By Joe Lederman and Charles Fisher A recent report released in the United States has found that there is insufficient evidence to support the U.S. Food and Drug Administration (FDA) definition of whole grains for a health claim. This article explores the current Australian position in relation to whole grains and health claims. We are grateful to toxicology expert Dr Roger Drew of Toxikos Pty Ltd for drawing our attention to some of these developments. Recent Developments in the United States Since 1999, the FDA has allowed manufacturers of food containing at least 51% whole grains to make label health claims linking whole grain consumption to reducing the risk of heart disease and certain cancers. For example, one health claim on products manufactured in the United States by General Mills states: Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol, may help reduce the risk of heart disease and certain cancers. Yet it was not until 2006 that the FDA defined whole grains as: the intact, ground, cracked or flaked caryopsis, whose principal anatomical components - the starchy endosperm, germ and bran - are present in the same relative proportions as they exist in the intact caryopsis. A recent study in America has found insufficient evidence to support a cardiovascular disease (CVD) or diabetes health claim when considering studies that conform to the FDA definition of whole grains. At the request of the Kellogg Company, the Life Science Research Office (LSRO) conducted a third-party, independent evaluation of the effect of strict application of the FDA definition of whole grains on the scientific basis for whole grains health claims. The study involved a comprehensive review of the relevant scientific literature about whole grains consumption and risk of CVD and diabetes. The key findings include: How are whole grains being marketed in Australia? A wholegrain consists of three essential components: bran, germ and endosperm. These components must be present for a grain to be considered ‘whole’. Common types of whole grains include whole wheat, oatmeal, whole oats, barley and brown rice. Many claims are being made on behalf of whole grains in Australia at the moment. An internet search yielded food company websites that claimed the following: A history of definition The Australia New Zealand Food Standards Code (‘the Food Standards Code’) currently defines a ‘wholegrain’ in Standard 2.1.1 as: “the intact grain or the dehulled, ground, milled, cracked or flaked grain where the constituents – endosperm, germ and bran – are present in such proportions that represent the typical ratio of those fractions occurring in the whole cereal, and includes wholemeal.” This broad definition allows any food product which uses every part of the grain including the outer layers, bran and germ to be called wholegrain even if these parts are separated during processing and regardless of whether the grain is in one piece or milled into smaller pieces. However, this current definition of ‘wholegrain’ only became law in 2005. Prior to Ministerial Council approval of Application A464, the definition of ‘wholegrain’ was: wholegrain means the unmilled products of a single cereal or mixture of cereals. This definition obviously excluded a number of manufactured products from being able to market themselves as containing ‘wholegrains’ (see First Review Report – Application A464, page 3): Very few cereal-based foods would qualify for wholegrain labelling under the current definition. For example, only limited commercial products such as brown rice and unpearled barley might qualify as unmilled cereal foods, whereas other products generally thought of as wholegrain such as wheat flakes or rolled oats would not. Therefore the definition of what constitutes a ‘wholegrain’ was changed in order to permit a whole range of food products to be marketed as ‘wholegrain’ and, at the time, FSANZ noted that milled and dehulled grains still contained the nutritional benefits of ‘intact’ grains. The FSANZ assessment of the new definition was initially rejected by the Food Regulation Ministerial Council on the basis that the new definition did not protect public health and safety but the Ministerial Council later approved the new definition. What can be said about whole grains? Currently, Transitional Standard 1.1A.2 of the Food Standards Code prohibits any claim that a food has a ‘therapeutic and prophylactic action’ or any reference to a ‘disease or physiological condition’. Arguably, all of the abovementioned claims could be in breach of this prohibition except that the claims are being made on behalf of the nutrient (wholegrains) and not the food product as such (like bread or breakfast cereal). This type of health claim is known as a nutritional property or nutritional function claim. The Draft Health Claims Standard and Diet-disease Relationships However, these types of claims would be subject to new regulations should the draft Health Claims Standard (proposed Standard 1.2.7) be approved by the Ministerial Council. While work has been ongoing on health regulations by Food Standards Australia New Zealand (FSANZ) for over a decade, the Ministerial Council recently announced that it was once again giving a time extension to FSANZ: the next draft of the Standard (the fourth draft) is due in March 2010. The abovementioned claims found on food company websites on whole grains would be considered ‘high level’ health claims as they refer to a ‘serious disease or biomarker’. All high level health claims require premarket approval by FSANZ before they can be used. FSANZ has reviewed a number of diet-disease relationships and has pre-approved eight of these relationships to be used as high level health claims on food products. These eight relationships have been approved on the basis that they have been substantiated with sufficient expert evidence to merit a high level health claim. In the drafting of latest version of the Health Claims Standard, FSANZ assessed whether a high level health claim could be substantiated and allowed on behalf of whole grains. The high level health claim that whole grains can reduce incidence of coronary heart disease was assessed by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) in January 2006. The review, entitled ‘Relationship between wholegrain intake and risk of coronary heart disease’, focused on wholegrains and bran, not fibre. Analysis of available studies revealed that there was not a sufficient level of convincing evidence to support the relationship between a higher intake of wholegrains and a reduction in coronary heart disease. The review states on page 26: “The central issue remains that of valid biomarkers to show cause and effects and for which the evidence seems to be conflicting, absent or presumptive.” Therefore, a high level health claim on wholegrain products (for example, wholegrains reduce the risk of developing heart disease) would not be permitted under the new draft health claim standard. However, express permission has been given to allow a ‘general level’ health claim on behalf of wholegrains (for example, wholegrains keep you healthy). Furthermore, studies have indicated that during processing (milling), two of the three essential components of wholegrains, bran and germ, are removed. This results in decreased fibre, vitamins and minerals, protein and increased carbohydrates, in contradiction to FSANZ’s statements in Application A464. Many consumers buy wholegrain food products for its perceived health benefits. The FSANZ definition of wholegrains means that products can be labelled as being a wholegrain product even if the wholegrains have been processed. Consumers are at risk of being misled or deceived as to the nutritional value of food products containing processed wholegrains. Food manufacturers should be aware that it is a breach of sections 52, 53 and 55 of the Trade Practices Act 1974 to mislead or deceive consumers into purchasing a product. Implications The release of the report in the United States revealing that there is insufficient evident to support the FDA’s definition of whole grains for health claims has highlighted the importance of monitoring science as it is constantly evolving and changing. Change in scientific consensus can be illustrated using the case of antiseptic mouthwashes. In a recent article published in the Dental Journal of Australia suggested that there is now ‘sufficient evidence’ that ‘alcohol-containing mouthwashes contribute to the increased risk of development of oral cancer.’ This issue of science changing was examined in depth in FoodLegal Bulletin’s article ‘The Scientific Tipping Point: When science changes the legal position’ in its May 2008 edition. If food regulators in Australia or elsewhere are to remain responsible for ensuring ongoing consumer protection and safety, then it is critical that the food regulators also monitor the scientific developments. Special attention must also be paid to the relevancy of the definition used for that food in the scientific literature compared with the relevant prescribed definition in the Food Standards. This is especially important in relation to any food for which FSANZ has acknowledged that a health claim or nutritional function claim is capable of being made. ----DISCLAIMER---- This article is NOT legal advice. You must not rely on the contents of this article for any purpose, including (without limitation) reliance as the basis for formulating any legal position or making any commercial decision. Legal advice on all regulatory compliance and legal matters should be sought only from a qualified lawyer who has been briefed on the particular facts and circumstances of your situation and has been requested to advise on the basis of the full circumstances with full instructions to provide professional and qualified legal advice.
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(Guidance for Industry and FDA Staff on Whole Grain Label Statements)
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