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current affairs

Issue 118

July 2013


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

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Latest Regulatory News

American Botanical Council exposes product adulteration in herbal products

Established in 1988, and with members in 81 countries, the American Botanical Council (ABC) is the leading independent, nonprofit, organization providing education using science-based and traditional information to promote the responsible use of herbal medicine. In 2011, ABC, together with two other nonprofit organizations – the American Herbal Pharmacopoeia (AHP) and the University of Mississippi’s National Center for Natural Products Research (NCNPR) – initiated the ABC-AHP-NCNPR Botanical Adulterants Program. This large-scale program, now supported by more than 100 entities, educates members of the herbal and dietary supplement industry, the botanical medicine community, and other stakeholders about accidental and intentional ingredient and product adulteration. As part of this program, ABC recently published its 5th botanical adulteration article, an extensive review of the adulteration of black cohosh(Actaea racemosa), which is often used to treat the symptoms of menopause. More information can be found at the Botanical Adulterants webpage at http://abc.herbalgram.org/Adulterants.

American Botanical Council: Providing education using science-based and traditional information to promote responsible use of herbal medicine.RFA is proud to be a long-standing Corporate Member of the ABC.

 

ACCC fines Coles for misrepresenting fruit & vegetable origins   2nd July, 2013

Coles misled its customers into thinking certain fruits and vegetables were produced on Australian farms, when they were in fact from overseas, the ACCC has found.The supermarket chain has paid six fines to the tune of $61,000 after the Australian Competition and Consumer Commission investigators found imported fruits, asparagus and almonds were displayed under price boards declaring 'Helping Australia Grow', which also included the triangular Australian Grown symbol, between March and May this year.The fruits were in fact from the United States and France.

The ACCC conceded Coles had correctly identified countries of origin on stickers on the product, packaging or under the display bin. But it decided the small size of the stickers compared to the signage meant consumers could still be misled.

The investigation was triggered by a customer complaint about the prominent signage hovering above imported navel oranges and kiwi fruit. “This is a lesson to all retailers that they need to take care when undertaking significant advertising campaigns to ensure consumers are not misled by those campaigns.”

Read more: http://www.smh.com.au/business/coles-fined-for-helping-australia-grow-with-fruit-from-the-us-and-france-20130701-2p6my.html#ixzz2Xql6rbOf

 

Recalls by TGA - Safety advisory.

20th June, 2013 - GNY Slimming Pills - labelled as MSV (Strong Version), ESV (Extra Strong Version) and GRL (Rapid Loss Soft Gel Capsules) - as they pose a serious health risk.Testing by the TGA has found that these products contain sibutramine, a prescription-only ingredient that has not been declared on the product labels.Sibutramine was the active ingredient in Reductil, which was withdrawn from the Australian market in October 2010 because a major study revealed that it caused an increased risk of cardiovascular events.

GNY Slimming Pills should not be taken as they may be harmful and can cause symptoms including headaches, dizziness and dry mouth.

5th June, 2013 - Yong Gang tablets. Yong Gang tablets pose a serious risk to your health and should not be taken.The Therapeutic Goods Administration (TGA) has tested Yong Gang tablets and found that they contain the undeclared prescription substance tadalafil. Consumers are advised that tadalafil is a prescription-only substance (which is the active ingredient in the medicine Cialis). They also contain the undeclared prescription substance sildenafil. Consumers are advised that sildenafil is a prescription-only substance (which is the active ingredient in the medicine Viagra).The supply of Yong Gang tablets is illegal.

5th June, 2013 - Black Ant King tablets. Black Ant King tablets pose a serious risk to your health and should not be taken.The Therapeutic Goods Administration (TGA) has tested Black Ant King tablets and found that they contain the undeclared prescription substance sildenafil. Consumers are advised that sildenafil is a prescription-only substance (which is the active ingredient in the medicine Viagra).The supply of Black Ant King tablets is illegal.

2nd July, 2013 - Maxman IX Capsules (green in colour) and Maxman XI Capsules

Maxman IX and Maxman XI Capsules pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested Maxman IX (& XI) Capsules and found that they both contain the undeclared prescription substance sildenafil - despite the product label claims that it is 100% Natural and contains no medicines.

 

Database of Adverse Event Notifications (DAEN) 19th June 2013

The Therapeutic Goods Administration (TGA) receives adverse event reports associated with medicines and medical devices. These reports come from a wide range of sources, including members of the public, general practitioners, nurses, other health professionals and the therapeutic goods industry.

There are two search facilities: DAEN - medicines(provides information about adverse events related to medicines and vaccines used in Australia), and DAEN - medical devices(provides information about adverse events related to medical devices used in Australia).

Further information can be read at http://www.tga.gov.au/safety/daen.htm

 

TGA Consultations:
  • International harmonisation of ingredient names. This consultation closes on 10 July 2013.

As reported in our June 2013 RFA Newsletter, the TGA is seeking comments from interested parties on proposed changes to approximately 472 ingredient names, and an update to the guidance document TGA Approved terminology for medicines as part of the International Harmonisation of Ingredient Names project. Read more at http://www.tga.gov.au/newsroom/consult-ihin-130515.htm

 

  • Regulating the advertising of therapeutic goods to the general public. This consultation closes 12 July 2013.

The purpose of this Consultation RIS is to seek public comment to help inform the Australian Government in decision making on proposed regulatory reforms to improve the management of public health risks in relation to the advertising of therapeutic goods to the general public.

Read all the details at http://www.tga.gov.au/newsroom/consult-advertising-ris-130531.htm

 

  • Australian regulatory guidelines for complementary medicines (ARGCM) Part D: Registered complementary medicines. This consultation closes on 22 July 2013.

The TGA is seeking comments from interested parties on the draft document Australian regulatory guidelines for complementary medicines (ARGCM) Part D: Registered complementary medicines.

The ARGCM Part D represents a revision and restructure of the current document 'ARGCM Part I: Registration of complementary medicines'. Changes to the original document include formatting, corrections and clarification of information. While the revised document does not introduce any new procedures or procedural changes, the existing ARGCM Part I contained outdated information which has been amended to reflect current regulatory practice.

Contribute or read at http://www.tga.gov.au/newsroom/consult-cm-argcm-partd-130624.htm

 

  • Proposal for automatic adoption of new versions of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products. This consultation closes on 12 August 2013.

The TGA is seeking comments from interested parties on the proposed automatic adoption of new versions of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S GMP), with a transition period of 6 months from the date of publication by PIC/S, in combination with an improved industry consultation process on future revisions.

Check out http://www.tga.gov.au/newsroom/consult-manuf-automatic-adoption-pics-130529.htm

 

Natural Products Association (NPA) presents Webinar Wednesday, July 10 (1-3pm US EST)

This should be of direct interest to our many clients working in the USA market but still present interesting comparisons for clients in many jurisdictions.With more than 300 inspections conducted in 2012, FDA has proved that it is committed to inspectingdietary supplement manufacturers and will continue to enforce compliance to the Good Manufacturing Practices (GMP). This new webinar will help prepare you for the inevitable inspection and answer all the questions you didn’t know you had.

Download the registration form here: http://www.npainfo.org/App_Themes/NPA/docs/education/Nuts%20%20Bolts%20of%20FDA%20GMP%20Inspection%20Webinar%20Flyer%207-10-2013.pdf

 

5th Global Summit on Medicinal and Aromatic Plants. Dec. 8-12, 2013. Miri, Sarawak, Malaysia.

This summit will provide a forum for research scientists, healthcare practitioners, academics, medical and pharmaceutical representatives, conservation biologists, and more to discuss and share information and experiences related to medicinal and aromatic plants.Early registration ends Aug. 30, 2013.

Read about this exciting regional conference at http://www.gosmap2013.com/

 

Search for herbal cure for viral fevers(Source: The Hindu 14/06/2013)

The project, cleared by the research committee of JNTBGRI on Thursday, seeks to develop scientifically validated herbal drugs capable of accelerating the platelet count in victims of viral diseases and even cancer. In the first phase, it is proposed to conduct pre-clinical studies of three plant species. The second phase will focus on inter-institutional collaboration to apply system biology at different levels, namely cell, tissue, organ, organism and system.

Read The Hindu at http://www.thehindu.com/news/national/kerala/search-for-herbal-cure-for-viral-fevers/article4811761.ece

 

Dietary Nicotine from Solanaceae Plants May Reduce Risk of Developing Parkinson's Disease(Source: American Botanical Council)

Using data from a population-based study, researchers from the University of Washington recently found that ingestion of dietary sources of nicotine — as found in various plants in the Solanaceae family, such as tomatoes (Solanum lycopersicum), potatoes (S. tuberosum), and peppers (Capsicum spp.) — may reduce one’s risk of developing Parkinson’s disease. The findings were published online in May 2013 in the scientific journal Annals of Neurology.

Full details at http://cms.herbalgram.org/heg/volume10/06June/SolanaceaePD2.html?t=1370013499

 

Keeping food safe – safely(25 June 2013)

NSW Food Authority CEO Polly Bennett has welcomed a court decision to impose a fine upon a man who threatened a NSW Food Authority officer in the course of his duty.An authorised officer of the NSW Food Authority was investigating the operation of a food business selling seafood from a fishing vessel in Ulladulla Harbour on the state’s South Coast, when he was threatened by the owner during the course of his inspection.The offender pleaded guilty to a charge of Threaten Officer in the exercise of the officer’s functions under the Act under section 43(3) of the Food Act 2003. The Court convicted the offender and imposed a fine of $1,800 and ordered the offender to pay $3,000 professional costs to the Authority.

In handing down the decision the Magistrate noted that deterrence was very important in these matters and stated that the purpose of the legislation was about food safety and for the benefit of the community.

 

NSW Food Authority Scores on Doors Working Group formed (14 June 2013)

The NSW Food Authority is looking at ways to improve and extend participation in its voluntary ‘Scores on Doors’ food business hygiene rating program. A Working Group made up of key participants and stakeholders has been formed to consider the future development of the program.Scores on Doors was introduced as part of the NSW Food Authority’s work to reduce foodborne illness in NSW. Better compliance with food hygiene helps reduce foodborne illness.The program is one of a suite of initiatives in place to help improve the safety of food sold in NSW and allow consumers to make informed choices about the food they eat.It is designed to recognise good performance and provide the opportunity for businesses to present the rating to their consumers.The initiative also provides an opportunity to establish a standardised inspection checklist to get a more consistent inspection program across NSW.The rating system is based on the outcome of the routine unannounced inspection of a food business, undertaken by Councils using a standardised checklist. The result is then displayed prominently in that business, usually on the front door or window.

 

The original Vitamin Converter, created by RFA, has now received nearly a quarter of a million hits. You are welcome to use this useful tool.

 
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