New Bill signals tighter regulation of natural health products

The Natural Health Products Bill, a First Reading of which has been unanimously passed before Parliament recently, paves the way for positive reform of the New Zealand natural health products industry.

The Bill proposes establishment of a Natural Health Products Regulatory Authority who will assess the safety, quality and efficacy of all natural health product ingredients. In addition the Bill gives power to the Regulatory Authority to impose penalties against those manufacturers or importers who contravene new Regulations. In this way, the proposed legislation aims to ensure that all natural products are safe and of high quality to give consumers and manufacturers confidence that natural health products are true to label.  This is a positive move for both industry participants and consumers.

Current natural health products are regulated as dietary supplements under the Dietary Supplements Regulations 1985 or supplemented foods under the New Zealand (Supplemented Food) Standard 2010. These dual standards are widely considered to be confusing for the industry and difficult to enforce.

The main reforms under the Bill include:

• All New Zealand manufacturers and importers will be required to notify the Regulatory Authority before releasing their products onto the market; 
• All natural products for distribution in New Zealand will have to comply with labeling requirements who will be set out in Regulations to be issued by the Regulatory Authority. Each existing natural product ingredient will be considered either approved or prohibited; 
• All manufacturers will need to apply for a license to manufacture under the Bill which will only be issued if the applicant and the applicants manufacturing facilities meet the requirement of a Code of Practice; and
• Penalties against those entities who commit an offence under the Bill will include product recall and prosecution including financial penalties of up to $500,000 for companies and up to $50,000 or 5 years imprisonment for individuals.

The Bill will go before the Health Select Committee next term who will then call for submissions in due course (likely from February 2012 onwards). The Bill may come into effect as early as next year following the drafting of Regulations.

James & Wells Intellectual Property is a principal sponsor of the voluntary industry body, Natural Products New Zealand, and acts for a large number of companies in this sector.   We believe the Bill is a positive step to protect consumers and facilitate growth of the natural products industry through stringent regulatory standards. We look forward to working with the industry on submissions to the Select Committee and the drafting of Regulations to effectively implement the Bill.

This article was written by Justin Sweetman. To contact Justin please email him on justins@jaws.co.nz or phone 09 914 6740.