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Every bit matters: Why we need to talk about excipients

By Michael Osiecki

- Last updated on GMT

© iStock
© iStock
The food industry is experiencing growth in the demand for natural products, as people become more savvy and selective about what they put into their bodies. Consumers are willing to pay a premium for “pure” products and want to know what is in their foods, where they are sourced, if they are free from chemicals and whether they confer health benefits. 

They are taking more ethical decisions. Just witness the backlash towards palm oil over rainforests fears, or the new British £5 note which contains a tiny fraction of beef tallow. These show how an unlisted ingredient that may be ethically questionable can be very damaging to a brand.

Michael Osiecki
Dr Michael Osiecki

Providing transparency is crucial in order that people make educated decisions on purchases that fulfil their health and ethical needs. This is not the case in the labelling of supplements, however, as a product’s excipients—inactive substances such as colouring agents, preservatives, and fillers—only need to be listed with the Australian Register of Therapeutic Goods, and not on labels. 

Finding information on excipients may thus be very difficult for the public, who should be aware that the additives used to help manufacture formulations may pose a risk to some people’s health, especially when they contain common allergens. It follows that adverse reactions to hidden excipients can potentially damage a company’s brand. 

Considering that excipients generally make up more than 40% of a tablet, the selection of hidden excipients will be an important factor in purchasing, particularly as the market becomes better aware. This is already evident in the practitioner market where customers want to know if products are free of certain allergens, including gluten or soy. They want to know if a product is vegan, or contains GMOs. They question the use of magnesium stearate. The list is endless. 

Customers are becoming wary of the safety of excipients. In the case of an excipient like titanium dioxide, the only risk assessment was done in 1969 by the World Health Organisation, which stated that there was no absorption or tissue storage following its ingestion. We now know, however, that the compound is absorbed and localised to the liver and spleen, meaning that reassessment of its safety is required. 

In 2017, the TGA, the supplements industry’s regulator, will require potential allergens and other excipients to be listed on each label under TGO92, similar to what now occurs on food labels. We can no longer hide away from this issue, particularly when addressing the growing market demand for “pure​” products. Furthermore, a product’s excipient profile and the rationale for the use of each excipient must now be questioned. 

Is there another way to design the excipient profile that has lower health risks for patients and fewer ethical problems? Do manufacturers move to capsules rather than tablets? Will the new absorption technologies, with all their added excipients, be acceptable to the newly aware market? Can the public accept an increase in cost of goods due to slowing the manufacturing process without the lubricants and flowing agents?

Removing manufacturing excipients or replacing them with ones that are more acceptable is the easy part. The difficulty is in sourcing the active ingredients that meet the public’s purity requirements. 

When you consider that dextrose from corn GMO is commonly included as an excipient in raw ingredients, that pesticides are present in herbal extracts or that tocopherol is sourced from either soy or palm oil, this becomes troubling. Furthermore, depending on TGA deliberations on TGO 92, warnings on the labels of those ingredients or excipients from certain food sources may be required. 

All these issues will be driven by the market, particularly as consumers become more aware and demand pure and unadulterated products. 

This will mean pressure on raw material suppliers and manufacturers to meet this growing market demand by providing raw ingredients that are free from problematic excipients. Cost will not be the only driver of sales growth, however. Quality, purity, efficacy, safety and ethical standards will become a major contributor to buyers’ purchasing decisions.

  • Dr Michael Osiecki is a director of Bio Concepts, a practitioner-only provider of therapeutic nutraceuticals​.

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1 comment

Excipients

Posted by Anna Jacobs,

I read the article with great interest. Thank you. I'm having trouble with corn/maize, which is a common excipient but which affects me very badly - wheat and corn can both cause atrial flutter to a dangerous degree. Even the small amount in the tiny warfarin tablets was enough to affect me when ingested daily. I wish manufacturers and the TGA would include maize/corn in the list of allergens because its dangers seem to largely unrecognised at present and to be increasing at a rapid rate. Go to the Facebook page of Corn Allergy and Intolerance and you'll find sufferers with huge problems, some reacting if they even touch maize flour.

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