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The Evolution of FDA Regulations and the Rise of the Empowered Consumer

FDA and the Rise of the Empowered Consumer

October 28, 2013

The Cheerios you buy today would have been considered a drug under old Food and Drug Administration regulations, Professor Lewis Grossman from American University Washington College of Law told a lecture hall full of students as he explained the dramatic shift in FDA food and drug policy over the past 50 years.

In the 60s and 70s food health benefit claims such as the “heart healthy” description that appears on Cheerios,  would have forced the FDA to classify the food as a drug. Even content descriptions such as “fat free” and “cholesterol free” would have kept the food off the market, Grossman said.

Today, in exchange for requiring manufacturers to make more detailed disclosures, the FDA has simultaneously allowed manufacturers to liberally boast about potential health benefits of foods, even if the scientific community is not in full agreement about those benefits, Grossman claimed. So long as the manufacturer uses the proper disclaimer and has some basis for the claim, it is more or less allowed under the current regulatory regime, to make fairly generalized health claims, Grossman said.

The shift to the current state of FDA regulations evolved over the past several decades, with more liberal regulations stemming from a cultural shift in the FDA’s perception of the average consumer, Grossman added. The FDA used to consider the average consumer passive and disinterested in warnings beyond what his or her doctor advised and, therefore, highly restricted the claims manufacturers could make about foods. For the same reasons, over-the-counter drugs were also scarce.

Today, the FDA views the consumer as educated, informed and proactive about their food and drug choices and, therefore, seeks to deliver as much information to the consumer as possible, Grossman said. Therefore, health claims on foods are ubiquitous as are over-the-counter drugs.

Grossman recognized, however, that the FDA’s more liberal standards are not always a good thing. Consumers are sometimes over saturated with information and often misguided into thinking that they could consume food without moderation because it is “fat free,” for example, or that the dosage requirements on over-the-counter drugs should not be taken as seriously as their prescription counterparts.