TGA Revamps Complaints Handling for the Advertising of Therapeutic Goods

The Therapeutic Goods Administration (TGA) is responsible for ensuring that therapeutic goods available for supply and use in Australia are safe and fit for their intended purpose. This includes complementary medicines such as vitamins, herbal and traditional medicines. Advertisers of therapeutic goods should note that the current 2015 Therapeutic Goods Advertising Code expires at the end of this year and that the new 2018 Code will commence on 1 January 2019. Complaints received by the TGA will get classified as low, medium, high or critical, with corresponding actions taken by the TGA depending on the classification.   Source: Advertising complaints 2018 code

TGA Changes Advertising Code 2018 Following Public Consultation During April 2018

Advertising to the public for therapeutic goods must comply with the Therapeutic Goods Advertising Code (the Code). The Code ensures that the marketing and advertising of therapeutic goods is conducted in a manner that promotes the quality use of the product, is ethical and does not mislead or deceive the consumer. A draft version of changes to the Code was sent for public consultation in April 2018, with the updated version taking effect from 1 January 2019. The definitional references to 'complementary medicine' and 'listed' have been deleted and a number of new definitions have been included or amended, among several other changes.   Source: Advertisng code changes

Negative Advertising Outcome for Gumby Gumby Capsules

Suppliers of Gumby Gumby capsules have been found guilty of illegally promoting their product as a cure for cancer. They promoted their product by way of testimonials claiming not only benefit to cancer sufferers but also to people with arthritis, chronic fatigue syndrome, or skin diseases. Gumby Gumby capsules have never been registered on the Australian Register of Thereapeutic Goods (ARTG), which is a mandatory requirement for all medicines supplied in Australia. Note that ‘advertising’ refers not only to print media but also to all e-media including websites and social media of all sorts.   Source:  Gumby gumby fail

Pre-Market Evaluation of Herbal Component Names Discontinued

Where a herbal ingredient comprises of chemical constituents, these chemical constituents are referred to as "herbal components". A Herbal Component Name (HCN) for use in listed medicines is a name for a herbal component of its parent herbal ingredient. HCNs are not standalone active ingredients for use in listed medicines. Certain herbal components are mandatory to declare in listed medicine applications. These mandatory herbal components are identified in the Therapeutic Goods (Permissible Ingredients) Determination, and are mandated by the Poisons Standard or for safety reasons. Sponsors will no longer be able to submit new HCN applications for pre-market evaluation effective immediately. After 1 October 2018, sponsors will not be able to select HCNs from the TGA list of approved HCNs for use in new listings. The TGA will continue to work with industry to discontinue pre-market evaluation of HCNs.   Source: HCN FAQs

TGA Details Education Priorities for 2018-19

The Therapeutic Goods Administration is committed to delivering a range of educational materials for sponsors, health professionals and consumers in 2018-19. Many of the priority areas for education relate to reforms implemented following the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR). Information is now available detailing the high priority education programs for 2018-19.  Source: Education 2018-19

TGA Safety Advisories—   Source: https://www.tga.gov.au/current-year-alerts

Mutant YK-11 Capsules: The capsules contain the undeclared substance tadalafil.

Big Penis U.S.A Tablets: The tablets contain the undeclared substances sildenafil & chloramphenicol.

BFB Be Fast Block Capsules: The capsules contain the undeclared substance clenbuterol.

Lanky Genuine Capsules: The capsules contain the undeclared substances sibutramine & phenolphthalein.

Sherb Detox Capsules: The capsules contain the undeclared substance bisacodyl.

You Slim'xs Capsules: The capsules contain the undeclared substance sibutramine.

 

Sydney Pharmacist Charged Over Illegal Supply of Cancer Drug

A pharmacist on Sydney's lower north shore, and her alleged accomplice, have been charged over allegations that she supplied $500,000 worth of a cervical cancer vaccine to the man, before it was illegally exported for resale in Hong Kong. The Gardasil 9 Human Papillomavirus 9-valent vaccine is used for the prevention of cancers in men and women, including cervical and anal cancers, as well as other diseases caused by human papillomavirus. Gardasil is administered by a course of three injections over six months. Administration of the drug in Australia has been funded through the National Immunisation Program since 2007, which has seen it supplied to girls aged 12-13 years at school.   Source: Lucy Cormack, SMH Cancer vaccine

Botanical Adulterant Program Expands

The American Botanical Council (ABC)-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Prevention Program is an international consortium of nonprofit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. The program advises industry, researchers, health professionals, government agencies, the media, and the public about the various challenges related to adulterated botanical ingredients sold in commerce. In its most recent expansion of activities, this consortium’s latest proposal wishes to set up a new program: “Best Practices SOP for the Disposal/Destruction of Irreparably Defective Articles.” If you would like to review and comment on the proposal, please go to http://abc.herbalgram.org/site/MessageViewer?em_id=41987.0&dlv_id=96250 ; Related conference (Germany): Adulteration and Fraud of Botanical and Natural Health Ingredients: Issues, Challenges and Prevention Tools for the Industry

Botanical Adulterants Prevention Program Publishes Guidance for Tea Tree Oil

As the previous story explains, the ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) actively works to minimise adulteration of botanical ingredients in the global marketplace. As part of its most recent efforts, the program has released a Laboratory Guidance Document (LGD) on tea tree oil, the essential oil obtained from tea tree (Melaleuca alternifolia and M. linariifolia) leaves. Australia is the major producer of tea tree oil, providing an estimated 80% of the global supply. In 2018, Australian tea tree oil exports reached a market value of AU$35 million (roughly US$21 million). “In the past three decades, tea tree oil has become a significant ingredient in many consumer health products, particularly topical products used for their antibacterial, antifungal, and other beneficial health effects,” said Mark Blumenthal, founder and executive director of ABC and founder and director of BAPP. “The rise in tea tree’s popularity has motivated unscrupulous suppliers to add cheap, sometimes synthetic chemicals to materials that are fraudulently being marketed as ‘tea tree oil’ in international commerce. The Tea Tree Oil Laboratory Guidance Document, when utilized by reputable company laboratories, will enhance the quality control process and help protect responsible companies from being victimized by sellers of fraudulent material.”   Source: Tea tree oil adulteration

FDA Warns of Fraudulent Dietary Supplements

USA Federal regulators continue to warn consumers about tainted, dangerous products that are marketed as dietary supplements. These fraudulent products can cause serious injury or even death. The Food and Drug Administration (FDA) has found nearly 300 fraudulent products—promoted mainly for weight loss, sexual enhancement, and bodybuilding—that contain hidden or deceptively labelled ingredients. Unlike Australia’s TGA (which categorises these products as ‘complementary medicines’), dietary supplements, in general, are not FDA-approved. Under USA law (Dietary Supplement Health and Education Act of 1994), dietary supplement firms do not need FDA approval prior to marketing their products. It is the company’s responsibility to make sure its products are safe and that any claims are true. Just because consumers see a supplement product on a store shelf does NOT mean it is safe or effective. When safety issues are suspected, FDA must investigate and, when warranted, take steps to have the product removed from the market. However, it is much easier for a firm to get a product on the market than it is for FDA to take a product off the market.   Sources: Fake supplements ; Keep supplements clean

USA: Psychedelic Mushrooms are Closer to Medicinal Use (It’s Not Just Your Imagination)

Researchers from Johns Hopkins University have recommended that psilocybin, the active compound in hallucinogenic mushrooms, be reclassified for medical use, potentially paving the way for the psychedelic drug to one day treat depression and anxiety and help people stop smoking. The study comes as many Americans shift their attitudes toward the use of some illegal drugs. The widespread legalization of marijuana (in USA) has helped demystify drug use, with many people now recognizing the medicinal benefits for those with anxiety, arthritis and other physical ailments. Psychedelics, like LSD and psilocybin, are illegal and not approved for medical or recreational use. But in recent years scientists and consumers have begun rethinking their use to combat depression and anxiety.   Source: Laura Holson, NYT Magic mushrooms

Reminder: Changes to Complementary Medicine Claims – TGA Fee Free Period Available

Do you have complementary medicines listed with the TGA? We remind you that you must revise the indications for use (“claims”) to only include those on the permitted indications list by 6 March 2021 or products will be cancelled. Currently  the TGA has a fee free period. Click here for our website and contact details.

 

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