Folic acid (minimum recommended daily dosage of 400 micrograms)

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

I, Dr 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 in paragraph (a) below to be used in advertisements directed to consumers (including their use on the label of the goods/or in information included in the package in which the goods are contained) for the goods identified in paragraph (b)² but only if the advertisement also contains any relevant advisory statements relating to neural tube defects contained in the Required Advisory Statements for Medicine Labels³ as updated over time:

1. Representations to the effect that the goods may help to prevent neural tube defects such as spina bifida and/or anencephaly:
   1. when trying to conceive and during the first trimester of pregnancy, and/or
   2. for at least four weeks before conception and during the first trimester of pregnancy.
2. Medicines included in the Australian Register of Therapeutic Goods (ARTG) for which:
   1. the recommended daily dosage of the medicine provides a minimum of 400 micrograms of folic acid.

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.
3. Medicines Advisory Statements Specification 2014