Is lactase enzyme gluten-free?

Lactase is an enzyme that breaks down lactose, the sugar found in milk and dairy products. Lactose intolerance is caused by a shortage of lactase enzymes in the small intestine. This results in an inability to properly digest lactose, leading to gastrointestinal symptoms like bloating, gas, abdominal pain and diarrhea after consuming lactose-containing foods and beverages.

Lactase enzyme supplements can provide the missing lactase needed to digest lactose and avoid uncomfortable symptoms. They are taken prior to consuming dairy products. Lactase enzymes are available in tablet, caplet, liquid and chewable form. Popular brands include Lactaid, Dairy Ease and Align Daily Probiotic Supplement.

Gluten is a protein found in grains like wheat, barley and rye. A gluten-free diet excludes these grains and products made from them. It is necessary for people with celiac disease or non-celiac gluten sensitivity. There is conflicting information on whether lactase enzyme supplements are gluten-free or not. People following gluten-free diets need to know if lactase contains gluten, to determine if it is safe for them to consume.

Does lactase enzyme contain gluten?

Lactase is an enzyme that catalyzes the breakdown of lactose into glucose and galactose. It is produced commercially through microbial fermentation processes. The lactase enzyme is secreted from yeasts and fungi like Aspergillus niger and Kluyveromyces lactis. The genes responsible for lactase production are isolated from these microbes and inserted into yeast strains to optimize manufacturing yields.

Lactase enzyme supplements are highly purified preparations of lactase only. They do not contain other significant amounts of ingredients, excipients or contaminants from the production organisms. Many brands explicitly state their lactase products are gluten-free on the label or packaging. This suggests the manufacturing processes result in negligible or undetectable levels of gluten, if any.

Independent testing has also found lactase enzyme supplements to be gluten-free. ConsumerLab.com tested 38 products labeled as gluten-free, including lactase brands like Lactaid. Testing did not detect the presence of gluten in these lactase supplements above 20 parts per million, the recognized standard for gluten-free certification in the U.S. and many other countries.

Why uncertainty exists on gluten content

Despite evidence suggesting lactase supplements are gluten-free, uncertainty persists around their gluten content for several reasons:

– Trace amounts below 20 ppm may exist but be undetected by current gluten testing methodology
– Manufacturing processes could change, altering impurity levels
– Risk of cross-contamination with gluten-containing grains during production
– Some brands do not specify gluten-free status or testing

This leads some sources to advise caution and recommend individuals with celiac disease or sensitivity avoid lactase supplements unless they are verified gluten-free. However, the majority of evidence indicates properly produced, purified lactase enzyme products do not contain concerning levels of gluten.

Are the production organisms for lactase gluten-containing?

The main microorganisms used to manufacture lactase enzyme are yeasts like Saccharomyces cerevisiae and fungi such as Aspergillus niger and Aspergillus oryzae. Kluyveromyces yeast strains are also utilized.

These organisms are not sources of gluten themselves:

Saccharomyces cerevisiae

– Species of yeast used in baking and brewing
– Not a gluten-containing grain
– Considered gluten-free

Aspergillus niger

– Filamentous fungus used in industrial fermentations
– Grows on a variety of organic substrates
– Not a gluten-containing organism

Aspergillus oryzae

– Filamentous fungus used to produce lactase enzymes
– Traditionally used to ferment soybeans for soy sauce
– Not a gluten-containing organism

Kluyveromyces lactis and Kluyveromyces marxianus

– Yeast strains used as expression hosts for lactase
– Not gluten-containing organisms
– Considered dairy-free

So while trace amounts of the production organisms may be present in finished lactase products, the microbes themselves do not contain gluten. Any remnants are likely to be minimal.

What ingredients are in lactase enzyme supplements?

Lactase enzyme supplements typically contain very few ingredients. The primary component is the purified lactase enzyme. This constitutes most of the pill or capsule.

Common additional ingredients may include:

– Fillers like microcrystalline cellulose and maltodextrin
– Anti-caking agents such as silica
– Vegetable-based stearates as lubricants
– Dextrose or sucrose
– Natural flavors and citric acid

These minor ingredients help provide bulk to form the supplement and keep it in a powdered, free-flowing form. They are present in very small quantities compared to the lactase enzyme itself.

Importantly, the excipients used are generally gluten-free. Fillers like microcrystalline cellulose are made from cellulose, an insoluble plant fiber derived from pine or eucalyptus trees. Maltodextrin can be made from corn, potatoes or rice. Stearates are derived from plant-based fatty acids.

However, maltodextrin could potentially be made from wheat or barley in rare cases. This is why checking the label or contacting manufacturers is recommended if maltodextrin is listed as an ingredient.

Are lactase drops and liquid forms gluten-free?

Lactase supplements are available in liquid formats in addition to solid pills and capsules. Popular liquid brands of lactase enzyme drops include Lactaid and Dairy Ease.

These liquid lactase products typically contain very minimal ingredients beyond the lactase enzyme itself. The main additive is glycerin, used to help suspend the lactase enzyme particles.

Glycerin, also known as glycerol, is a colorless, odorless liquid produced from plant oils like palm, soy or coconut. It is gluten-free.

Other minor ingredients in liquid lactase supplements may include flavorings, potassium sorbate as a preservative and water. But the products are essentially free of major additives beyond the purified lactase enzyme and glycerin.

Liquid lactase drops do not contain any gluten-based ingredients according to product labels and manufacturer information. The liquid format provides an alternative method of delivering lactase enzyme that avoids ingredients commonly found in solid pills and capsules.

Do lactase supplements contain wheat starch?

Some lactase enzyme supplements may list wheat starch as an ingredient on the label. Wheat starch is derived from wheat grain, so it contains gluten.

Lactaid Fast Act is one brand that states it contains wheat starch. Therefore, Lactaid Fast Act capsules are not gluten-free and should not be taken by those avoiding gluten.

However, wheat starch appears to be an uncommon additive in general. Other major brands of lactase like Lactaid Extra Strength, Dairy Ease, Align Daily Probiotic, and store generic versions do not contain wheat starch. Wheat starch may be more commonly used as an ingredient in lactase products meant for veterinary use rather than human consumption.

Checking the packaging is advisable to see if wheat starch or any other gluten source is listed in the ingredients. Contacting the manufacturer directly can also help clarify the presence of wheat starch or gluten.

Can cross-contamination occur if lactase is made with wheat starch?

In theory, brands listing wheat starch as an ingredient could potentially cross-contaminate lactase products without wheat starch through shared production equipment and facilities. However, this seems unlikely to occur at levels that would cause issues for the majority of gluten-sensitive individuals.

Manufacturers make efforts to thoroughly clean equipment between production runs of different products. Also, some brands specifically note their lactase is produced in a gluten-free facility, which avoids cross-contamination concerns.

Extremely sensitive celiacs following strict gluten-free diets may still wish to avoid lactase supplements that are made by brands using wheat starch in certain products. But for most people avoiding gluten, lactase supplements not containing wheat starch as an ingredient should be safe, even if made by the same manufacturer.

What about lactase derived from fermented fungi?

There are claims online that lactase derived from fungal fermentation sources could result in the presence of mycotoxins, understood to be toxic, carcinogenic compounds. However, there is no good evidence indicating lactase enzyme supplements contain concerning mycotoxin contamination.

Lactase production requires growing the fermentation organism first. After sufficient growth, the organism secretes the enzyme lactase into the fermentation broth. The lactase enzyme is then purified and concentrated.

While mycotoxins may be produced during the initial fungal growth phase, the lactase enzyme fraction is separated and extensively purified. Mycotoxins, if formed, would not likely carry over to purified lactase enzyme end products given the extensive processing and testing protocols.

Reputable lactase supplement brands also follow quality control and good manufacturing practices that test for impurities like mycotoxins and prevent their presence. There are no established cases of lactase supplements causing toxic effects from mycotoxins when taken as recommended.

Could yeast sensitivities impact use of lactase sourced from yeast?

Rare individuals may have sensitivities to yeast that could theoretically extend to lactase enzyme derived from yeast sources. However, lactase supplements are highly purified and contain minute amounts of residual yeast, if any.

Symptoms of yeast sensitivity are typically gastrointestinal in nature and associated with live, proliferating yeast in the body. Purified yeast-derived enzymes like lactase are non-living and present no risk of overgrowth. Enzymes also break down in the digestive tract so little intact protein would be absorbed.

Those with known yeast allergies or sensitivities can try plant-derived lactase supplements to be extra cautious. But there are no reports of adverse reactions to yeast-sourced lactase when taken at suggested doses.

Conclusion

In summary, the majority of evidence indicates commercially produced lactase enzyme supplements, whether solid or liquid, are gluten-free. The fermentation organisms used to manufacture lactase do not contain gluten naturally. Lactase enzyme is also extensively purified during processing, which removes impurities from the production organisms.

Independent lab testing has not found detectable gluten content above 20ppm in leading lactase brands. Many state they are gluten-free on the label. Wheat starch is an occasional additive but not common in human lactase supplements. Brands using wheat starch are unlikely to cross-contaminate other products without it.

For individuals with celiac disease or avoiding gluten, selecting major lactase supplement brands that specifically declare themselves ???gluten-free??? on packaging provides assurance. Contacting manufacturers directly for verification is also recommended. But for most following a gluten-free diet, lactase enzyme supplements appear to be safe options for digesting dairy, with minimal risks of gluten exposure.

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