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The Schlafender Hase Team

Food Follows Pharma into Tighter Regulatory Territory

From, July 2016

From, July 2016

Regulators’ growing interest in food and nutraceuticals (foods with added health benefits) reflects growing government interest in helping consumers to make better dietary choices. This will affect the pharma industry, which wants its share of these adjacent market opportunities. Nutraceuticals in particular offers a new take on preventative healthcare (keeping people well, as opposite to treating them after they become ill): Transparency Market Research[1] estimates the nutraceuticals opportunity could be worth US $278.96 billion globally by 2021.

But however they approach this, firms need to appreciate the relative lack of maturity in regulatory compliance in adjacent markets – a situation that will be challenged as the authorities exert greater control over food claims and consumer information.

Earlier this year the FDA issued new guidance on food labelling[2], to drive greater standardisation in the way health and nutrition information is presented to US consumers, and make more direct links between diet and chronic diseases. New requirements, mandatory two years from now, encompass updated serving sizes, highlighting of calorie content, added sugar content and nutrient information.

In Europe, new rules come into force from December this year[3], covering new font sizes for mandatory information; clearer and harmonised presentation of allergens for pre-packed foods; information on nutrition content, the origin of refined oils and fats, substitute ingredients, and whether goods have been frozen and defrosted.

No one wants to get caught out by the new requirements. Food recalls are an almost everyday occurrence. Without due processes, it’s a minefield.

In the fast-growing nutraceuticals market, rules are becoming stricter too. Authorities in Scandinavia are clear that if nutrition companies are going to start making medicinal claims about their products, they must categorise themselves as pharmaceutical businesses and be bound by similar requirements. And countries from Japan and India to Canada have already put the regulatory wheels in motion.

Organisations with an interest in health foods and nutraceuticals must start putting in place processes and systems now, to address all of the new requirements and avoid costly mistakes on product labels and packaging.

One approach that has found appeal in life sciences, and which adjacent industries can now learn from, is automating initial rounds of label checks using sophisticated text verification – a process which can very quickly pick up even the tiniest discrepancies between what’s there and what should be there. It can save several rounds of laborious proofreading, freeing up skilled resources for more specialist work and maintaining momentum in getting products to market.

It’s a simple, clear way to prepare for growing regulatory demands as manufacturers strive to make headway in exciting new markets, and the right kind of measure to be putting in place now.

This article is taken from, July 2016


[1] Global Nutraceuticals Market to Reach US$278.96 bn by 2021 owing to Increasing Demand for Nutritional Diet, Transparency Market Research, April 2016:

[2] Changes to the Nutrition Facts Label, FDA:

[3] Food information to consumers – legislation, European Commission:

Peter Muller, Schlafender Hase

Author Biography

Peter Muller, Managing Director, Americas at Schlafender Hase has worked on software and process improvement projects relating to proofreading with Fortune 500 companies from various industries: Pharmaceutical, Medical Device and Consumer Goods for over 25 years. He has a wealth of experience working with international clients to define their organization’s goals and help them leverage new technologies to achieve productivity gains, process improvements and cost savings.

Do you want to find out more about how your proofreading life can be easier? Get in touch and we’ll tell you all about it.

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