Botanical innovation limited by safety considerations and EU health claim processes

08 Jun 2023 --- Although demand for botanicals is soaring, no new botanical health claim applications can be authorized in Europe, which limits how companies can market their products. The assessment of botanical health claims has been “on hold” since 2010 by the European Food Safety Authority (EFSA) and it is unclear when this situation will change.

Methodologies used to authorize claims on specific nutrients, such as vitamins and minerals, are ineffective for botanicals, which are more complex foodstuffs. 

“The biggest issue botanicals face is that claims on botanicals are still on hold,” Dr. Steffi Dudek, senior consultant at Analyze & Realize – a regulatory and clinical research consultancy in Germany – tells NutritionInsight. 

Dudek adds that another issue stems from innovation in the industry to improve known weaknesses of botanical extracts, such as bioavailability. “If you improve bioavailability, you will also improve potential toxicity issues. With the current technologies and procedures to assess toxicity, it’s becoming more and more difficult not to be challenged.” 

Efficacy or safety? 
Dudok sees a conflict between how some botanicals may be promoted, their efficacy and toxicity levels. Selling a botanical with particular health benefits in marketing requires a high bioavailability, but that is impossible with a clean toxicity level. 

The assessment of botanical health claims has been “on hold” since 2010 by EFSA.“Either the marketing claim is too fantastic, or the toxicity study suggests that the bioavailability is so low that there is nothing to be toxic about.” 

If products on the market have insufficient safety data, there is a risk that regional monitoring bodies raise a red flag, which has happened for a few products, explains Dudek. 

“If data emerges that questions the general safety, EFSA may be in the position to reevaluate the safety and change the upper limits.” 

For example, Ashwagandha (Withania somnifera) has been prohibited in food supplements in Denmark after a 2020 safety assessment. The Finnish Food Safety Authority is deliberating whether to follow the Danish decision and a public consultation is currently underway requesting data on the plant’s safety. 

“Ashwagandha may be completely safe,” continues Dudek. “But if the data is unavailable, you will end up in a situation where the authorities cannot confirm the safety.” 

Novel Food legislation 
The more innovative a botanical extract is, the more it runs the risk of becoming a Novel Food, explains Dudek. This can occur by processing extracts into specific fractions, significantly improving their bioavailability or changing physical-chemical properties. 

“The moment you are not similar to the original traditional products, the risk that a product is Novel is quite high.” 

EU legislation defines Novel Food as food that humans have not consumed significantly in the EU before 15 May 1997. To bring these products to the market, companies must obtain food use approval. 

Novel Food application is extensive and costly, especially if a business needs to conduct additional testing. Dudek estimates that if toxicity analyses are required, the application process can cost “anything from €400,000 to over €1 million. (US$430,000 to US$1.08 million.)” 

The more innovative a botanical extract is, the more likely it is a Novel Food, explains Dudek.Some businesses do not further develop a product if it might require a Novel Food application, though others take the risk. 

Dudek adds that there is a “gray zone of products where we are not completely convinced that everything is according to the books, but there’s no indication that something is completely wrong. There’s very often no clear boundary.” 

Suppose it needs to be clarified whether the legislation applies. In that case, businesses can consult with their national food safety authority, which checks other national authorities to determine if a product was on the market before 1997. 

If something is Novel, Dudek urges businesses “look for help to review available data and documentation to conduct the missing analysis to notify all the studies that still need to be done to EFSA, and to start preparing for the application.” 

“Status quo” 
EFSA has published a list of botanical health claims that are put on hold. Dudek explains that, in theory, businesses can still use these claims as long as they meet the specifications of the product in question and the conditions of use. 

“It should be a claim that has at least some scientific evidence. So if it’s a complete fantasy, we will never recommend using it. There are applications where studies were not that bad, or the proposed claim is plausible.” 

At the same time, this situation gives a status quo to businesses, explains Dudek. A decision would “force companies to react.” 

“If the same measures are applied to botanical claims, as to all the other claims, like vitamins and minerals, then the majority will never be approved. If there will be a range of traditional use like peppermint, rosemary and household remedies, many of them can be maintained.”  

As food is not allowed to heal, treat or prevent anything, the effect size is minimal making it difficult to prove in studies.Authorizing new health claims 
The main reason why health claims are not authorized is a systemic issue, explains Dudek. 

“Food is not allowed to heal, treat or prevent anything. So the effect size is minimal and you must select your target group so carefully and creatively to visualize your effect that the chances you’ll fail are quite high.” 

Moreover, companies need to know about a mode of action, which can be difficult. “I’ve seen claim applications without an obvious connection between the botanical and the effect. It was pure coincidence that somebody found it.” 

“If you already have a weak effect and no cause and effect relationship, then your claim application is unlikely to be approved.” 

“Sometimes it is questionable whether the business case [for health claim application] makes sense,” Dudek continues. “Some studies require so much effort in terms of time and budget that it is questionable that they will ever pay back.”

Creating clinical trials 
Setting up a clinical trial to gather data for health claim applications is challenging, emphasizes Dudek. These need to include people at risk of developing a specific health condition while not suffering from it yet. Also, studies need to take place over a long time. 

She continues that it is challenging to screen and enroll sufficient candidates for some health indications, such as blood pressure, blood sugar management and cholesterol. 

“If you’re not experienced in this respect or have the budget and the muscles to do it right, a study may fail. The likelihood that you come up with a pertinent, acceptable study, especially with substances that are not that easy to be characterized, is substantial.”

By Jolanda van Hal