A new study from the U.S. Government Accountability Office concludes that the Food and Drug Administration needs expanded authority to investigate "structure/function" claims on food labels -- specifically, the ability to compel companies to turn over the evidence they have used to substantiate such claims' scientific validity.
According to the study report, the FDA's lack of authority to require (as opposed to request) that companies produce their evidence supporting the scientific validity of health-related food claims has become of concern in regard to claims that relate to a food's effects on body structure or function -- such as "boosts immunity" or "builds strong bones."
These claims are of growing concern because they have become more common in recent years, according to the report.
Technically, the FDA also lacks authority to compel companies to produce documentation of other types of claims as well, but "health" and "qualified health" claims require pre-market FDA approval, and so presumed review of the research behind these, explains Lisa Shames, GAO director for food safety and agricultural issues.
To date, the FDA has not adopted a disclaimer or notification requirement for structure/function claims on food labels (although there is such a requirement for these claims on dietary supplements), and there is no research requirement for such food claims. The agency's inability to compel production of supporting evidence hampers its determinations, according to FDA attorney statements referenced in GAO's report.
In contrast, the Federal Trade Commission does have the authority to compel production of supporting evidence as part of its oversight of advertising claims, including structure/function claims, the report points out. For instance, the FTC employed company evidentiary documentation in its complaints against Kellogg for advertising claims regarding Frosted Mini-Wheats' and Rice Krispies' abilities to boost kids' attentiveness and immunity, respectively, which were resolved through settlements requiring advertising claims restrictions.
In response to GAO's evidentiary authority recommendation, the FDA said it would work to determine better approaches to enhancing its oversight of structure/function claims, including whether additional statutory authorities are needed. The FDA would need to request such expanded authorities from Congress. (Authority questions aside, levels of operational funding for the FDA, and funding for implementation of the new Food Safety Modernization Act, are among the budget items that will be debated as Congress tackles deficit-reduction issues in the months ahead.)
The FDA also indicated support of a GAO recommendation that it provide guidance to the food industry on the evidence needed to support structure/function claims, and agreed to "consider developing such guidance as agency resources permit."
However, the FDA disagreed with a GAO recommendation that it provide inspectors with procedures to identify false or misleading structure/ function claims while in the field, calling this impractical because such judgments require substantial grounding in the science that would support or refute the claim. The GAO conceded this point, but maintained that the FDA could still amend inspector instructions to help them identify claims that might warrant further FDA review.
Most Common Types of Claims
In a survey of claims on food labels in grocery stores conducted in 2006-07, the FDA found that structure/function claims accounted for 5.5% of total claims across seven types reviewed (some labels carried multiple claims).
Nutrient content claims -- which, GAO noted, can be checked by consumers who take the time to read the nutrition facts label -- were by far the most prevalent, accounting for 53.2% of the total.
Claims of being a "significant source" of some nutrient, vitamin or other ingredient made up 20.5%. "Healthy" (implied nutrient content or health benefits claims) accounted for 7.6%. "Health" claims (those about a food's relationship to disease or health-related conditions, approved by FDA as being backed by "significant scientific agreement or an authoritative source") represented 4.3%.
"Qualified" health claims (health claims accompanied by explanations of the strengths and weaknesses of the scientific support) represented just 0.4% of total claims found in the survey.
GAO cited various research indicating that consumers tend to be confused about the meaning of the various types of claims, and have difficulty distinguishing among them.
The reasons behind the growing use of structure/function claims and relative lack of use of health and qualified health claims in food marketing?
GAO cited a 2008 study by the International Food Information Council that found that consumers are just as likely to purchase products with structure/function claims as those bearing health claims that require FDA review of their validity according to the "significant scientific agreement" standard.
The IFIC also found structure/function claims to be "perhaps the most popular" among consumers. "Most consumers liked their brevity and general health messages more than health claims, which they saw as too wordy and too disease-specific," according to GAO.
Since 2000, the FDA has spent at least $12.8 million on activities relating to health and qualified health claims, GAO reported.
Between December 2009 and February 2010, the FDA issued 17 warning letters to food companies regarding food labeling claims compliance, two of which involved qualified health claims. (Those were issued to Fleminger, Inc. for claims about disease-reduction benefits related to high consumption of green tea, and one to Diamond Food, Inc. for claims related to heart-health benefits from Omega-3 in walnuts.)
The FDA received 16 petitions proposing 60 qualified health claims for food labels between 2002 and 2006, denied 42 and has thus far allowed 12.