 27:47.255
because of a belief that it was better

27:47.275 --> 27:50.535
to get plant-based burgers on the market than

27:50.675 --> 27:54.015
to say something critical that could slow down progress.

27:54.795 --> 27:57.775
And I think that that is misguided perspective.

27:58.735 --> 28:03.405
I think that animal protection should not, does not need

28:03.405 --> 28:07.965
to be sacrificed for advances that benefit all of us,

28:08.235 --> 28:12.125
including animals, including the planet, including

28:12.835 --> 28:16.925
species that are not considered food animals at all.

28:17.825 --> 28:21.085
So those were the things that I derived from the research,

28:21.265 --> 28:22.845
and I hope that now

28:22.845 --> 28:25.685
that the article is living its life out in the world,

28:25.955 --> 28:28.445
that others see value in it as well.

00:00 - I became interested in the question of why a new, extremely innovative food company would do testing on animals when other companies that have been long established and other new and innovative companies were not testing on animals. So I wanted to know if this, the, the new companies

00:24 - that test on animals were doing so because they thought it would give them a marketing advantage. Did they think that the FDA rules required it? Were they trying to avoid liability at the state level, consumer protection type, litigation? What was going on that we would see this difference between and among the companies? So I started with what the companies said, and the company said that, FDA rules

00:56 - required animal testing. But when I looked very deeply into that question, I learned that FDA rules do not require animal testing. And so I needed to look further about what the motivations could be. Now, the study takes into account two different companies to contrast them and contextualize the research I was doing. One is the Company Beyond Meat, which came out with this replica of a hamburger, Patty in 2015.

01:31 - It did so without, doing any testing on animals and fully met FDA requirements. The product was received very well by consumers. It even had the mouth feel flavor and bleeding properties of a real hamburger patty. in 2016, impossible Foods came out with a burger called Impossible Burger, which unlike Beyond Meat's product, involve some animal testing because it had a novel genetically modified, organ organism in the, production process.

02:13 - They couldn't get the bleeding property without modifying genetically a yeast that could feed on beet root to produce that red color. And it also gave a distinctive taste that would be more like Hamburger Patty. So, the Beyond Meat Burger did not involve animal testing because it did not involve a novel food ingredient. So it could pass FDA requirements very easily because there was no novel food ingredient

02:49 - that needed to be tested. But impossible foods needed to assess the safety of this ingredient that they were using, which was novel. Alright, so FDA rules require that, such a novel food additive be assessed for safety. And if the, scientific community agrees that it is a safe product, the company doesn't even have to notify FDA, they can just put it on the market. They don't have to go through any approval process

03:26 - before point of sale. However, impossible Foods thought that there would be an advantage to getting what is called a no questions letter from the FDA and A No questions letter says in effect that this company has submitted this assessment of safety of a particular product. And we agree that with the process they used, they have established, sufficiently that the ingredient is safe.

03:59 - The FDA doesn't repeat any of the work, it just reviews the work that's been done. Now, let's say that Impossible Foods submitted the request for review and a no questions letter to be issued. And the FDA said, you know what? We don't think that the work that you did actually supports your claim that it's a safe product. We, we, we can't tell that from this, then

04:25 - the Impossible Foods would've had the opportunity to just simply withdraw their petition and put this product on the market anyway, because there's no requirement to get FDA approval. They could also have negotiated with FDA in order to work out a test protocol that could meet FDA requirements. Instead, what Impossible Foods did when they, got a little bit of pushback from FDA was to decide to do animal testing,

04:59 - and they, subcontracted that to a product testing company. And that product testing company tends to use animal-based tests. And FDA guidelines allow for such tests, and that would be the fastest way to get that product to market. So, if the testing company had a suite of non-animal tests or Impossible Foods had worked

05:31 - with an organization like peta, which maintains a division of scientists to help companies meet the requirement of safety assessment without testing on animals. If they had done those either of those things, they could have avoided animal testing. But that could take some time if they are going to go through an organization with scientists to help them negotiate with FDA as to what would be okay, and working with a test product testing company that has animals already in cages

06:05 - and is able to do this work more quickly. And the tests are covered by FDA guidelines as guidelines, not requirements, then Impossible Foods could get their product to market much more quickly. In 1958, when the Food Drug and Cosmetic Act, FDCA was amended, there was a new requirement placed on FDA to assess the safety of particular types of additives to food and novel food ingredients. That is, they haven't been consumed

06:44 - by consumers regularly up to that point, fell into the class of substances that FDA needed to review. Well, it turns out there are a lot of them. There are a lot of these chemicals. They were, there were already a lot when the law was, amended. And now in the context of GMO foods, we're seeing even more, novel food ingredients coming into, the marketplace. And so if FDA had to do all of those assessments themselves,

07:19 - we would see the need for great expansion of the FDA at, at considerable cost and at considerable time. So what the FDA ultimately decided to do and finalized this role in 2016, was to allow companies to voluntarily notify FDA of their having done the safety assessment that is FDA wouldn't do the assessment. A company would be responsible for doing the assessment. And if they wanted their ingredient to be listed so that others could learn about the fact that it had gone

07:59 - through a safety assessment process, then the company could contact FDA and request that no questions letter that I mentioned. They didn't have to do that. FDA left it totally up to companies to make these decisions. Now this created some controversy. And so there was pushback both in lawsuits and also with proposed legislation to require FDA to do these assessments themselves because it seemed to many people inappropriate

08:30 - for the companies wanting to sell these products to be the ones doing the safety assessment. And the fear was that companies might take shortcuts and might use tests that were less reliable simply because they were faster. Okay? So FDA issues this, these guidelines for this kind of assessment in something called the Red Book. The most recent version of the Red Book is in, came out in 2000.

09:01 - And this version of the Red Book states clearly that animal tests are not required and states clearly that the science of doing safety assessments should be reflected in how companies actually do these things. And as science evolves and more techniques are developed, they should be used if they provide more reliable results. At the same time, the guidelines for each of the types of assessments that are necessary,

09:32 - the these guidelines will give an example that is an animal-based test. So if a company wants to most quickly move through the process, they might gravitate towards using one of those tests because after all the FDA has mentioned it as an example. So only a company that can readily find an alternative test that meets the same safety assessment rigor, that the FDA requires,

10:05 - only in those cases would accompany be likely to choose a different kind of test. Okay, so that raises a question of how reliable animal tests are. And now we have, because of the developments of alternative test methods, not just in this country, but in Europe for example, we have a variety of methods. And not only is animal welfare implicated, but consumer safety is at issue

10:37 - because many of those non-animal tests lack the validity, the scientific validity of the non-animal tests. So in those cases where that situation exists, consumers receive a less safe product if the company relies on animal testing because their subcontractor safety assessment company uses animal testing or because they really want just very quickly to get through the process and don't wanna have to negotiate

11:10 - with FDA about whether a particular non-animal test meets their standard. Now, organizations like peta, it's not the only organization that does this kind of work regularly meet with FDA evaluators of these notifications that companies set. And so these organiza organizations are actually, educating FDA officials about what could be acceptable as a safety as assess assessment measure. so there is progress FDA looks at

11:47 - that learns about these things, but it's a time consuming process. So If a company that has no obligation to notify FDA at all simply uses a test that appears in the guidelines, they will shortcut the process, the length of time it takes in order to get a product to market. So FDA guidelines clearly state that animal testing is not required, and that was confirmed in subsequent litigation. There is room for optimism

12:20 - that the culture at FDA will change because in 2022, a law was passed called the FDA Mod Modernization Act 2.0, which removes FDA's prior mandate to test new pharmaceutical drugs on animals. They might still be used if the company and FDA think that that is state of the art for assessing, the pharmaceutical in question, but they need not if the company shows that another method

12:56 - will provide the type of rigor that the safety assessment or the dosage standardization assessment requires. So part of what's happening as a culture in companies that they use, product safety assessment companies not in-house, and those assessment companies may not have within their repertoire a number of alternative tests and instead rely on animal tests. Another piece of this is the culture at FDA, which is used to receiving these kinds

13:34 - of notifications based on animal tests. So companies can look for non-animal testing options. They can also work with FDA to change the relationship between FDA's assessment of animal based testing and non-animal based testing options. They can also look to Congress to try to, change this configuration of, test expectations. I think since they're only guidelines at this point, I thought that one thing that might be animating a company's

14:14 - decision to do animal testing was concern about consumer safety laws at the state level. Up to this point, I've been talking about federal laws. So would there be any incentive stemming from concern about consumer or originating litigation at the state level at this point? These kinds of questions about food safety are addressed by the FDA. Under federal laws. There are many of these law,

14:50 - there are at least three of these laws. And tellingly, they preempt state law. So somebody, a consumer who eats, a, a burger with a novel food ingredient in it and, and then feels ill and thinks it's attributable to the manufacturer, having used a novel food ingredient, may want to sue under federal law, but doesn't have standing, doesn't have the legal ability to sue under federal law

15:23 - because the FDA is the one that has enforcement power, not consumers. So the most that someone can do is file a complaint with FDA, that they have been harmed by this product. But even that route is problematic because they're going to have to show causation. And if somebody consumes that burger, the evidence will pass through the digestive track and really not be available for review most likely. So even in the few instances where there's

16:00 - a a, a place where consumers can seek relief, either because they go to the FDA with a complaint or because there's a little window of opportunity in those federal laws, they are still gonna come up against this hurdle of having to show that this product and this ingredient in this product resulted in the injury they're complaining about. And this turns out to be extraordinarily difficult. So we don't see any litigation really.

16:31 - We've seen one case about, an ingredient in popcorn microwave, popcorn diacetyl, which has been shown to injure people if they're exposed to it heavily and over a long period of time, which is the case with employees who work in microwave popcorn companies. So ultimately, there's a consumer who consumes a lot of microwave popcorn, develops, lung problems similar to those of employees in popcorn, microwave, popcorn companies, and the court when finding that the plaintiff

17:12 - could go forward, set based that on the epidemiological, the human based evidence from those employees in microwave. Popcorn companies did not rely on animal testing. So that's the only case I could find. And scholars in the field are seeing, we don't see this litigation because causation is a huge problem. So given this scenario, given this landscape, a company would be irrationally risk averse to, to

17:47 - test on animals to avoid a lawsuit, that just is not going to happen. And so suppose, suppose they are that risk averse. how would a court look at this kind of evidence based on animals? Well, we just don't have this kind of evidence about food, but we do have it about pharmaceuticals. So we do have litigation about companies using animal testing in order to assess the efficacy of a drug to assess the safety

18:21 - of a drug, those kinds of, of of tests. And we find courts thinking, why are you, why are you testing on animals who are not like humans in all relevant respects? And you are giving animals massive doses that don't replicate the amount that a human would be taking in? And why are you putting this in front of us when there is viable epidemiological evidence available that does not support, your claim about safety?

19:00 - It could go the other way that, you know, somebody may want to use animal tests to show that the company avoided a responsibility, but courts are not very receptive to animal testing if the test doesn't take into account these kinds of variables. The differences between the species used and the human, and also fails to fully consider epidemiological data, which doesn't rely on animals at all. So if you are irrationally risk averse as a company

19:37 - and you decide to do animal testing despite the low, extraordinarily low probability of litigation, you are likely to be in a situation with a court saying, I don't like your evidence. I'm not going to accept your evidence. So I could find no reason for a company to be doing animal testing to avoid a problem at the state law level. Third piece of my project was to consider whether there was a marketing advantage that is,

20:08 - would consum would consumers believe that a product was safer because it had been tested on animals? So I wanted to know consumers perspectives about animal testing in, in these contexts, but I narrowed it to the question of animal testing on novel food ingredients in plant-based burgers. I chose burgers because as our survey indicated, 98% of those people who participated in the study did eat burgers, right?

20:43 - it was a demographically representative sample. almost all, participants eat meat. And that was fine. We did not wait the vegetarians or vegan participants in this, because my thinking was that the company was thinking, these are meat eaters we're trying to get over to plant-based burgers. We're doing that by making the burger taste just like a meat-based burger.

21:15 - And so these people eat meat. They're not gonna care about testing on animals. If they did care about testing on animals, they'd be vegetarian or vegan. And so, I wanted to test this hypothesis that a company might be working under, which is that meat eaters don't care. So it was a demographically representative sample with pretesting. We learned that we, with the particular instrument we used,

21:41 - that we could get a statistically valid survey if we did it with, maybe 300, but we doubled that for 600 people. And what we presented to them was three choices of burgers. In one of them. The, novel ingredient was tested on animals, the animals experienced pain. And the second example was the novel ingredient was tested on animals. The animals did not experience pain. And the third example was a burger produced by a company

22:18 - that said, I'm not testing on animals. Some of the study participants were asked, does the FDA require testing on animals? And most people did not know. we asked some of the participants because we wanted to see the effect of knowledge of animal test methods. We asked some of them, do you know what animal tests are typically like? And with some of them, the question set

22:50 - educated them about it. And what we found was that across the board, no matter what they knew about the FDA, no matter what they knew about animal testing methods, they didn't like animal testing. They consistently, at a statistically significant level chose the burgers whose ingredients were not tested at all on animals. I, I guess as the researcher, I was very uncomfortable

23:21 - with the option of testing on animals, but they experience no pain. That is just not how it works. Animal testing necessarily involves suffering of various kinds. However, I really wanted to see if that would make a difference if the humane treatment aspect would make a difference. And it didn't. What surprised me was that, many people, the, the majority, the strong majority

23:51 - of people, well over 70% said they didn't care if the company or its subcontractors for ingredients or whatever had done the testing, they thought it should be on the label. So going forward, one of the takeaways from the study, not the only one, but one of the takeaways is that companies should put on their labels whether they have tested on animals or not, because it is relevant to the consuming public.

24:24 - One of the conclusions I reached as a result of this, work was that consumer safety organizations should be concerned about the implications of less reliable tests being used for toxicity assessments, allergenicity assessments, for example, and should be on the side of animal protection organizations seeking to reduce reliance on animals in context in which really there is no nothing to be gained by involving animals.

25:06 - And animals suffer so tremendously from being used in this way. So here we have the possibility of a productive alliance that stands the public in better stead than they have been because they will get more reliable products. And a very large majority of the American public when asked in various surveys, really supports animal welfare. Animal protections really cares about whether there is unnecessary testing on animals.

25:40 - And so the alliance that's possible, between these types of organizations strikes me as an underutilized opportunity to benefit both animals to consumers. Another takeaway is the need for, evolution to be pushed a little bit in the direction of using non-animal based testing. Now we have all of these kinds of methods of assessing the different kinds of things we want to assess without involving inflicting suffering on animals. And since we have that our laws,

26:22 - our requirements should actually be, adjusted to account for that. So one of the suggestions I make is that the FDA not require negotiation about the alternative tests, but require showing that an animal test is the state of the art for that type of chemical. So more safe harbors that are non-animal tests, I think should appear in the Red book, the guidelines. And I think Congress could expand its footprint in this area beyond the,

27:01 - FDA modernization Act 2.0 by including this type of testing as well as the what that law covers, which is testing of, pharmaceutical products. So the final takeaway that means a lot to me as somebody who works in this field and cares about animals is the need for animal protection organizations to stand up and tell people this product involves animal testing. But what we saw in the cases that I'm describing now, what we saw, what we heard was silence from most

27:42 - of those organizations because of a belief that it was better to get plant-based burgers on the market than to say something critical that could slow down progress. And I think that that is misguided perspective. I think that animal protection should not, does not need to be sacrificed for advances that benefit all of us, including animals, including the planet, including species that are not considered food animals at all. So those were the things that I derived from the research,

28:21 - and I hope that now that the article is living its life out in the world, that others see value in it as well.

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