AAHF, and its European affiliate, the Alliance for Natural Health (ANH), have submitted writtencomments to FDA as part of the agency's consultation on functional foods. In early December, FDA held a public hearing on functional foods to initiate debate on how to tailor regulations for a food category that has grown in importance and is regarded by some as occupying a grey area between conventional foods and dietary supplements.
The two associations are urging FDA to contemplate a process that balances consumer choice and safety issues with compliance issues for companies.
"The FDA should not over-burden the industry or penalize educated consumers who are looking at reducing their risks from chronic diseases like heart disease and diabetes," said AAHF executive director Brenna Hill. "Consumers have an exponentially greater interest in taking responsibility for their own health."
One issue hanging in the debate balance is that of health claims and how clear or explicit they can be. Another one raised by AAHF/ANH concerns whether FDA could move in the direction of the tighter regulations on dietary supplements in place in Europe.
"The tight regulation of health claims has been prioritized in Europe and a new regulation is about to be imposed, affecting Europe's 450 million strong population," said AAHF scientific director and ANH executive director Robert Verkerk. "The regulation is in our view far too stringent, requiring a very high level of scientific substantiation including human clinical trials that would not be out of place in the field of drugs licensing."
AAHF/ANH are at odds with tight regulations that disproportionally affect smaller companies which have produced advanced and innovative products.
"The sorts of provisions that the FDA appears to be contemplating in their bid for increasing oversight on health claims is likely to significantly narrow the gap between the legalrequirements for getting foods and drugs onto the market.." said AAHF general counsel Michael Ruggio. "Consumers could be the big losers here, unless we see a very well thought out approach which doesn't disadvantage the smaller players in the industry.""