Complaint to TGA – Pharmacare Laboratories Pty Ltd, Nature’s Way Kids Smart Omega-3 Fish Oil products

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Acknowledgements: This complaint was worked up by Monash BMS3052 students; then checked and submitted by Assoc Prof Ken Harvey.

Product and Sponsor Product name: Nature's Way Kids Smart Omega-3 Fish Oil High DHA products Sponsor: Pharmacare Laboratories Pty Ltd Address: PO Box 384, MONA VALE, NSW, 1660 Australia ARTG no: 123469 Nature's Way Kids Smart ARTG no: 136327 Nature's Way Kids Smart Trio ARTG no: 150228 Nature's Way Kids Smart Strawberry ARTG no: 159514 Nature’s Way Kids Smart Complete ARTG no: 278590 Nature's Way Kids Smart DHA Drops ARTG no: 283117 Nature's Way Kids Smart DHA 300mg Triple Strength ARTG no: 312268 Nature's Way Kids Smart Complete Multivitamin + High DHA Fish Oil ARTG no: 313445 Nature’s Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil ARTG no: 324963 Nature's Way Kids Smart Omega-3 Fish Oil High DHA Specific indications: (e.g. ARTG 123469)

• Kids Smart Omega-3 burstlets are specifically formulated to be high in DHA, an essential brain nutrient your child needs throughout the developing years. Boosting your child's intake of omega-3 DHA can help support cognitive health and their ability to think and learn.

Permitted Indications: (e.g. ARTG 324963) • Maintain/support healthy eye function • Maintain/support general health and wellbeing • Maintain/support cognitive function/mental function • Maintain/support learning and information processing • Maintain/support brain function • Maintain/support nervous system health

Product Ingredients: • Natural fish oil

Advertisement type: Internet – Website

Accessed on: 15/01/20

URL(s) listed (screen shots appended) • https://www.naturesway.com.au/product/kids-smart-burstlets-omega-3-fish-oil-strawberry-

50s • https://www.chemistwarehouse.com.au/buy/56442/nature-s-way-kids-smart-omega-3-fish-

oil-strawberry-flavour-50-chewable-capsules? • https://www.mrvitamins.com.au/natures-way-kids-smart-omega-3-fish-oil-trio-180c • https://shop.coles.com.au/a/a-national/product/natures-way-kids-smart-strawberry • https://www.amazon.com.au/Natures-Way-Omega-3-Strawberry-

Kilograms/dp/B00C1W4EW0

Complaint to TGA – Pharmacare Laboratories Pty Ltd, Nature’s Way Kids Smart Omega-3 Fish Oil products

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• https://www.goodpricepharmacy.com.au/nature-s-way-kids-smart-vita-gummies-omega-3-dha-trio-120-pastilles

• https://www.pharmacy4less.com.au/catalog/product/view/id/11193/ • https://www.priceline.com.au/brand/natures-way/nature-s-way-kids-smart-burstlets-

complete-multivitamin-high-dha-fish-o-100-capsules • https://www.mychemist.com.au/buy/59657/nature-39-s-way-kids-smart-omega3-fish-oil-

trio-180-capsules?rcid=660 • https://www.woolworths.com.au/shop/productdetails/251746/nature-s-way-kids-smart-

omega-3-fish-oil • https://www.pharmacydirect.com.au/natures-way-kids-smart-omega-3-fish-oil-fruity-50-

chewable-capsules?search=nature%20way%20kids%20smart&description=true • https://www.cincottachemist.com.au/natures-way-kids-smart-gummie-omega-multi-50-

pastilles?search=natures%20way%20kids%20smart&description=true • https://www.ebay.com.au/i/232627659159? • Etc.

Complaint Summary (also for pasting into the online complaint form) These products claim, ‘Omega-3 oils are important for a child’s healthy developing brain and supplementing the daily intake of DHA can help support healthy brain function and healthy learning.’

This is not in accord with current scientific evidence. It is alleged that all the advertisements listed above breach s.9(a), 9(b), 10(a)(ii), 10(c) of the Therapeutic Goods Advertising Code (No.2) 2018.

We also allege a s.19(2) Code breach as the cartoons on the products target kids aged under 12. Kids can demand a product that appeals to them and place significant pressure (‘pester power’) on parents. In addition, the sponsor states,

‘Nature’s Way Kids Smart Omega-3 Fish Oil has been designed for kids so they will want to take them. Each chewable burstlet has a great strawberry taste.’

Some advertisements had extra claims not listed on the ARTG summary; others and lacked information required for therapeutic goods that are not available for physical examination before purchase.

Overall, it is alleged the advertisements illustrated breach the Therapeutic Goods Advertising Code (No. 2) 2018, s.9(a), 9(b), 9(d), 10(a)(ii), 10(c), 10(d)(iv), 15(3)(b) and 19(2).

In addition, the ARTG public summary information also needs revision. Alternatively, and preferably, these products should be delisted from the ARTG.

Introduction Pharmaceutical companies advertise Omega-3 supplements to parents who want the best for their children by making a number of claims. Omega-3 fatty acids are important for a child’s healthy developing brain (true). Most children (and adults) do not eat enough Omega-3 rich foods such as oily fish (true with respect to recommended dietary guidelines). Supplementing the daily intake of DHA can help support healthy brain function and healthy learning (not supported by scientific evidence).

Claim disputed List citing relevant literature, rationale and details of alleged regulatory breaches

Complaint to TGA – Pharmacare Laboratories Pty Ltd, Nature’s Way Kids Smart Omega-3 Fish Oil products

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‘Supplementing the daily intake of DHA can help support healthy brain function and healthy learning’

A recent systematic review (Cooper et al. 2015) examined 24 randomised controlled trials in adults and school-aged children for the effects of omega-3 polyunsaturated fatty acids (n-3 PUFAs) on cognition. They found no evidence that n-3 PUFAs) had a beneficial effect on cognition in the general population, or in those with neurodevelopmental disorders There was some evidence of improvements in those with low n-3 PUFA status. The authors concluded that in order to provide a more conclusive picture future trials should employ larger sample sizes and should focus on supplementation of those who are n-3 PUFA deficient. They suggested that regulators and producers of omega-3 products should consider this evidence when promoting their products.1

Montgomery et al, (2018) randomised 376 healthy children, underperforming in reading, aged 7-9 into one group receiving 600mg/day DHA and another group receiving placebos for 16 weeks. 2 Reading, working memory, and behaviour change scores showed no consistent differences between intervention and placebo group. These findings failed to replicate the results of an earlier study on the effectiveness of nutritional supplementation with DHA for learning and behaviour. Both studies were done by the same group. Possible reasons for the failure of replication of complex interventions was discussed.

We also allege a s.19(2) Code breach as the cartoons on the products target kids aged under 12. Kids can demand a product that appeals to them and place significant pressure (‘pester power’) on parents. In addition, the sponsor states,

‘Nature’s Way Kids Smart Omega-3 Fish Oil has been designed for kids so they will want to take them. Each chewable burstlet has a great strawberry taste’

Some advertisements had extra claims not listed on the ARTG summary (e.g. behaviour); others lacked information required for therapeutic goods that are not available for physical examination before purchase.

Overall, it is alleged the advertisements illustrated breach the Therapeutic Goods Advertising Code (No. 2) 2018, s.9(a), 9(b), 9(d), 10(a)(ii), 10(c), 10(d)(iv), 15(3)(b) and 19(2).

In addition, the ARTG public summary information also needs revision. Alternatively, and preferably, these products should be delisted from the ARTG.

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

Associate Professor Public Health and Preventive Medicine

Monash University 30 January 2020

1 https://journals.sagepub.com/doi/abs/10.1177/0269881115587958 2 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0192909

Complaint to TGA – Pharmacare Laboratories Pty Ltd, Nature’s Way Kids Smart Omega-3 Fish Oil products

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Appendix (Screen shots with offending claims arrowed)

https://www.naturesway.com.au/product/kids-smart-burstlets-omega-3-fish-oil-strawberry-50s

Complaint to TGA – Pharmacare Laboratories Pty Ltd, Nature’s Way Kids Smart Omega-3 Fish Oil products

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https://www.chemistwarehouse.com.au/buy/56442/nature-s-way-kids-smart-omega-3-fish-oil-strawberry-flavour-50-chewable-capsules?

https://www.mrvitamins.com.au/natures-way-kids-smart-omega-3-fish-oil-trio-180c

Lacks required information 12(3)(f), 13(6),(7)

Chinese explanation

Complaint to TGA – Pharmacare Laboratories Pty Ltd, Nature’s Way Kids Smart Omega-3 Fish Oil products

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https://www.mrvitamins.com.au/natures-way-kids-smart-omega-3-fish-oil-trio-180c (translation)

https://shop.coles.com.au/a/a-national/product/natures-way-kids-smart-strawberry

Lacks required information 13(6)

Facilitates the health of skin, gum and blood vessels

Assists in body

absorption and

utilization, strengthen the calcium

of bones and teeth This product does not

contains colour additives, preservatives, lactose and

other unexpected ingredients

Protect body tissues

Help maintain good eyesight, growth of health

bones and teeth

Complaint to TGA – Pharmacare Laboratories Pty Ltd, Nature’s Way Kids Smart Omega-3 Fish Oil products

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https://www.amazon.com.au/Natures-Way-Omega-3-Strawberry-Kilograms/dp/B00C1W4EW0

https://www.goodpricepharmacy.com.au/nature-s-way-kids-smart-vita-gummies-omega-3-dha-trio-120-pastilles

Lacks required information 12(3)(f),

13(7)

Lacks required information 12(3)(f), 13(2)(b)