Due to recent events and current industry concerns in regards to selected USA brands of dietary supplements being targeted by the TGA in Australia for unauthorised use of therapeutic claims and inappropriate labelling etc at point of sale. Syn-Tec Nutriceuticals (Syn-Tec) would like to communicate the following position statement to all of its retailers and distributors in Australia and New Zealand.
Many of the USA brands have dietary supplements for sale in Australia which do not conform to the Australian and / or New Zealand food regulations or dietary supplement regulations. Many labels, advertising and presentation of ingredients used in the USA products don't meet the standards set by Australia or New Zealand. This crack down by the TGA is to make sure that all products presented for sale in Australia have the correct labelling, presentation and appropriate product classification. USA products which do not meet the New Zealand standards will fail to be legal for sale in Australia if imported under the Trans Tasman Mutual Recognition Act 1997(TTMRA). The TTMRA rules regulate the sale of goods within the collective Australian and New Zealand domestic market place.
How does this affect Syn-Tec Nutriceuticals products being sold in Australia.
Syn-Tec sees this as a positive event as it will help to align the hyped up USA dietary supplement brands with locally produced brands. There are specific labelling requirements that must be met in Australia and New Zealand. The consumer needs to be aware and have easy access to nutritional information which shows exactly what ingredients and in what quantities are present in all products. This is something that many USA brands hide by claiming proprietary Blends (their secret herbs and spices so to speak). Proprietary Blends often don't disclose the exact quantities or proportions of the claimed active ingredients in the package or container or in each serving size. A full nutritional panel and or ingredient listing must be presented on all labels. Compliant labels will help to educate a more informed consumer as to what ingredients are present in every product. This will promote awareness amongst consumers that the locally produced products are of an equal quality and in some cases better quality than the USA imported products. The reliance of hyped up USA advertising campaigns are also under scrutiny which again only helps to even out the advertising playing fields which will enable consumers to compare apples with apples ... not an apple wrapped up in a Ferrari verses an apple in a plastic bag... so to speak.
The only way that a New Zealand made food type dietary supplement can be classed as being a therapeutic dietary supplement, is if it is presented for sale with a therapeutic claim (outside of normal permitted health claims as may be allowed by other legislation) on its label or in its advertising material that refer to the product as being a medicine that is designed to diagnose, treat, cure or prevent a disease or ailment and is so classified under any New Zealand jurisdiction. Thus, while therapeutic claims are not permitted under the New Zealand Dietary Supplement Regulations 1985 (NZDSR), health claims are not prohibited. Inclusion of the term ‘dietary supplement’ on the product label is required under this regulation, which assists regulators in identifying any labels and ingredients to be assessed against the NZDSR.
Under the Food Standards of Australia and New Zealand (FSANZ) regulations Standard 2.9.4 Formulated Supplementary Sports Foods, general health claims are allowed in context to maintaining a healthy diet and good nutrition in context to the role that specific nutrition plays in supporting specific performance goals. New Zealand also has an extended regulatory regime where food type dietary supplements that don't fall under the FSANZ food regulations are regulated under the New Zealand Dietary Supplement Regulations 1985 (NZDSR) which are regulated by New Zealand Food safety Authority (NZFSA). These regulations have specific labelling requirements that relate to Food Type Dietary Supplements (FTDS) and their ingredients and labelling must be assessed in accordance with these regulations.
Syn-Tec products are formulated and labelled to conform to one of these sets of regulations and as such currently comply with all conditions that are required for legal sale in New Zealand and also Australia. Legal interpretation of the Trans Tasman Mutual Recognition Act 1997(TTMRA) in reference to New Zealand made food type dietary supplements that meet the legal requirements that satisfy New Zealand regulations, states that they are legal to sell in any Australian jurisdiction.
FOOD TYPE DIETARY SUPPLEMENTS ENJOY FREE TRADE BETWEEN AUSTRALIA AND NEW ZEALAND
Here is a brief summary of the Trans Tasman Mutual Recognition Arrangement (TTMRA) and how it relates to the importation of Food Type Dietary Supplements (FTDS) into Australia from New Zealand. This brief, outlines the legal interpretation of the TTMRA.
The TTMRA applies to food products and under the Joint Food Standards System Treaty which is administered by Food Standards Australia and New Zealand (FSANZ) there has been harmonisation in many areas of food standards. However, variations in standards may occur in three ways: where an ‘Australian only’ standard affects the content or labelling of food; where New Zealand has exercised its powers under Annex D of the treaty to ‘opt out’; and in relation to dietary supplements where agreement is not reached, the food item will be subject to mutual recognition as food is not exempted from the TTMRA.
TTMRA applies to regulations affecting the sale of goods which include FTDS by allowing producers to meet only one set of standards, rather than two or more, which reduces barriers and costs to movement across jurisdictions.
“If goods meet the regulatory requirements of their home jurisdiction, they can lawfully be sold in all participating jurisdictions”.
In reference to TTMRA Part 2… Goods:
Part 2. Section 10 Entitlement to sell goods…
The TTMRA principle is that, subject to this part, goods produced in or imported into New Zealand, that may lawfully be sold in New Zealand, either generally or in particular circumstances, may, by virtue of this Act, be sold in an Australian jurisdiction either generally or in particular circumstances, (as the case may be). Without the necessity for compliance with further requirements imposed by or under the law of that jurisdiction as described in part section 11.
Section 11. Requirements that DO NOT need to be complied with…
The further requirements referred to in section 10 are any one or more of the following requirements relating to sale that are imposed by or under the law of the Australian jurisdictions concerned:
(a) a requirement that the goods satisfy standards of the jurisdiction relating to the good themselves, including for example requirements relating to their production, composition, quality or performance;
(b) a requirement that the goods satisfy standards of the jurisdiction relating to the way the goods are presented, including for example requirements relating to their packaging, labelling, date stamping or age;
(c) the requirement that the goods be inspected passed or similarly dealt with in or for the purposes of the jurisdiction.
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