How JSHealth conquered the UK market with compliance precision

JSHealth is an Australian supplement company that specializes in manufacturing and selling a diverse range of vitamin and mineral products for different health goals, with a primary focus on women. JSHeath’s entire range is formulated and made in Australia.

JSHealth was looking to expand its market presence by entering the UK, particularly through a collaboration with Boots, one of the UK’s leading pharmacy-led health and beauty retail chains. While Boots expressed interest in partnering with JSHealth, the existing product range was tailored for the Australian market. The formulations and labels were not aligned with UK regulations, hindering Boots' regulatory team from approving the products for the UK market.

Sam's approach with JSHealth involved carrying out a comprehensive legal compliance check for the entire product range. This included the analysis of formulations, recreation of labels, and reassessment of marketing claims. The approach was two-pronged:

1. The products were judged according to UK/EU food law standards to ensure that the products would be suitable for sale in the UK
2. The products were also assessed so as to meet the standards set by Boots. The retailer has additional standards applied to products that go above and beyond the standards required by law.

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Because the regulatory requirements were vastly different for the UK versus Australia, the main challenges included:

• Checking the status of the botanical ingredients to ensure that no medicinal ingredients were being used 
• Checking that none of the products contained Novel Food ingredients, as these require authorization before they can be used
• Some of the additives being used for the Australian market were not approved for use in the UK/EU markets 
• Some of the vitamin/mineral levels exceeded the maximum levels set by the European Food Safety Authority (EFSA) 

As a result, many of the formulations required minor adjustments before they could be submitted to Boots for approval. 

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Here are just a couple of the changes that were needed before JSHealth’s entry into the UK and Boots:

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Ingredient Additions: While suitable for sale in Australia, the product ‘Skin + Digestion’ did not contain any ingredients with EFSA-authorized health claims related to digestion. As a result, the product was updated to contain a source of calcium, which has a health claim for ‘the normal function of digestive enzymes’. This allowed the product to continue to be marketed towards supporting digestive health.

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Product Name Changes: Since the term ‘probiotic’ has not been approved for use on foods being sold in the UK, the product ‘Probiotic’ which contained multiple strains of friendly bacteria was updated to ‘Bio Pro’. This removed this non-compliance while also retaining the key messaging of the product.

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Without the regulatory checks and updates, JSHealth's products would not have been made available in Boots; in fact, they would not have been able to enter the UK at all. Thanks to Sam's regulatory expertise, JSHealth’s supplements range gained approval for sale not only in Boots stores but also across any retail store and online channel in the UK. The brand now enjoys the confidence that its formulations and product labels are legally compliant in the UK.

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This project started in October 2021 and the first set of products were introduced in Boots stores in early 2022. By the end of 2022, the entire product range was available in Boots stores in the UK, on the Boots website, and in Boots stores in the Republic of Ireland. 

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Sam's involvement extended beyond the UK market, aiding JSHealth in translating labels into Dutch and ensuring compliance for the Netherlands. This success has positioned JSHealth for a promising launch into the EU market, marking a significant step towards establishing long-term success outside of Australia.