The TGA can only grant advertising approval for a restricted representation if the representation is accurate, balanced, not misleading and in the public interest. The TGA has now approved restricted representations for two probiotic products:
- Puremedic Pty Ltd (9 June 2016); Qiara Pregnancy & Breastfeeding (ARTG L. 269433);
- Nutricia Australia Pty Ltd (11 December 2014); Profutura Pregnancy and Breast Feeding Multi + Probiotic’ (AUST L 227779) and Profutura Mastitis Relief (AUST L 228818)
The representations allowed are:
- “Mastitis relief during breastfeeding”,
- “May help to relieve or reduce breast pain and discomfort associated with mastitis”,
- “May reduce the recurrence of mastitis. Use at the first signs of mastitis”
As Amir et al., note in their article, “Probiotics and mastitis: evidence-based marketing?“, one unreplicated trial in the public domain containing numerous methodological problems is hardly sufficient evidence to allow claims that probiotics, “Help relieve or reduce breast pain or discomfort associated with mastitis during breast feeding”. Nor is there good evidence that probiotics, “Reduce the recurrence of mastitis”. While much of the Profutura promotion has been directed at health professionals, some is readily available to consumers via the Internet, albeit containing a disclaimer, “For health professionals only”. See also,
- Concern over promotion of probiotics for mastitis
- What’s the evidence for using probiotics for mastitis?
It has been suggested that the TGA may have been given access to unpublished studies that supported their decision. Medicines Australia Code of Conduct (for promoting prescription products) clearly states that advertising claims made on the basis of unpublished studies are unacceptable. The TGA should follow the same ethical principles.
In an even more bizarre example of decision making, the TGA approved a restricted representation for a homeopathic medicine to advertise “restless legs relief”. This despite the NHMRC concluding that there are no health conditions for which there is reliable evidence that homeopathy is effective! I understand that the TGA is not obliged to consult with the other expert groups about such decisions. However, I believe the TGA would have been saved considerable embarrassment had they done so. One of the functions of the Therapeutic Goods Advertising Code Council (TGACC) is to make recommendations to the Minister about submissions for restricted representations (if asked). The TGACC is comprised of a number of stakeholders, including consumer groups, and is more likely to provide a balanced judgement, taking into account the public interest, than an isolated TGA officer.
These cases provide a salutary example of the problems likely to arise if the TGA takes over all advertising approval and complaint functions, as has been proposed.
Disclaimer: I am a member of the Therapeutic Goods Advertising Code Council (TGACC) representing the Australian Consumers’ Association.by