Health Claims and Food – GAO Issues a Report – FDA Needs to Clarify

Last week, the General Accounting Office issued a report entitled “FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims” where – well, the title sort of gives away the gist of the thing, doesn’t it.  FDA does need to re-think this.

The report is significant for a number of reasons:

1. The role of food and health and medicine is converging.  Not only has there been an increase on the part of food manufacturers to market foods with claims, there is an increasing market medical foods and nutraceuticals;
2. The report demonstrates that the current environment is not well defined; and
3. The report serves as an excellent referral source for those who wish to learn about the different types of health labeling and food and sort through the complexity.

The first sentence of the report kind of says it all, but still is an understatement when it comes to labeling and health claims – “FDA’s efforts to protect consumers from false or misleading claims are conducted in a complex and challenging legal and regulatory environment.”

Part of the reason for the complexity is that there are so many different kinds of claims (structure/function claims, nutrient/content claims, health claims and implied health claims).   Let’s first take a look at the different types of claims before we look at the conclusions of the GAO report.

Qualified health claims are characterizations on the label of a relationship between a substance (specific food or food component) and a disease or health-related condition.  For a qualified health claim to be allowed, there needs to be a degree of scientific evidence in support of the statement.  Accordingly a petition is filed with FDA by any entity wishing to make such a label claim.  The supportive evidence is then considered and a decision made. From 2002 through 2010 the agency received 16 petitions proposing 60 claims for food labels, with the agency deciding in favor of 12 such claims.

And, as noted above, qualified health claims are distinct from other kinds of claims. Nutrient content claims, for example, involve a claim on a food product that directly or by implication characterizes the level of a nutrient in the food.  Structure Function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, for example, “calcium builds strong bones.” In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, “fiber maintains bowel regularity,” or “antioxidants maintain cell integrity,” or they may describe general well-being from consumption of a nutrient or dietary ingredient.  A structure/function claim has a different standard than the qualified health claim – it must be truthful and not misleading, but unlike a qualified health claim, it is not pre-reviewed or authorized by FDA.

The GAO report is a really good primer for those who want to get familiar with this topics, and includes not only concise definitions, but an overview of FDA activities around different health claims in food in general (with a table describing each action) as well as the two during 2010 that were particular to qualified health claims.

Not surprisingly one of the conclusions of the report is that stakeholders find the various types and levels of health-related labeling to be confusing.  All you have to do is try to sort through the various areas of FDA’s Web site about health label claims and one can easily see why.  There is no easy way to discern the differences or any basic English communication that explains it.   The GAO report also stated that the FDA has not given companies enough guidance on the types of scientific support needed in support of a claim.

On a side note, it is also important to point out that along with FDA, the Federal Trade Commission is also involved in regulating claims.  There were at least two instances in 2010 where health claims and labels got in trouble with both the FDA and the FTC for the same product.  As we head into an era of greater interest in health and food, it is important for the environment to be clarified and simplified for all stakeholders – manufacturers and consumers.