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    Health E-Insights

    Training to Manage Divergent International Regulations

    Understanding differences in labeling, quality testing, manufacturing, and claims for regional markets presents a learning curve for global brands.

    Training to Manage Divergent International Regulations
    By Sheldon Baker04.06.23
    Abbie Harris is a director with Regulatory Training Pty Ltd. based in Sydney, Australia. She has expertise in product development and project management and has worked with brands in various channels and markets. Harris has led product development and cross-functional teams in the successful development and commercialization of natural healthcare products, as well as improvement to internal processes and business reporting.

    Her experience is supported by a passion and drive for the wellness industry, academic qualifications as an Australian-trained Naturopath and Bachelor of Health Sciences, and dedication to company projects. She collaborates with commercial, technical, procurement, regulatory, and quality teams, as well as third-party providers for complementary medicines, dietary supplements, food products, and cosmetics. Harris has a unique capability for understanding and finding viable solutions for competing stakeholder demands while ensuring products remain connected to consumer needs and up-to-date with industry advances and trends.



    Health E-Insights (HEI): What (and who) is Regulatory Training Direct?

    Harris: Regulatory Training Direct (RTD) is a dedicated online training company for the health products industry. The company was founded in 2022 by both me and Robert Forbes (formerly of Robert Forbes & Associates), shortly after the sale of that business to DTS Consulting. We each have decades of experience in the industry, running successful regulatory and product development consulting firms. RTD is a natural progression of our consulting work.

    In RTD, we have a carefully curated team of expert trainers that are the very best in their respective fields. Our team has hundreds of years of combined experience in various aspects of regulatory affairs, legal, product development and strategy.   

    Our training courses have been developed to provide up-to-date and easy to understand information on the regulatory requirements for complementary medicines, dietary supplements, food products, and cosmetics. Regulations for health products can be extremely difficult to navigate. The RTD team has deep knowledge and experience in the industry, and we understand the complexities and major pitfalls that companies face. We teach both new and established businesses how to navigate the regulatory framework and implement procedures to develop and maintain compliant products in the market.

    HEI: Do you focus primarily on the Australian Complementary Medicine market?

    Harris: Currently our courses focus on both the Australian and New Zealand markets. We have 18 courses available that cover complementary medicines, dietary supplements, foods, cosmetics, sunscreens, sports supplements, as well as social media and advertising across all product categories.

    However, this is only the beginning. We have exciting growth plans to launch courses covering other markets, including the U.S. Through our decades of experience and industry connections, we have inducted first-rate compliance experts in other markets and have a training team in place already in the U.S. Watch this space.

    HEI: How much of your business is global?

    Harris: We have had phenomenal support from global and overseas businesses. To date, most of our bookings have been from Australian and New Zealand participants, but we’ve had a lot of interest from U.S. companies and attendees from overseas, including a few from the UK and Continental Europe. The nutraceuticals industry is vibrant and established; today many brands are global and distributed into several markets. Our customers have a presence across most global markets. 

    HEI: Please discuss the global training courses you will be offering.

    Harris: We will be offering courses in U.S. FDA and FTC compliance for dietary supplements, cosmetics, foods, pet foods, trademarks, Proposition 65, as well as marketing and branding of both finished products and ingredients. We are also developing innovation and NPD courses that will be relevant to all global markets and product categories.

    HEI: What is the biggest challenge facing corporate leaders? How can RTD help?

    Harris: Divergent international regulations are a huge challenge for global brands. There are significant differences in requirements for labeling, quality testing, manufacturing, and permitted claims. It can be daunting for leaders to navigate these differences. It demands an immense number of resources to properly understand and comply with so many different regulations.

    Differences in permitted claims is especially challenging. Australian suppliers of complementary medicines must understand the limited scope of claims permitted in the U.S. for dietary supplements, compared to the list of approximately 1,000 permitted therapeutic claims for complementary medicines in Australia.

    For leaders wanting to expand into new markets, RTD can teach their teams local regulatory requirements. Our courses include resources, links, and procedures that can be implemented into their business to enhance compliance.

    HEI: In what direction do you see the supplement industry moving? Any potential pitfalls in the AU market?

    Harris: We are seeing unprecedented fast-paced regulatory changes and new enforcement approaches by regulators. It can be difficult for companies and their staff to keep up-to-date and comply. RTD is dedicated to staying abreast of these changes and developing courses that simmer down complex information into a thorough yet succinct form that our customers can easily digest and incorporate into their business.

    HEI: Are you still involved with the Natural Product Centre you founded a few years ago?

    Harris: Yes, I am the principal consultant at NPC and continue to lead the business. We support companies across all aspects of product development, formulation advice, technical writing, and regulatory affairs. NPC has global customers and we’ve recently added new consultants to the team to help support the growing demand for our consultancy services.

    HEI: What significant industry trends are you seeing in Australia and the U.S.?

    Harris: In the U.S. and Australia strong growth across the industry has resulted in a highly competitive landscape with new brands rapidly emerging. To better stand out in the crowd, we are seeing brands take a more creative approach to formulations and marketing and give more focus to their brand personality.

    Globally, we have seen strong interest in formulating products designed for cognition, relaxation, and beauty. This reflects recent Euromonitor insights on trending categories. In Australia, we are seeing greater regulatory enforcement. The Therapeutic Goods Administration (TGA) has ramped up compliance monitoring and has issued several infringement notices; while the Australian consumer watchdog (ACCC) is targeting misleading testimonials and endorsements by social media influencers (in response to tip-offs from consumers).

    This changing regulatory environment will inevitably change the way brands promote their products. In response to the current climate, we have just launched a course on advertising and social media compliance. It’s been our most popular course yet.

    HEI: Who are Regulatory Training Direct’s customers?

    Harris: We have delivered training courses to brand marketers, raw material suppliers, manufacturers, distributors, universities, laboratories, and newcomers who want to become involved in the industry. We have courses tailored for various departments, including regulatory teams, quality teams, product developers, marketers, digital teams, and sales staff. We’ve also had interest from managers and executives who want a better understanding of the work their team undertakes. 

    HEI: How are RTD training courses delivered?

    Harris: We have two delivery options. Live training sessions are run by appointment via Zoom. This option allows for Q&A and customized content based on level of experience and areas of interest. We’ve had fantastic feedback on the anecdotes provided and personalized experiences of our live training sessions. E-learning training sessions are recorded modules available 24/7 on-demand through our secure online portal. They can be completed at your own pace. There is a quiz at the end of each module to test the new skills you’ve learned.



    About the Author: Sheldon Baker is CEO of Baker Dillon Group LLC and has created numerous nutraceutical brand marketing communications and public relations campaigns for well-known supplement and food industry companies. For Health E-Insights interview consideration or brand marketing consulting, contact him at SBaker@BakerDillon.com.
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