Dietary supplements are known by many different terms around the world, including food supplements, vitamin and mineral supplements, nutraceuticals and health supplements.
They are generally defined as products that improve well-being by augmenting an everyday diet with nutrients that might be missing.
In some cases, DS provide nutrients that are hard to obtain in a particular region of the world; in others, they help to improve health, address lifestyle-related issues and even alleviate stress and anxiety.
Regardless of their purpose, the demand for DS is stronger than ever before. If you consider the chaotic global environment during the last 5 years, it's no surprise that consumers want to clawback autonomy of their own well-being and lifestyle, whenever possible.
For a formulator, there are several fundamental factors to consider in DS product formulation; some are related to the regulatory framework and others to customer preference. These are two key aspects for which a company such as Colorcon can lend significant expertise.
Regulatory considerations
- Which sources of vitamins, minerals, micronutrients and plant extracts can be used? What levels are acceptable?
- Can tablets be formulated with any excipient or food additive? What levels are acceptable?
- Where can I sell my products? Which countries will accept them?
- Are all ingredients stable and will I need to protect the formulation with additional packaging? How does this impact extended producer responsibility (EPR) regarding packaging waste, recycling, the use of recycled materials and more?
Consumer preferences
- Are all components stable or will I need to protect the formulation with additional packaging?
- What is the impact of the ingredients used and of my product and its packaging on the environment? What is the origin of these nutrients and are they responsibly sourced?
- Are these food additives acceptable to consumers?
- Where is the product made? Does the plant use renewable energy?
- How can I convince the consumer to trust my product?
In some regions of the world, and in the eyes of some important groups, DS are classed as
- foods (US, EU, WHO, Codex) and follow food regulations
- complementary medicines (Australia, Canada, Pakistan) where some form of registration and licensing is required
- something in between (Japan and India), where the product follows food regulations set out by Food Safety and Standards Authority (India/FSSAI), but production sites need to be licensed).
In general, where DS fall under food law, medical claims such as those to diagnose, treat, prevent and cure and illness, cannot be made. The exception here is in the EU, where some claims are permitted once scientific evidence is reviewed by the European Food Safety Authority (EFSA).
Establishing an understanding of the regulatory framework
Globalisation was not really a consideration 25 years ago; now, however, many companies have ambitions to sell their formulations more widely, claiming acceptability in as many global markets as possible.
Inherently, this means they need to locate, interpret and understand the various applicable regulatory frameworks. This is not easy to achieve as, in some countries, it is very clear what can or cannot be used in a dietary supplement formulation.
Take the European Union, for example; the EC 1333/2008 regulation tells you which food additives can be used and at what level. Moreover, EU regulation 231/2012 will tell you what the purity criteria or quality standard of these food additives should be.
To add a note of clarification here, as there are so many food additives in use within the food industry, EU 231/2012 regulation assigns a number to each additive to differentiate it.
These are referred to as E-numbers. There is a similar system employed by the World Health Organization (WHO) called the International Numbering System for Food Additives (INS).
In almost all cases, the E-number and INS number refer to the same material; and, although there is a significant amount of harmonisation, it is worth checking that the quality standard is the same.
To touch on consumer preferences, there is a prevailing opinion among consumers that E-numbers are bad and should be avoided. E-numbers indicate that an additive meets a recognised quality standard.
The driving force behind this may reside with the idea that foods should not contain any food additives. Unfortunately, dietary supplements in tablet or capsule form could not exist without lubricants, fillers, disintegrants and flow aids.
In the EU at least, it is not compulsory to use the E-number on the label, so the name of the food additive itself is often used.
There are similar frameworks in place for the US, Canada, Japan, Australia, the Gulf Co-Operation Council (GCC), the Eurasian Economic Union (EEU) and WHO.
There will be similarities in each one of these scenarios, but there are also significant differences, which ultimately means it is extremely difficult to have a one-size-fits-all approach to a global dietary supplement formulation.
Many compromises would need to be made in the formulation of the product, so it is common to have different formulations for different markets — thereby adding complexity to the supply chain.
Keep in mind that many countries do not have the resources to be able to implement their own regulatory framework for dietary supplements. What these countries typically do is adopt an already established framework and align it with their closest trading partners.
Regulatory framework changes and fragmentation
Once familiar with the regulatory framework, continued monitoring must happen to ensure that any changes in the acceptability of components are seen as soon as possible. A good example of this is when the EU banned the use of titanium dioxide (E171, INS171) in foods, including dietary supplements.
A handful of countries aligned with the EU’s decision, whereas the majority — including the US, Canada, Japan, UK, Australia and New Zealand — conducted their own risk assessment and subsequently determined that there was no risk to human health from consumption.
They have therefore continued its use with no limit on consumption.
So, when we see one region adopting a precautionary approach to eliminate a hazard instead of mitigating its risk — compared with other regions using a pragmatic approach to identify the hazard, assess the risk and implement mitigation — regional restrictions on food additives are the result, which makes a single global product even harder to achieve.
The EU’s titanium dioxide ban in foods is responsible for a major fragmentation of the DS market. There are several US states wherein congressional bills have called for the ban of five federally approved food additives, including titanium dioxide.
Should this get approved in any state, the result is a different regulatory landscape within one country, making a standardised product even harder to manage.
What is unfortunate is that this activity is often driven by political and social motives, rather than a balanced safety assessment of the additive. There are many excellent qualified nutritionists providing valuable advice all over the world; however, this is not the only “advice” out there.
Anyone with an opinion and a keyboard can gain a following, which might eventually lead to enough voices being raised against a particular additive for formulators to avoid its use.
It may even lead to a regulatory change. Unfortunately, there is often little credible science behind such social movements, but they are powerful and cannot be ignored.
Conclusion
The regulatory framework for dietary supplements varies significantly across the globe. This variation reflects differing approaches to consumer safety, market control and public health priorities.
Although the US adopts a more market-friendly stance with post-market surveillance, the EU and Canada emphasise pre-market approval and scientific validation of health claims.
Australia and Japan also enforce rigorous standards to ensure product safety and efficacy. For manufacturers and consumers, understanding these regulations is crucial to navigate the global dietary supplements market effectively.
