Complaint to TGA – Blackmores Probiotics+ Daily Health · Blackmores Probiotics+ Daily Health is a five-strain probiotic and prebiotic formulation that claims to, ‘restore digestive

Complaint to TGA – Blackmores Probiotics+ Daily Health

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Acknowledgment: This complaint was worked up by a Monash Honours research student, then checked and submitted by Assoc Prof. Ken Harvey.

Complaint Summary:

Blackmores Probiotics+ Daily Health is a five-strain probiotic and prebiotic formulation that claims to, ‘restore digestive balance and maintain intestinal health’, ‘relieve symptoms of bloating, gas, and flatulence’, ‘support a normal healthy immune system’ and ‘support general wellbeing’. Blackmores’ also claim their product is, ‘formulated based on scientific evidence’ and contains, ‘five clinically trialled probiotic strains’.

The references provided by Blackmores do not support these claims. In addition, ‘clinically trialled’ is a meaningless term as clinical trials may not support the claims made (as in this case).

It is alleged the promotion of this product breaches section 9(a), 9(b), 15(2)(b), and 15(3)(a) of the Therapeutic Goods Administration Code (No.2) 2018.

There is also a problem with the ARTG Public Summary information where the strains of probiotics are not recorded. This appears to be a generic problem with probiotic products. Given that the clinical benefits of probiotics are strain specific, this is an important omission. This also results in the absurdity that the same probiotic microorganism appears to be present in different doses. Probiotic strain information should appear in ARTG Public Summaries.

Product and Sponsor: Product name: Blackmores Probiotics+ Daily Health Sponsor: Blackmores Ltd Address: PO Box 1725, WARRIEWOOD, NSW, 2102, Australia ARTG ID: 318343

Product ingredients (ARTG):

• Bifidobacterium lactis – 7 billion CFU • Bifidobacterium lactis – 2 billion CFU • Bifidobacterium lactis – 7 billion CFU • Inulin – 100mg • Lactobacillus acidophilus – 7 billion CFU • Lactobacillus paracasei – 7 billion CFU

Product ingredients (Blackmores official website):

• Bifidobacterium lactis Bi-07 – 7 billion CFU • Bifidobacterium lactis HN019 – 2 billion CFU • Bifidobacterium lactis Bl-04 – 7 billion CFU • Inulin – 100mg • Lactobacillus acidophilus ATCC 700396 – 7 billion CFU • Lactobacillus paracasei Lpc-37 – 7 billion CFU

Permitted indications (ARTG):

• Maintain/ support general health and wellbeing • Decrease/ reduce/relieve flatulence/ carminative • Maintain/ support intestinal health

Complaint to TGA – Blackmores Probiotics+ Daily Health

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• Maintain/ support healthy mucous linings of the digestive system • Maintain/ support intestinal good/ beneficial/ friendly flora • Helps maintain/ support good/ beneficial/ friendly gut flora during antibiotic use • Help restore good/ beneficial/ friendly gut flora after antibiotic use • Nourish good/ beneficial/ friendly intestinal flora • Maintain/ support gastrointestinal system health • Relieve digestive discomfort • Decrease/ reduce/ relieve gastrointestinal pain • Maintain/ support healthy gastrointestinal immune function

Claims (Blackmores official website):

• Restore digestive balance and maintain intestinal health • Relieve symptoms of bloating, gas, and flatulence • Support a normal healthy immune system • Support general wellbeing • Contains a prebiotic which provide a source of nutrition for gut flora

Advertisement Type:

Internet – website

Accessed on:

29/08/2020

URL(s) listed (screenshots appended):

• https://www.blackmores.com.au/products/probiotics-daily-health • https://www.chemistwarehouse.com.au/buy/82129/blackmores-probiotics-%C2%A0daily-

health%C2%A090-capsules • https://www.woolworths.com.au/shop/productdetails/572423/blackmores-probiotics-daily-health • https://www.priceline.com.au/blackmores-probiotics-daily-health-30-capsules • https://www.goodpricepharmacy.com.au/blackmores-probiotics-daily-health-90-capsules • Etc.

Complaint Details:

Blackmores Probiotics+ Daily Health is a five-strain probiotic and prebiotic formulation that claims to, ‘restore digestive balance and maintain intestinal health’, ‘relieve symptoms of bloating, gas, and flatulence’, ‘support a normal healthy immune system’ and ‘support general wellbeing’ (screen shots in appendix). Blackmores’ also claim their product is, ‘formulated based on scientific evidence’ and contains, ‘five clinically trialled probiotic strains’.

The references provided by Blackmores do not support these claims. In addition, ‘clinically trialled’ is a meaningless term as clinical trials may not support the claims made (as in this case).

The first study cited was conducted by Ouwehand et al. (2014) and looked at reducing antibiotic-associated diarrhoea (AAD) and Clostridium difficile- associated diarrhoea (CDAD) with the probiotic combination of Lactobacillus (L.) acidophilus NCFM, L. paracasei Lpc-37, Bifidobacterium (B.) lactis Bi-07, and B. lactis Bl-04

Complaint to TGA – Blackmores Probiotics+ Daily Health

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at two different doses (4.17 x 109 CFU and 1.70 x 1010 CFU).1 Significant reduction in AAD incidence was only found in the high-dose group (p=0.005) and not in the low-dose (p=0.28).

Reducing the incidence of AAD was not a claim made by Blackmores for this product. Furthermore, this study used a commercial four strain probiotic combination (HOWARU(®) Restore), not the Blackmores 5-strain combination plus a prebiotic. This study is not relevant to the claims made by Blackmores.

The second study cited was conducted by Waller et al. (2011), which looked only at B. lactis HN019 but at two different dosages; 1.8 billion CFU and 17.2 billion CFU.2 This particular study measured whole gut transit time (WGTT). The study concluded that there was a statistically significant difference in WGTT for both the high dose (33% reduction) and low dose (25% reduction) compared to the placebo (no change observed).3 However, there was variability in baseline characteristics, which may have biased these results and the study was underpowered. Similar to the previous study, this study is not relevant to the claims made by Blackmores.

The third study cited was conducted by West et al. (2014), where B. animalis subsp. lactis Bl-04 (2x109 CFU) and a combination of L. acidophilus NCFM and B. animalis subsp. lactis Bi-07 (1.0x1010 CFU/day) were investigated.4 They found a significant risk reduction in upper respiratory tract infection (URTI) episode (sore throat, runny nose, stuffy nose, sneezing) in the single strain group (p=0.02) and a non-significant risk reduction of 19% in the combination group (p=0.15). No conclusions could be drawn about gastrointestinal illnesses as the numbers were too small. This study is also irrelevant to the claims made.

It is alleged that these claims made for this product breach section 9(a) and 9(b) of the Therapeutic Goods Advertising Code (No.2) 2018, as they are inaccurate and misleading. In addition, the papers cited are not relevant to the claims made, thereby breaching section 15(2)(b) of the Therapeutic Goods Advertising Code (No.2) 2018. Finally, this product breaches section 15(3)(a) of the Therapeutic Goods Advertising Code (No.2) 2018 as financial support was provided for the study conducted by Waller et al. (2011) from Fonterra Research Centre. Furthermore, in the study conducted by Ouwehand et al. (2014), one of the authors (Arthur Ouwehand) was noted as an employee of DuPont Nutrition & Health, who manufactures and markets the probiotics tested in this study.

There is also a problem with the ARTG Public Summary information where the strains of probiotics are not recorded. This appears to be a generic problem with probiotic products. Given that the clinical benefits of probiotics are strain specific, this is an important omission. It also results in the absurdity that the same probiotic microorganism appears to be present in different doses in the ARTG Public Summary. Probiotic strain information should appear in ARTG Public Summaries.

A recent useful reference is appended, Suez et al, (2019) The pros, cons, and many unknowns of probiotics.5

Signed and dated Dr Ken Harvey MB BS, FRCPA, AM

Associate Professor Public Health and Preventive Medicine

Monash University

1 https://pubmed.ncbi.nlm.nih.gov/24291194/ 2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3171707/ 3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3171707/ 4 https://www.clinicalnutritionjournal.com/article/S0261-5614(13)00261-6/fulltext 5 https://www.nature.com/articles/s41591-019-0439-x

Complaint to TGA – Blackmores Probiotics+ Daily Health

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31 August 2020

Appendix (Screenshots):

Blackmores Probiotics+ Daily Health

https://www.blackmores.com.au/products/probiotics-daily-health, accessed 29/08/2020

Product

Ingredients

Overview

Complaint to TGA – Blackmores Probiotics+ Daily Health

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Indications

Chemist Warehouse

https://www.chemistwarehouse.com.au/buy/82129/blackmores-probiotics-%C2%A0daily-health%C2%A090-capsules, accessed 29/08/2020

Ingredients

Indications

Woolworths

https://www.woolworths.com.au/shop/productdetails/572423/blackmores-probiotics-daily-health, accessed 29/08/2020

Ingredients Not shown.

Indications

Complaint to TGA – Blackmores Probiotics+ Daily Health

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Priceline Pharmacy

https://www.priceline.com.au/blackmores-probiotics-daily-health-30-capsules, accessed 29/08/2020

Ingredients

Indications

Good Price Pharmacy Warehouse

https://www.goodpricepharmacy.com.au/blackmores-probiotics-daily-health-90-capsules, accessed 29/08/2020

Ingredients

Indications