Regulation & legislation

The ANH wants to see the THMPD in court over the treatment of herbal products in the EU

NGO set to file THMPD legal challenge by end of March

By Ben Bouckley

Non-governmental organisation ANH-International is set to file its legal challenge to the controversial Traditional Herbal Medicines Product Directive (THMPD) at the High Court in London by the end of March, NutraIngredients.com has learnt.

Inside the European Court of Justice

Lisbon Treaty could permit EU health claim challenges

By Shane Starling

A Lisbon Treaty-led broadening of the rights of individuals and corporations to act against European Union law could permit generic, article 13 health claim challenges, even though they, “are not addressed to individuals”, according to an EU food law...

HiPPy times for one German company (and potentially others) as EFSA's health claims panel approves an article 14 thiamin claim for neural development in under-3s

EFSA health claim opinion

EFSA approves vitamin B1-infant brain health claim

By Shane Starling

The European Food Safety Authority (EFSA) has approved a health claim linking thiamin (vitamin B1) and “normal neurological development and function” in infants and children up to three years of age.

BioGaia has been investing in clinical research in 2010

Swedish probiotics player sales surge 16%

By Shane Starling

Swedish probiotics supplier and product manufacturer BioGaia has seen sales increase 16 per cent in 2010 to €27.77m from €23.08m in 2009, with after-tax profit increasing 31 per cent year-on-year to €5.35m.

Could NCCAM's probiotic position influence other agencies and regulators?

P-Day: Could US research save probiotics in Europe?

By Shane Starling

European probiotic researchers are welcoming last week’s commitment to probiotic study by a major US government health and nutrition agency, with biomarker development a real possibility.

Biotivia is hoping its resveratrol supplements will make a splash in the UK, but admits regulatory challenges remain

Biotivia launches first UK resveratrol supplement

By Ben Bouckley

Herbal supplement producer Biotivia has launched a resveratrol supplement onto the UK high street for the first time, but has expressed frustration at the EU regulatory climate.

Some MEPs are calling for a revision of DHA-infant ye development claims

MEPs question omega-3 baby milk benefits

By Shane Starling

Members of the European Parliament (MEPs) are questioning whether omega-3 form DHA can benefit infant eye sight, despite the nutrient winning endorsement from one of the world’s toughest claims assessment agencies – the European Food Safety Authority...

Brain claims are OK, says ASA

Vitamin-herb brain claims are ok, finds UK authority

By Shane Starling

The UK branch of German pharma player Boehringer Ingelheim has had brain health adverts for a vitamin-based medicine backed by local watchdog, the Advertising Standards Authority (ASA).

European nutrition science will go on, but will it earn health claims?

Special edition: Outsourcing

CROs (slowly) piece together EFSA's health claim science puzzle

By Shane Starling

In the second part of this special series on global outsourcing trends NutraIngredients explores how the European Union nutrition and health claims regulation (NHCR) is impacting activity in the contract research organisation (CRO) sector.

Ginkgo biloba

UK ASA rules against botanical marketing

By Shane Starling

UK firm Healthspan has been told to amend marketing materials for herbal-based blends after the Advertising Standards Authority (ASA) found advertorial materials in breach of its fair marketing code for making medicinal and unauthorised claims.

Synbiotics may protect kids from asthma: Danone study

By Stephen Daniells

Supplements containing a mix of probiotic bacteria and prebiotic fibers reduced the prevalence of asthma-like symptoms in children at risk of the condition, says a new study from the Netherlands.

The eyes have it, but the brain

EC hands omega-3 mixed results

By Shane Starling

An article 14 children’s development health claim submitted to the European Union by drug giant Merck linking omega-3 form DHA with infant visual development has been approved at committee level by the European Commission.

Industry is finding the EU health claims system hard to swallow

Are health claims making your business sick?

By Shane Starling

2010 has been another tough year for the European functional food and supplements industries as health claim rejections have continued to flood in, leaving some in a state of high anxiety, fear and dread. Others are just mildly annoyed at a situation...

EFSA affirms soy protein health claim rejection

EFSA explains soy protein claim rejection

By Shane Starling

The European Food Safety Authority health claims panel has defended its controversial rejection of a soy protein-cholesterol lowering submission in July this year by highlighting the fact the industry agreed to its tight definition of soy protein.

Professor Tine Rask Licht - Winner of the Danisco Award

The opportunities and obstacles for gut health science

By Nathan Gray

It’s been a bad year for good bacteria: A raft of negative health claims opinions from the European Food Safety Authority (EFSA) has left many in the industry predicting trouble ahead for probiotics and prebiotics in Europe. But Professor Tine Rask Licht,...

EFSA gives thumbs down to pre-submision meetings

EFSA Board: No resources for pre-submission claim meetings

By Shane Starling

The European Food Safety Authority (EFSA) confirmed at its Board Management meeting last week that the resources do not exist to accommodate meetings between its health claims panel and parties before claim submissions are formally made.

Could pre-health claim submission meetings actually save resources?

Probiotics industry unites over EFSA claims treatment

By Shane Starling

Four groups with an interest in pre- and probiotics will today send a letter to the European Commission and European Food Safety Authority spelling out their ongoing concerns with the European Union health claims system that, to date, has unanimously...

A healthy immune system is proving difficult to define. Is this man's system healthy?

EFSA gut/immune health meeting

ERNA: EFSA must clarify ‘boundaries of immune normality’

By Shane Starling

The high rate of European Food Safety Authority (EFSA) immune health health claim rejections is likely to continue unless parameters of a well-functioning immune system can be defined, according to a Brussels-based industry group.

Bischoff: Who will answer the

EFSA gut/immune health meeting

Health claims: Is the idea of disease risk factors, itself diseased?

By Shane Starling

Differentiating between disease risk factors and disease reduction in the way that the 2006 nutrition and health claim regulation does is too arbitrary and needs revision, according to a German nutrition professor. But if such a change is needed, who...

Vitamin D can help the elderly reduce falls, says DSM, in a new submission

DSM submits vitamin D health claim for “falling”

By Shane Starling

DSM Nutritional Products has submitted an article 14 disease risk reduction health claim linking consumption of a proprietary blend of vitamin D2 and D3 and reduced risk of falling over among the elderly.

How to build an article 13.5 dossier

How to build an article 13.5 dossier

By Shane Starling

The rejection of so many health claim submissions by the European Food Safety Authority is creating a major headache for the EU functional foods and food supplements industries, with many looking at resubmissions under article 13.5 of the regulation.

How significant will the botanicals reprieve turn out to be?

NHCR botanicals removal provides a longevity loophole?

By Shane Starling

The European Commission decision to remove around 2000 submissions for botanical extracts from the 2006 nutrition and health claims process will allow substances to remain on-market, and may provide a loophole to help companies thinking about herbal medicinal...

Yakult wants a word with the NDA about its rejected probiotic immunity claim

Yakult: EFSA must recognise cold symptoms

By Shane Starling

Japanese probiotics giant Yakult says its recent EFSA probiotic health claim rejection discounted peer-review validated respiratory tract health measures, and called on the European Commission to facilitate a discussion on the matter.

NDA panelist: Restoring the immune sytem could yield claims

EFSA gut/immune health meeting

NDA panelist offers restored immune system claims hope

By Shane Starling

Restoring a suppressed immune system to full-function could win a health claim, EFSA health claim panelist, Henk van Loveren said at last week’s gut/immune health meeting in Amsterdam.

How health claims could impact marketing ethics

How health claims could impact marketing ethics

The tough health claims environment in Europe could turn manufacturers towards more subtle – and maybe less ethical – marketing approaches, believes Henry Dixon of PR firm BDB.

A transatlantic view of regulations and health claims

A transatlantic view of regulations and health claims

By Stephen Daniells

Should the FDA work to be more like EFSA? Speaking at the NutraIngredients Health Claims 2010 conference Andrew Shao said the two organisations are already very similar in the way they review scientific claims.

CIAA is calling for greater dialogue with EFSA's health claims panel

EFSA gut/immune health meeting

CIAA calls for drug-like health claim pre-submission advice

By Shane Starling

The CIAA says EFSA’s immunity/gut health workshop has revealed the lack of clarity that remains in the European Union health claims process and called for pre-submission meetings between applicants and EFSA’s health claims panel.

Danone says there is not enough claims clarity to make a submission for Actimel and other products

EFSA gut/immune health meeting

Danone tells EFSA: Health claims “learning experience” is too costly

By Shane Starling

The European Food Safety Authority (EFSA) has repeatedly emphasised that the 2006 EU nutrition and health claims regulation is a learning experience for everyone involved – from its health claims assessment panel to industry stakeholders, to the member...

EFSA is communicating more but industry may not like what it is hearing

EFSA gut/immune health meeting

EFSA gut/immune function meeting leaves industry wanting more

By Shane Starling

Key members of the European pre- and probiotic industries left Amsterdam frustrated that the majority of their questions about immune and gut health claims remained unanswered after a meeting with the European Food Safety Authority’s health claims panel...

Defining the drug/food borderline is an

EFSA gut/immune health meeting

NDA details the food-drug divide and its “impossible task”

By Shane Starling in Amsterdam

“It’s a critical issue to figure out how to show the health benefits with foods without crossing the borderline into medicines,” European Food Safety Authority (EFSA) NDA health claims panel working group member, Maria Saarela, told NutraIngredients at...

Salminen: Hard to reach a 'constructive' end result

NDA: EC gave inadequate guidance on health claims

By Elaine Watson

The depressingly high rejection rate for ‘article 13.1’ health claims is hardly surprising given the nature of the submission process, according to one member of the expert panel tasked with assessing them.

Prebiotic or not prebiotic? That is the question

EFSA health claim opinion

EFSA issues first positive prebiotic opinion – or does it?

By Shane Starling

The European Food Safety Authority (EFSA) has issued its first positive health claim opinion for a prebiotic with a laxative effect – but it was not achieved via a typical prebiotic effect, according to a leading academic in the area.

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