Report: FDA's Gottlieb indicates 'healthy' may be defined on a case-by-case basis
- The U.S. Food and Drug Administration commissioner Scott Gottlieb recently sat down with a reporter from The Wall Street Journal to discuss where the food portion of the FDA is heading and talk about the agency’s operating definition of “healthy” when it comes to food claims.
- Gottlieb said that the FDA intends to prioritize from a public-health standpoint which claims the agency should be more involved with determining proper use. Use of the term “healthy” could be one of those claims. He told The Wall Street Journal, “I want to see the agency step in to adjudicate some of the important claims that product developers want to make on labeling that could be important in informing consumers.”
- “When certain claims that might be important to providing information to consumers get made in the absence of a scientific framework and get litigated in state courts and torts, outside [FDA] review, I think that isn’t what was intended. I think we have a role to play,” Gottlieb told the newspaper.
As consumers look more closely than ever at labels, they should be able to believe the health benefits made on product packaging because companies are required to have scientific proof backing their statements. The reality is, however, that food manufacturers sometimes toe the line between truth and making a questionable claim for marketing purposes in order to sell a product. There are countless examples of label claims that have been struck down or challenged in recent years.
Of particular concern is the use of the term “healthy,” which has no clear-cut scientific definition and consequently can have many and varied interpretations. “Healthy” can mean very different things to different people depending on their needs and circumstances.
In this interview, Gottlieb appears to indicate the agency will take a more holistic look at the full range of claims being used by brand marketers where the FDA previously hasn’t played a role, and then decide “from a public-health standpoint” where it’s important to get involved. He told the reporter that “in order to allow innovation around things that produce public-health benefits, we need to allow people to make claims around those public-health attributes.”
Such a statement sounds like the FDA could be headed toward a case-by-case definition arrived at through innovations. This could look like last year’s reversal of the FDA's stance on KIND. The FDA issued a statement saying, “… we understand the company’s position as wanting to “use ‘healthy and tasty’ as part of its corporate philosophy, as opposed to using ‘healthy’ in the context of a nutrient content claim. The FDA evaluates the label as a whole and has indicated that in this instance it does not object.”
Evaluating claims and the different ways companies apply the term “healthy” on a case-by-case basis could create more problems than it solves. The FDA was in the process of getting public input to define the term, opening the process last September, taking comments through spring, and even holding a public hearing earlier this year. Nothing has happened in the process since the comment period closed in April.
While not establishing a definition of terms like "healthy" may mean fewer regulations, it also could lead to more potential litigation and government intervention. This is probably not the most efficient way to do business given the increasing level of innovation, new product introductions and label claims being made across the food industry.
- The Wall Street Journal Where the FDA Is Going Under Trump
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