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Advertising exemption: Calcium (minimum recommended daily dosage of 290 mg of elemental calcium)

15 May 2015

Notice of permission to use restricted representations under section 42DK of the Therapeutic Goods Act 19891

I, Jane Cook, Assistant Secretary, Post-market Surveillance Branch, Therapeutic Goods Administration and delegate of the Secretary of the Department of Health for the purposes of subsection 42DK(1) of the Therapeutic Goods Act 1989 (the Act), give notice under that subsection of permission for the restricted representations described in paragraphs (a) and (b) below to be used in advertisements directed to consumers (including their use on the label of the goods and in information included in the packaging in which the goods are contained), for the products identified in paragraph (c)2:

  1. Representations to the effect:
    1. '... may assist in the prevention of osteoporosis when dietary intake is inadequate' and;
    2. 'Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life'.
  2. Information that contains representations that refer to osteoporosis in the context of its risk factors that is accurate, balanced and not misleading or likely to be misleading and which reflects the body of contemporary evidence, only when such information accompanies representations made in accordance with paragraph (a)(i) and/or (a)(ii).
  3. Medicines included in the Australian Register of Therapeutic Goods (ARTG) for which the minimum dose of elemental calcium delivered in the recommended daily dose for the medicine is at least 290 milligrams.

Dated this 15 day of May 2015

Dr Jane Cook
Delegate of the Secretary to the Department of Health
Post-market Surveillance Branch

Footnotes

  1. This permission takes effect on the day on which it is published on the TGA's website.
  2. The effect of this permission is to allow persons to use the restricted representations set out in this notice without contravening paragraph 42DL(1)(c) the Act, or section 42DM of the Act (by virtue of an alleged breach of section 5(2) of the Therapeutic Goods Advertising Code 2007). However this permission does not affect other aspects of the therapeutic goods legislation and regulations, and all relevant provisions relating to a medicine must be complied with. For example, section 22(5) of the Act sets out that it is an offence to advertise a medicine for an indication that is not an indication accepted in relation to the medicine's inclusion in the Australian Register of Therapeutic Goods.

Explanatory notice: Calcium (minimum recommended daily dosage of 290 mg of elemental calcium)

15 May 2015

Background information for restricted representation category permission for use of references to 'osteoporosis'

The primary objective of the therapeutic goods advertising legislation, including the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code 2007 (the Code), is to ensure that the advertising of therapeutic goods to consumers is accurate, balanced and not misleading. Both the Act and the Code prohibit the use, without prior approval or permission from the TGA, of representations in consumer advertising that make reference to serious forms of diseases, conditions, ailments or defects that are specified in the Code (restricted representations).

The Secretary of the Department of Health or their delegate can, under subsection 42DK(1) of the Act, give permission for specific restricted representations to be used when therapeutic goods are advertised to the public.

Permission to make claims about prevention of osteoporosis

Osteoporosis meets the definition of a restricted representation set out in the Code and therefore cannot be used in advertising to the public without prior permission or approval.

Current contemporary scientific evidence indicates that when dietary calcium intake is inadequate, calcium supplementation may help to prevent osteoporosis. As this is an important public health message, it is appropriate for advertisers to refer to osteoporosis in this context in certain circumstances. The delegate has therefore decided under subsection 42DK(1) of the Act to give permission for advertisements for specified calcium-containing medicines to make representations to the effect identified in the Exemption Notice.

The representations permitted under subsection 42DK(1) of the Act are set out in the Exemption Notice, and are limited to claims:

  • Relating to the prevention, rather than the treatment, of osteoporosis. The permission does not extend to claims about the treatment of osteoporosis because a large number of medicines with indications relating to osteoporosis are regulated as listed medicines and therefore are not permitted to make claims about treatment of disease.1
  • Referring to supplementation only where dietary intake of calcium is insufficient. It is important that consumers are aware that calcium supplementation is only likely to be of benefit where dietary intake of calcium is inadequate. Calcium is a threshold nutrient meaning that above a certain level for each individual, excess calcium is excreted. There is currently no evidence that healthy adults consuming calcium at levels higher than recommended intakes receive any additional skeletal benefit.
  • About medicines containing a minimum dosage of elemental calcium of least 290 mg delivered in the recommended daily dose for the medicine.
    Why elemental calcium?
    Different kinds of calcium compounds are used in calcium supplements. Each compound contains varying amounts of calcium - referred to as elemental calcium. For example, calcium carbonate contains approximately 40% calcium by weight, whereas calcium citrate contains approximately 21% calcium by weight. Due to the large number of different calcium compounds eligible for inclusion in listed medicines, it would be cumbersome to identify each compound and the minimum amount of the compound necessary to be of benefit in the prevention of osteoporosis. Identifying the minimum amount of elemental calcium is therefore necessary.
    Why 290 mg?
    The recommended daily intake (RDI) of calcium for adults ranges between 1000-1300 mg per day, depending on gender and age.2 The dietary intake of calcium will vary between individuals. Based on these variations, it is difficult to determine precisely the amount of calcium supplementation needed to be of benefit in the prevention of osteoporosis.

The minimum daily dose of 290 mg of calcium is based on the following:

  • The minimum amount should be significantly lower than the average adult RDI for calcium of 1150 mg, because it is assumed that the average person will achieve a significant quantity of the RDI for calcium through dietary intake alone.3
  • The minimum amount should be at least 25% of the average RDI for calcium, given that the TGA's Evidence Guidelines specify that a listed medicine that is intended to supplement a named nutrient must provide at least 25% of the RDI for that nutrient.4 Twenty-five percent of 1150 mg is equal to 287.5 mg.
  • A Food Standard developed by Food Standards Australia New Zealand to regulate nutrition content claims and health claims on food labels (Food Standard 1.2.7) specifies 290 mg as the minimum amount of calcium that must be contained in one serve of a food in order for the claim to be made that the food reduces the risk of osteoporosis for persons aged 65 years and over.5

In the event that there are further scientific developments in relation to the use of calcium supplements in the prevention of osteoporosis, the Exemption Notice (and accompanying explanatory notice) may be updated.

References

  1. Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations) states that for a medicine to be eligible for listing in the ARTG, the sponsor of the medicine cannot propose an indication that refers to the treatment of any of the diseases, conditions, ailments or defects specified in Appendix 6 Parts 1 or 2 of the Therapeutic Goods Advertising Code. Medicines with these indications must be registered, rather than listed, in the ARTG. See also the Overview of listed complementary medicines in the Australian Regulatory Guidelines for Complementary Medicines.
  2. Australian Government National Health and Medical Research Council and New Zealand Ministry of Health, Nutrient Reference Values, Calcium.
  3. According to the Australian Bureau of Statistics, 2014. Australian Health Survey: Nutrition First Results - Foods and Nutrients, 201122-12 - Australia: "In 2011-12, the daily amount of calcium consumed from foods and beverages averaged 865 mg among males and 745 mg among females" Calcium
  4. Evidence Guidelines: Guidelines on the evidence required to support indications for listed complementary medicines, p.52.
  5. Food Standard 1.2.7 requires that such a claim only be made where accompanied by words to the effect that it is effective where a person has a diet high in calcium and adequate vitamin D status.