Post 1 in Series: The Relationship Between the Level of Government Regulation under the FDCA and the Health Status of a Product’s Targeted Population

Cheerios -- a Drug?

This past May, the FDA issued a warning letter to General Mills stating that the claim on Cheerios cereal that “you can Lower Your Cholesterol 4% in 6 weeks” turned the Cheerios from a food into an illegally marketed drug. When bloggers heard the news, posts ran from scolding the FDA to “grow-up,” to those which lauded the FDA’s action.

Who is correct? Is targeting a cereal one of those cases where, as one blogger suggested, the FDA has its priorities wrong? A look at one recent food trend may help answer this question.

By making its cholesterol lowering claims, Cheerios is entering the growing market for functional foods. In 2008, functional foods -- which are defined as foods that claim to have health benefits over and above the delivery of nutrients -– were a $30.7 billion dollar market. This market is predicted to grow by 40% over the next several years.

Examples include: probiotics in salsa and ketchup; omega-3 fatty acids in orange juice, eggs and peanut butter; pasta enriched with calcium; heart healthy ginger ale infused with green tea; ‘energy’ drinks with amino acids for joint health. The list goes on and on. One never knows what might pop up in a favorite food.

And now a new category of functional foods is cropping up which industry is calling cosmeceuticals -– foods that are being marketed to enhance appearance. (A bit confusing because that term is commonly used to describe drugs that are being marketed as cosmetics. Perhaps cosmefood would be better?). One example of a cosmeceutical for skin beauty is a product on the market that consists of marshmallows infused with allegedly skin-boosting collagen.

Fortified foods are not new. Iodine has been added to salt since 1924 to reduce the incidence of goiter. Grains have been fortified with niacin, thiamin, riboflavin and iron since 1943, a public health move that almost eliminated brain/skin degenerating pellagra within a decade. However, present day functional foods are flooding onto the market before the science exists on the effectiveness of many of their associated health claims.

Where should the FDA draw the line on regulation? Should the level of product regulation be linked with the health status of the product’s targeted population? While not stated explicitly, it appears that this is the strategy that the FDCA has followed since its inception. See Van Tassel, K., Slaying the Hydra: The History of Quack Medicine, The Obesity Epidemic and the FDA's Battle to Regulate Dietary Supplements, 6 Indiana Health L. J. 203-251 (2009).

Traditionally, the greatest amount of regulatory protection under the Food Drug & Cosmetic Act (“FDCA”) has been applied when products are targeted at vulnerable, unhealthy populations and claim to aid in an individual’s struggle to return to normal health. Examples of products that fall into this category by making health remedy or recovery claims include drugs and devices. For these products, the modern FDCA establishes a premarket enforcement process that places the majority of the cost and burden on the product manufacturer to establish safety and efficacy through the clinical trial process prior to distribution to the public. Without premarket approval from the FDA, these products will be deemed both adulterated and misbranded as a matter of law.

Conversely, the FDCA requires less regulatory protection when products are targeted to healthy populations to maintain or improve a normal state of health. Examples of products that fall into this category are traditional foods, and (until recently) a very limited number of functional foods and (once again, until recently) a similarly narrow category of dietary supplements. For these products, the FDA carries the burden of removing an unsafe or ineffective product by proving that it is adulterated or misbranded.

Currently, far too many functional foods and dietary supplements are being marketed to the unhealthy and vulnerable by making health recovery or remedy claims without demonstrating through premarket approval that their products are both safe and effective. It appears that Cheerios is just one product of many that are making these claims.

An abnormally high cholesterol level is a serious risk factor for disease and those with high cholesterol levels are in an abnormal state of health. Cheerios is claiming to help this group of unhealthy consumers with their struggle to return to a normal state of health. As one commentator remarked, it is possible “that some people with high cholesterol will see eating breakfast as a clinical treatment, perhaps even offsetting a more pressing need to cut back on French fries.” Consequently, by sending its warning letter to Cheerios, it appears that the FDA is heading down the right path.

The merits of the FDA’s position on Cheerios specifically, and functional foods more generally, may become more apparent by looking at another category of products that claim to help unhealthy people return to a normal health status -– weight loss products.

The next in this series of blog posts will provide a general introduction of the current problems with the claims being made by weight loss products, particularly in the context of the obesity crisis. The focus on the example of weight loss products will provide a structure for the following posts which will take a look back through the history of the relationship between the FDCA, the FDA and predatory commercial interests. Through this exercise, regulatory patterns will be identified that appear to link the level of product regulation with the health status of the product’s targeted population.

The goal of this series is to take lessons from the past and apply them to assist in the analysis of current regulatory issues involving food, functional food and dietary supplements. This first series will provide the ground work for the second series which will delve into the use of nanaotechnology in consumer products for direct and indirect human consumption -- including food (directly and through the food production process), food supplements, cosmetics and sunscreens.

— KVT