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The Schlafender Hase Team

Regulators Hunger for Control of Nutrition and Nutraceuticals

As the shelves of any supermarket soon reveal, public demand for healthier diet choices and enriched functional foods is at an all-time high. Governments and health service providers are encouraging the trend, promoting illness prevention through better lifestyles and eating habits, as a means of reducing the strain on healthcare and of bringing chronic diseases under control.

The life sciences industry, keen to reduce its reliance on expensive blockbuster drugs, has recognised the opportunity and wants its share of the action. Many firms are now embracing health foods and nutraceuticals through acquisition or partnership, or the expansion of existing businesses to include new divisions.

Yet, where operations and staff have come from outside the pharma industry, it is likely that there will be gaps in those businesses’ understanding of the strict regulatory landscape they will be subject to.

Growing diet consciousness

Accurate product labelling will be a big area. In May this year, the FDA issued new guidance on food labelling[1], to drive greater standardisation in the way health and nutrition information is presented to US consumers, bringing national requirements more in line with Europe.

Its new Nutrition Facts label guidance, which applies to packaged foods, aims to ensure that labelling reflects the latest scientific information, including the link between diet and chronic diseases. New requirements also include updated serving sizes, and a refreshed design which highlights information such as calorie content, portion size and added sugar content. New nutrients must be declared too, including Vitamin D and potassium, to combat associated deficiencies. Most manufacturers will have until July 26, 2018 to comply with the final requirements; smaller players will have an additional year to make the changes.

In Europe, food labelling changes are further ahead. New requirements issued in 2014 will need to be met from December this year[2]. Key changes include improved legibility of information (minimum font size for mandatory information); clearer and harmonised presentation of allergens (e.g. soy, nuts, gluten, lactose) for pre-packed foods (emphasis by font, style or background colour) in the list of ingredients; requirements around certain nutrition information; specific detail on the vegetable origin of refined oils and fats, and of substitute ingredient for ‘Imitation’ foods; and clear indication of “formed meat” or “formed fish”, as well as products that have been frozen and defrosted. Health Canada has issued its own proposed guidance which is now with the industry for comment[3], so we can expect to see more requirements filtering through in due course.

No one wants to get caught out by the new requirements. Food recalls are an almost everyday occurrence. Just recently, The Nut House in the UK was forced to recall cakes containing whey powder, because this wasn’t mentioned on the label. Another labelling error saw Lidl UK recall an Italian chicken product, while rival Aldi had to withdraw a range of yoghurts because the labels failed to mention hazelnut among the ingredients.

Let food be thy medicine

In the soaring nutraceuticals market, rules are becoming stricter too. In addition to meeting emerging standards on what is presented, and how, companies will need to watch that they aren’t making claims they can’t substantiate about a product’s secondary benefits. Authorities in Scandinavia have been quite 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.

The concept of ‘functional foods’ originated in Japan in the 1980s[4], according to the European Food Information Council (EUFIC). Local health authorities had homed in on the need to control soaring healthcare costs and improve people’s quality of life, as the nation’s population aged and grew. This resulted in the development of foods specifically to promote health, or reduce the risk of disease.

It is no surprise, then, that Japan (the third largest health food market in the world) now has the most evolved approach to associated labelling[5]. In April 2015 the country’s Consumer Affairs Agency (CAA), the government body with oversight of food labelling and health claims, set out new provisions for labelling of ‘Food with Functional Claims’ (FFC). For the time being, these are voluntary, but the expectation is that they will lead to more formal requirements in the not-too-distant future – and the rest of the world would do well to take heed, as similar measures are likely to fan out to other regions and countries eventually.

For now, the measures are more enabling and empowering than restrictive, designed to accelerate product approvals and stimulate growth in the market. For example, Japan’s guidance permits companies to display a product’s specific health benefit and an associated area of the human body on retail food packaging. The associated registration process is more streamlined than that used for the existing Food for Specialised Health Uses (FOSHU) category. This eliminates the need for a protracted approvals process before a company can add a specific functional claim to the label of qualifying products.

Under the new FFC guidelines in Japan, FFC labelling must include cross-category quality labelling items as well as 16 specific items ranging from ingredients and recommended daily intake, instructions and precautions, and various safety notices. CAA has also revised its regulations for Food with Nutrient Functional Claims (FNFC) to increase product eligibility, expand the list of eligible nutrients, and to include fresh foods.

In other markets, requirements around nutraceuticals vary considerably: it is early days in regulatory terms in most regions. In the EU, products that claim to be a ‘nutraceutical’ must be certified by the European Food Standards Authority. In the US, by contrast, products don’t (yet) have to pass stringent government tests as long as they are not claiming to treat or prevent a specific disease[6]. But the likelihood is that the authorities will have to clamp down. The public will expect it, and there may be risks to consumers if they aren’t given adequate and consistent guidelines on when and how to use a nutraceutical product, or about the possible contraindications if they are already taking other dietary supplements.

Health Canada has been considering the regulatory imperative and challenges too[7]: how nutraceuticals/functional foods should be defined; whether such products ought to remain as either foods or drugs under the Food and Drugs Act; what kinds of health claims (if any) should be allowed on food labels; and what standards of evidence would be necessary and sufficient to prove a health benefit.

India has also been consulting and drafting regulations[8]. As well as serving its own market, India will have seen the opportunity to provide nutraceuticals to the world market, because of its low costs of production. International nutraceuticals firms are likely to look to this economy to bolster profits in an area of business with greater pressure on pricing (compared to drugs). The signs are that India may take a tough line, too, to engender trust in its products. Earlier this year, the Food Safety and Standards Authority of India ordered companies to follow strict norms in manufacturing and testing of health supplements launched after 2011[9].

Prevention is better than cure: staying ahead of the regulators

All in all, the above is a good indication of what is coming. If food and nutraceuticals manufacturers are found to fall short of regulatory labelling requirements, they will have to take prescribed corrective action and preventative action (CAPA). This will include showing that they have or plan to develop a system for addressing non-compliance issues and product recalls. So far better that they put such measures in place up front.

That means defining processes and systems which ensure that costly mistakes are not made on product labels and packaging – something companies can show to auditors, which spans the whole production chain. It is the absence of rigour that will lead to omissions and errors.

It isn’t just health claims that regulators need to control, either. Growing public consciousness means customers are becoming more demanding in their expectations to know every aspect of a product’s origins and its social, ethical and environmental credentials. In January, Brazil’s Ministry of Justice issued fines totalling $3 million to big names including Nestlé and PepsiCo for failing to disclose that their goods contained genetically modified organisms (GMOs).

Managing changes to labelling is a full-time job that should not be underestimated. In heavily regulated industries such as life sciences, Regulatory Affairs teams work flat out to check and double-check every detail, aware that the slightest misprint or mistranslation could have serious ramifications.

It is no coincidence that the food and nutraceuticals industries are now beginning to look to pharma for guidance on best practices. The market has 2-3 decades’ experience of managing complex control processes of the kind other manufacturers now need, so provides a valuable reference point. One of the techniques many companies here have adopted is an automated approach to initial rounds of label checks, using sophisticated text verification. This process can make very light work of substantial proofing burdens, quickly picking up even the tiniest discrepancies between regulatory text, artwork briefs and packaging artwork.

Emerging labelling requirements exceed the scope that an artwork team, supplier quality function, print supplier or marketing department can realistically handle, and threaten to take time away from other important tasks. While human beings should never be distanced entirely from critical checks, reliable automation provides a valuable shortcut through several layers of laborious proofreading, accelerating time to market and freeing up skilled resources for more specialist work. It is these kinds of labour-saving techniques that adjacent markets will need to consider now, as they prepare for what is coming down the line.


This article is taken from International Pharmaceutical Industry September 2016


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

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

[3] Consulting Canadians to Modernize and Improve Food Labels: What We Heard, Health Canada:

[4] Functional foods: The basics, EUFIC, June 2006:

[5] Japan’s New Health Claims Labeling System Creates Opportunities, USDA FAS GAIN report, August 2015:

[6] Nutraceuticals and the future of intelligent food, KPMG/, September 2015:

[7] Archived policy paper: Nutraceuticals/Functional Foods and Health Claims On Foods, Health Canada, June 2013:

[8] Draft Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical purpose, Functional Foods, and Novel Food) Regulations, Government of India, Ministry of Health and Family Welfare, Food Safety and Standards Authority of India 2015:

[9] New FSSAI rules on nutraceuticals may leave companies like Sun Pharma, GSK ailing , The Economic Times, April 2016:

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