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Natural Health and Supplementary Products Bill

 

The Natural Health and Supplementary Products Bill will establish a new regulatory regime, separate from those in place for food and medicines. It will control low-risk natural health products such as garlic capsules and Echinacea, and supplementary products such as vitamin tablets. The full regulatory scheme will be phased in over three years after the legislation comes into force, which is expected to be around November 2016, and the Regulations are expected to come into force shortly afterwards.

The new Natural Health Products Bill establishes the types of claims that can be made about a product, the health conditions that claims can be made about, and the type of evidence that product notifiers must hold to support their claims. The Bill also requires product notifiers to make available to the public a summary of evidence that supports the claim(s) made in respect of the product.

 

 

Evidence requirements for health benefit claims:

 

Claims made with respect to NHPs must be accurate and not misleading. Claims must be consistent with clause 5 of the Bill and be supported by either traditional or scientific evidence.

 

Traditional versus Scientific (or both):

 

Traditional claims are claims that an ingredient or product has been used within a recognised therapeutic model that sits outside modern conventional medicine. Traditional medicine is an integral part of many cultures and includes a diverse range of health practices, approaches, knowledge sets and belief systems relating to medicines. Traditional claims must indicate that the health benefit is based on long-term use and experience in a specific traditional model. 

 

Scientific claims are made in relation to conventional modern medicine and are supported by scientific literature, such as clinical studies or systematic reviews.

 

Traditional Evidence:

 

The Authority proposes that the time required for something to be considered traditional use is three generations (75 years, 25 years per generation). Schedule 2 of the Bill lists approved pharmacopoeia that can be used as sources of traditional evidence. Other sources include confirmation by an individual recognised within a specific culture as having the authority to speak on such matters, that an ingredient or product has been traditionally used in the manner you are claiming. Published studies detailing traditional use and treatises on traditional medicine could also be considered to be forms of evidence of traditional use.

 

Scientific Evidence:

 

Types of scientific evidence include systematic reviews, peer-reviewed journal articles and unpublished studies (provided the product notifier holds the full details of the studies and the studies are well-designed). Internationally recognised monographs or pharmacopoeias maintained by other international regulatory bodies are also sufficient to support claims made by the monograph or pharmacopoeia and general claims such as nutrient supplementation. Specifically, systematic reviews, critically appraised topics, critically appraised articles or papers, randomised controlled trials, cohort studies, and case controlled studies are considered acceptable evidence.

 

 

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What is a "summary of evidence"?

 

A summary of traditional evidence must support a claim that a particular substance was used within the relevant tradition and be applicable to the claim. It must also include the claim made in respect of the product, the source(s) of the evidence (such as approved pharmacopoeia), and the traditional model that supports the claim (for example, traditional Chinese medicine).

A summary of scientific evidence must include the claim made in respect of the product, the source(s) of the evidence, the objective and method of the experiment, and the key findings and conclusions. In addition, a summary of scientific evidence must not conflict with a wider body of evidence, be accurate and not misleading, and be applicable to the claim.

 

Important considerations for scientific evidence:

Some important points to remember when considering the evidence:

  • Your research has to be relevant to the specific indication that you are making a claim for.

  • The active ingredient(s), dosage, and route, duration and frequency of administration of the product must be consistent with the summary of evidence and what has been demonstrated in the scientific evidence.

  • You must consider the study population, unless your product is targeted at a specific population you need to have studies representative of the New Zealand population.

 

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What do I need to do to get a "summary of evidence"?

 

Search for traditional and/or scientific evidence and prepare a summary of evidence (see examples above for traditional and scientific). See above for where to access traditional evidence. For scientific evidence, a thorough literature search done in a systematic way is required. An assessment of quality, bias, and results is also needed to confirm that you have “a robust summary of evidence”.

 

How do I do this?

 

Employ us! Or check out the links here under the subheading for guidance on a particular topic.

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Literature search done in a systematic way:

 

Website: Univeristy of Auckland, Medical Library

How to search the literature:

 

Journal Article: Searching the literature and Selecting the Right References

 

Website: University of Auckland, Medical Library

 

 

How to assess quality, bias, and results:

 

Website: University of Auckland Medical Library

 

Journal Article: How to critically appraise an article

 

Journal Article: Critical Appraisal of Scientific Articles:

 

Journal Article: How to read a Scientific Research Paper

 

Journal Article Series: Basic Statistics for Clinicians series 1-4 (Hypothesis testing; Interpreting study results, Confidence intervals; Assessing the effects of treatment, measures of association; Correlation and Regression).

 

Website: Critical Appraisal Skills Programme (CASP) Making sense of evidence (Checklists)

 

Although considered “gold standard” controlled trials and meta-analyses can still have some pitfalls as well:

 

Journal Article: Assessing the quality of controlled clinical trials:

 

Journal Article: Investigating and dealing with publication and other biases in meta-analysis:

 

Lastly very useful if somewhat older Journal Article series. On this page you will find links to articles in the BMJ that explain how to read and interpret different kinds of research papers:

Where and How to find evidence:

 

Website: University of Auckland, Medical Library

 

Website: University of Otago, Library

 

Journal Article: How to Find the Best Evidence

 

 

Searching in PubMed:

 

Website: U.S. National Library of Medicine Pubmed Online Training

 

Website: U.S. National Library of Medicine Tutorial

 

Website: Icahn School of Medicine at Mount Sinai, Pubmed Tutorial 

 

Other databases:

 

For Scopus, Web of Science, Embase, Cochrane, and Proquest Bio help, see the database help files on each database website, also search YouTube for videos. Once you get the hang of PubMed you’re in a good position to tackle these ones.

 

Website: Embase tutorial from the Hardin Library for the Health Sciences (University of Iowa)

 

For the Ovid databases and many useful videos under many categories go to the Yale Library of Medicine website.

 

 

 

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