TGA Presentation Given at ASMI Workshop on “Evidence Guidelines & Checklists”
This presentation provided an overview on evidence guidelines & checklists. It was presented by Kaylene Raynes, Office of Complementary Medicines, at Australian Self-Medication Industry (ASMI) workshop 29 April 2014
Read the whole presentation here: http://tinyurl.com/pxpaf7w
29 April 2014
The Australian Competition and Consumer Commission has accepted a court enforceable undertaking from Carlton & United Breweries (CUB) in relation to ACCC concerns that it represented that Byron Bay Pale Lager was brewed by a small brewer in Byron Bay when this was not the case.
CUB has also paid two Infringement Notices to the value of $20,400 in relation to this conduct.
In providing the enforceable undertaking, CUB acknowledged that the labelling may have misled consumers. CUB has agreed to cease distribution of product with the misleading labelling. More generally, CUB has undertaken that it will not make false or misleading representations concerning the scale of the brewery in which its products are brewed or the place of origin of its products.
CUB will place corrective notices on its website and in trade publications, and it will also provide a corrective notice for retailers to display at point-of-sale.
Food Standards Australia New Zealand (FSANZ) today released the first phase of the 24th Australian Total Diet Study (ATDS) which looked at Australian consumers’ dietary exposure to acrylamide and aluminium.
FSANZ Chief Executive Officer, Steve McCutcheon, said levels of acrylamide in Australian foods and beverages were generally comparable, or lower than those observed internationally.
Acrylamide forms naturally in carbohydrate-rich foods during high temperature cooking, such as baking, frying and grilling. It can also occur through food processing methods used to enhance flavour and colour in snack foods such as potato crisps.
The Department of Agriculture monitors imported food at the border for compliance with Australia's standards. If you import food, you are legally responsible under the Imported Food Control Act 1992 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.
For a full list of tests in tabular form: http://tinyurl.com/m963t9k
For specific tests applied to “risk foods”: http://tinyurl.com/kmpwbs8
King Sports Industries Pty Ltd has recalled Dexaprine XR Green Apple due to the presence of prescription only medications, including oxedrine and high levels of caffeine. Prescription only medications may pose health risks which may be seriously increased if taken with interacting drugs (including caffeine) by people consuming this product. Consumers should not use this product and should return the products to the place of purchase for a full refund.
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.
Read six different checklists here: http://tinyurl.com/lh4ajml
The Western Australian Supreme Court recently decided that the ban on the sale of products that are designed to resemble a tobacco product in the Tobacco Products Control Act 2006 (WA) extends to electronic cigarettes (e-cigarettes). Some media reports about the decision have mentioned the importing of nicotine in personal amounts as being exempt from regulation, apparently in reference to the personal importation scheme for therapeutic goods under the Therapeutic Goods Act 1989.
In order to use this scheme, and so you don't inadvertently commit an offence, you need to be aware that to import nicotine for personal use, you must hold a prescription from a registered medical practitioner. You should also be aware that any legislation in your state or territory governing the sale and use of electronic cigarettes may apply irrespective of whether you are complying with the Therapeutic Goods Act.
TGA uses a combination of fees and charges to recover the costs of regulation of therapeutic goods. A fee is charged for a service, and a charge is a form of tax imposed, and is applied on an annual basis. Annual charges are applied to recover the cost of monitoring and compliance activities.
Annual charges apply to all product entries (except export only products) on the Register at any time during a financial year, regardless of whether the product is subsequently cancelled within the same financial year.
Sponsors who wish to cancel a product from the Register should submit their request no later than 31 May of the current year to avoid incurring annual charges for the new (subsequent) financial years. A product sponsor can seek an exemption from the annual charge if the therapeutic good qualifies for the low value turnover (LVT) exemption.
To view important annual charge and LVT deadlines: http://tinyurl.com/ksn78o4
The American Herbal Products Association (AHPA) has launched the AHPA Botanical Identity References Compendium as a resource for manufacturers and researchers to accurately identify botanical ingredients.
The AHPA Compendium is a cooperative and centralized source of information on physical characteristics and test methods that can be used by qualified and experienced analysts to determine the identity of plant species and articles of trade obtained from these plants. It currently provides such information for nearly 200 commonly used botanical species, and will continue to be expanded by AHPA staff and by participating contributors.
Unauthorised and potentially harmful medications continue to arrive on Australian shores to be intercepted by customs and quarantine officials.
The following products have been tested by the Therapeutic Goods Administration (TGA), and found to pose a serious risk to your health and should not be taken.
- Maxman II capsules. http://tinyurl.com/k3n82fb
- Ying Dao Di capsules. http://tinyurl.com/lfel9bn
- Zhansheng Weige Cahoyue Xilishi tablets. http://tinyurl.com/m5ku2zh
- Vigour 800 tablets. http://tinyurl.com/mcpkq9x
- Stree Overlord Strong tablets. http://tinyurl.com/k4qcsdb
- Black Ant Strong tablets. http://tinyurl.com/n6qvyed
- Germany Niubian tablets. http://tinyurl.com/myj6q35
- The Rock capsules. http://tinyurl.com/ljvt374
- Top Man 3 capsules. http://tinyurl.com/k49322a
- REDDES (or REDDIES) capsules. http://tinyurl.com/lejr5za
- My Man His Enhancer 12 Pack tablets. http://tinyurl.com/kkosl2v
- Play Hard for Men capsules. http://tinyurl.com/mehuo52
- Bull's Genital tablets. http://tinyurl.com/kjfsmax
- So Hard for Men tablets. http://tinyurl.com/n943xet
- Robust tablets. http://tinyurl.com/mhat5r4
All of the above products contain either of the undeclared prescription substances sildenafil, tadalafil, or analogues of these two ingredients, which are commonly found in either Viagra or Cialis medicines. The supply of these products is illegal. These products have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.
Testing by the TGA has detected the presence of Ethoxyquin in multiple Krill oil products sponsored by Nature’s Care. Ethoxyquin is not approved for use as an additive in foods in Australia and should not be present in these products. TGA testing has also found that the levels of Krill oil fatty acid esters are below the expected levels. Based on risk assessment reports that Nature’s Care has undertaken, it is Nature’s Care’s position that there are no immediate safety concerns with the majority of Nature’s Care Krill Oil products currently on the market. However, Nature’s Care has decided to recall the affected products containing Krill Oil at the retail level to prevent any further exposure of Ethoxyquin to consumers.
Source: http://tinyurl.com/k9bpadq(& search for “Krill Oil”)
Footnote: “Ethoxyquin is not permitted for use in Australian foods, nor is it approved for use within the European Union, however, it is an accepted additive in the U.S.A.
Even though it has been approved for use in foods and as a spray insecticide for fruits, ethoxyquin has not been thoroughly tested for its carcinogenic potential even though it has been suggested it is a possible carcinogen. Source: http://tinyurl.com/lrgu62c
Food Standards Australia New Zealand (FSANZ) today called for submissions on an application to permit a food additive (sodium hydrosulphite) used to change the colour of abalone.
“The applicant wants to use the additive to change the black colour of New Zealand abalone (paua) to a colour that’s more acceptable to consumers,” Mr McCutcheon said.
“The FSANZ safety assessment concluded that the food additive is technologically justified and the treated abalone is safe for human consumption. FSANZ welcomes comments from government agencies, public health professionals, industry and the community on this application.”
The closing date for submissions for this application is 27 June 2014.
Hundreds of tonnes of tiny plastic beads contained in cosmetic products are finding their way in to the fish we eat as people unwittingly wash them down the drain. The microbeads are used in cosmetic products like facial scrubs, toothpastes and shower gels, though most consumers have no idea they are there. The tiny beads are too small to be filtered by sewage treatment plants and, because of this, find their way into rivers, lakes and the open sea.The beads, which contain toxins, are eaten by marine life such as fish, mussels and crabs.Cosmetic firms began using the beads in their products in the late 90s. The scale of the problem is huge with one estimate showing up to 1,200 cubic metres of microplastic beads washed down drains annually in the US.The Independent reported that last week that New York State became the first place in the world to ban plastic micropellets in cosmetic products.
Source (The Independent): http://tinyurl.com/kktjlc9
Pyramid schemes are illegal schemes that promise big returns on your money. They rely on the recruitment of new members so the people at higher levels of the pyramid earn money. The problem is, there needs to be an endless supply of members for the scheme to keep operating.
There are different types of pyramid schemes, but they all have one thing in common. The main source of income is the recruitment of members, rather than the sale of products or services. Usually, new members will pay money to join and they receive payments depending on the number of members they recruit. Sometimes there are products or services that are sold as part of the scheme, but they tend to be worth very little or they are not related to the returns that are promised.
Read the whole of this article: http://tinyurl.com/jvnzsl6
PM KiddieCal (AUSTL 170915) by Pharmametics Products (Max Biocare Pty Ltd) has been cancelled as there was insufficient evidence to support the indications for the product, and the certification made by the applicant under s26A(2)(j) was incorrect.
For this year’s complete list of ARTG product cancellations: http://tinyurl.com/mtha7o5
Natural Standard was founded by healthcare providers and researchers to provide high-quality, evidence-based information about complementary and alternative medicine including dietary supplements and integrative therapies. Grades reflect the level of available scientific data, for or against the use of each therapy for a specific medical condition. The Natural Standard database has moved to a new server. https://naturalmedicines.therapeuticresearch.com/
This report by the TGA gives a general overview of TGA activities, describes what & how it regulates and discusses current trends and statistics regarding TGA activities for this period.
To read the full report: http://tinyurl.com/p8obj8j