Is Vegan Whey Protein Safe?

What FDA Documents Reveal

This article analyzes the safety of vegan whey protein powder.

We cover allergies, genetic safety, chemical safety, and a ton more.

(P.S. Vegan whey is also known as animal-free whey protein and non-animal whey protein.)

Let’s jump in.

This article is based on 24 research papers, 3 regulatory documents, and 1 patent. Last updated: Sep. 13, 2023. See our disclaimer.

This image shows the safety profile of vegan whey protein powder. Caution is warranted for people with milk allergy. More data is necessary to determine the protein safety of vegan whey protein powder. Vegan whey protein powder is likely safe with respect to lactose intolerance, yeast allergy, heavy metals, toxins, chemicals, and genetics.

Summary

Of immediate concern:

  • Milk allergy: people with milk allergy may experience an allergic reaction to vegan whey protein powder.

Of uncertain or lesser concern:

  • Protein safety: the protein in vegan whey is extremely similar—but might not necessarily be identical—to the corresponding protein found in cow’s milk.
  • Lactose intolerance: pure vegan whey protein powder doesn’t contain lactose.
  • Yeast allergy: purified animal-free whey protein powder is unlikely to contain yeast proteins that lead to allergies.
  • Heavy metals: purified non-animal whey protein powder contains very small amounts of heavy metals.
  • Genetic safety: vegan whey protein powder is extremely unlikely to lead to any diseases or disorders as a result of the (unlikely) consumption of genetically modified organisms or their genetic material.
  • Biochemical safety: purified vegan whey protein powder is unlikely to contain toxins, dangerous chemicals, antibiotics, or harmful levels of disease-causing microbes.

Milk Allergy

This image shows that vegan whey is a milk allergen.

Vegan whey protein is not suitable for people with milk allergy and it may lead to an allergic reaction. 1–4

The main whey protein found in vegan whey protein powder is called recombinant bovine beta-lactoglobulin (BLG). 1–3,5

That’s just a fancy way of saying that genetically modified (recombinant) organisms,

Like yeast,

Produce a whey protein (BLG) that is chemically similar to the BLG produced by cattle (bovines).

So if you’re allergic to BLG found in cow’s milk, you’ll most likely be allergic to the BLG found in vegan whey…

Because both BLGs are basically the same, despite being produced by different organisms. 1–3

For details on why they’re chemically similar, see this article:

How is Vegan Whey Protein Made? 3 Ways

Lactose Intolerance

This image shows that pure vegan whey protein powder is lactose free.

Pure vegan whey protein powder doesn’t contain lactose and it will not lead to lactose intolerance. 1–3 However, products that contain vegan whey protein may have other additions or ingredients that do contain lactose.

Therefore,

The only way to be sure if a product with vegan whey protein is lactose-free,

Is to look at the label for any such information or to ask the manufacturer directly.

For ingredient details, see the following article:

The Best Vegan Whey Protein Powders

Yeast Allergy

This image shows that vegan whey protein is unlikely to cause a yeast allergy.

Vegan whey protein is unlikely to cause a yeast allergy in people susceptible to yeast allergens. 1–3

Sure,

Vegan whey protein is made by yeast and other fungi.

However:

During manufacture,

The yeast (and their structural/functional proteins) are largely filtered away from the vegan whey proteins the yeast secrete.

(Related: How is Vegan Whey Protein Made? 3 Ways)

That being said,

No purification process is perfect.

Moreover,

The exact methods used to purify the vegan whey,

And to remove the yeast cells and the yeast proteins out of the final product,

Vary from manufacturer to manufacturer. 1–3

Typically,

The amount of yeast protein that’s left over inside the vegan whey protein powder is small…

Around 0.01%–6.7% of protein content (depending on the details of the manufacture and purification process). 1–3

But we all know that even small amounts of allergens can cause significant reactions in people allergic to yeast proteins.

And FDA documents reveal that some of the leftover yeast proteins found in the vegan whey protein powder…

Are roughly 35%–42.5% similar to known allergens. 1–3

So if vegan whey protein powders contain small amounts of yeast protein,

And some of those yeast proteins are somewhat similar to known allergens,

Then why don’t vegan whey protein powders contain a yeast allergy warning?

It’s because the fungi (including yeast) used for the manufacture of vegan whey don’t appear to cause any allergies in healthy adults in the first place. 1–3

In other words:

There is no yeast allergy warning on vegan whey protein powder,

Not because there are 0 yeast proteins in the powder,

But because the yeast that are used to manufacture vegan whey protein powder,

Are not linked to any allergies in healthy adults.

The yeast (and other fungi) used to make vegan whey protein powder have been used by the food industry for a long time, and so far without any known allergic reactions.

Heavy Metals

It’s possible for vegan whey protein powder to contain tiny amounts of heavy metals, much like dairy-based whey protein, or even more simply our drinking water. 1–3,6,7

(Related: Vegan Whey vs. Normal Whey: Nutrition & Safety)

From the data available,

Here is the approximate amount of heavy metals one can expect to find in vegan whey protein powder:

Heavy Metal Parts Per Billion (ppb)
Arsenic <10.0 – 60.3 ppb
Cadmium <5.0 – 9.09 ppb
Lead <5.0 – 59.3 ppb
Mercury <5.0 ppb

Remember that this data is from a snapshot in time.

The exact amount of heavy metals in any one bag of animal-free whey protein powder will vary from product to product and manufacturer to manufacturer over time.

So long as a responsible manufacturer takes all necessary precautions, we feel that heavy metals are not of significant concern when it comes to vegan whey.

Protein Safety

Purity

This image shows that up to 99.9% of vegan whey protein powder is beta-lactoglobulin.

At least 70% of purified vegan whey protein powder is composed of actual protein. Of this protein, at least 80% is a protein called beta-lactoglobulin (a type of whey protein).1–3

The rest of the powder is things like fat (<1.0%–4%), carbs (<2%–20%), and moisture (<6%–7%). 1–3

These protein percentages are conservative numbers.

In practice,

Data shows that purified vegan whey protein powder is likely closer to 84.3%–99.6% protein. 1–3

(Numbers vary based on the manufacturer, batch, purification process, and protein analysis method.)

Of this protein, around 83.0%–99.9% is a whey protein called beta-lactoglobulin. 1–3

The rest of the protein is likely remnants of fungal cell proteins from the fungi that produce the whey.

pH

This image shows that vegan whey protein powder has a pH of about 5.25 - 6.58.

The pH (“level of acidity”) of purified vegan whey protein powder is about 5.25–6.58. 1–3

This is about the same pH range as cabbage. 8

Biochemical Similarity

This image shows that the amino acid structure of vegan whey BLG is identical to the amino acid structure of bovine BLG but the post-translational modifications are similar but not necessarily identical.

The protein found in vegan whey is biochemically similar to the one found in cow’s milk but it might not be exactly the same in every way.

See…

Pure vegan whey protein powder is composed of a whey protein called beta-lactoglobulin (BLG). 1–3

There is more than one isoform (“version”) of BLG in cow’s milk.

The two major versions are: BLG-A and BLG-B.

BLG-A and BLG-B differ by only two amino acids. 9,10

Amino acids are the building blocks of proteins.

And the exact sequence of amino acids (the way the amino acids link up),

Is unique to each protein. 11

The BLG found in vegan whey protein powder has the same amino acid sequence as the BLG produced by cows. 1–3

Specifically:

During testing,

Scientists discovered that the major version of BLG found in vegan whey appears to be BLG-B.1–3

Ok.

So we just found out that the amino acid sequence of the whey protein (BLG) found in cow’s milk is the same as the one found in vegan whey.

In other words, it’s quite likely that the BLG in vegan whey is chemically identical to the one in cow’s milk. 1–3

But…

There’s one last thing we need to consider.

Proteins can undergo something called post-translational modification (PTM).

Put another way:

After a protein is made, it may undergo one of many different types of biochemical changes. 12–14

It’s like after a car is made…its color can be changed, its suspension might be lifted, or a bike rack may be installed.

So too…proteins can change a bit after production.

This post-production change (the PTM) may be large or small, and

It may be easily detected using scientific techniques or not, and

Such a change may (or may not) significantly alter the structure and function of the protein,

And the way it interacts with the human body as a result.12–19

So naturally…

The FDA wanted to know if the BLG in vegan whey undergoes any form of PTM.

Here’s the low-down of what FDA, patent, and research documents reveal: 1–3,9,12,15,18–24

While it’s possible for vegan BLG to undergo PTM in some circumstances…

Testing has shown that either vegan BLG doesn’t undergo PTM…

Or if it does…

Any such change was so small that it was not detected during testing.

Therefore:

The most honest conclusion is that the BLG-B found in vegan whey is similar to the one in cow’s milk, especially with respect to its amino acid sequence and PTMs.

But we can’t be 100% sure that it’s exactly the same in every possible way:

Especially the way by which it interacts with the human body.

Said differently:

There’s still the possibility that BLG produced by fungi may undergo one or more PTMs that are not found naturally in bovine BLG. 23,25,26

The possible existence of these PTMs depend on a vast collection of factors, like:

The species of fungi used to make vegan whey, the various possible fungal growth conditions used during manufacture, the methods used for detection of the PTMs, and a lot more.12,15,19,23

Without a doubt:

Further research would help clarify if any PTMs are present in vegan whey, if that’s a consistent finding depending on a wide range of conditions, and if any such PTMs have any actual health-related consequences of note. 16,18,19,27,28

Genetic Safety

GMO Consumption

This image shows that you're unlikely to consume GMOs when consuming vegan whey protein.

Vegan whey protein is made by genetically modified organisms (GMOs), namely yeast and other fungi.

(See this article for details: How is Vegan Whey Protein Made? 3 Ways)

Does that mean you consume these GMOs when you consume the vegan whey protein powder?

Probably not.

See,

During manufacture the GMOs (the fungal cells) are separated away from the vegan whey protein itself. 1–3

Barring a few stray fungal cells in the purified protein powder,

It’s unlikely that you’re going to eat any of these GMOs.

Moreover,

The fungal organisms used for the production of vegan whey,

And their relatively minor genetic modifications,

Are both considered safe with respect to human health.

So even if you were to eat a small amount of these GMOs, it’s very unlikely to cause you any problems. 1–3

Transfer of DNA

This image shows that it's unlikely that any genetic material from GMOs used to produce vegan whey can transfer to a human cell.

It’s very unlikely that any genetic material,

From the genetically modified fungi used to produce vegan whey protein,

Can transfer from the fungus to a human.

There are several reasons for this: 1–3,29,30

  • Research shows that the fungi used for the production of vegan whey protein are unable to transfer genetic material very well (if at all) to begin with.
  • That genetic material is unlikely to be harmful to people in the first place (for example, no antibiotic resistance genes are inserted into the fungus).
  • Any fungal genetic material would have to survive the manufacturing and purification process.
  • Any fungal genetic material that survives the manufacturing process would have to survive being digested in your stomach and intestines.
  • Any fungal genetic material that happens to survive all of the above is likely to be fragmented (due to digestion) to the point where it is no longer viable nor functional.
  • The fragmented DNA would then have to cross the protective barrier in your digestive tract to formally enter your body.
  • The DNA would then enter your bloodstream and would have to survive being neutralized by your immune system or being filtered out of your body.
  • From there, any fragmented (and thereby likely nonfunctional) genetic material that makes it inside a human cell is extremely unlikely to be integrated into the genetic material of that cell.

As you can tell, the sequence of events that must occur for the transfer of genetic material,

From a genetically modified fungus used for the production of vegan whey,

To a human,

Is improbable but not impossible.

None of this is said with a wave of the hand, by the way.

We are not dismissive of the potential consequences of the transfer of genetic material from GMOs (genetically modified organisms) to humans.

For example,

Genetic material from GMOs doesn’t have to enter a human cell to cause human disease. 29,30

Here’s what we mean:

It’s possible that genetic material from GMOs may transfer to the microbes living in our gut.

As a result,

Such a transfer of genetic material might play a part in digestive issues,

(In some people),

Without actually altering the person’s genome in any direct way.

So far much of this is in the land of scientific theory and speculation but it is good food for thought.

And don’t forget:

A lot of this can also happen with completely natural,

(Non-genetically modified),

Organisms that we consume on a daily basis. 29,30

Biochemical Safety

Biosafety Level 1

The fungi used to produce vegan whey protein powder are classified as Biosafety Level 1 (BSL-1).

BSL-1 fungi are highly unlikely to cause disease in healthy adults. Such fungi are widely used in the food industry all over the world,

Such as for the production of food enzymes. 1–3,31

Microbial Contamination

For yeast, mold, and coliforms: vegan whey protein is expected to have less than 10 CFU (colony forming units) of each, per gram of product. 1–3

In other words:

The chance of any significant microbial contamination in vegan whey protein powder is extremely low so long as the manufacturer follows all standard precautions and procedures.

Disease

The fungal organisms used for the production of vegan whey do not appear to cause any disease in healthy adults. 1–3

Toxins

The fungal organisms used during the production of vegan whey protein are unlikely to produce any toxins that harm human health, so long as all appropriate production procedures are followed. 1–3

Antibiotics

This image shows that fungal organisms used to produce vegan whey might be able to produce antibiotics but not under the conditions used to manufacture vegan whey protein.

The fungal organisms used for the production of vegan whey protein do not contain any genetic modifications related to antibiotic resistance. 1–3

Some types of fungi used for the production of vegan whey can naturally produce antibiotic-like compounds.

These compounds,

In experimental conditions,

Might be harmful to the human body (although this isn’t certain). 1–3,32

In practice though,

The production of such natural antibiotics requires very specific fungal growth conditions.

Growth conditions that are very different from the ones used to produce vegan whey.

Put another way:

These natural antibiotics are not produced during the standard manufacture of vegan whey even if the fungi can produce them in theory under different conditions.

Chemicals

According to company documents submitted to the FDA,

The chemicals used for the production of vegan whey protein powder are considered safe, and meet predefined specifications and quality standards common to the food industry. 1–3

References

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  2. Re: GRAS Notice for Non-Animal P-Lactoglobulin Whey Protein from Fermentation by Komagataella phaffi. U.S. Food and Drug Administration.
  3. GRAS Notice for Non-Animal Whey Protein from Fermentation by Trichoderma reesei. U.S. Food and Drug Administration.
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