On May 20, the FDA issued new guidance on food labelling, bringing it more in line with Europe and the aim to create greater standardisation in the way health and nutrition information is presented to the consumer.
The FDA’s new Nutrition Facts label guidance applies to packaged foods. It is designed to make it easier for consumers to make better informed food choices, by ensuring that labelling reflects the latest scientific information. This includes the link between diet and chronic diseases, such as obesity and heart disease.
The label format being replaced is more than 20 years old. The changes reflect updated scientific information, new nutrition and public health research, more recent dietary recommendations from expert groups, and input from the public. New requirements include updated serving sizes, and a refreshed design which highlights information such as calorie content, portion size, 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; those with less than $10 million in annual food sales will have an additional year to make the changes. Foods imported to the US will need to meet the final requirements, as well as packaged food manufactured in the country.
EU shows the way
Food labelling changes in Europe are further ahead. New requirements issued in 2014 will need to be met from December this year (http://ec.europa.eu/food/safety/labelling_nutrition/labelling_legislation/index_en.htm). The new Regulation (EU) No 1169/2011 on the provision of food information to consumers entered into application on 13 December 2014. The obligation to provide nutrition information will apply from 13 December 2016. The new law combines 2 Directives into one legislation: 2000/13/EC – Labelling, presentation and advertising of foodstuffs (applicable until 12 December 2014) and 90/496/EEC – Nutrition labelling for foodstuffs.
Key changes in the EU 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 (http://www.hc-sc.gc.ca/fn-an/label-etiquet/modernize-report-moderniser-rapport-eng.php), so we can expect to see more requirements filtering through in due course.
Sign of the times
All of this may be the tip of the iceberg in terms of increased regulation and tougher requirements for labelling. The lines between food and pharma (a highly regulated industry, for obvious reasons) are beginning to blur, for example, as nutritionally enhanced products and superfoods move closer to supplements and health aids. At the same time, 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.
Although the new demands will be introduced gradually, with a grace period for manufacturers to exhaust existing supplies, mandated switchover dates will soon loom large. No one wants to get caught out by this and risk having products pulled from the shelves. Or worse being held to account by being publicly hauled across the coals due to a failure to comply. 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).
On a less dramatic scale, 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.
Learning from the experts
Managing changes to labelling is a full-time job which should not be underestimated. In heavily regulated industries such as life sciences, chemicals and cosmetics, 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 industry is now beginning to look to these more experienced sectors, particularly pharma, for guidance on best practices – and as a source of regulatory professionals as they seek to bolster their teams. The new labelling requirements exceed the scope that an artwork team, supplier quality function, print supplier or marketing department can realistically handle. They threaten to take time away from other important tasks, and come with an expectation that those responsible will know how to deliver the specifications needed.
The pharma industry has 20-30 years’ experience of managing complex control processes of the kind needed now in the food sector. All it would take would be the manufacturer substituting an ingredient, and failing to follow this through with changes to the labelling for the particular batch or lot number, to land the company in trouble. It isn’t all that long ago that a dairy in Sweden was penalised for using undeclared lactose in a product advertised as being lactose free. Often it isn’t until a serious event happens that companies realise the seriousness of having poor controls.
Pharma has come a long way in refining its processes and harnessing technology to streamline workflow and tighten up reliability, so as an industry it provides a valuable reference point. One of the techniques a lot of companies here have adopted is an automated approach to label checks, using sophisticated text verification – a process which can very quickly pick up even the tiniest discrepancies between regulatory text, artwork briefs and packaging artwork, irrespective of the font or language in use. Although humans should never be distanced entirely from critical checks, using reliable automation can save on several rounds of laborious proofreading and accelerate time to market, freeing up skilled resources for more specialist work.
It is these kinds of labour-saving techniques that the food industry will need to consider as it plans and prepares to meet growing regulatory demands without taking resources away from its core business.