• a&r News Digest October 2017

Regulatory news on botanicals and Novel Foods, SSW

a&r’s News Digest – We dedicate this month’s issue to regulatory news on botanicals and Novel Foods, a brief overview on SupplySide West and relevant information about clinical trial registration.

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Regulatory

Health claims for food supplements containing botanicals – Light at the end of the tunnel?

Under the Commission’s Regulatory Fitness and Performance (REFIT) programme, botanicals have been under “reflection” concerning the use of health claims to establish a community list of permitted general health claims for foods. The draft conclusions from a report by the European Commission on whether the health claims regulation 1924/2006 is “fit for purpose” with regard to botanicals will be presented to EU member states and stakeholders and discussed at workshops at the end of this month (in OTC bulletin – 20 October 2017).

a&r comment: It seems that very soon there will be a decision concerning health claims and botanicals. We look forward to receiving more detailed information on this matter!

Draft Union List for Novel Foods published

On 5th of October 2017, the European Commission published the draft implementing a decision establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 and a first draft for the actual Union list. The Union list contains specifications and conditions of use for foods and food ingredients that are authorized in the European Union.

The two documents will be open for comments until November 2, 2017. Please have a look at the list and provide your comments!

News

European Food Supplements Conference – 8-9 March 2018 in Berlin – Save the date

After 15 years of the Food Supplements Directive being in effect, we would like to raise awareness for the next European Food Supplements Conference that will happen in Berlin early next year. This event will be organized by the German Federation of Food Law and Food Science (BLL; www.bll.de) in co-operation with Food Supplements Europe, the association representing the sector at European level.

The aim of the event is to analyze current developments, to discuss future challenges, and to exchange ideas and solutions – to give fresh impetus to the discussion surrounding pending issues in the field of food supplements within Europe, and how to address them. It will focus on the most significant topics currently discussed across Europe such as botanicals in food supplements, harmonized maximum levels of vitamins and minerals, and the role of food supplements for health and wellbeing. For this discussion, key players from regulatory authorities, science, industry, and society will come together.

Registration for the event will open soon. Please feel free to email: berlin-conference@bll.de for more information.

Clinical News

Clinical trials registration

Clinical investigation of a product’s health benefits is based on careful design and accurate conduct of a human clinical trial. As encouraged by governments and scientific organizations, this should be complemented by the registration of a clinical trial within a publicly accessible platform. Registration, i.e. the publication of particular information on trial design, conduct, and administration in a registry, serves a number of purposes, which benefit both the public and the scientific community. Availability of information on planned or ongoing trials enables potential participants and referring physicians to decide upon enrollment. Among the ethical reasons for trial registration is the “return” to study participants in terms of available information on trial outcomes. Furthermore, by providing transparency, registries promote synergies for performing high quality and state-of-the-art clinical trials. The World Health Organization (WHO) established the International Clinical Trials Registry Platform (ICTRP) with the aim to “strengthen the validity and value of the scientific evidence base” by ensuring “that a complete view of research is accessible to all those involved in health care decision making”.

Given these benefits, trial registration including report of study results upon its completion is encouraged by the WHO and the International Committee of Medical Journal Editors (ICMJE), and it is stated as part of the revised version of the Declaration of Helsinki (2008). In the USA, clinical trials registration is required by law, as laid down in the FDA Amendments Act of 2007 (FDAAA 801). While this law applies to certain human trials of drugs, biologics, and medical devices, registration is recommended for products of other regulatory categories such as food supplements as well, as it reserves the chance of subsequent publication of study results in a prestigious scientific journal. Upon decision by the ICMJE, since 2005, registration of a human clinical trial is a prerequisite for it to be accepted for publication in a scientific journal.

A growing number of registries exist, with clinicaltrials.gov being the first and currently the largest database. It is managed by the National Library of Medicine at the National Institutes of Health and, at present, contains more than 250,000 observational and investigational trials conducted worldwide. Among the other platforms that belong to the WHO network and, thus, are accepted by the ICMJE, are the United Kingdom’s ISRCTN registry, the German Clinical Trials Register (DRKS), and the EU Clinical Trials Register (EU-CTR).

Human trials should be registered before enrolling the first subject (but no later than at the time of first enrollment), should be updated in a timely manner, and the results should be summarized after study completion. Depending on the statutory requirements of the registry, registration can be performed by the sponsor of the trial, the designated principle investigator, or a third party such as a contract research organization (CRO).

a&r comment: Publication of promising study results should not be hampered by a lack of trial pre-registration. Therefore, when commissioning a CRO with the design of a clinical trial, registration should also be considered. Given its experience and competence, a&r can provide support in trial registration, including choice of registry and compilation of appropriate information. Please contact us at business@a-r.com for more details and support.

SupplySide West (SSW)

a&r take home message

Once again, a&r attended SupplySide West in Las Vegas. SSW is a platform selected as a catapult by ingredient suppliers and service companies to introduce their new ingredients, products, technologies and solutions.

Our main take-aways after this event on ingredients, health and market trends:

INGREDIENT TRENDS

  • Branded ingredients with clinically proven efficacy and IP assets are the future of the nutraceutical industries.
  • Ketogenic diet, a high-fat, adequate-protein, low-carbohydrate diet, is gaining popularity and can be supported with ketone-based food supplements.
  • Concerns about authenticity of herbal ingredients are rising.
  • As already seen last year, there is a continued interest in new sources of protein; as developing countries’ economies grow, so does their demand for protein.
  • An increased interest in ingredients sourced from marine plants was spotted as research showing their benefits is growing.
  • Probiotics are still on high demand; whether for digestive health, immune, or mood as acceptance by healthcare providers and consumers continues to grow.
  • There is increased demand for cognitive health ingredients, not only for brain health but also in sports nutrition. The growth in sport nutrition is attributed to the boom in the connection between the brain’s mental activity and performance.

HEALTH TRENDS

The health areas with the most focus this year were support of healthy aging with increased focus on maintenance of muscle mass (dietary essential amino acids) and joint health.

The growing aging population, increasingly youth-centric society, and consumer motivation for self-care are driving the demand for healthy aging solutions. Moreover, the Baby Boomers also focus on healthy aging.

MARKET DRIVERS 

A strong driver for this market is personalized nutrition, as healthcare providers and consumers are becoming more aware that “one size fits all” is not a viable option in health.

There is a shift towards a “Fitness Move” as consumers are searching for preventive rather than reactive measures to avoid future health problems. The rising costs of healthcare worldwide also promote this preventive trend. Furthermore, there is also an increased interest by Millennials in food supplements for energy.

When it comes to business strategies for the nutraceutical industry and for innovators to expand their business, commercial transactions (licensing and matchmaking) are a strategy for innovation. Companies are buying products or companies to have access to new products, technologies, and desirable geographic markets. This is why a&r just launched its MatchMaking Platform, so we could better support our former and new clients with their business. For more details about our platform visit us at: https://www.a-r.com/matchmaking/

MatchMaking Platform

We are proud to announce the launch of our new a&r MatchMaking Platform. This platform aims to accelerate local and global transactions for in/out-licensing or sale/acquisition of natural health products. Unlike other platforms, it is focused on the area of natural health products. The platform is now live: https://www.a-r.com/matchmaking-database/. Please register to find great business opportunities!

a&r brings its unique combination of passion and expertise into this field. For more than 20 years, we have been developing a strong network in the natural product industry with more than 1000 clients. This allows us to efficiently select the most attractive business partnering opportunities to increase revenue in your future business.

In addition, a&r can confidently assist clients in the different stages of the matchmaking process, including technology and product scouting, due diligence, competitive intelligence, market analysis etc.

Dr. Naira Quintana recently joined a&r to lead the MatchMaking Platform. She brings a strong blend of academic expertise in natural products research and industry experience in the OTC business.

Contact Dr. Naira Quintana in order to explore your next business opportunity: matchmaking@a-r.com

Mintel GNPD (Database)

We have access to Mintel’s Global New Product Database (GNPD). The database reflects new product launches worldwide, giving a host of information about the products, from label and ingredients to launch date to manufacturing and distributing company, and many more.

With this tool, we are able to provide you with:

  • competitor analysis in your target markets, including pricing, packaging images, claims,
  • product examples for certain ingredients, e.g. all products containing beta glucan, and
  • landscaping of certain market segments
  • and other topics

Please contact us so we can discuss which information is relevant for you and how we can adapt the search criteria to get the most valuable output for you!

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaScientific Consultant

At analyze & realize, we are experts in the field of natural health products, having provided our services for more than 20 years. We offer a unique combination of expertise in natural health products through our scientific, regulatory, and strategic innovation consulting and our clinical research organization with its own clinical trial center in Berlin, Germany. Thanks to our close interaction with the natural product market as well as our extensive network, we are always at the forefront of the latest information and innovation trends. With its international team of 35 employees, a&r is a leading European one-stop-shop ready to guide and support your needs in natural health product innovation.

Don’t hesitate to contact us: newsletter@a-r.com

2017-10-24T14:18:37+00:00