Can you label GM food as a natural product? The US position remains unclear

Food Label Print publication


US judges request the FDA to decide on whether GM products can be labelled as ‘natural’

In July and November 2013, three US judges asked the US Food and Drug Administration (the FDA) to give a determination on whether food products containing ingredients produced using bio-engineered ingredients may be labelled ‘Natural’ or ‘All Natural’ or 100% Natural. Their request arose from their handling of cases where the plaintiffs allege that such labelling is misleading because the products are grown from bio-engineered, genetically modified (GM) seeds. The judges stayed their cases pending the FDA’s response.

The judges’ requests were followed by a letter to the FDA from the Grocery Manufacturers Association (GMA) in December 2013 which also asked for a review of whether GM foods can be labelled as ‘natural’.

In their letter of 5 December 2013, the GMA, which represents leading players in the international food market, alerted the FDA to their intention to file a citizen’s petition in early 2014 requesting the FDA to regulate on whether such foods containing ingredients derived from biotechnology could be labelled ‘natural’. The GMA believed the FDA’s involvement was justified because:

  • there have been a high number of class action lawsuits filed against food manufacturers over whether foods alleged to contain GM foods can be labelled natural
  • difficulties arise because there is no definition of a ‘natural’ product
  • several of the most common GM ingredients are from crops such as sugar beet and corn
  • the issue is an important one to the GMA’s members and warrants FDA involvement
  • the FDA has statutory authority, experience and the appropriate expertise to regulate food labelling
  • the FDA published a natural claims policy in the early 1990s and has applied it since
  • that policy gives guidance that a natural product will not contain anything ‘artificial or synthetic’ – and the GMA argue that GM foods are neither
  • despite the policy, numerous labelling claims have arisen and a consistency of approach to such claims is needed
  • without the FDA’s determination, there’s a risk that different decisions may be made in different states resulting in confusion
  • the issue is specific, straightforward and important.

The FDA Response

The FDA has now replied to the judges [1] and declined to determine whether and under what circumstances GM foods may be labelled ‘natural’. The FDA explained its decision as follows:

  • it acknowledged that it had not promoted a definition of ‘natural’ and referred to the guidance set out on the issue in its policy
  • it believed, given the complexity of the issue and the varying interests of the different players in the food industry, changing this policy would require a wide-ranging public process (and could not be effected by giving a determination to be used in private litigation proceedings as requested by the US judges)
  • the definition of ‘natural’ impinges on a wide scope of other issues beyond those raised by GM foods. There would therefore be no guarantee that a public process considering the definition of natural would in any case result in a change to the FDA’s current policy
  • the FDA’s available resources are focused on food public health and safety matters – and priority had to remain with those issues.

In its response, the FDA also referenced the GMA’s notice that it would serve a citizen’s petition to deal with this issue. The FDA dismissed their request on the basis summarised above and in its belief that ‘the public would be better served if…’ this policy issue was resolved by the FDA’s administrative processes rather than as part of the private litigation being handled by the judges.

The UK position

In the absence of an FDA determination, the American food industry must await the outcome of the judge’s deliberations. But what is the current position in the UK?

In the UK, GM food authorised for sale by the Department for Environment, Food and Rural Affairs (Defra) must be labelled under the GM Food and Feed Regulation (EC) No. 1829/2003 and the Genetically Modified Organisms (Traceability and Labelling) (England) Regulations 2004 (the 2004 Regulations).  These require any authorised GM food product to be given a unique identifier and apply to food, feed and beverages:

  • which contain or consist of genetically-modified organisms (GMOs)
  • are produced from GMOs (such as glucose syrup from GM maize), or
  • contain ingredients, additives or flavouring produced from GMOs (for example, lecithin from GM soya, which is used as an emulsifier in chocolate bars).

Where GM products are sold loose, information must be displayed immediately next to the food indicating that it is GM. In practice, this means products intentionally incorporating GM ingredients at any level or if derived from a GM source should be labelled as GM. However, products using GM technology (for instance, cheese produced using GM enzymes) or deriving from animals fed on GM animal feed do not have to be labelled. Whilst a small threshold exists allowing presence of GM ingredients that is accidental or 0.9 per cent or less, non-compliance leaves an operator open to having committed an offence under Regulation 8 of the 2004 Regulations. This is punishable by a fine, up to three months’ imprisonment, or both. An appointed inspector may also serve written notice:

  • prohibiting the product from being placed on the market
  • requiring an existing product is withdrawn from the market for a prescribed period, and/or
  • requiring the product is appropriately labelled within a specified period.

The definition of ‘operator’ here is wide. Whilst excluding the final consumer, it encapsulates any natural or legal person who either places a product on the market or receives a product placed on the market in the EC (be it from a Member State or from a third country), at any stage of the production and distribution chain. Further, the Food Standards Agency (the FSA) has established that food containing GM ingredients sold to caterers must also be labelled, so not just by the time it is delivered to the end-use consumer. Businesses are expected to take all reasonable precautions and exercise all due diligence to ensure products sold meet the relevant labelling requirements. What is considered ‘reasonable’ depends on all the circumstances, including the businesses’ size and resource.

The fact that products derived from animals fed on GM animal feed (such as milk, eggs and meat) do not trigger mandatory labelling has already raised discrepancies between EU countries as to when foods can be claimed to be ‘GM-free’ or ‘natural’. Certain Member States, including Germany, Austria and France, have introduced national schemes promoting standardised use of such claims where food is produced without GM technology. Yet inconsistency remains in relation to the necessary criteria for making of GM-free claims – creating confusion for customers and practical difficulties for operators selling products in more than one country. In contrast, other EU countries have no such requirements, believing consumers should be given information about the presence of something in a product rather than its absence. In January 2013, the FSA launched an investigation into whether a harmonisation of ‘GM-free’ labels was required [2]. As yet, however, no findings have been published.

No specific rules exist in the UK governing the use of ‘GM-free’ or similar expressions. The Food Safety Act 1990 makes it an offence for anyone to:

  • sell any food that is not of the nature, substance or quality demanded
  • give or display a label, have in their possession, publish or be a party to publication of an advertisement falsely describing the food or which is likely to mislead, or
  • sell, offer or expose for sale any food presented in a way that falsely describes or is likely to mislead.

So the general legislation simply ensures claims are only made if they are accurate and not misleading. Food marketed as ‘organic’ cannot contain GM ingredients, come from animals that consume GM feed, and 95 per cent of the farm-grown ingredients must be organic. Special rules and more specific legislative requirements exist for some particular food products, including bottled water, cocoa and chocolate products, fish, and honey – foodstuffs regarded as high-value, where there is a risk of misleading substitution by lower quality alternatives. More broadly, any food sold pre-packed must clearly show on its face:

  • the name of the food
  • a ‘best before’, ‘use by date’ or where to find it
  • the quantity
  • any necessary warnings.

Other product labelling should detail:

  • ingredients (where more than two)
  • the name and address of the manufacturer, packer or seller
  • any relevant lot number
  • special storage conditions
  • cooking instructions, where necessary.

Beef, veal, fish and shellfish, honey, olive oil, wine, poultry, and most fruit and vegetables imported from outside the EU must show the country of origin. Origin should also be detailed if customers are otherwise likely to be misled, for instance if UK-made pizza features an image on the packaging showing the leaning tower of Pisa.

What do the US deliberations mean for UK food producers?

While the UK regulations will not be directly affected by the US deliberations and ultimate decision on whether GM food can be described as natural, the high-level of US imports will mean increasing numbers of products in the UK marketplace will be affected. It is also likely to encourage further changes to the existing UK position at a time when food labelling generally is already a hot topic.

Enforcement of the Food Information Regulation (EC) No. 1169/2011 (the FIR) is imminent in the UK, seeking to improve the information provided to consumers. However, despite having been published in November 2011 and the majority of provisions applying from 2014 (with nutrition declarations becoming mandatory from 2016), Defra is still developing the FIR’s supporting legislation and implementing framework [3]. Alongside this, in June 2013, the Government launched guidance to ensure consistent front-of-pack design across all products, combining colour-coding and nutritional information to convey fat, salt, sugar and calorie content [4]. Whilst the system remains voluntary, key names within the industry are already involved.

One key problem for UK producers and suppliers is simply understanding and implementing the piecemeal regulations and guidance. This is not helped by the fact that, whilst responsibility for general labelling policy rests with Defra, the FSA maintains responsibility for food safety-related labelling issues – for instance, ‘use by’ dates and allergen labelling.

Any changes to legislative provisions regarding food labelling has considerable cost implications for producers, suppliers and other businesses within the industry. Time and money will be incurred redesigning, repackaging and reproducing goods to ensure compliance. In addition, imposition of newly-agreed criteria for when a foodstuff may be labelled ‘GM-free’ would entail testing and regular monitoring to ensure any requirements were being met. Products and brands established in the marketplace based on their ‘natural’ credentials may find their marketing position and unique selling point irrevocably threatened if unable to comply.

[1] From FDA’s response of 6 January 2014) (Obtained via site)
[2] Short consultation: EU harmonisation of ‘GM-free’ labelling (30 January 2013)
[3] Consultation: Food Information Regulations 2013 (30 January 2013)
[4] From Department of Health’s ‘Front of Pack Nutrition Labelling Guidance’ (19 June 2013)