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Proposed Changes to the Regulation of Dietary Supplements: The Supplemented Food Standard

Submissions and Responses

23 December 2008

This document summarises the submissions received by the New Zealand Food Safety Authority (NZFSA) on the proposed New Zealand Supplemented Food Standard (the proposed Standard). Comments are arranged under general headings. Please note that in the interests of brevity, comments have been paraphrased. An NZFSA response follows each point raised.

A number of editorial errors in the proposed Standard were noted by submitters. These errors will be corrected in the proposed Standard.

A number of submitters asked about the ability to add substances not specifically listed in the proposed Standard. It is the intention that the proposed Standard only lists those substances that are prohibited or restricted. Other substances that are not listed are permitted subject to the general provisions of section 9(2) of the Food Act 1981 which requires, in effect, food to be safe and suitable for its intended purpose.

Some submitters commented on the future regulation of therapeutic-type dietary supplements. NZFSA notes that there is no substantive change proposed for the regulation of therapeutic-type dietary supplements at this time. Such products will remain under the New Zealand Dietary Supplements Regulations 1985 (DSR), which are to be amended to exclude food-type dietary supplements and to require registration of therapeutic-type dietary supplements (free of charge).

Future regulatory arrangements for therapeutic-type dietary supplements are the responsibility of the Ministry of Health (MoH). Comments on the regulation of therapeutic-type dietary supplements have therefore been forwarded to MoH for information. MoH has advised that there is no intention to regulate therapeutic-type dietary supplements as pharmaceutical products. The Ministry also wishes to assure stakeholders that any proposals for the future regulation of therapeutic-type dietary supplements will be subject to full consultation.

Definitions

Several submissions raised questions about the use of various terms in the proposed Supplemented Food Standard. To provide clarity the terms to be used in the proposed Standard are defined below:

NRV: Nutrient Reference Values for Australia and New Zealand. Amounts of nutrients required on an average daily basis for adequate physiological function and prevention of deficiency disease. (NHMRC. 2006. Nutrient Reference Values for Australia and New Zealand including Recommended Dietary Intakes. Canberra and Wellington: National Health and Medical Research Council and Ministry of Health).

AI: Adequate intake. The average daily nutrient intake level based on observed or experimentally-determined approximation or estimates of nutrient intake by a group (or groups) of apparently healthy people that are assumed to be adequate. (NHMRC. 2006. Nutrient Reference Values for Australia and New Zealand including Recommended Dietary Intakes. Canberra and Wellington: National Health and Medical Research Council and Ministry of Health).

Food Code: The Australia New Zealand Food Standard Code.

One day quantity: The amount of that food which is to be consumed in one day in accordance with the directions specified on the label.

RDI: Recommended dietary intake. The average daily nutrient intake level that is sufficient to meet the nutrient requirements of nearly all (97-98 per cent) healthy individuals in a particular life stage and gender group. (NHMRC. 2006. Nutrient Reference Values for Australia and New Zealand including Recommended Dietary Intakes. Canberra and Wellington: National Health and Medical Research Council and Ministry of Health)

UL: The highest average daily nutrient intake level likely to pose no adverse health effects to almost all individuals in the general population. As intake increases above the UL, the potential risk of adverse effects increases. (NHMRC. 2006. Nutrient Reference Values for Australia and New Zealand including Recommended Dietary Intakes. Canberra and Wellington: National Health and Medical Research Council and Ministry of Health).

1. General Comments

This section includes comments covering the appropriateness of the proposal for regulatory change, the effect of the proposals on the regulation of therapeutic-type dietary supplements, the proposed transition period, and the status of Food Code standards in the proposed Standard.

Appropriateness of the proposals

NZFSA has underestimated the value of dietary supplement sales in New Zealand.

• NZFSA accepts that the figures used in the discussion document are well out of date and defers to the estimate of export value provided in Natural Products New Zealand’s Industry Capability Study & Implementation Plan (June 2008), of $300 million.

Regulatory changes must be broad enough to cover the range of products currently produced in New Zealand.

• The proposed Standard was designed with the objective of maintaining existing rights while protecting public health and safety. Products that are currently legally able to be sold in New Zealand will be legally able to be sold after the proposed Standard has been introduced.

The review and the regulatory separation is supported, as is alignment of the proposed Standard with the Food Code.

• Noted.

A ‘technical’ framework would be preferable over the current proposed regulatory structure. Such a framework would cover training and other standards. This framework could replicate the processes the food and health industries have established through the Industry Training Act 1992.

• The proposed Standard deals with the requirements for food-type dietary supplements. Industry capability requirements are not within the scope of this consultation.

The Standard must consider technical aspects of the food-medicine interface.

• The proposed Standard was developed taking interface issues into account.

Consideration should be given to the interaction between regulatory and educational standards for those manufacturing and dispensing therapeutic-type dietary supplements.

• The proposed Standard deals only with food-type dietary supplements. Comment referred to MoH.

This proposal needs to provide for the addition to food of substances for which there is currently no appropriate permission under the Code.

• This is one of the objectives of the proposed Standard.

Confirmation is requested that co-products will be recognised under the Food Code rather than the proposed Standard if they meet all the requirements of physical presentation and promotion. This is necessary as there may be some cultural differences in how a product is perceived in a ‘Western’ New Zealand setting but purchased and consumed in an Asian context.

• If there is an existing Food Code standard for the product, that product will not fall within the definition of a supplemented food.

• The definition of a supplemented food is a food that has had a substance or substances added to it or has been modified in some way –

i. to perform a physiological role beyond the provision of a simple nutritive requirements; and

ii. in relation to which the Code does not otherwise apply

How did NZFSA inform the public that submissions on the Supplemented Food Standard were being called for?

• The consultation document was sent to around 300 individuals and organisations that had expressed an interest. A media statement was also released and the document was placed on the NZFSA website.

• Industry meetings were held in New Zealand and Australia prior to and following the release of the consultation document.

The Supplemented Food Standard would ensure a consistent approach to both food and current food-type dietary supplements in terms of labelling and composition of products in the medium term. However, it would be better to develop the permissions to cover this type of product under the Food Code rather than develop an interim standard. There is a danger in creating an interim standard that it could allow products to be created that may not be desired under the Food Code and thereby creating a precedent for the continued sale of such products.

• It is agreed that the ideal would be to have all food-type dietary supplements regulated under the Food Code. However, since that is not currently possible, and there continues to be significant growth in the range of supplemented food products available, it is not considered prudent to wait any longer for such permissions to become available. The precedent of a standard has effectively been in place since the Dietary Supplementary Regulations were made in 1985. The Supplemented Food Standard maintains existing rights provided by the Dietary Supplement Regulations since that time. While the long-term goal is to have these products under the Food Code, it is necessary to provide more effective regulation that aligns with the Food Code in the interim.

There is an implicit assumption in the Discussion Paper that appropriate permissions will be incorporated into the Food Code at a later date. The permissions proposed in the new Standard could not be directly incorporated into the Food Code as such incorporation would require revision of existing standards or development of new standards. Bringing supplemented foods within the ambit of the Food Code is likely to be complex and time consuming.

• It is acknowledged that there are significant hurdles to overcome before all food-type dietary supplements can be covered by the Food Code. The alignment of the proposed Standard with the requirements of the Food Code is, therefore, considered the best option at this stage. This is not intended to detract from work that might be undertaken to amend or develop standards over time to accommodate these supplemented foods.

The proposed Supplemented Food Standard appears inconsistent with a number of current policy guidelines [as issued to FSANZ by the Australia and New Zealand Food Regulation Ministerial Council], potentially giving rise to difficulties in bringing supplemented foods into the Food Code.

• Policy Guidelines such as those for the Addition of Substances other than Vitamins and Minerals do not preclude the bulk of foods likely to be covered by the supplemented food standard even though the Food Code does not at this time cater for them.

An accompanying guidance document should be developed with the proposed Standard. Such a document would assist in providing clarity to industry on the intention and interpretation of the proposed Standard.

• NZFSA intends to produce a guidance document.

Therapeutic-type dietary supplements

The products covered by the Standard are natural medicines not supplemented foods.

• Comment referred to MoH. Therapeutic-type dietary supplements will remain under the Dietary Supplement Regulations.

The proposed register of therapeutic-type products should be free of charge to producers.

• There will be no charge for the proposed registration requirement under the DSR. Comment referred to MoH.

Therapeutic-type dietary supplements should be classified in a completely separate category.

• Comment referred to MoH.

Consideration needs to be given to Rongoaa Maaori. The Supplemented Food Standard may pre-empt existing and future standards development for therapeutic-type dietary supplements and Rongoaa Maaori standards.

• The proposed Standard deals only with food-type dietary supplements. Comments referred to MoH.

Are there products that would have fitted under the old DSR definition that don’t fit under the new supplemented food one?

• Therapeutic-type dietary supplements will remain under the amended DSR administered by MoH. The status quo will be retained for therapeutic-type supplements under the amended DSR.

• Some food-type dietary supplements may need reformulating or re-labelling or may be better suited to the Food Code. Part 2 of the Standard provides the status quo as a two-year transitional arrangement for food-type dietary supplements (supplemented foods).

Herbal remedies are safe. Taking away the right to use such products will have a terrible impact on our heritage.

• Comment referred to MoH.

Natural, herbal products retailers should be encouraged to market their goods in a way which informs the public without restriction (except disclaimers noting that it is advisable to consult a naturopath or medical herbalist before consuming).

• Comment referred to MoH.

There is a definite benefit to regulation; however, therapeutic-type dietary supplements require a very different level of regulation to that of pharmaceutical products. Statistics show that death due to adverse reactions to pharmaceuticals is high. Authorities should seriously examine the role of pharmaceuticals in healthcare.

• Comment referred to MoH.

Warning statements in reference to the interaction of St John’s Wort with particular pharmaceutical products should be mandated on the pharmaceutical products in question rather than on the St John’s Wort products.

• In New Zealand there is currently no requirement to put a warning on medicines that interact with St John's Wort. However the Dispensing Guide 2004 of Pharmaceutical Society of New Zealand (Incorporated) contains a list of prescription medicines that interact with St John's Wort so that pharmacists can warn patients taking these prescription medicines if they are aware the patient is also taking St John's Wort.

• The Australia Therapeutic Goods Administration requires warning statements on complementary medicines containing St John’s Wort, to the effect that St John's Wort affects the way many prescription medicines work, including the oral contraceptive pill - Consult your doctor. Such a statement is not currently a requirement for dietary supplements sold in New Zealand.

Dietary supplements and pharmaceuticals are entirely different. Such products should be classified separately.

• Comment referred to MoH.

Herbal ingredients are safe. Such products should not be in the same regulatory control as pharmaceuticals.

• Comment referred to MoH.

There is no need to alter the existing situation. No harm has ever been suffered from Herbal Remedies.

• The proposed Standard relates to food-type dietary supplements only. Comments referred to MoH.

General comments on references to Food Code standards

Support for the omission of Standard 1.5.1 – Novel Foods from clause 7 of the Standard so that supplemented foods are not restricted from using novel foods and ingredients. Such substances need to be considered for their nutritive and functional benefits rather than whether they are approved as novel foods under that standard.

• Noted.

Why is the Novel Foods Standard not included by reference in the Supplemented Food Standard? Would this not exclude the use of nutritive substances such as DHA oils, phytosterols etc in supplemented foods?

• Such substances are not excluded from use in a supplemented foods, but all food sold must be safe and suitable. If a substance is assessed as unsafe by a competent authority (including FSANZ) the continued use of such substances is likely to be contrary to Section 9 of the Food Act 1981 that prohibits the sale of unsafe food.

Standard 1.1.1, division 1, clause (2) should also be included by reference so that changes to the Food Code can simultaneously be made to the Supplemented Food Standard.

• Agreed. The proposed Standard will be amended accordingly.

Fruit and vegetables should be included for clarity (ie. Standard 2.3.1) to cover, for example, supplemented savoury or pickled food. Keeping the food safety pH 4.6 limit is important here too.

• Savoury or pickled food would generally be expected to be covered by the Food Standards Code. Fruit and vegetables do not meet the supplemented food definition.

A units/meaning table is reference under Part 2 of the proposed Standard, however is not included in Part 1. A similar table should be added to Part 1 of the proposed Standard as it makes reference to units when listing maximum levels of vitamins and minerals per day for adults and children in supplemented foods.

• The units table from clause 8, Standard 1.1.1 of the Code has been incorporated by reference.

The proposition that certain standards or parts of standards from the Food Code be picked up by reference in the Supplemented Food Standard may give rise to legal uncertainty and have unintended consequences arising from the absence of reference to other supporting standards.

• The cross-references have been checked. The intention is to reduce current uncertainty by specifying exactly which Food Code standards and permissions apply.

The following clauses from Standard 1.1.1 of the Food Standards Code should apply in the proposed Standard: Clause 1(2), 2, 10, 11, 12, 13.

• The proposed Standard will be amended to include clause 1(2). Clause 2 of Standard 1.1.1 is covered in clause 5 of the proposed Standard (Interpretation). Clauses 10-13 are not necessary to the operation of the proposed Standard.

A number of key standards in the Code have not been considered, or have been excluded when developing the proposed Standard for Supplemented Food, possibly on the basis that they were considered beyond the policy intention and scope of the proposed Standard. Some foods and beverages that are regulated by those excluded standards may be Supplemented Foods, and as those standards have not been incorporated, anomalies have arisen

• The assumption that these Food Code standards are outside the policy scope is correct.

• It should be noted that while the proposed Standard seeks to align to the maximum degree possible, it is not a Food Code standard. We acknowledge, therefore that there will be differences and these differences are largely the reason why the proposed Standard is necessary. If there is an appropriate Food Code standard then the product must comply with that Food Code standard and not the proposed Standard.

Transitional provisions

There are a number of provisions in Part 2 of the proposed Supplemented Food Standard that are either inconsistent, or in conflict, with the Food Code and supports the earliest removal of these provisions without causing unnecessary economic hardship.

• The two year transition period was set following consultation on the separation concept in 2007. The large majority of submitters requested a two year transition period. It would therefore be a breach of good faith to reduce that time now.

Supports proposed two year transition period.

• Noted.

A 24 month transition period should be applied rather than the proposed transition date of 1 September 2010.

• The date given was indicative relative to the publishing of the discussion document (July –September 2008). The date will be amended in the final standard to provide for a 24 month transition period.

2. Interpretation/Regulatory split

This section summarises comments covering issues of interpretation, including the use and definition of particular terms in the proposed Standard and the definition of supplemented food. In reference to this latter definition, comments in this section also cover issues associated with the division of products formerly sold under the Dietary Supplements Regulations 1985 (DSR) into supplemented foods and therapeutic-type dietary supplements.

Definition of ‘supplemented food’

It is important that all sports nutritional supplements no matter how they are presented stay regulated under the Food Code.

• Presentation is a factor in determining regulatory coverage. Many sports nutritional supplements are currently being sold as dietary supplements under the DSR. The Supplemented Food Standard is intended to maintain permission for these products. Without the Supplemented Food Standard, if sports nutritional supplements were to be regulated under the Food Code as it currently stands, the majority of these products would be taken off the shelf or have to be regulated as therapeutic-type products.

There is no clear definition between the Food Code and the proposed Supplemented Food Standard. This is particularly relevant where whole piece deer co-products are sold with no health claim, though consumers buy the product in the belief that the co-products provide health benefits.

• Whole piece deer co-products are not supplemented foods (in the same way that an orange is not a supplemented food, even though some consumers may purchase an orange for its vitamin C content).

Under “form and presentation”, it is noted that a deer co-product may be presented simply as whole piece of an animal (similar to offal) however it is typically purchased for health benefits by people from the Asian community. It may not be advertised or promoted as giving health benefits; it is simply accepted by the culture. In a western sense the co-product is presented as a normal part of an animal.

• A supplemented food is a food that has had substances added or has been modified. A whole food is not a supplemented food.

If the product is not fortified, or is not actively promoting health benefits, then the item should come under the Food Code.

• Agreed, although it should be noted that health claims are currently not permitted for food (sold under the Food Code) or in the proposal for supplemented food.

Why is the Food Code standard for the addition of vitamins and minerals not included in the Supplemented Food Standard? Why is the addition of such ingredients outside the policy intention and scope of the Standard? Does this pertain only to food-type dietary supplements? These ingredients should be grouped under the same classification as the therapeutic-type dietary supplements.

• If the Food Code standard relating to the addition of vitamins and minerals was included in the proposed Standard it would severely reduce the number of products that are currently legally able to be sold. One of the policy objectives behind the proposed Standard is to maintain existing rights while protecting public health and safety.

The meaning (definition) of supplemented food included in the draft standard is not supported. This meaning allows for any substance represented as a food for the general population, excluding foods permitted under Standard 1.3.2 in the Code, to be supplemented with vitamins and minerals and marketed as such.

• Noted. However foods permitted to be fortified in Standard 1.3.2 will be permitted to be supplemented foods if fortification goes beyond the levels prescribed in the Food Code. The resulting product must still meet the public health and safety requirements of the Food Act 1981.

The intention is for this standard to apply to the high end sports market, specifically muesli bars and drinks, however there is concern that foods of minimal nutritional value, including foods such as chocolate and confectionery, could be supplemented and marketed within the current drafting. Allowing foods of minimal nutritional value to be supplemented is inconsistent with the Code and national nutrition policy, including the Ministry of Health’s Food and Nutrition Guidelines series for healthy New Zealanders. This is not in the best interests of public health and is inconsistent with the stated intent in the [earlier] public discussion paper; no. 05/08 (page 6).

There is provision for foods of minimal nutritional value to be supplemented under the current Dietary Supplements Regulations (DSR) 1985, but the costs involved have limited the range of foods supplemented to date. There is no guarantee that the costs of supplementation will remain prohibitive in the future. This proposed draft Standard is an opportunity to align permissions with the Code and the interests of public health, now and in the future.

Clause 6 should be strengthened to exclude foods of minimal nutritional value.

• The proposed Standard is not a public health measure; that is, it is not intended for the promotion of public health. It is not inconsistent with the stated intent to protect public health and safety and to maintain existing rights. The proposed Standard balances these two intents by improving on the current provisions while maintaining access. It is important to note that the bulk of these products are internationally traded and, as a category of food, have not been identified as causing safety concerns.

• The proposed Standard aligns the regulation of food-type dietary supplements with the Food Code by incorporating 41 of the 54 joint standards (either in total or in part). This is a significant change to the regulation of food-type dietary supplements and signals a clear intent to regulate all such products under the Food Code when adequate permissions for these products become available.

• While these foods are available to the general population they are usually targeted to specific sub-population groups seeking additional benefits (ie athletes, people over 60 etc) and as such are likely to continue to seek a premium price. This is the case internationally. Given the current market appeal is to those seeking additional health or nutritional benefits it is hard to see strong demand for ‘unhealthy’ supplemented foods.

• If New Zealand was to set a restrictive measure for public health purposes, the measure would have to be justified pursuant to New Zealand’s World Trade Organisation (WTO) Sanitary and Phyto-Sanitary Agreement (SPS) and Technical Barriers to Trade Agreement (TBT) obligations. There is no evidence that NZFSA is aware of to suggest that food-type dietary supplements are detrimental to public health. If such evidence exists or is in train, NZFSA would consider this evidence as part of the review programme.

New Zealand's measure, as we have interpreted it, would determine whether a food should be regulated and marketed as a dietary supplement based largely on its physical form, packaging, and use as outlined through the questions found in Section 4.3. Caution should be taken in excluding more conventionally formed/packaged foods from regulation as dietary supplements, as would result from reliance on questions of appearance and presentation. Furthermore, form should not disqualify a product from being regulated, classified, and marketed as a Supplemented Food if daily consumption is limited for the express purpose of supplementing the daily intake of one or more nutrients/substances.

• Products that are legally able to be sold now will not be excluded from the New Zealand market. Therapeutic-type dietary supplements will remain, for the time being, under the DSR.

Dietary supplements in food form can co-exist with conventional foods through the use of clear labelling and directions for use. However, the proposals address a valid public health goal of guarding against those foods clearly intended for conventional use that may be masquerading as dietary supplements to evade conventional food fortification and supplementation requirements.

• Noted.

The discussion document does not recognise that fortified foods are also regulated under the Food Code. It is also unclear what the difference is between a ‘food’ which is regulated by the Food Code and a Supplemented Food. 

• If there is a Food Code standard for the product it is not within the definition of a supplemented food and the product will be regulated under the Food Code.

• The definition of a supplemented food is a food that has had a substance or substances added to it or has been modified in some way –

i. to perform a physiological role beyond the provision of a simple nutritive requirements; and

ii. in relation to which the Code does not otherwise apply.

Suggests the use of the term 'supplemented foods' could create confusion for both consumers and enforcement authorities with 'fortified foods’.

• Supplemented foods will be required to have ‘Supplemented Food’ on the label. This should make the product’s status clear to consumers and enforcement authorities.

The definition of Supplemented Food states that they are for the ‘general population,’ but the proposed standard provides for Supplemented Food specifically intended for children.

• The purpose of this provision was to ensure the safety of children so that products targeting children did not contain vitamins and minerals at adult levels. NZFSA is considering replacing this provision with an advisory statement for product containing vitamins and minerals over the level suitable for children states that: ‘This product is intended for consumption by persons over the age of 14 years.’ In addition, the definition of Supplemented Food will be amended such that a supplemented food is not intended for children aged 0-3 years.

The definition of the supplemented food includes the statement that the food has been modified to perform ‘a physiological role beyond the provision of a simple nutritive requirement.’ The Medicines Act 1981 defines ‘therapeutic purpose’ as ‘otherwise preventing or interfering with the normal operation of a physiological function, whether permanently, or temporarily…’ There appears to be a clash in the definition here.

• There is a close relationship between food and medicine. This is noted in the explanatory note to the DSR: ‘These regulations, in a sense, fill the gap between the Food Regulations 1984 and the Medicines Regulations 1984, in that dietary supplements are not food or medicine in the ordinary sense of those words. However, they are food within the meaning of the Food Act 1981, and will be related products within the meaning of the Medicines Act 1981 if therapeutic claims are made for them.’

• There are a number of foods that perform a physiological function, for example, foods that are rich in calcium or particular vitamins. The difference between a therapeutic product and a food is determined on a number of factors, for example on presentation, effect, history of use etc.

Regulatory separation

Just because an ingredient is presented in a capsule should not automatically make the product a therapeutic-type dietary supplement.

• The form is not the only consideration in determining the appropriate regulatory category for a dietary supplement product, but it is likely that the majority of products presented in capsule/tablet form will be classed as therapeutic-type dietary supplements.

If all capsules are deemed therapeutic, this will not stand up to legal scrutiny if challenged

• All regulatory decisions are open to challenge.

The major concern with the current changes in regards to food ingredients which are presented in capsules or tablets is that these products are now deemed to be therapeutic products.

• Currently food-type and therapeutic-type dietary supplements are regulated under the DSR. The present proposal only concerns food-type dietary supplements. There will be minimal change to the requirements for therapeutic-type dietary supplements under this proposal insofar as they will have to be listed. They will, nonetheless, continue to be regulated under the DSR.

Ingredients in many sports supplements that fall under the Food Code or the DSR are available in a powdered formula to eat on their own, or add to other foods or drinks etc. In some cases these same ingredients are presented in capsules for reasons of convenience. Capsules should continue to be allowed to be used in the presentation of all sports food type dietary supplements.

• The form, content, purpose, and history of use of a product needs to be considered to determine the most appropriate regulatory status on a case-by-case basis.

There may be confusion in determining if a product is a supplemented food or a therapeutic-type dietary supplement for products presented as powders with instructions for use.

• It is acknowledged that the food-medicine interface is complex and this is why a number of factors will need to be taken into account in determining the categorisation of products such as form, presentation, purpose, content and effect, and history of use.

Future documents explaining the food-medicine interface and the difference between supplemented foods and therapeutic-type dietary supplements would benefit from a pictorial representation (such as a decision tree) to complement the text.

• Agreed.

The concept of supplemented food referred to in the draft standard is similar to Chinese fortified food, but the draft does not clearly specify the concept of this kind of food as well as the category and scope of the product. For example, does the edible fish oil product belong in the supplemented food category? Examples are requested.

• It is acknowledged that the food-medicine interface is complex and this is why a number of factors will need to be taken into account, such as form, presentation, purpose, content and effect, and history of use. As an example, fish oil in capsule form which is taken in a prescribed dose on a regular basis would be a therapeutic type dietary supplement. However if the fish oil was being used as a cooking oil, or an ingredient in food, then it would be a food.

Definitions for technical terms used in the proposed Standard

The correct reference for the Nutrient Reference Values (NRVs) document needs to be used throughout the draft Standard, and the accompanying discussion documents. The correct reference is: NHMRC. 2006. Nutrient Reference Values for Australia and New Zealand including Recommended Dietary Intakes. Canberra and Wellington: National Health and Medical Research Council and Ministry of Health.

Please replace ‘recommended daily intake (RDI)’ with ‘recommended dietary intake (RDI)’ throughout the draft Standard, and the accompanying discussion documents.

• Comments noted and proposed Standard will be amended accordingly.

Clauses 10 (1) (b) and (2) (b) of the proposed Standard refer to Adequate Intakes (AI), but to be consistent with Standard 1.1.1 of the Food Code they should refer to the Estimated Safe and Adequate Daily Dietary Intake (ESADDI).

• The proposed Standard has used the more up-to-date NRVs for the basis of content claims for vitamins and minerals thus making ESADDI redundant.

It is clearly the intent that Section 10 should reference the table to clause 14 of Standard 1.1.1, Permitted Forms of Recommended Dietary Intakes (RDIs) and Estimated Safe and Adequate Daily Dietary Intakes (ESADDIs) for Vitamins and Minerals. However, under Section 7 it would appear that the only provisions of Standard 1.1.1 that apply to supplemented foods are clauses 6, 7 and 8.

• No. It is the intent of the proposed Standard to include reference to columns 1 and 2 only of the Schedule to Standard 1.1.1, i.e. ‘Vitamin and Mineral’ and ‘Permitted Form’. For the purposes of the proposed Standard, NZFSA is proposing the use of the more recent NRVs for Australia and New Zealand.

• Any reference to RDI and AI values are as defined in clause 5 of the proposed Standard and relate to the NRVs.

To avoid confusion, it may be preferable to include clause 14 of Standard 1.1.1 to this list in Section 7.

• Clause 5 of the proposed Standard provides for words or expressions defined in the Act or the Food Code and that are used but not defined in the proposed standard to have the same meaning as in the Act or the Code.

In reference to Standard 1.3.2, clause 9(1)(e)(ii), it is not very clear if it is permitted to list the %ESADDI or %AI or %NRV for Supplemented Foods, whilst it is only permitted to list the ESADDI quantity under the Food Code. The inclusion of something similar to the relevant clause in the Supplemented Food Standard with a permission to claim the percentage, irrespective of whether it is an RDI or ESADDI etc., would be useful.

RDI and ESADDI should be specifically excluded if they are not wanted, although these should be retained for consistency, at least as an option for adults.

Consistency is desirable between the requirements of the Food Code and the Supplemented Food Standard, for adults (at least) in terms of measure of vitamin/mineral levels. Suggests NRVs as an alternative as long as label clearly indicates which guideline is used (%RDI, %NRV, %ESADDI).

• NZFSA is proposing to use the NRVs for Australia and New Zealand. Any reference to RDI and AI values are as defined in clause 5 of the proposed Standard and relate to the NRVs.

In Part 1 (5) 3, RDI and NRV should be defined as they are in the Food Code under Standard 1.1.1 for consistency between regular and supplemented foods. Otherwise it will make for inconsistent confusing claims and comparisons between a fortified version and a non-fortified version.

The definition of ESADDI is missing, but the definition of AI mentioned. Please ensure consistency with the Food Code and stick to ESADDI as in Code.

• NZFSA is proposing the use the NRVs for Australia and New Zealand. Any reference to RDI and AI values are as defined in clause 5 of the proposed Standard and relate to the NRVs.

• Supplemented foods will be required to have the words ‘Supplemented Food’ visible in a prominent place on the label to distinguish these products from other foods.

3. Trans-Tasman Issues

This section includes comments on issues related to the trans-Tasman regulation of food products. It includes comments on the relationship between the proposals and the Trans Tasman Mutual Recognition Arrangement (TTMRA), and market access issues associated with differing standards.

Classifying all capsules (including sports food ingredients) as therapeutic products will restrict access to the Australian market as this would exempt these products from the Trans Tasman Mutual Recognition Agreement (TTMRA).

• The DSR are already listed as an exemption to TTMRA under Schedule 3, Special Exemptions, Therapeutic Goods. The determination of what is or what is not a therapeutic-type dietary supplement is entirely up to the importing country. The proposed New Zealand standard will not change Australia’s right to make a classification based on its legislation.

Supplemented foods are not required to comply with the requirements of Standard 2.9.4, although supplemented foods could be formulated using a similar base but with extra ingredients for particular effects. For example, a supplemented food could be developed to provide extended muscle recovery. This may cause interpretation difficulties for some Australian jurisdictions who may regard such foods as ‘illegal sports foods’ despite labelling the product as a supplemented food.

• It is acknowledged that there will be a conflict between standard 2.9.4 and the proposed Standard. Sports foods are one of the largest areas of food-type dietary supplements and New Zealand will be working with Australia to review standard 2.9.4.

4. Labelling

This section includes comments on labelling requirements under the proposed Standard. Comments focus on warning and advisory statements, nutrition information, health claims, food category identification (ie. the requirement for ‘supplemented food’ to be labelled on products), and general labelling requirements incorporated by reference from the Food Code.

Warning and advisory statements

All sports food-type dietary supplements manufactured under the DSR should have the same statements [as in standard 2.9.4] included on the labels.

• Noted, but it is intended that general warning or advisory statements would apply to all supplemented foods rather than having particular statements that only apply to specific categories of supplemented foods.

A sports food standard should control the presentation of the product so that they do not inappropriately appeal to children, but only to the intended consumer group. The definition of inappropriate regarding minors needs to be clearly defined within the proposed industry code of practice. This includes appropriate warning/advisory statements formulated through an appropriate risk management model.

• Sports foods are only expected to be one of the food products that will be regulated under this proposed Standard therefore it is inappropriate to have specific requirements for product presentation. However NZFSA commends industry-led initiatives that are in the consumer’s interest.

A repeat of the warning statement requirement under the DSR in Clause 8 should be added, just in case there are warning issues required (for example, with vitamin K and warfarin).

• This is outside the scope of the current consultation but suggestion will be referred to MoH.

The label of a package of supplemented food must include a warning statement where a danger exists if an overdose is taken, in particular for vulnerable groups.

• Agreed. The proposed Standard will be amended to address this point.

You should consider a ‘not suitable for children under X year of age’ warning statement requirement where there are issues with adult levels in commonly consumed fortified food products such as the juices and waters.

• NZFSA is considering an advisory statement for supplemented foods that contain levels of vitamins and minerals at adult levels. This would state the product is intended for consumption by persons over the age of 14 years. In addition, the definition of Supplemented Food will be amended such that a supplemented food is not intended for children aged 0-3 years.

The definition for warning statement sizing should be included as proposed. It is covered under 1.2.9, but not in the reference definition under 1.1.1, so for clarity it would be advisable to cover it in the Standard as well, alternatively it could be included under section 5, Interpretation?

• Noted, the proposed Standard will be amended to include minimum type face requirements for warning statements.

Add ‘advisory’ to the glucosamine ‘statement’ as it would be an advisory allergen statement.

• Glucosamine sourced from fish must be declared under Standard 1.2.3 Clause 4, which is intended to be incorporated by reference in the proposed Standard. Inclusion of glucosamine sourced from fish oil will therefore necessitate an advisory statement.

Glucosamine must have a statement saying it is derived from seafood as quite a lot of people are allergic to seafood.

• Glucosamine sourced from fish must be declared under Standard 1.2.3 Clause 4, which will be incorporated by reference in the proposed Standard.

If glucosamine is sourced from seafood, a statement to the effect that the ingredient was ‘derived from seafood’ must be included on packaging. Is this the case for other ingredients derived from seafood?

• Yes, Standard 1.2.3 of the Food Standards Code, which will be incorporated into the proposed Standard by reference, includes a requirement that seafood content be labelled for allergy warning purposed.

The proposed Standard requires a declaration for glucosamine when derived from seafood. This is redundant if the requirements of Standard 1.2.3 – Mandatory Advisory Statements and Declarations of the Code apply.

• Noted, the proposed Standard will be amended accordingly.

Suggest compulsory mentioning of the ‘adult’ fact for a consumption direction for the ‘maximum quantity per one day serving for adults’ where risks exist in relation to children’s consumption.

• NZFSA is considering an advisory statement for supplemented foods that contain levels of vitamins and minerals at adult levels. This would state the product is intended for consumption by persons over the age of 14 years. In addition, the definition of supplemented food will be amended such that a supplemented food is not intended for children aged 0-3 years.

It is important to define the required sizing of warning statement (vitamin K demonstrates this).

• Noted. The proposed Standard will be amended accordingly. In addition Standard 1.2.9 of the Food Code has been incorporated and this specifies the type size of warning statements.

The advisory statement as to appropriate age has the ages that apply included. Using the word ‘children’ is much too vague. ‘Produced for children from x to x years of age’ is more appropriate, or ‘Produced for children’ with a clear indication of the applicable age range.

• NZFSA is considering an advisory statement for supplemented foods that contain levels of vitamins and minerals at adult levels. This would state the product is intended for consumption by persons over the age of 14 years. In addition, the definition of Supplemented Food will be amended such that a supplemented food is not intended for children aged 0-3 years.

Nutrition content and health claims

Sports supplement products are not therapeutic products and are intended for use as foods, therefore it is not necessary to make the sort of claims that would require substantiation by regulatory authorities.

• Therapeutic Claims are currently and will continue to be prohibited on sports foods. A standard for health claims in the Food Code is still under development.

Criteria for making health claims should be based on dietary modelling and fitness of foods singly and in combination.

• A proposal to allow health claims on foods is currently under development.

The nutrient profile scoring criteria for determining whether a food is a suitable vehicle for supplementation should not be used for supplemented foods. The use of nutrient profiling systems is scientifically flawed.

• This is outside the scope of the proposed Standard.

Section 9 (sub-clause 2) places significant restrictions on the ability of manufacturers to communicate the benefits, functions and physiological actions of the supplemented food beyond a simple nutritive statement. There are serious concerns about the suitability of such a restrictive requirement on foods that are designed to provide a benefit above and beyond the simple nutritive value of foods. This is not the same as making claims for the inherent benefits of an ingredient, but is about an ingredient added to a food for a specific effect and it is necessary to communicate this intended effect to the consumer.

Where there is a clear and scientifically substantiated relationship between a nutrient and a physiological or disease condition these statements should be permitted on a label.

• Allowing health claims on supplemented foods would not be consistent with the stated intent to align the provisions of the proposed Standard as much as possible with the Food Code.

A reference to proposed Standard 1.2.7 should be included so that as soon as the Nutrient and Health Claims framework comes into place it will apply to supplemented foods.

• It is not possible to reference a standard that is not yet in place. It is possible to amend the Supplemented Food Standard in the future.

The 10% source, 25% good source should be included as proposed in clause 8 and a 40% or 50% category for very high/ very rich category should also be considered for inclusion, in line with past protein claims under the Food Regulations and the very high fibre claims under the proposed Standard 1.2.7 (Health Claims).

• This suggestion would be beyond the stated intention to align the provisions of the proposed Standard with the Food Code as much as possible.

Use of the word ‘health(y)’ should be permitted on labels. However, the product itself, as a whole, needs to evaluated to see whether or not in the interest of the consumer it is worthy of the word health being attached to it.

• This is outside the scope of this proposal and relates to the development of the health claims standard that is under development.

In order to communicate the physiological role of a supplemented food it may be necessary to make a specific health claim.

• This is outside the scope of this proposal and relates to the development of the health claims standard that is under development

Promotion of products helps to give the average person a chance to know about these simple and cost-effective gentle remedies.

Without advertising some herbs could go out of use and could be lost forever.

• The proposed Standard includes a continuation of the existing prohibition on health claims and associated advertising.

The transitional health claims standard (1.1A.2) has not been referenced in the several relevant clauses of the proposed Standard.

• The relevant clauses from Standard 1.1A.2 have been included in clause 8 of the proposed Standard.

Does the decision not to incorporate Standard 2.6.4 of the Food Code (which prohibits %RDI claims on added vitamins) by reference in the proposed Standard mean that %RDI claims can be made in relation to supplemented foods? Will it also be possible to make %RDI claims on B vitamin content?

• Yes.

Food category identification

The wording ‘Supplemented Food’ should be on the principal display panel in lettering no smaller than 3mm in lowest case (i.e. be classified as a warning statement) to clearly indicate right up front that this is quite different from ‘normal’ food.

It is very important that clear distinctions are maintained between foods and supplemented foods, especially with foods that are bought for the family and consumed by children, for example, fortified waters and juices.

• The wording ‘Supplemented Food’ will be required to be in a prominent position on the food label. The 3mm type face size is being reserved for label content that is required for safety reasons, for example, warning statements.

General labelling requirements

Nutrition information should be present on all foods without exemption.

• A nutrition information panel will be required on supplemented foods through the inclusion by reference of the relevant labelling standards from the Food Code

Standard 1.2.2 should apply as they form the basis for traceability of lots in the event of recall and in locating the manufacturer.

• NZFSA is satisfied that clause 8 of the proposed Standard provides for the same outcome as Standard 1.2.2.

All ingredients should be listed on the labels of supplemented foods, including additives, fillers, and flavourings, etc.

• Ingredient listing will be a requirement for supplemented foods. The relevant standards (1.3.1 and 1.3.3) from the Food Code will be incorporated by reference into the proposed Standard.

The term ‘per one day serving’ is not used in the Code. It would need to be clearly defined and appear on the product’s label.

• The term ‘per one day quantity’ will be used to align with the Food Code. The term will also be defined in the ‘interpretation’ section of the proposed Standard.

Manufacturers must be able to label their products for a specific target group with no restrictions on the product composition.

• The Food Code requires all ingredients to be listed on a food label. If a content claim is made about a particular ingredient, the level of that ingredient must be included in the Nutrition Information Panel on the label. The relevant labelling standards from the Food Code will be incorporated by reference in the proposed Standard.

5. Composition and Risk Management Framework

This section includes comments on issues related to the composition of products that can be sold under the proposed Standard, including permissions for particular substances. It also covers comments on the management of risks associated with products that may fall under the regulatory coverage provided by the proposed Standard, and includes restrictions and prohibitions on certain substances. Although some comments relating to warning and advisory statements are included under section 4 above (Labelling), a number of submitters commented on threshold levels for particular substances, especially caffeine, which will trigger a requirement for an advisory statement. A number of submitter raised concerns that, although supplemented foods are not intended for consumption by children, this may not prevent foods being marketed to children. Comments relating to this point are also covered in this section.

Permissions under the proposed Standard

All ingredients used in food type dietary supplements should be allowed unless specifically prohibited. The risks of the actual food ingredients used in sports nutrition formulations dictate the level of regulation required for this specialist field.

• The proposed Standard sets certain prohibitions and restrictions for use where there is evidence to support such prohibitions and restrictions. There is also a general prohibition under Section 9(2) of the Food Act 1981 on the sale of unsafe food.

There are certain types of artificial sweeteners which have been allowed to be added to foods under the word flavouring. It is important that the public can make an informed choice.

It is good the Standard will limit the kinds of preservatives allowed in supplemented foods as this will provide greater safety to consumers and a lot less suffering from allergies.

The fewer the number of colourings permitted the better. Colourings cause a huge amount of allergy in our communities. Also the amount of aluminium needs to be carefully considered because of its possible link to dementia and Alzheimer’s disease.

The first two permitted sweeteners listed should not be included and not enough is known about the third. A healthy natural sweetener such as Stevia should also be permitted.

• The additive standards in the Food Code will be incorporated by reference into the proposed Standard.

• Assessing new additives, such as Stevia, is outside the scope of the proposal for the regulation of supplemented food.

Agree to the inclusion of Standard 1.4.4 by reference but notes there are some discrepancies here: for instance borage oil is permitted under the DSR at the moment but not in foods. Please cross check for other conflicting permissions/exclusions.

• In order to align the proposed Standard as much as possible with the Food Code there may be some ingredients that will not be permitted in supplemented foods that are currently permitted in dietary supplements. This will only apply to food-type dietary supplements so these ingredients will continue to be permitted in therapeutic-type dietary supplements.

The wording at the top of clause 14 is ambivalent on added and total (including inherent) levels of vitamins and minerals permitted in a one day serving. However, the safety of magnesium seems to be primarily related to added magnesium so the 175mg mentioned there as 50% of the UL of 350mg/d does seem to cover just the Added. I suggest that the combination can be resolved with the addition of another column, a column 2 for amount that can be added, and a column 3 for amounts that can be present. Similar to other legislation differentiating columns for claimed and present. Then the wording could be ‘may be added not to exceed the amount in column 2 and the total amount present in the food not to exceed the amount in column 3’.

• It is NZFSA's intention that the maximum levels for vitamins and minerals in supplemented food in clause 14 reflect the total quantity of the vitamins or minerals from naturally occurring and added forms.

As concern has been flagged in the supporting documentation about vitamin K3, a limit should be included for that.

• This would be more restrictive than the table in Standard 1.1.1 of the Food Code which has no specified limit for vitamin K3. Including a limit for this vitamin would therefore go beyond the intention to align the proposed Standard as much as possible with the Food Code.

Vitamin K1 should be required to be manufactured under standards of GMP. The inclusion of this provision should be made in the interests of clarity.

• This would be more restrictive than the table in Standard 1.1.1 of the Code which has no permitted form for vitamin K specified. Specifying the form of vitamin K would therefore go beyond the intention to align the proposed Standard as much as possible with the Food Code.

Regarding the final paragraph in Section 2 re Folic Acid: this is one excellent recommendation on your behalf which we thoroughly endorse. Recommendations should include advising women to be aware of the benefit of taking Folic Acid for 3 months prior to getting pregnant where possible.

• Noted and referred to the MoH which is responsible for New Zealand’s recommendations on folic acid and pregnancy.

In table 3 (and Clause 15, table 5) you have used the word ‘folate’. Note that in the NRVs document, the Upper Levels of Intake apply to folic acid only. Folic acid is the form added to foods as a fortificant and used in supplements. It is different from the naturally occurring folate.

• This will be amended in the proposed Standard.

Though it is proposed to increase the permissible level of folic acid to 500mcg for dietary supplements that have been produced under Good Manufacturing Practice (GMP), the proposed limit of 500mcg for supplemented foods specified in the New Zealand (Supplemented Food) Standard document, Table 3 Maximum Supplemented Food Levels for Vitamins and Minerals per day for Adults, does not state a GMP requirement for supplemented foods containing 500mcg of folic acid. The requirement for GMP should be the same for both supplemented food and dietary supplements – either both are required to be produced under GMP or neither is required to be produced under GMP.

• Supplemented foods will be able to contain up to 500mcg of folic acid as this is 50% of the UL for adults.

• The proposed increase to 500mcg for therapeutic-type dietary supplements will be given effect through an amendment to the DSR. The requirement for therapeutic type dietary supplements containing 500 mcg folic acid to be manufactured under GMP is proposed because these products are used by women for a therapeutic purpose therefore it is important that the product is made to a standard that guarantees the product is manufactured to an approved standard.

The proposed maximum levels of Selenium, Zinc, Vitamin D and Folic acid specified in Table 3 Maximum Supplemented Food Levels for Vitamins and Minerals per day for Adults are higher than those levels specified in Section 18 – Maximum daily doses (page 13). This is illogical. We propose that the highest maximum limit for all Vitamins/Minerals are specified in Section 18 (maximum daily doses), or the limits in Sections 14 and 18 are harmonised.

In addition, the proposed maximum levels of Selenium, Zinc, Vitamin D and Folic acid specified in Table 3 Maximum Supplemented Food Levels for Vitamins and Minerals per day for Adults are higher than those levels specified in Dietary Supplement Regulations 1985. This is illogical. We propose that the highest maximum limit for all Vitamins/Minerals specified in the ‘Draft New Zealand Food (Supplemented Food) Standard 2008’ and the ‘Dietary Supplement Regulations 1985’ are harmonised.

• Part 1 and Part 2 do contain separate provisions. Part 2 is the status quo for transitional purposes and Part 1 has been reviewed and updated in line with the NRVs.

The maximum level for Calcium is suggested at 1250mg and Magnesium 175mg. Many opinions understand that the ratio of calcium to magnesium should be a ratio of 2:1. Suggest raising quantity of magnesium to 350mg - the upper limit, or lowering the maximum calcium quantity to 1000mg.References provided: http://www.nhmrc.gov.au/publications/synopses/_files/n36.pdf, http://www.acu-cell.com/acn2.html, http://www.acu-cell.com/mr.html

• The proposed levels have been based on 50% of the UL for calcium and magnesium as per the NRV. The rationale behind the limit was included in the discussion document Appendix ‘The Addition of Vitamins and Minerals to Food-Type Dietary Supplements’ and references the scientific papers on which the determinations are based. This document is still available on the NZFSA website (www.nzfsa.govt.nz/consultation).

Sucralose should be added to the list in clause Part 2, subpart 2, clause 30(2).

• Part 2 replicates existing requirements. Amending Part 2 would be contrary to the policy intention of maintaining status quo arrangements for the 24 month transition period. However, manufacturers are able to choose to comply fully with Part 1 at any time within the transition period.

Standard 1.3.3 Processing Aids, does not currently allows the inclusion of polyvinyl pyrrolidone and its derivatives, however there are permitted in the DSR. Consideration should be given to including this group of compounds in the proposed Standard, or including them in Standard 1.3.3 of the Food Standards Code.

• Polyvinyl Pyrrolidone is listed in Standard 1.3.1 Food Additives. Standard 1.3.1 will be incorporated by reference into the proposed Standard.

Is it the case that only those substances listed in the standard can be added to supplemented foods?

• No, the proposed Standard does not provide a positive list of substances that can be added, but instead lists those substances that are either restrictive, or have certain restrictions applied to them. The addition of other substances will fall under the general requirements of section 9(4) of the Food Act 1981.

As Clause 7 of the proposed Standard references Standard 1.3.1 but does not reference Standard 1.3.2 Vitamins and Minerals, does this mean that other vitamins and minerals not stated in clause 14 and elsewhere can be added to ‘supplemented food’ products, and if so are there any Maximum Quantity per One Day Serving levels which apply to them— and if so what are they?

• Yes it will be possible to add other vitamins and minerals and there will be no specific Maximum Quantity per One Day Serving level applied to them. Addition of such substances to food will be subject to the general provisions of section 9(4) of the Food Act.

Inositol, Choline and PABA should be permitted ingredients in supplemented food.

• Yes, they will be able to be used.

In setting the limit at 50% of the UL at 17.5mg/L for nicotinic acid and 450µg for Nicotinamide is mystifying. In general, Nicotinamide is regarded as the less toxic compound, therefore it is difficult to understand why the Maximum Quantity per One Day Serving for this compound is less than half a milligram.

• The UL for Nicotinamide is proposed to be set at 450mg/l per one day serve.

Currently the DSR allow a maximum daily limit of 150µg selenium as against the proposed 200µg in the Supplemented Food Standard. Currently selenium is a pharmacy only medicine above 150µg per day in New Zealand and Australia.

• Noted, the proposed Standard will be amended restrict the maximum daily limit of selenium to 150 µg.

The proposed level of 550 µg of iodine for adults is too high given iodine over 300 µg is a pharmacy only medicine.

• Agreed. The proposed Standard will be amended to limit the addition of iodine to 300 µg.

There is no mention of Chromium as a permitted substance.

• It will be permitted. Substances will be able to be added unless explicitly prohibited or restricted, subject to section 9(4) of the Food Act.

Fluoride should not be permitted to be added to supplemented food.

• FSANZ has recently released a draft assessment of an application to add fluoride to bottled water (public submissions close on 23 December 2008). If the Food Code is amended to allow the addition of fluoride to bottled water, such products would be regulated under the Food Code.

The requirement for folic acid dietary supplements of 500mcg to be manufactured under GMP should be extended to fortification of supplemented food with folic acid to that level.

• The proposed GMP requirement is for therapeutic-type dietary supplements only and is proposed because these products are intended to be use for a therapeutic purpose, and by pregnant women to reduce the risk of NTDs.

The highests maximum limit for all vitamins and minerals specified in the proposed Standard and the DSR should be harmonised.

• Comment referred to MoH.

Risk management

The safety of ingredients should be assessed; however efficacy of ingredients should not be reviewed by NZFSA.

• NZFSA has no plans to assess the efficacy of ingredients. Manufacturers, importers and retailers should be aware of their obligations under Section 10 of the Food Act 1981, the relevant provisions of the Fair Trading Act 1986 (misleading labelling) and Section 9 of the Food Act (prohibiting the sale of unsafe food).

• Safety assessments of other competent authorities will be taken into account if necessary.

Unlike foods regulated under the Food Code, food-type dietary supplements are entering the food supply with little or no safety assessment (including no impact analysis on dietary exposure).

• This is acknowledged. Establishing such a system for these products in New Zealand would be a significant cost. Manufacturers, importers and retailers should be aware of their obligations under Section 9 of the Food Act which prohibits the sale of unsafe food.

Education on overall dietary intake can reduce the risks associated with both high and inadequate levels of vitamins and minerals. Appropriate labelling of the products that identifies the addition of vitamins and minerals, education on dispensing and consumption is also essential.

• Education accompanying any regulation is ideal. The proposed labelling of levels of vitamins and minerals will assist consumers in identifying appropriate levels.

The risk assessment for the consumption of vitamins and minerals from supplemented foods given the available data is supported. Factors influencing risk to the consumer require consideration and management at an individual level and cannot be managed on a population-wide level. Nevertheless, the approach of limiting the maximum amount of vitamins or minerals that can be added to a supplemented food to 50% of the Upper Limit is appropriate.

• Noted.

NZFSA has not discussed how it intends to monitor the impact, safety and adherence to labelling of FTDS while this proposed standard remains outside the Food Code. The public discussion paper no. 05/08 mentions an implementation survey and compliance survey, which is an inadequate response to ensure public safety.

• Implementation and compliance surveys are usual practice for New Zealand food standards. It is acknowledged that there has been a low level of monitoring of the DSR. In recent years, this has been due to the uncertainty regarding changes to the regulation of dietary supplements. NZFSA is unable to comment on the reasons for the inadequate monitoring pre-2002.

We note that the draft Standard Part 1 does not include provision for penalties for non-compliance with the Standard. We note that Part 3, Offences and penalty, from the original DSR, has not been included in the draft Standard 2. Therefore, it is unclear in the Standards how non-compliance will be managed and what penalties will apply. Appropriate penalties and disincentives for non-compliance are required for draft Standard 1 and 2.

• Offences and penalties provisions are contained in the Food Act 1981 (in particular sections 9, 10, and 11O and 11Q). There is no empowering provision in the Food Act to set penalties and offences in food standards as there is in regulations (section 42).

NZFSA’s decision to permit supplementation to a maximum of 50 percent of the UL as a risk management approach is not appropriate. The risk to some population groups of exceeding the UL for essential vitamins and minerals under this approach remains high. NZFSA should consider setting a maximum level of supplementation of up to 100 percent of the RDI, or AI where an RDI is not set. The RDI is the average intake level sufficient to meet the nutrient requirements of nearly all the individuals in the population group, which includes a margin of safety.

• There appears to be a range of products currently on the market that contain levels of vitamins and minerals that exceed adult RDIs. NZFSA is not aware of any recorded safety concerns to individuals from exposure to these products. Further, prescribing compositional permissions at 100% of the RDI could require a group of manufacturers affected by this proposed Standard to reformulate a significant number of products. This would be inconsistent with the intent of the proposed Standard, specifically to maintain existing rights.

• Supplemented foods by definition have had substances added to or have been modified in some way to perform a physiological role beyond the provision of a simple nutritive requirement therefore the level of vitamin or mineral required is likely to be beyond that prescribed by an RDI.

We hope New Zealand can make necessary explanation for the science and rationality of the limit determination (50 % of Upper Limit of RDIs) method in the standard.

• The rationale behind the limit was included in the discussion document Appendix ‘the Addition of Vitamins and Minerals to Food-Type Dietary Supplements’ and references the scientific papers on which the determinations are based. This document is still available on the NZFSA website (www.nzfsa.govt.nz/consultation)

There is a risk that people will exceed nutritional requirements for micronutrients if many foods are fortified and sold as supplemented foods.

• NZFSA has proposed that a maximum level of addition of 50 per cent of the Upper Limit for a substance be set to take account for intake from other sources.

Nutrients such as folic acid should be assessed for their availability and compatability with the food vehicle.

• Pre-market safety assessments will not be required under the proposed Standard. If evidence becomes available of food safety risks associated with the use of certain substances, the proposed Standard will be amended to require restrictions or prohibitions as necessary. Assessing product efficacy is outside the policy scope of the proposed Standard.

Apart from the Consumers Guarantees Act, what standards and controls will be applied to ensure the content and stability of the vitamins and minerals added to supplemented foods?

• There will be no additional standards. GMP generally applies to therapeutic products. The production and manufacture of food must comply with food safety legislation, such as the Food Act 1981, the Food Hygiene Regulations 1974, or the Animal Products Act 1999.

Restrictions and prohibitions

This Standard lists substances in addition to those listed in Standard 1.4.4 Prohibited and Restricted Plants and Fungi of the Code. Associated risks identified on warning labels alone will not provide quality assurance for such substances.

• Quality assurance is the responsibility of industry under Section 9(2) of the Food Act which prohibits the sale of unsafe food.

Actaea/Cimicifuga racemosa was classified as prohibited in the proposed Standard. However, no obvious adverse reactions have been observed for long term of consumption of Cimicifuga racemosa, as shown by corresponding pharmacology react research abroad. Therefore, the New Zealand Government should provide scientific evidence, on which the decision to prohibit Cimicifuga racemosa was based.

Black Cohosh should not be proposed as a prohibited substance. What are the reasons for this? Is the decision based on the small number of cases reported of hepatotoxicity and carcinogenesis? In both of these instances evaluation of the case reports is inadequate and confounding variables were not adequately explored

• Actaea/Cimicifuga racemosa (black cohosh) does not have a history of established use as a food ingredient in New Zealand. It has been associated with liver failure and therefore poses a safety issue when it is used in foods that are intended for the general population.

• Actaea/Cimicifuga racemosa will continue to be permitted in controlled dose therapeutic-type dietary supplements which are sold to targeted groups.

• Research to support this decision is available in Chow E, Teo M, Ring JA, Chen JW. ‘Liver failure associated with the use of black cohosh for menopausal symptoms’. MJA 2008; 188 (7): 420-422, and Lontos S, Jones R, Angus P, Gow P. ‘Acute liver failure associated with the use of herbal preparations containing black cohosh’. MJA 2003; 179: 390-391

The section on intoxicating substances should list the specific substances, their congeners and analogues and the basis for their inclusion in the prohibited list.

• The prohibition on intoxicating substances in the proposed Standard is necessarily general. This is so that the addition of any substance intended to intoxicate, or with the effect of intoxicating, will be captured. Listing specific substances would not provide the flexibility to prohibit the addition of other substances (eg. newly developed substances) that could have an intoxicating effect.

What is the likely approach to the inclusion of other non-culinary herbs, either in the prohibited list or as substances subject to restriction?

• If safety issues arise, the proposed Standard will be amended to include those substances. For other substances, the general provisions of section 9(4) of the Food Act will apply.

Caffeine

The caffeine advisory should be extended from covering 320mg/litre to 320mg/litre for beverages and 1325 mg/kg for processed foods in ratio to the artificial colour allowances (70 vs 290mg/kg) under Schedule 4 to Standard 1.3.1.

• This ratio is only permitted for artificial colours specified in Schedule 4 to Std 1.4.4. Caffeine is not specified here so it is outside the stated intention to align the proposed Standard as closely as possible with the Food Code.

Caffeine must be less than 320 mg/I of caffeine in the supplemented food, and caffeine content must be labelled.

• NZFSA is not intending to restrict the level of caffeine in supplemented foods but is considering an amendment to require the level of caffeine to be included in the nutrition information panel when added in excess of 145mg/l per one day serve.

There is a risk that products may sneak in under the Supplemented Food Standard with an ingredient that includes caffeine that will not require a warning label. Why not just start the warning at a lower level as in Standard 2.6.4?

• Noted. The proposed Standard will be amended accordingly.

Without a maximum allowable limit on caffeine content supplemented food products could contribute to caffeine toxicity in consumers.

• An upper level for caffeine hasn’t been included because there is no internationally available evidence for upper levels for caffeine intake.

Caffeine advisory statements should be further quantified by adding the words ‘per serve as consumed.’

• This can be accommodated.

It is not clear as to the rationale for including specific substances mentioned as restricted items, yet in the case of caffeine a limit of 320mg/L has been set.

• There are known safety issues for caffeine consumption above this level.

For the purpose of the proposed Standard, is there a difference between the addition of caffeine to the food and its presence there as a natural ingredient?

• The trigger level for the requirement to use an advisory statement for caffeine will be based on the level of added caffeine only.

Differential permissions to account for possible consumption of supplemented foods by children

Re Section 18 of the Draft - How does this relate to Section 14? Why the two? It would be useful to have a Max Daily Dose Chart for Under 8s also.

• A manufacturer may comply with either Part 1 of the proposed Standard (updated permissions) OR Part 2 which maintains the status quo for food-type dietary supplements as a transitional arrangement for a period of two years.

The risk for children aged 0-8 years (and up to 13 years in the instances of choline and possibly copper) exceeding Upper Levels of Intake (UL) for essential vitamins and minerals is concerning. In the public information paper; no. 09/08, tables 11 and 12 clearly identifies children aged 0 to 8 years are at risk of exceeding the UL for almost all essential vitamins and minerals when consuming the maximum quantity per one day serving for adults as proposed for FTDS.

Clause 15 of the draft Standard appears to try and mitigate this risk by setting maximum levels of supplementation for vitamins and minerals per day for children aged 0 to 8 years. Clause 15 (2) requires ‘food products specifically for children aged anywhere between 0 and 8 years must be labelled “Produced for children.”’

However, the maximum supplemented food levels for vitamins and minerals per day for children aged 0 to 8 years (table 5) are based on UL values for children aged 4 to 8 years. Fifteen of the twenty nutrients listed have lower UL levels for children aged 1 to 3 years compared to children aged 4 to 8 years. For infants up to one year of age, ULs were not possible to set due to insufficient evidence or no clear level for adverse effects. If most ULs for children aged 1 to 3 years are lower than for children aged 4 to 8 years, it is likely that infants up to one year will exceed ULs for most nutrients based on the maximum levels in table 5.

Therefore, the inclusion in Clause 15 of maximum supplemented levels for ‘children aged 0 to 8 years’ is misleading and inconsistent with ULs in the NRVs. As well, there remains a real risk that children aged 0 to 8 years will consume FTDS produced for adults, as there will be no statement on the label indicating they are unsuitable for children.

Adding to the risk of children exceeding ULs is their consumption of supplements. The Ministry of Health’s Food and Nutrition Guidelines for Healthy Children (Aged 2-12 years): A background paper, does not recommend supplements for children. In the public discussion paper; no. 05/08 you wrote that ‘it is not expected that younger populations will be large consumers of these food products.’ However, the 2002 National Children’s Nutrition Survey found 5 percent of New Zealand children (aged 5 to 14 years) reported using a dietary supplement. The most frequently used supplements were multivitamins and minerals, vitamin C, and meal replacements (Ministry of Health. 2003. NZ Food NZ Children: Key results of the 2002 National Children’s Nutrition Survey. Wellington: Ministry of Health).

To lessen this risk to children, the following amendments should be made:

i. Clause 15 is deleted from the draft standard.

ii. Clause 14 is expanded to include the following:

14 (3) Supplemented food products produced for adults must be labelled ‘Produced for adults. Not suitable for children.’ This statement should also be explicit in any accompanying marketing.

If i and ii above are not included, and if table 5 in Clause 15 is retained, Clause 15 (2) should be amended to:

15 (2) Supplemented food products produced specifically for children aged up to 8 years must be labelled ‘Not suitable for children aged less than 4 years’.

• NZFSA is considering an advisory statement for supplemented foods that contain levels of vitamins and minerals at adult levels. This would state the product is intended for consumption by persons over the age of 14 years. In addition, the definition of Supplemented Food will be amended such that a supplemented food is not intended for children aged 0-3 years.

The proposed standard requires that Supplemented Food for children aged 0-8 years to be labelled as ‘Produced for Children’. However, Supplemented Food for adults requires no age related labelling. Clear labelling of Supplemented Food intended for adults may be warranted to reduce the risk of children consuming these foods. The specification of age zero also raises the issue of whether manufacturers could produce an infant formula-type product and sell it as a Supplemented Food.

• NZFSA is considering an advisory statement for supplemented foods that contain levels of vitamins and minerals at levels intended for adults. This statement would indicate that the product is intended for consumption by persons over the age of 14 years. In addition, the definition of Supplemented Food will be amended such that a supplemented food is not intended for children aged 0-3 years.

The Maximum Quantity per One Day Serving level proposed in the Standard for iron is 22.5mg/L, which represents 50% of the UL in the NRVs. However the maximum daily does in the DSR is 24mg/L which is also the level now permitted in Australia for Listable Medicines on the ARTG. The 24mg/L level should be adopted over the lower level proposed.

• The 50% UL will apply to the addition of all vitamins and minerals.

6. Trade Issues and Implications

This section summarises comments made in respect to international standards and the implications for New Zealand’s trading relationships with other countries associated with the implementation of the proposed Standard.

Australia and New Zealand have an obligation to notify the WTO of changes to food standards

• Yes, this was done as required.

New Zealand should accept the Protocol (to amend the Trade Related aspects of Intellectual Property Rights (TRIPS) agreement to replace the interim waiver for export of patented pharmaceuticals) and amend Patent Legislation to allow New Zealand to export patented pharmaceuticals under compulsory license in line with the protocol.

• This matter is outside the scope of the supplemented food proposal.

The category and scope of the additives permitted to be used in Standard 1.3.1 referenced in Part 1: Clause 7 of the Supplemented Food Standard are inconsistent with that in Codex Alimentarius Commission Standard 192-1995 (rev.6-2005). For example, Codex allows the use of mannitol, maltitol, sorbitol and dilauryl thiodipropionate, which are not included in Standard 1.3.1. New Zealand should adopt the Codex standard to reduce unnecessary technical barriers to trade.

• One of the key objectives of the proposed Standard is to align with New Zealand’s main source of food regulation, the Australia New Zealand Food Standards Code (the Food Code). The Food Code and the proposed Standard are, as required under the SPS Agreement, based on Codex requirements but do not (and are not required to) conform to the Codex Guidelines.

• Inclusion of additives that are not approved for use in the Food Code is outside the scope of the proposed Standard.

As currently drafted the proposed measure could have adverse trade effects on products currently marketed in the United States as dietary supplements. Scientific validation of proposals need to be provided.

• Therapeutic-type dietary supplements that can currently be legally sold in New Zealand will continue to be able to be sold. For food-type dietary supplements, the status quo will continue for the next two years. Changes to the regulation of food-type dietary supplements are for public health and safety purposes. The proposed Standard will also align the regulation of these food products with the main source of food regulation in New Zealand: the Australia New Zealand Food Standards Code (the Food Code). The only substances with prohibitions and restrictions are those that have evidence of potential harm.