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How do we do our research on our ingredients? Are you TGA listed?

Woooooo, we love a good question! #yesplease

As a part of our research, we have a third party who works directly with our manufacturer/formulators (they’re like a team of wizards!) to ensure each ingredient that goes into our TGA listed products has an evidence backing. We want to ensure that our products are top quality, and that our supplements are consistent with our medical indications given.  With the help of our regulatory solutions for food and natural medicine and their research on our ingredients, we truly believe our products will help our community.

 As our products are listedmedicines with the TGA we must comply with their regulations regarding indications, ingredients and post market compliance. There are different process’ for listed assessed listed and registered medicines, and the TGA take a risk-based approach to regulation where we have more rigorous controls on higher risk registered medicines than lower risk listed medicines. The TGA remind us of that scary teacher in school who you just did not want to annoy haha! But deep down, they’re just strict because they have to be!

Listed medicines (which is what we have) are lower risk and can be purchased off the shelf from pharmacies, health shops, and supermarkets. The TGA However, requires us to certify that the medicine complies with all relevant regulation, and that they hold evidence that their medicine does what it says it will (which we do!). 

With our wonderful regulatory solution wizards, we have a tough process for the evidence that goes into our products! Our partners provide us with an evidence package that is set out like the below. (an example)

Related ingredient: Zinc and Vitamin C

Indication: Maintain/support general health and wellbeing

Evidence item:

[1] National Institute of Health. US Department of Health and Human Services. Zinc monograph. US Department of Health & Human Services. https://ods.od.nih.gov/factsheets/Zinc-HealthProfessional/ (accessed June 2021)

 

Part 1: Filter for credibility of evidence (yes/no)

  • Is the source of evidence an internationally recognized monograph or pharmacopeia? OR
  • Has the evidence been published by a credible institution such as a government body or international agency?

 

Part 2: Filter for relevance of evidence (yes/no)

Ingredient:

  • Is the scientific name (including relevant salt) of the mineral, vitamin or nutrient the same as the ingredient listed in your medicine?
  • Does the medicine provide at least 25% of the RDI (recommended daily intake), AI (average intake) or nutrient reference value for that nutrient consistent with the NHMRC guidelines?
  • Is the vitamin, mineral or nutrient in a form that is available for absorption by the body that is likely to provide the RDI?

Indication: (yes/no)

  • Is the use described in the evidence consistent with your medicine indication?

Risks, cautions and contradictions: (yes/no)

  • Is the information in the evidence regarding any risks, cautions or contradictions reflected in your medicine information?

Then – once that tough stuff is done – then we double down on the information which is called a ‘balance of evidence’. This includes

  • Citation details
  • Type of study
  • Primary, secondary quality
  • Supports the indications OR
  • Does not support the indications

Once this is completed, we then do an assessment of the balance of evidence.

This is PER INGREDIENT and per indication (and per source haha!)! So, you can imagine how much work goes into every single product.

We truly hope this gives you an insight into how much of our heart and soul goes into our products.

Love, the Yes Please Team!