How to de-risk pharmafood development:
Regulatory considerations for functional ingredients

Dr Pretima Titoria, Principal Consultant: Scientific & Regulatory Affairs, explains the regulatory challenges of including functional ingredients in food and beverage products.

As traditional boundaries between food and medicine become less distinct, it’s important to be aware of the complexities of the regulatory landscapes around the world. Mistakes could be costly, potentially resulting in product recalls or withdrawals as well as lasting brand damage.


Pharmafoods present opportunity and risk

We are continually learning about the relationships between functional ingredients and health, both mental and physical. For instance, caffeine has a long association with alertness, but ingredients such as lemon balm and turmeric are also increasingly used for purposes including stress management and reduction of inflammation.

Functional ingredients from familiar edible plants (e.g. St. John’s Wort, lavender and basil), as well as the more exotic (e.g. ashwagandha and Chanca Piedra) have been seen to exert much potential. They can be used to address the nutritional needs of specific cohorts, such as the elderly, women and athletes or those with specific health issues like joint inflammation or acid reflux.

Consumers expect these products and their ingredients to be safe and effective, with transparent, sustainable and natural sourcing. There are also regulations surrounding the use of these ingredients and claims made about the products containing them. Such regulations can vary greatly across different geographical markets.


How regulatory insight can de-risk R&D

When developing products that use functional ingredients to impart health benefits, three key regulatory factors have a bearing on success:

  • Permissibility of ingredients in target markets
  • Acceptability of the emerging technologies
  • Use of health claims in marketing

The following points indicate some of the complexity they bring.


1.    Are the functional ingredients permitted in target markets?

Understanding which functional ingredients can be used in different target markets is fundamental when formulating food and beverage products with health properties. This is a complex area, and a product’s categorisation (‘supplement’ vs. ‘food and beverage’) has an impact on which national and regional regulations or guidelines apply. This influences everything from labelling and logos to taxation.

In the EU, ingredients which weren’t extensively consumed before 15 May 1997 are considered ‘novel’ and require pre-market authorisation. This may cover foods that have a long history of consumption outside the EU, such as baobab fruit pulp. In contradiction, Australia tends to accept the use of any foods which have traditionally been consumed in other parts of the world.

Requirements for functional ingredients with physiological effects vary between different markets. It may be necessary to profile safety, dosage, bioavailability and toxicological features. This is important, because depending on the dosage, some products may be classified as ‘medicinal’ in some markets, and therefore cannot be sold as a food/beverage/supplement. Furthermore, product development also needs to verify that the presence of other ingredients does not modify the behaviour of functional ingredients.

For products targeting multiple markets, it’s important to be aware of regulatory variances at an early stage so decisions about multi-market launches are fully informed.


2.    Is the processing technology acceptable?

On-shelf stability and in vivo bioavailability profiles are critical quality markers for pharmafoods. It follows that new technologies that reduce or eliminate the degradation of functional compounds are of great interest to manufacturers. Enzymatic treatment and UV treatment, as well as extraction, microwave and plant-breeding technologies, are among the approaches that might be considered. They may enable pure extractions of functional ingredients, as well as delivery of intact functional compounds or more bioavailable forms.

Manufacturers need to be mindful of how emerging technologies relate to existing regulatory frameworks. Before implementing a new approach at scale, it is prudent to check its compliance with the national regulations of target markets. There have been instances where a technology that comes under Generally Recognized as Safe (GRAS) classification in the US is deemed ‘novel’ in the EU. Detailed upfront assessment helps reduce risk and avoids complications later.


3.    Can health claims be used in marketing?

Any claims that will impact product positioning need to be determined at an early stage so they can be properly substantiated. Claims for pharmafoods can fall into two categories ‘Nutrition and Health claims’ and ‘Marketing claims’. Requirements vary between different markets which can complicate matters for products sold globally.

Nutrition claims relate to beneficial nutritional properties, whereas health claims imply that a particular ingredient confers a health benefit.

The regulatory situation for nutrition claims is fairly consistent across different markets. However, when it comes to health claims, regulatory definitions, requirements and processes can vary significantly. Any discrepancies may impact the positioning and labelling of products intended for multiple markets. 


The value of a regulatory review

Interrogating new product concepts is a prudent strategic move in circumstances where success or failure could have a significant impact on brand reputation.

Here at Leatherhead Food Research, we have the experience, knowledge and capability to provide an unbiased assessment of pharmafood concepts, technologies and claim propositions. Applying this expertise during the inception phase of product development helps de-risk the innovation process.

Marketing claims, such as ‘clean label’, ‘natural’ or ‘sustainable’ also need consideration. Unlike nutrition and health claims, for which there are clear regulatory statements, there is a lack of regulatory definition for this terminology. Instead, there are guidelines available. For instance, in the UK, the Food Standards Agency (FSA) specifies that a natural product is “comprised of natural ingredients, e.g. ingredients produced by nature, not the work of man or interfered with by man” as well as providing criteria for use of the term ‘natural’. (Full details are available here).


Need compliance support for your pharmafood or functional ingredient?

Get in touch with the team at [email protected] for more information. Remember, if you’re a Leatherhead Member you can use your Helpline allocation for support.



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