Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.


TGA Provides Guidance for Manufacture of Medicinal Cannabis

This guidance is for sponsors and manufacturers considering manufacturing non-sterile medicinal cannabis products for supply under provisions of access to medicines that have not been approved for general use, including medicinal cannabis for clinical trials. This guidance does not apply to medicinal cannabis products that are listed or registered on the ARTG (Australian Register of Therapeutic Goods). This guidance is essentially related to GMP.   Source: CBD GMP


Will Hemp CBD’s Regulatory Controversy Help or Hurt Its Future as a Supplement Ingredient in USA?

The USA Federal Drug Administration may not recognize hemp cannabidiol (CBD) as a dietary supplement ingredient, but that hasn’t stopped the ingredient from shooting up the supplement sales charts in recent years. In fact, the many headlines on CBD’s shaky legal status on the supplements market may actually be helping sales. The question, though, is how much that growth can continue if the ingredient’s regulatory baggage continues to follow it.   Source: Michael Crane, Nutritional Outlook FDA CBD


High on the horizon: A Glimpse Into Israel’s Budding Medical Cannabis Industry

Still controversial in the US, Israel is leading the way to develop the next generation of Medical Cannabis. Medical Cannabis (MC) is fast moving from the underground of niche research to a vibrant sector that is attracting significant attention across the globe. Interestingly, Israel has become recognised internationally as a leader in the MC field, taking charge of much of the research that is laying the ground for the next generation of development.   Source: Mia R-Campbell, Geektime Israel MC


Medlab Announces First Australian Cannabis Trial for Cancer Pain as Nutraceutical Sales Soar

Australian company, Medlab Clinical Limited, is preparing to start Australia’s first clinical trial using cannabis for oncology patients suffering intractable pain.   Source: Gary Scattergood, NutraIngredients Cannabis trial


Nutrition Professionals are ‘Allowing’ Industry to Dominate Policy-Making in Australia

Nutrition professionals, scientists and other public interest bodies are staying on the sidelines and allowing the food industry to dominate Australia’s nutrition policy-making, according to research analysis.   Source: Gary Scattergood, Food Navigator-Asia Food industry influence


What Legalized Recreational Marijuana Can Mean for Food and Beverage

Voters in California, Massachusetts, and Nevada passed legislation to legalize recreational marijuana, while in Maine it’s still too close to call.   Source: Adi Menayang, Food-Navigator-USA Cannabis vote


FTC V Herbalife Settlement – The Take Home Message

Federal Trade Commission’s Chairwoman, Edith Ramirez, recently dedicated a speech to the FTC vs Herbalife Settlement and more importantly, how the Commission would take it from there. The direct selling community often complains about the negative public perception about how the industry operates. However, the industry has a huge opportunity to address concerns by “enhancing transparency and fostering credibility”. There are two areas where the industry need to take effective actions to stop the practices that damage the credibility of the whole industry: Misleading income representations, and unfair or deceptive business structures that are not focused on real sales to real customers.   Source: Hakki Ozmorali, World of Direct Selling Direct selling


Australia’s Naturally Good Expo 2017 Introduces Complementary Medicines Pavilion 

The Complementary Medicines Pavilion is a dedicated exhibition area within Naturally Good Expo, the Southern Hemisphere’s largest and fastest growing tradeshow for natural and healthy products. The Complementary Medicines Pavilion has been introduced due to increasing demand for natural products like vitamin, mineral, herbal and nutritional supplements, which are retailed and prescribed by industry only attendees on a daily basis. With industry revenues expected to grow at $4.6 billion in 2017-18 in this category alone, the synergy and fit is a logical expansion of the event.   Source:  CMA pavilion 


Tips to Get Local Media Coverage

You’ve just hired a public relations person to develop future PR efforts to promote your company and products. Do you know their short and longer term strategy to generate media coverage right out of the starting gate? Here are 5 effective ways to maximize your company’s efforts when pitching to local media.   Source: Sheldon Baker, The Garner Group Local media


Quote of the Month:

“If you focus on change you will never get results. If you focus on results, you will always get change!”    Jack Dixon



Half of the 2015 Nobel Prize in Physiology or Medicine went to a researcher who spent her entire career researching traditional Chinese medicine. Scientist Youyou Tu, is based at the Chinese Academy of Traditional Chinese Medicine in Beijing (now the China Academy of Chinese Medical Sciences) since 1965. Traditional medical knowledge anywhere in the world has not even been on the radar for Nobel Prize prospects. Until 2015, that is. So how should we interpret this arguably seismic shift in international attention on traditional Chinese medicine?   Source: The Conversation Nobel Laureate, Youyou Tu 

Australia's beleaguered farmers are poised to unlock vast new export markets as producers, peak bodies and both sides of politics prepare to bury their differences to sell products into China under a "one brand, one logo" approach for the first time. The new strategy – under wording and a trade symbol designed for maximum Chinese impact – would pitch Australia in a head-to-head race against the gold-standard in export marketing, "100% Pure New Zealand".   Source: Mark Kenny, SMH Brand Australia

A Victorian beekeeper who accused a leading Queensland honey manufacturer of selling “toxic” foreign products has been gagged by the courts ahead of legal action. (Capilano defends product safety but is slow to respond to misleading country of origin labelling after accusations of using imported Chinese honey with the local product).   Source: RJ Whitehead, Food Navigator-Asia 'Toxic' honey


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