Lack of resources causes FDA health claim delays
claims petition, but in the past year their efforts to make public
links between certain ingredients and health benefits have been
held up by delays in the FDA's approvals process. Jess
Halliday asked Kathy Ellwood, director of nutrition programs
and labeling at the Center for Food Safety and Applied Nutrition,
what takes the FDA so long.
"We have very limited resources here," she said. "We do what we can with the resources we have."
Ellwood was not able to tell NutraIngredient-USA.com whether measures are being taken to remedy the situation or when the bottle-neck is likely to clear. But the administrative overload cited by the agency in its letters requesting extensions beggars the question as to why the government has introduced a program without devoting to it the resources to allow it meet its own deadlines.
In a guidance document on qualified health claims, the FDA says that a final decision will be sent to the petitioner on or before 270 days after receipt of the petition.
But in the case of a decision on American Longevity's lycopene/cancer health claim, for example, which the company announced yesterday has been delayed for a fourth time until August, more than 500 days have now passed since the petition was filed.
American Longevity said the agency has asked for extensions in its review of seven other pending qualified health claim petitions, citing a lack of agency resources.
Amongst the companies affected is Nutrition 21, with its petition linking chromium picolinate with a reduced risk of insulin resistance. A decision on this was originally expected in June 2004, but the latest information indicates that a decision will not be delivered until August.
A decision on LycoRed's tomato lycopene/prostate petition is also expected in August.
The FDA allows three different types of health claim: qualified health claims, 'unqualified' health claims, and structure/function claims.
While unqualified health claims - which must meet the Significant Scientific Agreement standard - have been allowed since 1993, qualified health claims for conventional foods were only introduced in September 2003. These acknowledge the benefit of providing consumers with information on labels concerning diet and health, even if the science is only 'somewhat settled' - i.e. does not need the Significant Scientific Agreement standard.
Unlike qualified and unqualified health claims, structure/function claims refer only to the effect that a substance has on the structure or function of the body, nor a specific disease. For example, "calcium builds strong bones".
According to the latest information available on the FDA website, the agency has so far received and approved nine qualified health claims petitions.
Ellwood said that her department currently has a lot of health claims under review. Each one is very time consuming and must pass through several different offices, including the FDA attorney's office. In some cases scientific experts need to be called in to evaluate the evidence for the claim, and unforeseen hold-ups can occur at any stage.
"It is not always predictable how long it will take. We do try to give companies something as concrete as we can," said Ellwood.
When asked what companies might do to speed up the approval process from their end, Ellwood said that initial delays can be avoided by proper completion of submissions.
"Submissions that meet significant scientific agreement are the ones we like to see companies strive for," she said.
Although this might not be possible for qualified health claims, Ellwood added that gathering as much scientific data as possible shows a strong level of commitment on the part of the petitioning company.
The indication that the FDA is not scrimping on the science, and is doing a thorough job of assessing the evidence so that that erroneous or misleading claims do not get through might offer some comfort to the industry.
But the danger is that the amount of time it takes for a company to start seeing a return on its investment will serve to discourage them from making petitions - especially since approved claims do not give the petitioner any competitive advantage but can be used by all companies marketing products containing the substance.
Rather, health claims could serve to boost the entire category, as has happened for omega-3 containing products since last September's approval of the claim that long-chain omega-3 fatty acids may help reduce the risk of heart disease.
According to ProductScan, foods fortified with omega 3 are on track for 70 percent growth over 2004, with 109 new market entrants up until May 31 compared with 170 for the whole of last year.
