Unified, clear health claim frameworks could bolster consumer understanding, flags roundtable

24 Nov 2021 --- Health claims play a crucial role in communicating with consumers but different regional approaches reveal a fractured scene.

Experts from Gencor, Lonza, Monteloeder and Lallemand Health Solutions tell NutritionInsight how they are navigating this complex space, especially around key ingredients like probiotics and botanicals.

“The COVID-19 pandemic has awakened a breed of miracle-cure charlatans. The internet allows scammers to bombard the public through social media and email with false or misleading health claims,” says Mariko Hill, global innovations manager at Gencor. 

While regulators cannot stop consumers from believing in and buying “miracle cures,” they can provide increased enforcement and consumer education.

“The messages or ‘claims’ shown on the labeling of functional food products are highly important. They help consumers identify the specific health benefits provided by the consumption of these products, as well as encourage consumers to make adequate food choices,” adds Maggie McNamara, marketing director at Gencor. 

Notably, consumers around the world are becoming more aware of the scientific backing of ingredients. For example, a 2020 survey by Innova Market Insights found that 54% of global consumers say they have spent time educating themselves on ingredients that support immune health. 

“Dietary supplement trends come and go, so creating products with claims that align with consumer health priorities and preferences is an ever-moving target,” adds Lindsey Toth, associate director of global marketing at Lonza Capsules & Health Ingredients.EU’s regulations date back to 2006 when decision-makers created harmonized rules for the use of health or nutritional claims on foodstuffs based on nutrient profiles. 

Differing study requirements
In the example of probiotics, consumers often struggle to appropriately define and differentiate the various associated benefits – despite a greater overall understanding of probiotics. 

Solange Henoud, global regulatory affairs director at Lallemand Health Solutions, says that this is unsurprising. “How could this differentiating be feasible if claims about the specific benefits of the probiotics cannot be made appropriately? This highlights the importance of claims on probiotics.”

Beyond probiotics, the road to approval for many ingredients can be rocky. “Any potential claim must be backed by solid science,” emphasizes Jonathan Jones, Monteloeder’s chief scientific officer.

Notably, the requirements for soliciting a health claim seem better defined in certain categories than others. In some cases, it is not well established which studies should be performed. There can also be ambiguity around the required duration and number of subjects or biomarkers and the level of clinical outcome efficiency, notes Jones. 

“The industry would greatly benefit from clear guidelines as to what studies are necessary to have a chance at getting a health claim.”

Relaxing recruitment measures
Another further challenge resides in the need to demonstrate efficiency in “healthy” populations. This makes recruitment very difficult, requiring individuals that surpass a certain threshold of well-being while not being serious enough to be considered a disease, Jones details. 

Not only is recruiting difficult but obtaining statistically significant results in such borderline populations is extremely challenging, he continues.  

“If the regulatory bodies would relax measures on the recruitment criteria, it would be significantly easier to demonstrate statistically significant improvements in the population study.” There are few authorities with a framework allowing for the review and approval of probiotic health claims, argues Henoud.

Spotlight on probiotics
Health claim regulation around probiotics is especially complex, with the European Food Safety Authority (EFSA) currently not allowing the use of the term “probiotic” or any related health claims. 

“Europe has faced an important negative impact this past decade from the ban. Only recently, the growth started to resume due to the increased knowledge of consumers that those Latin names refer to probiotic ingredients that are generally beneficial for health,” explains Henoud. 

However, she flags that this situation is slowly changing. “Happily, we are now seeing the situation unfolding with more and more member states tolerating or authorizing the use of the term ‘probiotics’ in the EU with applicable criteria and conditions.” 

“Nonetheless, probiotic health claims will not be possible until the authorities take the decision to do so.”  

In March, the International Probiotics Association also argued that creating an EU-wide framework around allowing the term “probiotic” has numerous industry benefits. 

Same product, different choices
In contrast to the EU, the US Food and Drug Administration (FDA) allows structural or functional claims such as “supports healthy digestion,” accompanied by an FDA-mandated disclaimer. 

“Growth in the US was amazing during the past decade when the EU was struggling. This provides evidence on the measurable impact of the regional variation between health claims regulations,” argues Henoud. 

She continues that even among countries allowing claims, differences can be huge. For example, in one country, a company may claim the results of the clinical trials, while in others, they would have to use more general claims.

“To illustrate this, a product reducing abdominal pain due to occasional constipation in Canada will be represented in the US as being for gastrointestinal comfort. Same product, same consumer, different choices just across the borders.” In the US, health claims must be reviewed by the FDA but can fall into either the authorized or qualified camps. 

EU challenges for botanicals
Botanicals pose another challenge, with Jones pointing out that in the EU, few of these ingredients have approved health claims.

According to McNamara, only glucomannan and olive leaf extract are permitted. 

“There are fewer still where a combination of them is used. In the case of the latter, the need to demonstrate that only the combination of those ingredients – at a specific ratio and extract concentration – is required to obtain the expected result makes it extremely difficult to get a claim,” she explains. 

“Due to EFSA preventing any health claims on botanical ingredients, suppliers must be innovative on brand names in order for consumers to understand what the ingredient is and does,” adds Hill. 

She anticipates that as more clinical research becomes published and a greater understanding of ingredients becomes known on a global basis, more branded botanical ingredients and other nutraceuticals will be widely accepted globally.  

Equally difficult across regions?
In Jones’ view, while each geographical region has its own regulations, they are all more or less equally difficult to obtain a health claim. However, there are certain advantages in the European market, for example. 

Here, an approved health claim can be used throughout the EU, as opposed to other regions where claims must be submitted and approved country by country. 

“On the other hand, there are very few approved health claims in Europe, limiting their use to very few ingredients. Furthermore, the number of health claims on hold is extremely high, with no clue as to when they may be resolved.”

In contrast, the US has a higher level of margin in terms of accepted claims, as long as they are backed by sound science.

“While this may seem at first as an advantage for the industry, it can also backfire. Sometimes a product can seep through the cracks and come out with misleading claims that are later removed by the FDA, which can have a negative impact on other companies that use the same ingredient.”

Asia-Pacific claims become more stringent
In the APAC region, each country has its own claims’ regulations. Toth notes that what is consistent across the region is that each country’s rules are becoming more stringent. 

Some countries like China and Korea have approved lists of claim wordings, including scientific requirements, and claims may only be made for indications on these lists. 

“Adding new claims language is very challenging – it is only the addition of new ingredients for the existing claims that is usually possible. Regulatory authorities are continuing to announce new legislation designed to closely monitor the dietary supplements industry and health claims made on products,” she explains. 

Hill elaborates that in Japan, there are only four categories approved for the nutrition claims: “rich in” “source,” “low” and “does not contain,” with minimal and maximal limits of the nutrients in question.

Finally, Australia also has permitted health claims – even analgesic claims – so long as the claims are approved by the Therapeutic Goods Administration (TGA). This is unique as ingredients that typically do not have permitted health claims in the US or EU, such as palmitoylethanolamide (PEA) for pain, can have analgesic claims in Australia.

By Katherine Durrell