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Application A604 – Phytosterols in Fruit Juice and Fruit Juice Drinks – Initial Assessment Report

10 February 2009

Dear Sir/Madam

Thank you for the opportunity to comment on this application. The New Zealand Food Safety Authority (NZFSA) supports Option 2 to accept this application but has the following comments to make regarding its future assessment.

Potential Health Benefit

There is limited research on the efficacy of phytosterols in fruit juice at reducing total blood cholesterol (TC), particularly compared to the evidence-base that exists for other phytosterol-fortified food and beverage products. NZFSA has reviewed clinical papers by Jones et al. and Devaraj et al. and accepts that consuming approximately two grams of phytosterols per day within a low-fat beverage may reduce TC in the short term (¹,²). The maintenance of the TC reduction in the long term, either singly or in combination with cholesterol-lowering medications, remains less clear for all phytosterol-fortified food and beverage products (³).

Food Technology Report

NZFSA supports the inclusion of a thorough food technology report for these forms of non-esterified phytosterols in fruit juice. Previous permissions for the addition of phytosterols to foods and beverages have generally involved a fat matrix rather than a non-fat beverage. NZFSA notes that the orange juice supplied to participants in the research paper by Devaraj et al. used a “patent pending” method for dispersing the phytosterols and stanols throughout the orange juice (1). Does this “patent pending” method limit the generalisability of the application to other fruit juices? What TC benefits are seen when the phytosterols are added using other methods?

Safety Assessment

We support the need for a thorough safety assessment, including reviewing the impact of consuming phytosterol-enriched products while taking cholesterol-lowering medications, such as statins. Hearty et al. found that consumers of phytosterol-enriched products who were also taking statins had a significantly higher intake of phytosterols than those who were not (⁴). Additionally, people taking TC lowering foods and medicines would generally be expected to take them for the rest of their lives so chronic rather than acute exposure to phytosterols needs to be the context for risk assessment. Further, given the product is targeted specifically at adults (>40 years) concerned about their TC, FSANZ should be mindful that these adults generally have existing co-morbidities such as type 2 diabetes, excess waist circumference and/or raised blood pressure. The addition of the beverage product to the dietary pattern should not exacerbate these conditions.

Dietary Intake Assessment

NZFSA supports the need for a full dietary intake assessment in both target and non-target groups, along with a detailed consumer behaviour assessment. Specifically, NZFSA would like to know if the target group already consumes enough phytosterols, or is there a need to widen the range of foods with added phytosterols.

Nutritional Impact

The volume of beverage required to achieve the maximum TC lowering benefit in the Devaraj et al. paper (240mls twice daily) and that proposed by the Applicant (250mls twice daily) is inconsistent with New Zealand dietary advice. Encouraging the daily consumption of 500mls of fruit juice would be inconsistent with New Zealand’s food and nutrition guideline statements for healthy adults as well as dietary guidance for the management of cardiovascular risk and/or type 2 diabetes – advice that is likely to capture the intended target group for this beverage product (⁵,⁶,⁷).

If the dose-response relationship that has been recorded for phytosterols and TC (⁸,⁹) is maintained even when the phytosterols are in a non-fat beverage matrix then some physiological benefit is likely to accrue from consumption of just one 250 ml serving of phytosterol-fortified fruit juice. NZFSA requests that FSANZ consider this in the draft assessment, as the recommendation of one 250ml serving per day of fruit juice would be consistent with New Zealand dietary advice and still promote truth in labelling with respect to potential ‘cholesterol’ statements.

NZFSA notes that fruit juice is going to be considered separately to fruit juice drink because of their different nutritional properties. NZFSA does not support the addition of phytosterols to fruit juice drink. Fruit juice drink is generally high in sugar and low in fibre and therefore its promotion as a vehicle for phytosterols is inconsistent with New Zealand’s public health nutrition messages. Restricting the type of food vehicle would be consistent with other previous permissions for addition of phytosterols to ‘healthy’ foods including ‘healthy’ breakfast cereals and low-fat milk.

Risk Management

At this stage, NZFSA would endorse measures previously applied to other phytosterol-fortified foods and beverages, such as the advisory statements listed under Column 2 of Clause 2, Standard 1.2.3.

Widening the range of foods with added phytosterols may lead to overconsumption therefore labeling requirements are pertinent. NZFSA has stated in previous submissions related to phytosterol-fortified foods that grams of phytosterols per serve need to be consistent across phytosterols vehicles and product labels should state the “recommended” number of grams and/or serves per day that would provide benefit. This would enable the consumer to manage their intake of added phytosterols from a number of food sources and help prevent overconsumption. As an ADI has now been set by JECFA and given the evidence that phytosterols provide no additional benefits when consumed in excess of three grams per day, NZFSA would support the declaration of phytosterols (or plant sterols) in the Nutrition Information Panel, per serving and per 100g to enable consumers to monitor their daily dietary intake of added phytosterols.

NZFSA notes that the Coca-Cola Company in North America produces and markets a 59 fl.oz bottle of phytosterol-fortified orange juice (approximately equivalent to seven 250ml servings) (¹⁰). While it is speculative to suggest similar packaged products would be available in Australia and New Zealand, it would be prudent for FSANZ to consider imposing a restriction on the size of the package to limit the daily overconsumption of phytosterols. This would be entirely consistent with previous risk management decisions made for other phytosterol-fortified beverages and Clause 5, Subclause b of Standard 2.5.1 (¹¹).

Further, the research paper by Devaraj et al. asked each participant to consume the beverage in a mixed meal situation i.e. with breakfast and dinner (1). The authors suggest in their conclusions that “the fat in the meal may have helped to emulsify the sterols” (pg. E27) (1). Are suitable directions for consumption therefore required in any supporting nutrition information?

Other comments

NZFSA considers that there may be a potential cost to Government in terms of the ongoing monitoring of exposure to phytosterols. EFSA in their opinion expressed on 15 February 2007 stated that “The Panel considers that quantitative intake data of phytosterols added to foods in the EU are needed for an adequate assessment and conclusion with respect to risk of over-consumption.” (¹²). NZFSA is equally concerned with the lack of quantitative intake data on phytosterol intake in New Zealand and raises this as a point for ongoing consideration by FSANZ. There are several streams of evidence that suggest greater efforts might be needed for monitoring. For example, access to phytosterol-fortified foods is becoming easier for most consumers as the range of products on the market increases. In the last five years, FSANZ has received at least four applications for the addition of phytosterols to food or beverage products (A433, A434, A508 and A596). It is proposed that this number may increase as consumers seek greater health benefits from food products. Additionally, the long term effects of overconsumption of phytosterols are not known, while existing advisory statements warning against overconsumption appear poorly understood. Reports prepared for FSANZ on this matter suggest that as little as one in ten consumers is aware of maximum and minimum consumption guidelines.

In summary, NZFSA supports this application going through to draft assessment. However, we have noted a number of concerns that we would like to see addressed in any future reports. NZFSA will consider further information in the draft assessment report should this application proceed.

Yours sincerely