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current affairs

Issue 115 

February 2013

Published by Robert Forbes & Associates Pty Ltd. www.robert-forbes.com

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Upcoming Conferences

Samantha King, RFA’s Regulatory Affairs Manager, will be attending the Direct Selling Association of Australia’s annual conference on the Gold Coast in Queensland on 4th and 5th March, and welcomes any clients or colleagues of RFA to meet up with her.

Robert Forbes will be attending ExpoWest at Anaheim on 7th to 10th March. Most of the time you will be able to find him at the “Ask the Experts” booth in Hall A, booth 492. Please drop by if you are attending. Robert will also be attending Natural Products New Zealand’s annual summit from 21st to 22nd March.

Latest Regulatory News

Deadline for comment on TGA’s proposed changes to indications for use for listed medicines

In a move that has dismayed many in the industry, the TGA is proposing to remove the “free text” area on applications for listed medicines. This free text area allows the applicant to type in indications for use, as well as choosing from a list of “coded” indications – commonly used indications that have been allocated a code to be used on the application. The TGA is proposing that when an applicant wishes to use an indication for which there is no code currently allocated, the applicant would have to submit an application to have a new coded indication added, via a newly formed committee along with an application fee. You can read about the proposed changes here: http://www.tga.gov.au/newsroom/consult-cm-permitted-indications-130114.htm and the closing date for comments is Friday 15th March 2013. If you object to these unnecessary changes you are strongly urged to submit your comments before the cut-off date.

More adulterated products seized

Imported non-registered products promoted for fat loss, Albuterex Xtreme, and Albutarex Femme Formula, were tested and found to contain the prescription-only ingredients theophylline and yohimbine, and very high levels of caffeine. These ingredients were not listed on the products' labels, and could cause symptoms ranging from nausea, sweating, increased heart rate, agitation and tremor, to life-threatening heart rhythms and seizures. Risks can be increased and symptoms can be worsened if other caffeine-containing products, or certain other medicines, herbal products or foods, are also consumed.

Non-disclosure of certain herbal extract details

The TGA has published revised guidelines and application forms for sup[pliers of active herbal extract ingredients who wish to keep certain details confidential from the companies who choose to use their herbal substances. Details that may be kept confidential include the details of solvents used in the extraction process, the concentration extract ratio and extract excipient details. Details that must be disclosed include the approved name of the herb species, the part of plant that is used, the ratio of equivalent dry weight to extract amount, the amount of each individual herbal active ingredient, and the percentage of any component of the herb that is claimed on the label. It is not possible to hide from the public the amounts of each active ingredient, as per USA-style “proprietary blends”.

Survey of inorganic arsenic in seaweed and seaweed-containing products available in Australia

FSANZ conducted a small survey investigating levels of inorganic arsenic in dried seaweed and products containing seaweed available in Australia. The levels of inorganic arsenic in various seaweed types tested were all below the maximum level (ML) for seaweed of 1 mg/kg in the Australia New Zealand Food Standards Code (the Code), with the exception of one composite sample of hijiki seaweed. The levels of inorganic arsenic in products containing seaweed (e.g. seaweed chips) were comparable with the levels reported for similar foods in other countries. Population groups or individuals that have a high exposure to arsenic from other sources in the diet, and who also regularly consume hijiiki seaweed, should be aware that they may have a higher potential health risk from arsenic than the general population. FSANZ has therefore reviewed and updated the factsheet for consumers regarding seaweed, which is available on the FSANZ website.

Proposal to adopt the revised Australian and New Zealand sunscreen standard (AS/NZS 2604:2012) for cosmetic sunscreen products

NICNAS is consulting on the regulatory impacts on industry, community, and government of the proposed adoption of the revised Australian and New Zealand Sunscreen Standard (AS/NZS 2604: 2012 Sunscreen products - Evaluation and classification) in the Cosmetic Standard 2007. The period for public comments on this consultation will finish at close of business on Friday 25 January 2013.

Outbreaks of Campylobacter food poisoning reported

FSANZ has advised that there have been outbreaks of Campylobacter food poisoning linked to dishes such as pâté, where poultry liver has been undercooked. Like other poultry meat, livers need to be cooked all the way through to kill bacteria that may be present. Lightly frying the surface is not enough. FSANZ states that cooked whole livers may still be slightly pink in the centre, but they should never be bloody or look raw.

Cancellations from the ARTG following compliance review

Five listed medicines have been removed from the ARTG following a compliance review.

Permitted (coded) indications for listed medicines

The TGA is seeking comments from interested parties on proposed reforms relating to 'Permitted (coded) indications' for listed medicines. Currently, when listing a medicine on the ARTG via the Electronic Lodgement Facility (ELF), sponsors may either select indications from a coded list or use a free text field to describe indications in their own words. Unlimited use of the free text field has resulted in a large number of inappropriate indications and other statements being entered on the ARTG. The TGA proposes to remove the free-text option and require sponsors to select indications from a list of permitted indications only.

Complementary medicines reforms

The Therapeutic Goods Administration (TGA) has started work on a series of reforms to complementary medicines that seeks to improve community confidence in the safety and quality of these medicines. The reforms are part of the TGA reforms: A blueprint for TGA's future ("the Blueprint"), including a number of recommendations from the Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines.

Three imported “herbal” products found to contain undisclosed prescription medicine

The TGA is working with Australian Customs and Border Protection Services (Customs) to help stop future shipments of Libigirl capsules, Best Slim capsules and Meizi Evolution Botanical Slimming soft gel capsules  from entering Australia. These products are presented as being “100% natural” or “herbal”. However, Libigirl capsules contain the undeclared prescription substances sildenafil and tadalafil, Best Slim capsules contain the undeclared prescription substance sibutramine, a prescription-only medicine - the active ingredient in Reductil – which was withdrawn in October 2010 after a study showed an increased risk of major cardiac events. Meizi Evolution Botanical Slimming soft gel capsules also contain the undeclared prescription substance sibutramine.

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