Makers of Nurofen Ran 'Misleading and Deceptive' Campaign Against Panadol

"Nurofen is better than paracetamol for common headaches," declared the advertisements in women's lifestyle magazines. The Federal Court has found that claim to be misleading and deceptive, after two pharmaceutical giants went head-to-head in a two-year legal battle. GlaxoSmithKline, the makers of Panadol​, alleged Nurofen's manufacturer, Reckitt Benckiser​, ran an advertising campaign saying Nurofen was faster and more effective than Panadol, or paracetamol, despite there being no scientific evidence to support it. The judge granted a permanent injunction, barring Reckitt Benckiser from making those or similar claims, and for the company to pay GlaxoSmithKline's legal costs.    Source: Pain for Nurofen

Editor’s note: Regular readers of our newsletter will remember that we reported in April 2017 that the makers of Nurofen, Reckitt Benckiser, were ordered to pay $6 million penalty for false and deceptive advertising   Nurofen penalty

ABC-AHP-NCNPR Announces Botanical Adulterants Program Name Change

The American Botanical Council (ABC) announces a change in the name of the Botanical Adulterants Program, updated to the Botanical Adulterants Prevention Program. ABC and its partners at the American Herbal Pharmacopoeia (AHP) and the National Center for Natural Products Research (NCNPR) at the University of Mississippi decided to add “Prevention” to the name in order to emphasize the purpose and intent of the program. “The program’s goal has always focused on prevention,” said Mark Blumenthal, founder and executive director of ABC and founder and director of BAPP. “What we’ve been trying to do is alert industry members about specific botanical materials that we have confirmed as being adulterated, and counsel industry on the optimum laboratory analytical methods to help determine authenticity of botanical ingredients. By adding the word ‘Prevention’ to the name, we are making our intention clearer to all stakeholders.”    Source: ABC prevention

ABC-AHP-NCNPR Botanical Adulterants Prevention Program Publishes Ginkgo Leaf Extract Adulteration Bulletin

The ABC-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Prevention Program is an international consortium of non-profit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. Ginkgo is one of the most important medicinal plants worldwide. Ginkgo leaf extract dietary supplements have been consistently among the 25 top-selling herbal supplements in the United States for more than a decade. Reports on ginkgo extract adulteration date back to 2003, when researchers observed uncharacteristically high amounts of the flavonoid rutin in a sample of bulk material. The addition of flavonoids from extraneous sources, which attempts to bring these “ginkgo” extracts in compliance with the 24% flavonol glycoside content standardization required by various pharmacopeial standards, has been confirmed in numerous subsequent papers.    Source: Adulterated ginkgo

TGA Announces Implementation of the NEW Uniform Recall Procedure for Therapeutic Goods (URPTG)

Sponsors of therapeutic goods needing to initiate a product recall are reminded that the new URPTG takes effect on Monday, 15 January 2018. From this date, sponsors must follow the provisions of the new URPTG and the former (2004) version will be archived.    Source: Recall protocol

TGA 2017 List of Complementary Medicines Cancelled from the ARTG

Following a review by the Therapeutic Goods Administration, complementary medicines can be cancelled from the Australian Register of Therapeutic Goods. There were 10 cancellations of complementary medicines in 2017. They are listed here along with the reason for cancellation: CM cancellations

TGA Warns Against Human Placenta Ingestion

The TGA is aware of several websites offering expectant mothers services for the preparation of the placenta for consumption; a practice known as placentophagy. They are advising expectant mothers to be aware of the potential risks associated with placenta consumption. Human placenta is a biological material and is capable of containing and transmitting infectious agents, including bacteria and viruses. In addition, preparation may inadvertently introduce infectious agents. The risk of transmission may be even greater if the placenta is ingested by another person or you ingest another person's placenta. Prepared placenta products, including in capsule or tablet form, are often associated with claims that consumption will have some therapeutic benefit for mothers and/or children, for example, improving mood, energy levels and milk production. Under the Therapeutic Goods Act 1989, it is an offence to make therapeutic biological products without holding the appropriate licence. Depending on the circumstances and the claims made in relation to the product, these laws could also apply to the midwife, doula or even the mother involved.    Source: Placenta ingestion

Business Process Improvements Supporting Complementary Medicines Assessment Pathways for TGA

The TGA acknowledged all respondents who provided submissions in response to the September 2017 public consultation paper Consultation: Business process improvements supporting complementary medicines assessment pathways. A total of 14 submissions were received. All submissions that gave permission are published here: Submissions & feedback

TGA Safety Advisories –    Source: 2018 alerts

Yunnan Feng Shi Ling capsules: the capsules contain the undeclared substance paracetamol (also known as acetaminophen).

RFA Breaking News

Complementary Medicines (“Dietary supplements”):

  TGA Assessed Listed Medicines Evidence Guidelines The assessed listed medicines pathway provides sponsors with a new method of listing a product in the Australian Register of Therapeutic Goods (ARTG).…

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Foods:

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Cosmetics (& Household cleaning products):

  To Be or Not To Be—‘Natural’. What’s in a Name? A naturally-occurring chemical is one of the following: Either, an unprocessed chemical occurring in a natural environment — chemicals…

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Marketing News:

  Chinese Millenials Key Demographic for Aussie Supplements Australian supplement firms should target Chinese millennials if they want to maximise their growth opportunities in the country, the founder and president…

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New Service From RFA Regulatory Affairs - New Product Development

Details at the bottom of this newsletter.

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Complementary Medicines (“Dietary supplements”):

  TGA Launches New Advertising Hub and Online Complaints Form Consumers can now report dodgy ads for medicines and medical devices through a single online form … anonymously! On 1…

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