Functional Foods: Addressing Claims & Labelling Concerns

Pharma IQ

Functional foods and beverages have represented a significant opportunity for growth within the food and drink industry over the past few years. However there are concerns regarding the claims made by manufacturers and product labelling.

The industry is experiencing increasing levels of scrutiny and criticism over the claims made about its products, which some say are not backed up by sufficient scientific evidence.

An increased public awareness of the effect of diet on overall health helped drive up sales of functional foods, prompting more players to enter the market.

A report published earlier this year by Leatherhead Food Research entitled Future Directions in Functional Foods said: "Over the last decade the global functional foods sector has experienced substantial growth, particularly in the beverage and dairy sectors, and penetration of functional foods in the total food and drinks market is expected to continue."

The Business Insights report The Future of Targeted Functional and Wellbeing Food and Drinks, also predicted the demand from the older generation will dramatically increase over the next four decades.

"Increased health awareness and consumer confidence coupled with an aging population has driven demand for products that improve the quality of life, have specific health benefits and can be used by consumers to self-medicate," said the report.

Authorities have now decided the time was ripe to step efforts up and provider stricter regulation of the industry – both in the claims that it makes and how these are represented to the public.

Regulation in the largest market

In the United States the Food and Drugs Administration (FDA) is responsible for assessing the validity of claims made in association with functional foods and beverages.

According to Companies and Markets, the market in the United States for such products is set to reach $36.7 billion (£23.4 billion) by 2012 – representing the largest functional food and drinks market in the world.

The debate over what information should be included on food packages is one that has been raging for years.

It was in 1994 that producers first began to display health claims on their packaging, following the introduction of the Nutrition Labelling and Education Act four years previously. Manufacturers argued if they were required to show the negative attributes of their products, then they should also be allowed to demonstrate the positive ones, Live Science reported.

However, the FDA has now said the proliferation of such labels and a lack of standardisation is causing problems for consumers who are unable to understand the various benefits of foods.

There are also doubts being aired about the scientific claims made surrounding functional foods, leading to calls that the FDA should apply the same process to verifying health claims of functional foods as it does with medicines.

A report by the Institute of Medicine highlighted that there are "no scientific grounds" for making a differentiation between functional foods and medicines within this area as they can both impact on public health.

Calls were made for a standard framework to be used by the food and pharmaceutical industries, and the regulatory authorities, using biomarkers, which will allow for greater accuracy in verifying health claims.

Committee chair John Ball, executive vice president of the American Society for Clinical Pathology, Chicago, said: "Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medications.

"Without changes in the way biomarkers are used and assessed, however, health care providers, regulators, and consumers will not be able to reliably collect or judge information to support claims."

European regulatory perspective

Across the Atlantic, similar calls are being made to the European Food Standards Agency (EFSA) to improve its regulatory mechanism for its assessment of function foods.

On the one hand, there are those claiming that manufacturers are exploiting the market for functional foods and beverages for their own ends, while others argue the current regulatory system is stifling industry growth.

The EFSA is currently working through 4,637 health claims and, as of July, 80 percent of the 900 assessed had been rejected, according to the BBC.

Common reasons for rejection outlined by the EFSA included an inability to identify the substances the claims were made about, insufficient "precision" surrounding the health claim or a lack of evidence from human studies on the subject.

The industry has reacted badly to this clamp down on health claims, with some arguing it will make the choice more difficult for the consumer and others saying it will damage the market.

Jenny Baillie, of the York-based health foods company Power Health, told the BBC: "EFSA is rejecting most of the proposed food supplement claims even established claims like cranberry for urinary tract health, which will mean that there will be no information on packs for the consumer to assess what the product is supposed to do."

However, a spokesperson for the EFSA, which is likely to allow a second round of applications to deal with confusion created during the first round, highlighted it cannot make a responsible decision unless  "the relationship between the benefit claimed and the substance or product [is] clear".