Notice of permission to use restricted representations under section 42DK of the Therapeutic Goods Act 1989[1]
I, Pio Cesarin, Assistant Secretary, Regulatory Practice, Education and Compliance Branch, Therapeutic Goods Administration and delegate of the Secretary of the Department of Health for the purposes of section 42DK of the Therapeutic Goods Act 1989 (the Act), give notice under subsection 42DK(1) of the Act of permission for the restricted representations described in paragraph (a) below to be used in advertisements directed to consumers (including their use on the label of the good/s or in information included in the package in which the goods are contained) for the goods identified in paragraph (b)[2]:
- representations of the following kind:
- the representation that the goods are "Not to be taken by asthma and allergy sufferers"; and
- the representation that "This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities - especially in asthma and allergy suffers"; and
- medicines containing royal jelly[3], royal jelly fresh or royal jelly lyophilised.
Dated this 4th day of August 2017
Pio Cesarin
Delegate of the Secretary to the Department of Health
- This permission takes effect on the day on which it is published on TGA's website.
- This permission permits advertisers to use the restricted representations set out in this notice without contravening paragraph 42DL(1)(c) of the Therapeutic Goods Act 1989 (the Act) and section 42DM of the Act (by virtue of an alleged breach of section 5(2) of the Therapeutic Goods Advertising Code 2007). However, the advertisement in which the representations are made must otherwise comply with the advertising requirements set out in the Act and the Therapeutic Goods Advertising Code.
- Also known as 'Queen Bee Jelly'.