The FDA is responsible for ensuring that all foods (bar meat, poultry and eggs) are safe, sanitary, secure and properly labeled. Under the Food, Drug and Cosmetics Act it regulates both conventional foods and dietary supplements, the latter through the 1994 amendment the Dietary Supplement Health and Education Act.
In fact, no legal definition of the term 'functional foods' has been drawn up to date, but a report published by the Institute of Food Technologists (IFT) last year defined them as: "Foods and food components that provide a health benefit beyond basic nutrition. This includes conventional foods, fortified, enriched or enhanced foods, and dietary supplements."
Although it is too early to hazard what the upshot of the measure may be, the hearing is likely to be welcomed by sections of the food industry, as it shows that the FDA is taking note of trends and developments and adjusting the regulatory rubric accordingly. By officially recognising the category, it may also help stimulate its further growth.
According to Euromonitor International, the US packaged functional/fortified foods market was worth $6.3bn at retail in 2005, and is expected to grow to $7.6bn by 2010.
The FDA said that the hearing, to be held on December 5, aims to share the current regulatory framework and rationale regarding safety evaluation and labeling of functional foods, and solicit information and comments on how the agency should regulate them under its existing legal authority.
However it has been clear not to imply that the lack of recognition to date means they present a risk.
"Although we are confident that the existing provisions of the act are adequate to ensure that conventional foods being marketed as functional foods are safe and lawful, we believe that it would be in the best interest of public health to begin a dialog with industry, consumers, and other stakeholders regarding the regulation of these products," said the agency.
David Seckman, president of the Natural Products Association, told NutraIngredients.com that some people could read the initiative as an attempt to incorporate supplements under a different category. Indeed, the IFT definition could imply as much.
But Seckman drew attention to the clear line between dietary supplements and functional foods drawn in the FDA meeting announcement and background information: it states that the definition of supplements specifically excludes products "represented for use as a conventional food or as a sole item of a meal or the diet".
Nonetheless, the FDA not entirely ignoring supplements regulation in this context, since some of the labeling provisions are likely to be relevant for both categories.
Seckman said that it is a good thing to have a dialogue between regulators, industry and consumers, and that it is appropriate that the FDA is the driving force behind this.
Following the publication of its report, entitled Functional Foods: Opportunities and Challenges, the IFT last year urged the government to expand its food labeling regulations to take account of functional foods. It is not known whether the planned meeting is in direct response to this, or whether it other factors may have prompted it.
According to the report, the foods already on the market represent only a small fraction of the full market potential, but existing terminology and regulations are "inadequate" to address the full scope and benefits.
"Arbitrary distinctions between food and medicine should not prevent consumer access to knowledge about the benefits of incorporating functional foods into their diets."In particular, the IFT report stressed that regulatory oversight will be more consistent and appropriate if the FDA were to expand its "nutritive value" definition: "[B]enefits for functional foods should be based on nutritive value or. . .a physical or physiological effect that has been scientifically documented or for which a substantial body of evidence exists. . ." It also suggest that, in the interests of consumer understanding, the wording of qualified health claims should indicate the degree of scientific certainty associated with modification of disease risk - a measure that would result in "enormous public health benefits" through greater consumer understanding.
"Claims that accurately reflect physiological changes to the body caused by food need to be allowed," said Fergus Clydesdale, PhD, chair of the IFT Expert Panel, co-author of the report, and department head of food science at University of Massachusetts last year.
"As long as the claims are scientifically valid, enormous public health benefits will result from having consumers understand and act on the benefit."
He added: "Consumers, manufacturers, and regulators want the same thing-credibility in the claims on food products."More information on the December 5 meeting and background to the regulatory issues is available online.