Food Supplements: How to Avoid Common Compliance Mistakes

Joanna Becker, Senior Regulatory Advisor specialising in Food Law at Ashbury, explains the current UK legislation for food supplements and how businesses can avoid making common - and potentially costly - compliance mistakes.

“When we talk about health-conscious consumers, we’re not just talking about those who hit the gym a few times a week and regularly eat their recommended seven portions of fruit and veg each day. ​

"Today, health-conscious means people of all backgrounds who are paying more attention than ever on what they consume - from ingredients and calorie information, to perceived health benefits, sustainability, and origin.​

“In the UK, new products containing Vitamin D rose by 20% between January and August 2020 ​compared to the whole of 2019, thought to be a result of Covid and a greater awareness of common vitamin and mineral deficiencies. ​

"As a result, many companies are moving into the food supplement space in a bid to offer consumers products which enable them to take control of their health and optimise it.​

What Regulations Apply in the UK? ​

“Food supplements here in the UK are required to be regulated just as food is and are subject to the same provisions of general food law. Northern Ireland still follows EU general food law according to the Northern Ireland protocol.​

“Food supplements in the rest of the UK are subject to three main pieces of legislation:​

·         The Food Information Regulations 2014​ ​

·         The Food Supplements (England) Regulations 2003​​

·         Food supplements are also required to abide by UK Retained EU Regulation No. 1169/2011​​ on the provision of food information to consumers.

“These three pieces of legislation largely lay out the requirements for food supplements when it comes to mandatory information that must be included on the label.​

How Should Businesses Prepare? ​

“Unlike some other countries worldwide such as China, food supplements to be sold in the GB market do not require registration approval with the FSA, although they must comply with all relevant legislation that covers the different aspects of a food supplement.​

“From labelling and advertisement, to permissibility of ingredients, additives used for making health and nutrition claims, permitted ingredients, and warning statements for vulnerable groups. ​

"Deciding to launch a food supplement in the GB market is no small challenge and in fact, it’s these areas that often fall short of the legislation.​

“Not meeting the specific regulations can result in costly changes to products and ingredients, labelling and packaging reprints and redesigns, and delays in getting products authorised for sale.​

“Companies must ensure they meet all mandatory particulars laid out in the three main pieces of legislation, providing all required information on the label and displaying product information in a clear, concise, and consumer-friendly format.”​

Avoiding Common Labelling Mistakes  ​

According to Joanna, it’s commonplace for UK authorities to challenge brands’ health, nutrition, and marketing claims - all of which feature heavily in the food supplement category as unique selling points to health-conscious consumers.

Making Health & Nutrition Claims ​

“Naturally, food businesses in this category are eager to promote the specific attributes and potential benefits of taking the supplements, but it’s essential that any claims made on the label are authorised for use from the GB Nutrition and Health Claims Register.​

“If brands wish to publicise an authorised health or nutrition claim from this register, it’s vital that the product meets all requirements defined for that specific claim.​

“For example, the term “generalised health claims” is commonly used to class products which reference a general benefit of a nutrient or ingredient in a food supplement for overall food health. ​

"But it’s important to note that any text on a food supplements label can be considered a generalised claim if the wording implies that the product has a health or nutritional benefit.​

“An example of a product requiring an authorised health claim on the label would be a supplement which uses “Vitamin Energy” as its slogan and which contains various vitamins, including B12. ​

It does not have on the label an authorised health claim from the GB register related to energy​ specifically, and so the slogan would therefore be classed as a generalised health claim, requiring an authorised claim on the label, such as “Vitamin B12 contributes to normal energy-yielding metabolism​”.

“In this case, there is a permitted health claim for Vitamin B12 that relates to energy. As long as the label contains the authorised health claim and meets the relevant criteria to use this claim, then the “Vitamin Energy” slogan can remain."​

Permitted Ingredients ​

“Another common stumbling block that many food supplement brands come up against is the use of permitted ingredients, which can be seen as a particularly grey area in UK food law as there is no official list of ingredients that are permitted in supplements. ​

"Botanical ingredients in particular can be hard to verify as to whether they are permitted or not, due to limited scientific research of their proposed benefits, and the lack of a defined list of permitted botanical ingredients for use in food supplements.​

“So, with a lack of concrete legislation in this category it’s recommended that any ingredients are checked against the UK’s Retained Annex of the EU’s novel foods list​​ to see if they are authorised. If they are not, a novel food application may be required, and the ingredient (and therefore the product) will not be compliant until it has been authorised.”  ​

“Another place ingredients can be checked is in the Medicines & Healthcare Products Regulatory Agency’s list​​ of herbal products, and their uses in medicine, food, aromatherapy and cosmetics. This documents the history of herbal ingredients and what they are commonly used in and not used in.​

Warning Statements ​

“Finally, there are a mandatory set of warning statements that are required on food supplement labels to ensure their safe use and consumption, especially to inform “at risk” population groups. The following warning statements are required on food supplements in accordance with the UK’s Food Supplement Regulations 2003:​

• A warning not to exceed the recommended daily intake/dose,
• A statement to the effect that food supplements should not be used as a substitute for a varied diet (plus ‘and healthy lifestyle’ if a health claim is made),
• A statement to the effect that the product should be stored out of the reach of young children.

“More warning statements may be required in addition to the above, depending on other factors such as vitamin and mineral levels . For example, a statement on Vitamin A levels in food supplements is recommended to be used on food supplements by the Department of Health, which says “This product contains Vitamin A. Do not take if you are pregnant or likely to become pregnant except of the advice of a doctor or ante-natal clinic”."​

Ashbury Advice​

“Overall, food supplements are tightly regulated and heavily scrutinised in the UK by the relevant authorities, due to the high-risk nature that non-compliant or unsafe supplements pose to consumers.​

“It’s more important than ever for brands in this category to ensure their food supplements fall on the right side of the legislation, first and foremost to protect the health and wellbeing of intended consumers, and secondly, to encourage sustainable business success by building a brand and product that is trusted, reputable, and safe.”​

Launched in 2011, Ashbury is a global product information specialist, helping businesses navigate the complex world of product information regulations for food and non-food products. For more information, please call 0845 459 5019 or visit www.ashbury.global​​.​

About the author

As Senior Regulatory Advisor at global product information experts, Ashbury, Joanna supports clients with complex queries focused on UK and Ireland food and supplements law.

With a degree in Food Science and Microbiology and an academic award in Food Microbiology, Joanna is passionate about helping businesses understand the complicated world of regulatory compliance and has over six years' experience of working across various domestic and international jurisdictions including the USA, Canada, Australia, New Zealand, West Africa, China, and India.