DAFF – Food Import Monitoring Programme
The Department of Agriculture monitors imported food at the border for compliance with Australian standards. If you import food, you are responsible for meeting the standards that apply to your products to ensure they are safe and suitable for their intended use. The following tables list the test type and tests that apply to specific food types and the standard against which the test results are assessed. Where there are no analytical tests the food will still be subject to a visual and label assessment.
A complete list of tests can be read here: http://tinyurl.com/m963t9k
DAFF Failing Foods - Monthly Reports
When food is inspected under the Imported Food Inspection Scheme, it may be subject to analytical testing for particular hazards. The data presented in the failing food reports has been compiled from the results of inspection activity on imported food consignments under the scheme. This data is published and released to the public in monthly failing food reports. Future consignments of failed food will be inspected at the rate of 100 per cent of consignments until the food demonstrates compliance with Australian food standards. Failing food reports identify foods that have been found to fail analytical testing or do not meet the compositional requirements of the Australia and New Zealand Food Standards Code. The report does not list foods that have failed for non–compliant labels, as the responsibility for the correct labelling of imported food lies with the importer. In these cases, the importer has an opportunity to bring the label into compliance with Australian food labelling standards. From January 2012, the producer of the food has been included in these reports. The producer is defined as the overseas entity that has grown, caught, manufactured or processed the food and is identified using information provided by the importer and the labelling on the foods packaging.
FSANZ Findings Show Raw Apricot Kernels a Risk
Food Standards Australia New Zealand (FSANZ) today released findings showing that eating raw apricot kernels could pose a public health and safety risk to consumers. FSANZ Chief Executive Officer Steve McCutcheon said FSANZ and the New Zealand Ministry for Primary Industries had looked at a range of foods that naturally contain a chemical that can be broken down after eating to release cyanide. ‘Cyanogenic glycosides are found in a range of foods including cassava root, linseed, bamboo shoots and apricot kernels,’ Mr McCutcheon said.
‘After testing these foods and conducting a risk assessment, FSANZ found only raw apricot kernels can pose a health and safety risk and may require further action.
‘Adults should eat no more than three raw apricot kernels per day and children should not eat any.
‘No other apricot products, including those made with apricot kernels, present a risk.’
Mr McCutcheon said some consumers eat apricot kernels in the belief they can cure or prevent cancer but Cancer Council Australia states that they are not only ineffective at treating cancer but could also be very dangerous.
‘While we are providing consumer advice and education, FSANZ is also working on a proposal looking at how to manage the risk of cyanogenic glycosides in raw apricot kernels.’
A call for submissions on the proposal is expected to be released mid-2014.
Herbal Supplements are the Most Commonly Used Type of Complementary Medicine in the US
Herbs and other dietary supplements besides vitamins are the most commonly used type of "complementary medicine" (also called alternative medicine) in the United States, followed by visits to chiropractors, yoga and massage, a new report finds.
Source: Rachael Rettner, Huffington Post http://tinyurl.com/musu4jt
TGA Safety Advisory - Swanson full spectrum cilantro herbal supplement
The United States Food and Drug Administration (FDA) has posted a voluntary safety recall for the product Swanson Premium Brand Full Spectrum Cilantro (Coriander) Herbal Supplement, item SW1112, on the internet because it has the potential to be contaminated with Salmonella. Recall - Firm Press Release: Swanson Health Products Recalls Full Spectrum Cilantro.
Swanson Full Spectrum Cilantro (Coriander) Herbal Supplement has not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation.
TGA investigations have shown that people in Australia may have bought the product online.
TGA Consultation on Low Value Turnover Exemption (LVT) Scheme
The TGA has commenced a policy and operational review of the low value turnover exemption (LVT) scheme. The first stage is the release of the Review of the Low Value Turnover Exemption Scheme consultation paper. Discussion and options are presented in the paper to generate feedback. It is acknowledged that changes to the LVT scheme would have varying impacts across individual sponsors. Given the potential impact on a broad range of charges, sponsors and products, it is important that each sponsor consider the impact of the current LVT scheme on their product/s and the potential impact of changes to the LVT scheme. Submissions are due by 5:00pm on 23 May 2014.
TGA Issues Guidance for New Registered Complementary Medicine Applications
TGA shows how to submit an application for a new registered complementary medicine in six ‘easy’ steps.This document is provided for applicants of new registered complementary medicines and explains the process for electronic submission of your application using the new TGA eBusiness Over The Counter medicine portal (eBS OTC portal) (April 2014).
An electronic application form for a new registered complementary medicine can only be submitted via the new Portal for Over the Counter (OTC) medicines in the TGA's eBusiness Services (eBS).
The portal has been designed to support the new OTC business process, and thus is fundamentally different to the previous eBS OTC portal. Importantly however, the new eBs OTC portal retains the ability to receive applications for registered complementary medicines, and this guidance document explains how you can use the new portal to make such applications.
N.B. If all this looks way too complicated, please contact RFA for Reliable & Friendly Advice!
TGA Issues Listed Medicines Evidence Package Checklists
The Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines specify the type of evidence required to support indications made for listed medicines (excluding sunscreens and disinfectants) and help sponsors understand their regulatory obligations in relation to holding that evidence. The following Evidence package checklists help sponsors and applicants of listed complementary medicines assess, record and present the available evidence for the indication/s for their medicine. Six checklists are provided.
N.B. Evidence collection to match up with therapeutic claims is an RFA specialty!
TGA Safety Advisories
The Therapeutic Goods Administration (TGA) continues to test medicines imported into Australia and find that they contain many undeclared substances.
TGA advises that it is illegal to supply any of the above products.
Complementary Medicines – TGA Compliance Reviews 2013
“More than 1600 new complementary medicines are listed each year. The TGA does not review these products before listing, because they are considered to be of relatively low risk to consumers and so we cannot guarantee they work - they may only contain pre-approved low-risk ingredients and must not make claims or imply that they have benefit for the treatment or prevention of a serious illness.
“Instead, we follow a risk management approach to set priorities and direct resources to those reviews that provide the greatest overall benefit for the Australian public, including the thorough evaluation of all prescription medicines. This approach enables the Australian community to have timely access to these products. Prioritisation is based upon the potential level of risk to public health and safety. We pay the most attention to the evidence that a sponsor holds to support the indications, the presentation of the medicine, and the advertising of the medicine”.
The issues found in the compliance reviews conducted of listed complementary medicines in 2013 and much more, can be read here: http://tinyurl.com/myafvdx
Complementary Medicines: Cancellations from the ARTG Following Compliance Review
Three products have been cancelled this year. The products, listing numbers, sponsor names and the grounds for cancellation are outlined here:
American Botanical Council Comments on New England Journal of Medicine Article on Supplement Safety
A “perspective” article in the April 3rd edition of the New England Journal of Medicine (NEJM) is unrealistic and confusing, says the non-profit American Botanical Council (ABC). In the editorial Pieter A. Cohen, MD, Assistant Professor of Medicine at the Harvard Medical School, calls for pre-market approval of the safety of dietary supplements (referred to as “nutritional supplements”) before they can be sold. He also calls for a much more extensive adverse events reporting system for supplements.
ABC believes that neither a revamped adverse event reporting system just for supplements, nor the requirement of a pre-market safety assessment for dietary supplements will deter unscrupulous manufacturers and marketers of fraudulent products from attempting to sell intentionally adulterated products, including illegal prescription drugs disguised as dietary supplements. What is needed is more robust enforcement on the part of the FDA, and fortunately, FDA has significantly increased such enforcement in this area in the past few years.
Read the whole ABC article here: http://tinyurl.com/na7re47
Food Standards Australia & New Zealand (FSANZ) issues Notification Circular 06-14
FSANZ discusses the following proposals:
A1095 – Natamycin – Extension of Use in Yoghurt:to extend the use of natamycin as a natural preservative to improve the quality and shelf life of fermented milk products
M1010 – Maximum Residue Limits (2014): to consider varying certain maximum residue limits for residues of agricultural or veterinary chemicals that may occur in food
TGA Safety Advisories
The Therapeutic Goods Administration (TGA) continues to test medicines imported into Australia and found that many contain undeclared prescription substances
TGA advises that the supply of all of the above products is illegal.
TGA presentation to clinical trial research forum, “Regulation of Complementary Medicines in Australia”
This short and concise presentation by Trisha Garrett (Head - Office of Complementary Medicines) provides an updated overview of the TGA role in regulating complementary medicines in Australia.
The accompanying PDF of 35 slides describes in a clear no-nonsense fashion, the terminology, the modus-operandi and the logic behind the TGA’s actions in this area. Plain English examples are given relating to product category, ingredients, manufacture, labelling, claims and compliance audits.
TGA Consultation - OTC Cough Medicines for Oral Use: proposed advisory statements for medicines
OTC medicines indicated for cough include ammonium salts, bromhexine, dextromethorphan, dihydrocodeine, guaifenesin, ipecacuanha, pholcodine, and senega and ammonia. Some of these medicines are unscheduled and others are included in Schedule 2 or Schedule 3 to the SUSMP.
The TGA proposes to amend the RASML by introducing a new advisory statement for these medicines. Interested parties should respond by close of business on Friday 25 April 2014.
TGA Consultation - OTC Nasal Decongestant Preparations for Topical Use: proposed advisory statements for medicines
The TGA is seeking comments from interested parties on proposed advisory statements for OTC nasal decongestant preparations for topical use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document when it is next updated. Interested parties should respond by close of business on Friday 25 April 2014.
TGA Consultation - Molybdenum trioxide: Proposed revision of the draft compositional guideline
At the request of industry, the TGA has revised a number of parameters included in the draft compositional guideline for molybdenum trioxide and now seeks comments on the proposed revision of the draft guideline from stakeholders.
TGA reforms - A Blueprint for TGA's Future: Progress report as at 31 December 2013
TGA reforms: A blueprint for TGA's future - Progress report as at 31 December 2013 is the third six monthly progress report on reforms to the TGA to ensure that it remains adaptable to community and industry expectations. The report outlines the TGA's progress in addressing reforms recommended in TGA reforms: a blueprint for TGA's future .
TGA - Advisory Committee on Complementary Medicines (ACCM)
The Advisory Committee on Complementary Medicines (ACCM) was formed in January 2010 to advise and make recommendations to the Therapeutic Goods Administration (TGA) on the inclusion, variation or retention of a complementary medicine in the Australian Register of Therapeutic Goods.
ACCM may also provide advice to the TGA on any other matters concerning complementary medicines, and any other matters referred to it by the TGA (whether or not related to a complementary medicine).
More information at: http://tinyurl.com/n4qfq9l