In this article, Sam Jennings FIFST debunks the myth that the world of food supplements remains highighly unregulated.
“The unregulated world of food supplements…”1; “…quality problems of unregulated food supplements”2. These comments, and many like them, are frequently heard or read in the media, particularly following an alert or tragedy relating to a product labelled as a food supplement. In 2013, after an inquest into the tragic death of a marathon runner, there was a call for “far better supervision of the so-called health food and supplement industry”3. This latter comment is perhaps the more accurate, although the comment that the victim took a “legal”3 supplement is less so.
The food supplement industry is highly regulated, with numerous laws controlling the composition, packaging, labelling, claims and marketing of food supplements. However, ‘supervision’, i.e. enforcement and control by the authorities, is sadly lacking in the United Kingdom (UK), owing primarily to major cuts to Trading Standards resources over the past decade.
Within the UK and European Union (EU), food supplements are controlled by all ‘horizontal’ food law. In other words, these are laws that apply to all foods consumed by humans, including food supplements. Such laws control hygiene practices, general composition (e.g. food additives), contaminants, general labelling and health claims, to name just a few. There are also laws specific to food supplements, which place additional controls on the composition, labelling and marketing of the products.
Figure 1 provides an indication of just some of the laws that a food supplement company must follow in order to ensure that the products they manufacture and/or market are legal within the UK.
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Figure 1: Some of the many laws controlling the sale of food supplements in the UK // Supplied courtesy of Berry Ottaway & Associates Ltd |
As the majority of responsible food supplement manufacturers will advise, to stay up to date and compliant with all laws affecting food supplements requires constant vigilance and an understanding of the impact that a legal change to any law affecting foods might have on the continued compliance of their products.
Unregulated, poor quality food supplements?
The quality of a food supplement relies, amongst other things, on its formulation, the individual ingredients, the manufacturing process, its packaging and its labelling. All of these points are strictly regulated. If a company follows the law at each stage, from development through to placing on the market, it should produce a quality food supplement4.
For instance, the formulator must ensure that the ingredients they intend to include are legally permitted in food supplements within the UK. Checking legal permissibility includes ensuring that they are not novel ingredients (i.e. they must have a significant history of use in food or food supplements in the EU before May 1997 or have been officially authorised as novel foods); and if they are ingredients that are controlled by specific lists, they must be present on the list for the use in food supplements. This latter requirement particularly affects vitamin and mineral sources in food supplements, as well as food additives and flavourings. There are many mineral sources, in particular, that are permitted in supplements in countries outside the EU, but are not on the list for use in food supplements marketed within the EU (see Figure 2).
The requirement additionally affects the components of compound ingredients, so the formulator has to check that all such ingredients are legally permitted. In addition, particularly in relation to plant ingredients, the formulator must ensure that the use of a particular ingredient will not push the product onto, or over, the borderline with medicines.
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| Figure 2. (a) Zinc sources that are permitted in supplements in some countries outside of the EU // Supplied courtesy of Berry Ottaway & Associates Ltd |
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| Figure 2. (b) (b) Zinc sources permitted in food supplements marketed within the EU // Supplied courtesy of Berry Ottaway & Associates Ltd |
Another key issue the formulator has to check is the quantity of the ingredients they are using. The use of food additives, for example, is restricted not only by a particular food category, but also by the amount that is permitted in that food category. For vitamins, minerals and certain other substances, the controls on levels may not be specifically laid down in law in the UK, but the legal requirement for food business operators to only place foods on the market that are safe and not injurious to human health means that consideration of a safe daily intake of the food supplement has to be a priority in the formulator’s mind.
The formulation must also be checked for stability, to ensure that each ingredient declared on the label (the ‘active’ ingredients) will be present at the declared amount at the end of the stated shelf life of the product (i.e. at the end of the expiry date stated on the label). This requires knowledge of the individual ingredients, in terms of any known stability issues; checking whether ingredients may lose activity by interacting with each other; being aware, particularly with vitamins, of the differences in losses of activity over time; the factors that impact those losses; and the potential substitution of some ingredients, or the use of e.g. microencapsulated ingredients, where this will improve the stability of the product. There is a requirement that food supplements must aim to provide the quantities of active ingredients declared on the label right up to the date stated as ‘Best before end’ on the product. Very small upper or lower deviations in the quantity may be accepted, if analysed by the enforcement authorities, as the label declaration should be an average value based on the manufacturer’s analyses of a number of batches, as opposed to being an absolute figure.
Once the general legality of the selected ingredients has been determined, the suppliers of those ingredients have to be sourced, at which point further legal restrictions must be taken into account. It is not acceptable for a company to simply go out and purchase the cheapest source of an ingredient without undertaking a detailed investigation. Each source of an ingredient has to be checked for its compliance with various laws, including controls on contaminant levels (chemical and microbiological), pesticide levels, extraction solvents, genetically modified organisms and irradiation. Food additives must be compliant with the specifications laid down in law, whilst for ingredients of animal origin, further controls are laid down, restricting in some cases the country of origin, the processing requirements and even the specific manufacturer of the ingredient.
The suitability of the ingredients for the formulation, in terms of moisture content; quantity of inert components, such as carriers; extract ratios etc. must also be taken into consideration, as these may all have an effect on the product stability and/or the declarations for the active ingredients in the product.
Once it has been confirmed that the formulation is viable and can produce the desired, stable product at the laboratory scale (and possibly also at pilot scale), the manufacturer can commence full-scale manufacture. Here there is a legal requirement for the company to meet all relevant aspects of good manufacturing practice (GMP). Under UK and EU law, the GMP legal requirements are not prescriptive, as they are written in a manner that applies to all foods. The principles have to be applied in a manner that is appropriate for each facility. Therefore, an industry sector guideline has been published to assist food supplement manufacturers with ensuring that they meet all relevant requirements of GMP in order to product a quality product. There is a self-assessment questionnaire to accompany the sector guide, which assists companies determine where they may or may not be meeting these requirements5.
Having a facility that is working to full GMP compliance is an essential starting point, but the manufacturer also has to ensure that the manufacturing process is capable of producing product that is of consistently high quality. This can involve mixing trials, to determine the most appropriate mixing speed(s) and time(s) for the ingredients; trials on production batch sizes, to determine the best batch size to reduce the risk of de-mixing of the ingredients; and batch tests to confirm that the product is still stable, and still meets its finished product specification, if the ingredient specifications are at the extremes of any of their stated ranges4.
Packaging of a food supplement product is another area that is strictly regulated. The selected packaging must be suitable for the finished product, in terms of supporting its stability during shelf life, whilst still being of a form that is consumer friendly, in terms of function and use. In addition, the packaging must meet legal requirements on packaging and packaging waste and also legal requirements on articles and materials in contact with food, both of which have an effect on the composition of the packaging materials.
Another point integral to the quality of a product is its label. It is no use for a company to produce a good quality product if they do not ensure that the label itself is compliant and contains all the information required by law to be provided to the consumer. Food supplement labelling is controlled by the general food labelling requirements, in addition to specific labelling rules laid down by the food supplements specific law. In addition, further mandatory labelling requirements for certain ingredients (e.g. authorised novel ingredients, certain food colours etc.), must be considered. The final label on a food supplement should be clear and legible, and should allow a consumer to view all details that will enable them to select the most appropriate product for their needs.
Of course, alongside the compulsory label information, companies also want to be able to entice consumers to purchase their particular product. Therefore, voluntary information may also be placed on the food supplement label. Such voluntary information may relate to the presence or absence of certain ingredients or components; the suitability for particular dietary regimen; the relative bioavailability of certain ingredients; or the benefits to health of certain ingredients contained in the product. All claims, whether related to health, the product composition or its individual ingredients, have to be supported by strong scientific evidence and must not be misleading to the consumer.
In the case of nutrition and health claims, these are strictly regulated and only authorised claims may be used. There are currently some ‘on hold’ health claims, which may be utilised in the UK until a decision is made regarding their status, but these claims can only be made on a product if particular conditions of use are followed.
Unregulated, unsafe food supplements?
Another complaint often made in the media is that food supplements are generally unsafe and unregulated. What is not recognised, however, is that in the (relatively few) cases where a food supplement product is found to be unsafe, it is usually because it has failed to comply with UK/EU law in one or more ways.
The tragic death of the marathon runner, referred to in the introduction above, occurred following her consumption of a food supplement containing dimethylamylamine (DMAA). Although the runner and her family assumed that the product she was consuming was a legal food supplement, the ingredient DMAA, before being determined to be a medicinal ingredient, was a novel ingredient under food law. Thus, the product was never compliant under UK/EU food law. Once determined to be a medicinal ingredient, the product then became non-compliant under medicines law. Hence, at no time was the product legally on the market.
Products often mistaken as food supplements are so-called diet or slimming pills. These frequently contain illegal ingredients, under food and/or medicines law, and are usually not labelled in a manner that is legal for food supplements. Sadly, severe illness or death is more common with these types of products, and the Medicines and Health products Regulatory Agency (MHRA) periodically run campaigns to warn consumers about the dangers of consumption of such pills and other illegal medicinal products6.
Unauthorised novel ingredients are a key concern in the food supplements sector. The UK authorities have recognised this concern and have ensured that, under the incoming new and revised novel foods legislation in January 2018, the enforcement powers to deal with products containing novel ingredients will be far greater than those currently in existence.
The safety of vitamins and minerals in food supplements, and the need for maximum levels to be set, is an issue that has been under discussion in the UK and EU for over almost 25 years, commencing long before food supplements were granted their own piece of legislation. Nutrient reference values (NRVs, formerly Recommended Daily Allowances, RDAs) have been set and periodically revised for the 13 recognised vitamins and for 14 minerals and trace elements. These values are not the maximum safe amount to consume, but are the levels that a person should aim to be ingesting as part of their daily diet. In certain cases, such as vitamin D, the NRV level is lagging behind current science and is lower than the daily intake amount recommended in public health messages.
Vitamins and minerals can be roughly separated into three groups8:
- Group 1: those that have no evidence of risk to human health at high levels of intake (i.e. no adverse effects have been found at levels dramatically higher than the NRV);
- Group 2: those that have a large margin between the NRV and the tolerable upper intake level (UL), which is defined as the maximum level of habitual intake from all sources of a nutrient or related substance judged to be unlikely to lead to adverse health effects in humans7; and
- Group 3: those with a smaller margin between the NRV and the UL.
| GROUP 1 | GROUP 2 | GROUP 3 |
| Vitamin B6 (as Pyridoxine) |
| |
| | |
| Biotin | | Calcium |
| Vitamin B12 (as Cobalamin) | | Copper |
| Pantothenic acid | Nicotinamide | Iodine |
| Vitamin K | Molybdenum | Iron |
| Chromium III | Phosphorus | Manganese |
| | Selenium | |
| | Magnesium | |
| | Folic acid (as pteroylmonoglutamic acid) |
| |
| | Potassium | |
Adapted from Food Supplements Europe, 20148
Some EU Member States have set national maximum levels for some or all of the vitamins and minerals permitted in food supplements. Although supposed to be based only on safety, in certain cases the maximum levels are based on multiples of historic RDA values. Currently there are no harmonised maximum levels for vitamins and minerals across the EU. The UK has taken a pragmatic approach to upper levels of vitamins and minerals in food supplements, accepting that certain consumers demand the option of being able to purchase a food supplement with a higher level of certain micronutrients. In order to retain that consumer choice, whilst also protecting consumers, the UK authorities require specific warning statements to be applied to food supplement products that contain higher levels of specific vitamins or minerals9.
Highly regulated, legally compliant food supplements: good quality and safe!
The majority of food supplements on the UK market are produced by responsible companies who take pride in the quality, safety and legality of their products. Many of these companies are members of relevant trade associations, thereby ensuring that they are kept up to date on the frequent changes to laws affecting the marketing of their products.
There is a small percentage of the entire UK food supplements market that is non-compliant in the ingredients the products contain and/or the product labelling and marketing information, especially with regard to nutrition and health claims. These products, though only a small percentage of the whole market, are the ones that end up gaining adverse media attention and lead to the belief that food supplements are ‘unregulated, poor quality and unsafe’.
A large proportion of the non-compliance of products is down to simple ignorance by the manufacturer or seller of the many laws with which they should be complying in order to produce a legal food supplement. Many non-compliant products are sold via the internet or via less traditional retail outlets, such as beauty salons and gyms. The Food Standards Agency is aware of the risk of lack of knowledge leading to non-compliance and has produce a leaflet to enable these less traditional retail outlets to gain an understanding of their legal responsibilities and how to assess whether the products they are selling should be on the UK market10.
Advice has also been prepared for consumers, retailers and would-be importers of food supplements by the trade body the Council for Responsible Nutrition UK (CRN UK), to help with the assessment of compliance of the product they wish to purchase or sell. The document outlines seven easy steps that can be followed to determine compliance, three by just looking at the label and four steps using lists11.
Misuse of health claims on food supplements is currently a particular cause for concern for both the UK authorities and the reputable food supplement companies, as it creates an unfair market place and some of the claims may be misleading to consumers. The lack of resources at enforcement level has meant that the food supplements industry, via relevant trade associations, is now working with the authorities to determine a means by which self-regulation at industry level may assist with reducing the degree of non-compliance confronting the enforcement agencies.
Food supplements are highly regulated food products. There are numerous laws in place to ensure that food supplements are safe to consume and that they do and say what they claim on the label. The food supplements that may be a cause for concern tend to be non-compliant with at least one piece of legislation, often more, and much of this non-compliance is down to ignorance of the law. The food supplements industry would welcome greater enforcement by the authorities against non-compliant products, especially those sold via the internet, but the industry acknowledges that enforcement agencies are now having to operate with far lower resources than were available in the past. A closer relationship is being built between food supplement trade associations and the UK authorities, to enable a cooperative approach to challenging non-compliance.
Sam Jennings FIFST
Director
Berry Ottaway & Associates Ltd
Web:http://www.berryottaway.co.uk/
References
1 http://www.independent.co.uk/life-style/health-and-families/healthy-living/up-to-40-per-cent-of-some-herbal-supplements-are-mislabelled-a7208776.html
2 http://www.ucl.ac.uk/pharmacy/pharmacy-news/food-supplements
3 http://www.telegraph.co.uk/sport/othersports/athletics/london-marathon/9837419/London-Marathon-death-Claire-Squires-boyfriend-calls-for-more-checks-on-supplement-industry.html
4 Council for Responsible Nutrition UK. Technical Aspects of Manufacturing Food Supplements. 2017 (https://crnuk.org/)
5 http://www.foodsupplementseurope.org/publications-guidelines
6 https://www.gov.uk/government/news/dodgy-diet-pills-dying-to-lose-weight
7 World Health Organization/Food and Agriculture Organization. A model for establishing upper levels of intake for nutrients and related substances. Report of a Joint FAO/WHO Technical Workshop on Nutrient Risk Assessment. Geneva: WHO/FAO, 2006
8 Risk management approaches to the setting of maximum levels of vitamins and minerals in food supplements for adults and for children aged 4–10 years. Food Supplements Europe, 2014 (http://www.foodsupplementseurope.org/publications-guidelines)
9 Food supplements Label advisory statements and suggested reformulations, Department of Health, 2011. (https://www.gov.uk/government/publications/food-supplements-guidance-and-faqs)
10 Food Standards Agency. Do you sell or supply food supplements? 2017 (currently hosted on the CRN UK website https://crnuk.org/safe-and-legal/)
11 Council for Responsible Nutrition UK. Seven easy steps to assess non-compliance of a food supplement. 2015 (https://crnuk.org/)
