Panel discussion on...
Insights on regulatory issues, delivery systems and safety
Consumer safety has been the cause that moves the constant regulatory update of the food chain. We can certainly say that the list of standards applied to the food sector is conspicuous and diversified, ranging from regulations that apply to the finished product, to those that apply to its ingredients, such as vegetable preparations (so-called botanicals), that constitute dietary supplements. If we wanted to indicate some of the most important regulations in this regard for the extract, we should certainly refer to Reg. 1881 of 19 December 2006, Reg. 2009/32 of 23 April 2009, Reg. 2283 of 25 November 2015, and their subsequent updates.
The 1st (Reg. 1881/2006) defines the maximum levels of some contaminants in food products, (e.g., heavy metals).
The 2nd (Reg 2009/32) regulates the use of extraction solvents used in the preparation of food products and their ingredients, including their particular conditions of use.
The 3rd (Reg 2283/2015) regulates the use of substances, preparations and/or extracts obtained from parts of plants with a history of significant food consumption before 1997. In fact, all preparations and extracts obtained from plants without a history of significant consumption before this date are configured as novel foods and therefore cannot be used without prior EU authorization.
A food supplement of 250mg could be composed of botanical extracts titrated or standardized in active ingredients whose mg content could be equal to the same that would be found in a 250gr of a specific food item.
While in the food supplement we know exactly the content in mg of active ingredients present in it, every time we eat a food instead, we can know this content only as a guideline, sometimes taking more and sometimes less. It is no coincidence that the integration chain was born on the basis of this principle.
Just think of the content in mg of Vitamin C that we know differs in different foods. Citrus fruits seem to be the most iconic sources of Vitamin C, in fact one medium sized blond orange (150g) contains around 75mg of vitamin C; actually, some fruits contain greater quantities for the same weight. The kiwi, for example, contains more than 90 mg per 100 grams. Blackcurrant, up to 180 mg per 100g. A vitamin C content similar to that of oranges, weight for weight, is also found in strawberries, papaya, and so on.
For vitamins and mineral salts, the Ministry of Health recommends daily doses (RDA) and the maximum permissible intakes in food supplements, which therefore do not present any risk of adverse effects in most healthy subjects; in the case of Vitamin C, for example, this maximum admitted intake which is precisely 1000 mg.
It should also be remembered that botanical extracts, unlike food, are obtained through extraction processes which can often concentrate the active ingredients many times; therefore, even if the daily consumption is minimal because it assumes a daily intake in very small quantities through integration, the active ingredients could already be sufficient for energy needs.
Since it is a question of consumer health, the regulation in force in the food sector would seem to be appropriate and adequate, and it is clear that increasingly stringent restrictions may arise in the future, which could limit innovation in this regard. The best way to move forward would therefore be to find in risk assessment studies the key to achieving the right compromise between precautionary and reckless action. Companies in the sector would hopefully be able to operate with ever more collaborative actions in order to identify emerging critical issues more easily and help competent institutions to formulate shareable opinions.
Delivery systems are an essential aspect to consider when formulating nutraceuticals. In recent years, the trend towards new delivery formats has been growing, particularly with the emergence of gummies and loose powders. This shift is likely due to the convenience and ease of consumption that these formats provide. Some people may struggle to swallow traditional capsules or tablets, and the number of powders required for a single serving can often result in large capsules or tablets that are difficult to take. The use of gummies and loose powders can help to increase compliance, especially in pediatric subjects who may resist taking traditional pharmaceutical forms.
However, the formulator’s challenge lies in creating a food supplement that not only provides nutraceutical benefits but is also appetizing. It can be challenging to make botanicals, which are not always palatable, taste good. In such cases, it is important for the formulator to know how to play with different excipients to make the product as pleasant as possible. In addition, the nature of the active ingredients present in the extracts plays a significant role in determining the most appropriate delivery system.
For example, an extract with lipophilic nature may require a different delivery system to ensure effective absorption in the body. The formulator needs to determine the best form based on the target market they want to reach. It is challenging to formulate a drink with polyunsaturated fatty acids that is palatable, but if the market requires it, it is possible. It is essential to pay attention to the specific therapeutic effect to be obtained from the supplement before putting it on the market. This approach ensures that the most appropriate pharmaceutical or food form is formulated, which maximizes the benefits of the supplement while also being palatable to the consumer.
Choosing the right delivery system is critical to the success of nutraceutical products. The formulator must consider various factors such as the nature of the active ingredients, palatability, target market, and therapeutic effect. By doing so, they can create effective and palatable supplements that meet the needs of consumers while also providing the desired health benefits.
Safety and therapeutic application in nutraceutical formulations
The safety and therapeutic application of botanical extracts is a complex field that requires careful consideration of many factors. One of the most important of these factors is the dose of a given molecule or phytocomplex, which can determine whether it will have a therapeutic effect or not.
For this reason, those who work in the nutraceutical field must carry out extensive studies to determine the best delivery systems for their extracts, as well as the maximum safe doses that can be used without risking adverse effects. Additionally, they must also consider potential interactions between different extracts in order to ensure that they are not combined in a way that could cause harm.
While the dose is certainly an essential element that R&D experts must take into account when developing new supplements, it is not the only factor that matters. In many cases, those who formulate these products are limited by the costs of the active ingredients, rather than by concerns about safety.
For formulators who are trying to balance the need for effectiveness with the desire to keep costs down, there are several different scenarios that can be considered. One possible approach is to use an extract at doses that are recommended by the scientific community, and supplement it with another botanical at a lower dose that still meets safety, efficacy, and scientific consistency standards.
Another option is to use multiple active botanicals at doses that are below the recommended levels, but which can still achieve a cumulative effect when used together. This can be especially useful in cases where the therapeutic doses of certain extracts do not fully reflect the safety standards, as is the case with fermented red rice titrated in monacolin K or green tea titrated in epigallocatechin-3-gallate.
In these situations, it is possible to combine multiple extracts with similar functions in order to achieve a synergistic effect that can help to enhance their overall therapeutic effectiveness. This approach can be particularly useful for formulators who are trying to balance cost concerns with the need to produce supplements that are both safe and effective.
References and notes
R&D Manager - Bionap
Scientific and Marketing Director - EPO
Head of Scientific Communications & Marketing - Euromed
CEO - Fermedix
R&D Coordinator - FLANAT Research Italia
Data Analyst - FMCG Gurus
CSO - Flytexia
Scientific Manager - Flytexia
Product Innovation and Development Manager - INDENA
Senior Research Manager - INDENA
Junior Product Scientist - INDENA
Medicine Hunter - KSM-66 Ashwagandha
Alessandro Giuseppe Tricomi
Food Supplement Manufacturing - Natural Ingredients Solution
Quality Control - Natural Ingredients Solution
Market Manager, Nutraceutical – ROELMI HPC
General Secretary – S.I.Fit. (Italian Society of Phytotherapy)
Associate Professor in Organic Chemistry - University of Milano-Bicocca
Associate Professor in Organic Chemistry - University of Milano-Bicocca
References and notes
- FMCG GURUS: Clean & Clear Label in 2021 - Global Report
- FMCG GURUS: Non-Alcoholic Beverages - Global Report 2022
- FMCG GURUS: Evolving Trends in the Immune Health Market - Global Report
- FMCG GURUS: Nutritional Supplements in 2022