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Should food-type dietary supplements be permitted to enter the Australian food
supply?
There does not appear to be any good evidence to justify the introduction of food type dietary supplements (FTDS) into the Australian food supply.
- There is no evidence of nutritional deficiencies in the general Australian population that would be remedied by such supplements. Any specific deficiencies in specific target groups would not be necessarily met by FTDS. These are generally met by fortifying targeted foods.
- Apart from the well known possible adverse affects of fortification (eg iron and haemochromatosis, folate and B12 deficiency, etc) there is also mounting evidence that supplementation with individual vitamins could have adverse effects in relation to cancer and cardiovascular disease. Relevant example references are:
- Vivekananthan, DP et al., 2003, Use of antioxidant vitamins for the prevention of cardiovascular disease: meta-analysis of randomised trials, The Lancet, 361:2017-2023
- Neuhouser, M et al., 2003, Fruit and Vegetables are associated with lower lung cancer risk only in the placebo arm of the beta-carotene and retinol efficacy trial (CARET) Cancer Epidemiology, Biomarkers and Prevention, 12:350-358.
- Rowe, PM, 1996, Beta-carotene takes a collective beating, Lancet, 347:249.
- Beta Carotene Cancer Prevention Study Group The Alpha-Tocopherol, 1994, The Effect of Vitamin E and Beta Carotene on the Incidence of Lung Cancer and Other Cancers in Male Smokers, New England Journal of Medicine,330: 1029-35.
- In the past food fortification played an important role in reducing widespread nutrient deficiencies. Todays challenge is to find a balance between nutrient deficiency and toxicity in a largely well-nourished population.
- A cornerstone of good regulation is a clear rationale for action. With respect to vitamins and minerals regulatory principles for the addition of vitamins and minerals to foods have been developed by the predecessors of FSANZ and the guiding statement is as follows:
Consistent with the Codex General Principles for the Addition of Essential Nutrients to Foods, the addition of vitamins and minerals to general purpose foods and special purpose foods should not be permitted where no adequate nutritional rationale can be provided. Regulatory principles that are elaborated in accordance with this Guiding Statement aim to prevent the indiscriminate addition of essential nutrients to foods thereby reducing the risk of health hazards due to essential nutrient excesses, deficits or imbalances.
This statement is based on that proposed by Health Canada who contents that without such a Policy Recommendation:
- there is risk that the addition of vitamins and minerals to food becomes disconnected from nutritional need, health benefit or purpose
- food fortification can potential undermine the concept of total diet by encouraging consumers to rely on a few highly fortified foods rather than a well-balanced diet consisting of a variety of foods consumed in moderation and
- the addition of vitamins and minerals to foods at levels that cannot be nutritionally justified would carry an implicit message to consumers that some benefit may accrue from consumption of nutrients at these levels
(directly quoted form FSANZ, Regulatory Principles for the Addition of Vitamins and Minerals to Foods)
Should food-type dietary supplements continue to be produced in New Zealand but not in Australia, and continue to be permitted to enter Australia from New Zealand?
No. This is not an equitable situation
Should food-type dietary supplements be permitted to be produced in both Australia and New Zealand?
Since the 2 countries have agreed to harmonise their food standards, the regulations should be the same for both countries -allowed in both or not allowed in both.
If food-type dietary supplements were permitted to be produced in both Australia and New Zealand, should there be restrictions on the types of foods that can be sold as food-type dietary supplements eg. softdrinks, breakfast cereals, biscuits, confectionery, alcohol?
Yes.
In line with current policies, foods used as vehicles for added substances should meet nutritional criteria.
Foods high in energy are not suitable as vehicles for added substances that are likely to increase their consumption, given that the level of obesity in Australia is amongst the highest in the world (Booth, M. et al, 2001, Australian and New Zealand Journal of Public Health, 25:162-169).
Decreased physical activity and increased energy intakes have contributed to the substantial increase in prevalence in overweight and obesity in recent decades. During the 10 years from 1985 to 1995, mean energy intake increased by 11% for girls and 15% for boys aged 10-15 years. This increased energy intake was mainly due to increased intake of cakes, biscuits, pies, pizza, some desserts, confectionery and sugar-sweetened drinks (Cook P. et al., 2001, Australian Food and Nutrition Monitoring Unit, UQ, Brisbane).
If food-type dietary supplements were permitted to be produced in both Australia
and New Zealand, should there be restrictions or prohibitions on the addition of
medicinal herbs? Please provide your reasoning.
Yes.
There is not enough data on the safety or efficacy of medicinal herbs consumed in this context and a precautionary approach is appropriate. Permission to add these to FTDS should require pre-market approval, ie, subject to risk assessment on a case by case basis.
They need to be subjected to the same rigorous assessment as they would as complementary medicines as they are required to be when assessed as complementary medicines.
If food-type dietary supplements were permitted to be produced in both Australia and New Zealand, should they have the same regulations on the vitamins and minerals that can be added as general food or should they be treated differently? Please provide your reasoning.
They should be subject to same regulations as general foods. This is in line with the conservative approach to the addition of vitamins and minerals to foods taken in both Australia and New Zealand. Given the concerns about the safety and efficacy of supplementation it would be prudent to continue with this approach
Should food-type dietary supplements be permitted to contain vitamins and minerals in excess of the recommended dietary intakes (RDIs)? Please provide your reasoning.
No
- RDIs are calculated on a population basis and already allow for 2 standard deviations above the average requirement of vitamins and minerals to prevent deficiency symptoms and diseases.
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Whilst we still lack evidence for some nutrients on the amount required for optimal health, these amounts are certainly not multiples of the RDI.
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RDIs are intended to be used for the total diet. Currently in general foods vitamins and mineral are not allowed above a certain percentage of the RDI's to prevent excessive consumption. If multiples of RDIs are allowed in individual foods, there is a strong likelihood of excess consumption of some vitamins and minerals in the total diet.
- It would be much easier for the consumer to consume excess amounts of nutrients in food vehicles than in the form of tablets or pills. Tablets/pills are more clearly distinguished as drugs with limits on dosage.
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Excessive consumption of some vitamins and minerals has the potential to endanger health.
Should the addition of vitamins and minerals be based on international upper daily safety levels (USLs)?
No.
Upper safety levels take into account total daily intake of a nutrient and should not be applied to individual foods.
Are there other substances that should be able to be included in/regulated as food type dietary supplements?
The use of caffeine and other drugs in FTDS should be strictly regulated, because of the possibility of excessive consumption
The addition of substances such as taurine, and others should be considered on a case by case basis.
Of relevance is the fact that formulated caffeinated beverages (considered to be a type of FTDS) are routinely sold with alcohol in bars and this does seem to be an abuse of the intended purpose of the drinks.
If food-type dietary supplements were permitted to be produced, should nutrition claims be permitted? (A nutrition content claim describes or indicates the presence or absence of a component in that food eg. This food is high in calcium)
- If the foods meet the current requirements for nutrient claims (Standard 1.3.2) then these should be allowed.
- It is meaningless to allow a FTDS to say it is high in X if it contains many more times the RDI for that nutrient. It simply becomes a marketing tool.
- Policy principles on fortification and nutrition, health and related claims are also being considered by FRSC working groups. Therefore this issue cannot be considered in isolation.
- There are a number of issues to be considered in the context of claims. Issues are bioavailability, stability, interaction with other nutrients which may enhance or decrease absorption, etc. These issues are magnified when large amounts of nutrients are added.
If food-type dietary supplements were permitted to be produced, should health
claims be permitted? If yes, under what circumstances?(Health and related claims
include all claims referring to nutrient function, enhanced function, reduction of disease risk or maintenance of normal health eg. Calcium is good for strong bones and teeth.)
- Currently health claims (apart from folate) are not permitted in Australia and New Zealand.
- The types of claims currently used on formulated caffeinated beverages eg increases physical performance, improves concentration and reaction speed, improves vigilance, stimulates metabolism are clearly in breach of the current regulations.
- Policy advice on nutrition, health and related claims is currently being prepared for the Ministerial Council. A policy on health claims for FTDS cannot be considered in isolation.
- In addition policy advice on fortification is also being prepared and this is very relevant to policy on FTDS.
- Therefore the 3 policy areas should be considered together so that a consistent regulatory framework is developed.
What system of labelling could be established to promote consumer understanding and awareness of food-type dietary supplements? (eg. should all generic food labelling provisions only apply to food-type dietary supplements or should there be additional requirements?)
FTDS will require their own standard which will provide the regulations on labelling.
The food labelling provisions of Standard 1.2.8 should apply but additional labelling provisions should apply similar to those in Standard 2.6.4 Formulated Caffeinated Beverages which as already said can be regarded as a type of FTDS.
For example:
- Levels of all nutrients added to the food. Whether this is part of the NIP or adjacent to or following the NIP will depend on the levels added.
- Warning statements if there is concern about consumption of certain nutrients by particular groups eg pregnant women or young children.
- Advisory statements about the level of daily consumption.
- Warning or advisory statements that the food is intended a supplement not as replacement for a healthy diet.
- Labelling provisions to ensure important consumer information is readily found. This is to avoid the situation where the warning about the daily consumption of the bars was hidden under the flap of the Viking Bars and could not be readily seen.
Is the labelling of products with general advisory statements that warn against consumption by vulnerable groups an appropriate risk management strategy for foodtype dietary supplements (eg. not recommended for children/pregnant women)? Should other strategies also be adopted? If so, what other strategies are needed and why?
Yes.
Vulnerable groups should be warned against consumption where such products could be detrimental to health. This include:
- Pregnant and lactating women
- Children;
- Persons taking medications that interact with substances added FTDS (eg, warfarin and vitamin K);
- Persons at risk of diseases where supplementation has been shown to be detrimental (eg, lung cancer and beta-carotene).
Should food-type dietary supplements regulated as foods be required to carry either a 'prescribed name' (eg food-type dietary supplement) or an advisory statement to the effect that this is a supplementary food?
Yes. It is very important that such foods are distinguishable from the general food supply to enable consumers to make an informed choice. The wording used must be clearly understood by consumers.
Are instructions regarding 'dosage' (ie. amounts and frequency) appropriate for food-type dietary supplements?
Dosage implies a drug. This underlines the difficulty of having a category of foods which are intended to be used more as drugs.
However consumers should be advised about appropriate levels of consumption of FTDS to protect them from consuming more than the RDIs or USLs of nutrients.
With respect to formulated caffeinated beverages, anecdotal evidence suggests that advice about level of consumption is generally ignored.
Are there any other general labelling issues that should be considered for food-type dietary supplements?
Most aspects already covered above.
Do you agree with the High Order Principles listed on page 14 of the Discussion Paper?
We generally agree with these. However the overriding principle is public health and safety. The other policy principles should not be given equal weighting - they take lower priority.
We wish to strongly emphasise that it is not possible to undertake an effective risk analysis in the case of FTDS because risk analysis relies on effective dietary modelling. The most recent national data we have is 1995 and in that there is no data on the consumption of FTDS. So using this data means that a much more conservative approach will have to be taken. There must be regular surveys of dietary intake in order to improve the risk analysis process but also to tell us which way diets are changing in response to regulatory changes.
Whilst it may be possible to make some predictions about the potential to exceed safe levels of individual nutrients added to in particular foods, it is very difficult to predict the long term effects of prolonged intake of increased levels of several nutrients (like vitamins and minerals) together.
Do you agree with the Specific Principles listed on page 14 of the Discussion Paper?
Generally agree with these but dispute that the level of risk can be accurately determined.
Are there other High Order Principles and/or Specific Principles that should be included?
No
Considering the policy options listed on page 14 of the Discussion Paper, what is
your preferred policy option for the regulation of dietary supplements?
Please include in your response:
- Which of the policy option(s) outlined in the Discussion Paper do you prefer?
- If your preferred option is a combination of aspects/elements from a number of
the proposed policy options, please explain what your preferred option would be.
- What do you think will be the advantages and disadvantages of your preferred
option?
- Can you see any possible implementation issues that need to be considered with
regard to your preferred policy option?
A general comment on Table 1. The overriding principle is public health and safety. If this is not satisfied that FTDS should not be allowed on a compromise basis to satisfy the other policy principles. These take lower priority. Other mechanisms should be found to satisfy them. Some of the No's in Option 1 should read Not Applicable.
Our preferred option is Option 1: Do not permit food type dietary supplements to enter the Australian food supply.
This is generally on the basis that that this policy needs to be considered along with the policies being developed on Nutrition, Health and Related Claims, and Fortification and should not be considered in isolation.
It is more specifically on the basis that:
- There is a lack of knowledge of the long-term safety effects of FTDS.
- There is emerging evidence of the adverse effects of supplementation in specific diseases and conditions that have major public health significance.
Comments on Cons in the Policy Options Paper
- The first con under Option 1 (ie, option is not science based or justified on public health and safety grounds) is contradicted by Table 1 which indicates that option 1 is supportive of the first higher order principle (ie, to ensure the protection of public health and safety through the use of a risk analysis process for FTDS). Unfortunately this sort of statement prejudices the case against this option, which in reality is the best option for protecting public health and safety.
- Some of the cons would be solved by NZ repealing their Dietary Supplement Act and thereby harmonising the Food Regulations. It is acknowledged that this would have an impact on NZ industries.
- Challenges under the WTO do not seem likely if Codex does not have any standards for FTDS.
- Limiting consumer choice by not making some products is an interesting issue. Currently the large supermarkets are working towards reducing the products they carry down to about a third to a quarter of what they currently stock (this is around 15,000 products on average). This likely to have a greater impact on consumer choice than not allowing FTDS.
Failing the adoption of Option 1 as policy, Option 3: Permit the restricted production and sale of FTDS in both Australia and New Zealand based on appropriate risk analysis options, would be the preferred option.
However this option would only be acceptable if a conservative regulatory approach was adopted. We have argued that given the lack of information about consumption of these products there is no alternative to a very conservative regulatory approach. As already indicated we would want to see:
- Restrictions on the food vehicle
- Nutrient additions within rather than exceeding RDI's
- Adequate labelling about the nutrients added
- Warning and advisory statements
- Differentiation from the general food supply and
- No nutrition or health claims until this area has been addressed
Any additional comments:
- We strongly believe that food regulation should support and underpin public health policy. Generally the concept of FTDS does not support national dietary guidelines and they could contribute to undesirable distortions in consumer's diets.
- We believe that the policy in this area is likely to be driven by the fact that food-type dietary supplements are available for sale in New Zealand under their Dietary Supplement Act. We believe that policy development in the area should proceed without this bias.
- There are two other policy principles currently being considered by FRSC working groups, ie Fortification and Nutrition, Health and Related Claims. Because of the relationship between these, the three policies should be progressed together rather than in isolation. These are very significant public health issues and it would be desirable to develop a broader overarching policy before addressing the specifics of each policy.
- This is a difficult regulatory area and should be considered carefully. Specific Codex principles for FTDS do not exist. The US regulations are flawed because they are not based on scientific principles. Other countries are clearly having difficulties with respect to the regulation of FTDS because they lie at the interface of food and drugs.
- The experiences with the PAN Pharmaceutical recall serve as a warning of the potential problems of supplements. The outcomes of the Expert Committee on this issue (expected soon) should be considered before progressing this policy on FTDS.
