Health claims and the law: the recent case of marketing probiotics for mastitis relief

by Laura Griffin

What happens if a medicinal or therapeutic product is marketed without the science to back it up? How does Australian law protect consumers from these advertisements?

Such circumstances have not given rise to much case law in Australia. This is likely because there is a complex regulatory regime – set up largely by the Therapeutic Goods Act 2010 (Cth) and enforced by the corresponding Therapeutic Goods Administration (TGA) – regarding marketing for health products. This includes strict rules about the wording of claims regarding health products and medical conditions in advertisements, though most of these rules do not apply to advertisements directed exclusively to medical practitioners.[1]

The lack of litigation in this area may also be due to the general nature of health claims found in advertising or on product packaging – that certain products ‘may’ produce health outcomes of various kinds. This is far from a promise or guarantee that every individual purchaser or user will experience the intended health outcome.

But such general statements do suggest or imply to audiences that there is sufficient science to back them up. And case law confirms that if there is no scientific foundation for a statement, this may be sufficient proof that the statement is misleading.[2] Such statements are prohibited by Australian Consumer Law, particularly section 18 which states that ‘a person must not, in trade or commerce, engage in conduct that is misleading or deceptive or is likely to mislead or deceive’.[3]

Probiotics and mastitis

These questions have recently arisen in relation to probiotic products being marketed to health professionals as preventing or treating mastitis.[4]

The science surrounding probiotics is complicated. Effects are dependent upon the particular species of micro-organisms, and even the particular strains involved. Scientists have isolated various strains of Lactobacilli from human milk, and these particular organisms are thought to help protect against maternal breast infections during lactation – in particular, mastitis.

Mastitis – which involves pain, redness, swelling and fever or flu-like symptoms – affects around 20% of breastfeeding women at some time.[5] If symptoms persist for more than 24 hours, antibiotics are usually recommended. Although antibiotics are available which are safe to use while breastfeeding, given the general wariness of patients and health professionals regarding medicine use during lactation, an alternative treatment would be welcome.

As a result, there is scientific interest in testing the efficacy of various probiotics for either preventing or treating mastitis. While various studies involving women are under way,[6] there are very limited publications to date.

One completed trial, from Spain, addressed the issue of treatment.[7] This trial set out to compare Lactobacillus spp probiotics with antibiotics for women with mastitis. But the published results reveal several methodological issues: the reported follow-up time (21 days) does not match the data collection points recorded in the trial registry (days 7, 14 and 28), and although the paper describes the trial as blinded randomised controlled, the described methodology reveals this as untrue.

Likewise, only one completed trial – involving a different strain – has investigated probiotics as preventing mastitis.[8] Again, there are issues with methodology, including the classifications of mastitis episodes employed, and the measures of bacterial counts used.

Marketing to health professionals

Despite the problematic nature of the published research, and the unfinished status of current trials, two probiotic products are currently being advertised to health professionals for treating mastitis. One of these has, since August 2015, been regularly advertised in Medical Observer, a medical magazine for Australian general practitioners.

These products have also been publicised through media releases, at breastfeeding conferences, through seminars held in major Australian cities, and to health professionals including general practitioners and maternal and child health nurses.[9] This marketing involves health claims that the products may address mastitis or its symptoms, but both products’ advertisements cite only the trial from Spain, as described above.

Approved, but still misleading?

Both suppliers sought and were granted TGA approval – in the form of ‘advertising exemptions’ – to make these claims. Nonetheless, even where all relevant statutory approvals have been granted for an advertising campaign for a particular product, it may still amount to misleading or deceptive conduct[10] if the claims are not (or not yet) supported by scientific evidence.

This is so regardless of the fact that the advertised product may pose little or no harm to consumers[11] (though in the case of mastitis, dissuading or delaying a sufferer from seeking medical care and antibiotics may itself be harmful). And as section 18 of the Australian Consumer Law imposes strict liability,[12] it is also irrelevant that the advertisers had no intention to mislead their audience.

Since concerns surrounding these marketing campaigns have been raised, the word has spread,[13] and one member of the Therapeutic Goods Advertising Code Council has called for changes in the TGA’s decision-making processes.[14] Hopefully the TGA will heed these calls, and provide stricter protection against health claims not supported by solid science.

Access the full article ‘Probiotics and mastitis: evidence-based marketing?’, here.

[1] Therapeutic Goods Act 2010 (Cth) Chapter 5; Therapeutic Goods Advertising Code 2007 (Cth).

[2] Janssen Pharmaceutical Pty Ltd v Pfizer Pty Ltd (1985) 6 IPR 227 at 234.

[3] Competition and Consumer Act 2010 (Cth) Sch 2 s 18. Relevant jurisprudence for this prohibition includes cases arising from its predecessor in the Trade Practices Act 1974 (Cth).

[4] Lisa H. Amir, Laura Griffin, Meabh Cullinane and Suzanne M. Garland, ‘Probiotics and Mastitis: Evidence-based Marketing?’ (2016) 11 International Breastfeeding Journal 19.

[5] LH Amir, D Forster, H McLachlan, J Lumley, ‘Incidence of Breast Abscess in Lactating Women: Report from an Australian Cohort’ (2004) 111(12) BJOG: An International Journal of Obstetrics and Gynaecology 1378.

[6] Trial registry records include: ‘Study to assess the preventive effect of new probiotic strain on lactational mastitis’ (available at http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4388); ‘Probiotics for the Prevention of Mastitis in Breastfeeding Women: A Randomised Controlled Trial (available at

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12615000923561); and ‘Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis’ (available at http://clinicaltrials.gov/show/NCT02203877).

[7] R Arroyo, V Martin, A Maldonado, E Jimenez, L Fernandez and JM Rodriguez, ‘Treatment of Infectious Mastitis During Lactation: Antibiotics versus Oral Administration of Lactobacilli Isolated from Breast Milk’ (2010) 50(12) Clinical Infectious Diseases 1551.

[8] L Fernandez, N Cardenas, R Arroyo, S Manzano, E Jimenez, V Martin, JM Rodriguez, ‘Prevention of Infectious Mastitis by Oral Administration of Lactobacillus salivarius PS2 During Late Pregnancy’ (2016) 62(5) Clinical Infectious Diseases 568.

[9] Information is also more widely available online, with the disclaimer “for health professionals only”.

[10] Peterson v Merck Sharpe & Dohme (Aust) Pty Ltd (2010) 184 FCR 1.

[11] Colgate-Palmolive Pty Ltd v Rexona Pty Ltd (1981) 58 FLR 391 at 201-2.

[12] Hornsby Building Information Centre Pty Ltd v Sydney Building Information Centre Ltd (1978) 140 CLR 216; Yorke v Lucas (1985) 158 CLR 661.

[13] Rada Rouse, ‘What’s the evidence for using probiotics for mastitis?’ Medical Observer 2 August 2016 (accessible at http://www.medicalobserver.com.au/medical-news/what-s-the-evidence-for-using-probiotics-for-mastitis); Clare Pain, ‘Concern over promotion of probiotics for mastitis’ Australian Doctor, 3 August 2016 (accessible at http://www.australiandoctor.com.au/news/latest-news/concern-over-promotion-of-probiotics-for-mastitis); ‘Marketing probiotics for mastitis ‘misleading’’ 6 minutes (accessible at http://www.6minutes.com.au/news/latest-news/marketing-probiotics-for-mastitis-misleading).

[14] Ken Harvey, ‘Bizarre advertising approval by TGA’, Medreach Pty Ltd, 4 August 2016 (accessible at http://www.medreach.com.au/?m=201608).

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