Dr. Aditi

Dr. Aditi

Editorially Reviewed by : Dr Aditi

Dr. Aditi

Dr. Aditi

Editorially Reviewed by : Dr Aditi

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Nutriessential Case study on Hypoallergenic formulations

Patient journey case study exploring hypoallergenic supplements and how Pure Encapsulations formulations may help individuals concerned about ingredient sensitivities and allergen exposure

Understanding hypoallergenic formulations

Some patients struggle with food sensitivities, allergies, digestive discomfort, or concerns about unnecessary additives. By removing many common allergenic and unnecessary ingredients, brands like Pure Encapsulations create hypoallergenic formulations that address these concerns.

Understanding the philosophy behind hypoallergenic formulations: Practitioner’s perspective

While recommending supplements to patients, healthcare providers face challenges. 

A study reports that more than 90,000 dietary supplement products containing vitamins and minerals are available in the USA market. Almost 52% of the adult population in the USA regularly takes vitamins and multivitamins.

Vitamins are considered “natural” and therefore “safe” ingredients, but literature suggests that they can induce allergic reactions when used topically. Although primarily reported with topical exposure, allergic reactions to vitamin-containing products highlight the importance of considering ingredient sensitivities.

Research study infographic highlighting healthcare practitioner concerns about ingredient sensitivities and allergic reactions associated with vitamin-containing products

A study explored the potential use of processed forms of the nine major food allergens in IgE-mediated food allergies, supporting pediatric allergists in partially liberalizing children’s diets and facilitating the development of tolerance. The results highlighted that future research should focus on identifying allergenic proteins in various foods and characterising how these proteins are altered during processing, contributing to the development of safe, high-quality hypoallergenic foods.

Healthcare providers trust hypoallergenic supplements. These formulations attempt to reduce exposure to many commonly questioned excipients and unnecessary additives, helping healthcare professionals feel more confident when recommending products for sensitive patients. 

Research infographic highlighting hypoallergenic foods as a potential solution for healthcare practitioners managing food allergies and ingredient sensitivities in patients

Why healthcare professionals trust hypoallergenic supplements?

Infographic explaining why brands develop hypoallergenic supplement formulations, highlighting patient needs, ingredient transparency, safety, personalization, and evidence-based nutrition

Healthcare professionals frequently encounter patients who report:

  • Skin rashes after taking supplements

  • Gastrointestinal discomfort

  • Headaches

  • Sensitivity reactions

  • Difficulty identifying the triggering ingredient

In many cases, the active ingredient is not the problem.

Research has shown that excipients (inactive ingredients such as dyes, preservatives, fillers, flavorings, and stabilizers) can sometimes trigger hypersensitivity reactions in susceptible individuals

Patient journey infographic showing the transition from supplement sensitivities to hypoallergenic formulations with improved confidence, simpler ingredients, and better long-term adherence

In 2022, a study entitled “Anaphylaxis to Excipients in Current Clinical Practice: Evaluation and Management” was published in Immunology and Allergy Clinics in North America. The study highlighted that excipients are the inactive ingredients in a drug or product. They are added to stabilise, preserve, or enhance the pharmacokinetics and bioavailability of the active ingredients. Excipient allergy is rare, which is either missed or misdiagnosed due to a lack of awareness of the need to carefully review all drug ingredients. For the patient, excipient allergy can be frightening and potentially disruptive to healthcare delivery. 

Another systematic review published in Internal Medicine Journal mentions, “Polyethylene glycol was the most prevalent allergenic excipient, followed by colouring agents. Clinical manifestations exhibited wide variability, ranging from mild to life-threatening reactions, and the most common presentations were urticaria and angioedema. Most patients recovered spontaneously after withdrawal of the offending agent, with less than half necessitating additional drug interventions and only a single instance of reported fatality, which cannot be attributed to the excipient alone. Despite being labelled as inert, excipients pose a significant threat to the development of allergic reactions.”

These studies highlight the need for the following considerations:

  • Patients should know that it is important to be aware of potentially allergenic excipients

  • Patients should be more aware of the availability of hypoallergenic supplements.

  • Healthcare providers should take a comprehensive dietary supplement history. They should ask patients about: Which brand supplement they are taking, for how long, who recommended it, etc.

 Nutriessential’s perspective 

Research study quote highlighting that supplement reactions may be caused by active ingredients, excipients, fillers, flavorings, and other inactive ingredients

The conversation is not whether PEG is safe or unsafe. The real question is: What do patients and practitioners value when selecting a supplement? For many, ingredient transparency, simplicity, and confidence in the formulation are important considerations. Hypoallergenic formulations are designed with these preferences in mind.

A case study on Patient's Journey to hypoallergenic formulation: Finding a Supplement That Works Without Triggering Sensitivities

The above information from the research paper highlights the role of excipients in trigerring allergies. One of the study even highlights the concept of hypoallergenic foods.

Hypoallergenic formulations are the best examples of how high-quality GMP-certified supplements, created with clinical understanding and based on science, work together to improve the overall healthcare experience. 

Patients who have experienced ingredient sensitivities may seek products with simpler ingredient profiles and fewer potential allergens. 

They don't buy hypoallergenic supplements because they want hypoallergenic supplements. They buy them because they have experienced fear, uncertainty, or adverse reactions from ingredients they never expected to be in a supplement.

Benefits of hypoallergenic formulation for patients

The Nutriessential team summarised the benefits of hypoallergenic supplements for patients:

  • Many patients have food sensitivities, allergies, digestive issues and even concerns about ingredient purity. The hypoallergenic formulation is designed around these concerns.

  • These supplements are beneficial for sensitive patients.

  • Brands like Pure Encapsulations, providing such options, communicate on ingredient transparency, manufacturing standards, quality testing and allergen considerations.

  • Healthcare providers trust hypoallergenic supplements due to cleaner ingredient lists, Clear disclosure of ingredients and evidence-based formulation philosophy.

  • These formulations improve supplement adherence.

Where to find hypoallergenic supplements?

You can find hypoallergenic supplements at Nutriessential. This company represent brands like sold by brands such as Allergy Research Group, Kirkland Labs, and Pure Encapsulations, known for providing hypoallergenic supplements.

Why do we represent these brands?

When you see the label of these brands and find the “hypoallergenic” label, you should know that these are formulated without ingredients known to be common food allergens, such as milk, fish, eggs or nuts. Manufacturers avoid the use of artificial sweeteners, artificial colouring agents, certain fillers, binders, flow agents such as magnesium stearate, or tablet or capsule coating agents.

What Pure Encapsulations mentions on Hypoallergenic supplements?

Common allergens and additives in dietary supplements infographic highlighting artificial colors, artificial flavors, fillers, hydrogenated oils, preservatives, and allergen awareness

Pure Encapsulations has defined “hypoallergenic” to mean the following:  

  1. Avoiding allergens in the sourcing and manufacturing of dietary supplements. 

  2. Avoiding unnecessary binders or fillers in the manufacturing of dietary supplements, as well as other substances commonly avoided by sensitive consumers, such as coatings, shellacs, artificial flavors, artificial sweeteners, and artificial colors.

  3. Screening for environmental contaminants

Pure Encapsulations products that meet the above criteria and do not contain any of the major food allergens are labelled with “hypoallergenic dietary supplement” as the statement of identity on the principal display panel.

To ensure the accuracy of Pure Encapsulations labeling, and the health and safety of individuals with food allergy, sensitivity or intolerance, any ingredient derived from the major allergens milk, fish, shellfish or soy is listed on the label. If a major allergen is present, it is prominently identified on the product label and the term “hypoallergenic” is removed from the statement of identity on the product label.

Ingredients that could potentially come into contact with an allergen during the production process (for example, enzymes or probiotics that are grown on an allergen-containing medium) are submitted for ELISA testing of potential allergen exposure. 

An exception to this rule is vitamin E derived from highly refined soybean oil, which is not labelled as containing soy. The process of making vitamin E from highly refined soybean oil removes any residual proteins, which could cause an allergic response. 

It is considered highly purified, and therefore, soy is not listed on the label in this case. Similarly, the medium chain triglycerides (MCTs) used in certain products are originally derived from coconut but are also considered highly purified, and therefore, coconut is exempted from labelling.

Note: We have taken this content exactly from the brand website resources.

Conclusion

Pure Encapsulations defines “hypoallergenic” as avoiding allergens, avoiding unnecessary binders, fillers and other substances, and screening for environmental contaminants in the sourcing and manufacturing of dietary supplement ingredients and products.  

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References:

Bruusgaard-Mouritsen MA, Nasser S, Garvey LH, Krantz MS, Stone CA Jr. Anaphylaxis to Excipients in Current Clinical Practice: Evaluation and Management. Immunol Allergy Clin North Am. 2022;42(2):239-267. doi:10.1016/j.iac.2021.12.008 

Seth, S., Lukose, L., Sud, K., Goh, J.X., Tesfaye, W., Small, F., Sridhar, S.B. and Castelino, R.L. (2025), Excipient induced allergies in oral medications: unravelling the covert threat – a systematic review. Intern Med J, 55: 353-368. (Source)

Malkawi, R., Altahrawi, L. Excipients in pharmaceuticals: mechanisms of hypersensitivity and the role of global pharmacovigilance. Saudi Pharm. J. 33, 18 (2025). (Source) 

Foti C, Calogiuri G, Nettis E, et al. Allergic contact dermatitis from vitamins: A systematic review. Health Sci Rep. 2022;5(6):e766. Published 2022 Oct 3. doi:10.1002/hsr2.766

Pecoraro, L.; Barni, S.; Mori, F.; Giovannini, M.; Castagnoli, R.; Arasi, S.; Mastrorilli, C.; Saretta, F.; Liotti, L.; Caminiti, L.; et al. Main Processed Hypoallergenic Foods: A Potential Tool to Improve Informed Dietary Choices in Children with IgE-Mediated Food Allergies. Children 2025, 12, 915. (Source)

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