The US FDA is being sued over its health claims regime – actions that are unlikely to succeed according to most pundits – but they raise serious questions about healthy food messaging and free speech that are being felt globally.
The actions are based on the idea that the Food and Drug Administration (FDA) is not abiding by First Amendment principles of free speech that have been applied in various court cases in the past 10 years.
In referencing those cases that affirmed, in essence, that companies should be able to make non-misleading claims about products even when the science is not conclusive, the present actions accuse the FDA of breaking the law.
A health claims system that adds so many negative qualifiers to individual claims as to render them commercially useless restricts free speech and is therefore unconstitutional, as upheld in cases such as Pearson v Shalala in 1999 and others that followed it.
Or in the words of Jonathan Emord, the attorney who is mounting the actions on behalf of a number of US groups, and who was involved in Pearson v Shalala, the FDA is acting like “a rogue agent”, by failing to apply the written law.
The FDA says it is merely representing the data available, and hence authorizing claims such as: “Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.”
New foods, new claims, new rules
The issue at stake here is the communication of science in foods claiming to have particular health benefits. While history is littered with 'functional' products from those claiming to be elixirs of youth to nascent cola products extolling their energy-giving properties, the rise of highly technical, fortified, healthy foods is causing regulatory head-scratching the globe over.
The law should sort the snake oil salesmen from the serious health-boosting contenders, but the line between the two is not always clear.
If product X claims to do Y when consumed in a certain way, how much science is enough? Or how do you demonstrate a product promotes wellness rather than prevents or reduces disease?
What kind of science is most appropriate and how is it best conveyed to consumers in a manner that can be understood by those that don’t have degrees in molecular biology?
As with the fields of nanotechnology or genetically modified foods, the laws are attempting to stay abreast of the technological development to protect the best interests of the community-at-large, but the unchartered territory makes their implementation difficult.
In the European Union, a health claims system is in the midst of being applied that is OK’ing claims with only the most robust of scientific backing.
On occasion, the claims assessor, the European Food Safety Authority (EFSA), has acknowledged some support for proposed claims ranging from omega-3 and eye health to probiotics and gut health, but not enough to meet its criteria.
The EU system has not yet been challenged in the courts, but it is being considered in some quarters, and there are many high-profile food lawyers who believe the system would struggle to withstand the scrutiny of a court room.
In places like Australia, even tougher systems exist, creating a void where functional foods and supplements marketers would say healthy communications should exist.
Developing regions such as Asia, eastern Europe and latin America are seeing a rise in these kinds of products and implementing systems of their own, often modeled on those in the US or the EU. With billions of dollars at stake, the detail of such laws have massive financial impact.
The ideal remains the same – that companies should be able to honestly tell the story of their products; to exercise free speech. But food science is an emerging science and offers few of the monochrome certainties food law seeks to propel such ideas of free speech into the tangible world.
Shane Starling is the editor of NutraIngredients.com and has written extensively about health claims. If you would like to comment on this article please feel free to get in touch at shane.starling'at'decisionnews.com.