[Co-authored with Robert Fitzsimmons, Harvard University]
Fifteen years ago today, the U.S Food and Drug Administration (FDA) published its final rule authorizing the use of the health claim linking soluble fiber from whole oats and reduced risk of coronary heart disease.1 In essence, the FDA agreed with The Quaker Oats Company that consumption of soluble fiber from whole oats, as part of a diet low in saturated fat and cholesterol, lowered blood cholesterol levels. This was a seminal event because prior to this ruling, the FDA had prohibited food manufacturers from using any language on product labels that linked specific foods to specific health conditions.2 However, upon reviewing the totality of evidence presented by Quaker and the rigor of the underlying scientific research, the federal regulators concluded that the health claim was justified, making Quaker the first company to gain FDA health claim approval for a specific food and later serve as the model for other manufacturers seeking health claims.3
Quaker made history as one of the first companies to cooperate with regulators for an authorized health claim; previously regulators and industry had engaged in a tug-of-war over nutritional messaging. Ironically, a health fad centering on oat bran during the late 1980s proliferated misleading health information on packaging. This type of abuse was a primary motivator for the Nutrition Labeling and Education Act (NLEA) of 1990, which gave the FDA broad authority to control nutrition information on food packages. Quaker was one of the most vocal supporters of regulation; the company viewed the oat bran fad as a detriment to its hard-earned reputation for science based claims, responsible labeling and appropriate use of nutrition information. Following the passage of the NLEA, Quaker was well positioned to make the case for the heart health benefits of oats, with over a dozen independent nutrition studies; but what type of claim could Quaker make on its Quaker Oats packages?
Label claims have existed in three types since the 1990 legislation. Quaker was one of the first to garner a claim with the highest level of regulatory approval (a “Health Claim Meeting Significant Scientific Agreement (SSA)” which links a food to a reduction of disease risk). The other types of claims, such as nutrient content claims (e.g. “contains 500mg of calcium”), structure-function claims (e.g. “calcium helps maintain bone density”), and qualified health claims6 (e.g. “Supportive but not conclusive research shows that eating 1.5 ounces per day of walnuts, as part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease”) have increased steadily to encompass about one-third of product labels, albeit with significantly greater FDA oversight than in the pre-NLEA period.4 Quaker’s oat claim joined government-initiated heart health claims for fruits, vegetables, and low-fat foods. The claim served as a trendsetter for a class of manufacturer-petitioned claims related to heart health. Barley and psyllium grains were added to the oat claim in later years, and whole grains, plant esters and soy protein are other food substances with claims linked to the reduction of heart disease risk that have resulted from manufacturer entreaties. Altogether, the FDA now recognizes 16 claims in total, with several from manufacturer requests and a majority from government recommendations.5
Quaker’s ground-breaking heart health claim cemented the company’s reputation as a maker of nutritious, heart-healthy foods, and has served as a consistently valuable promotional tool. Quaker’s commitment to heart health in particular, and health and wellness in general, has continued following the company’s 2001 acquisition by PepsiCo, where the brand now serves as a beacon of nutrition grounded in the wholesome goodness of oats.
Most importantly, as part of PepsiCo’s multibillion dollar portfolio, and sitting side by side in Chicago with PepsiCo’s Global Nutrition Group (recently created to deliver breakthrough innovation in the areas of fruits and vegetables, grains, dairy, and functional nutrition7), Quaker has the unique opportunity to leverage multiple platforms and brands to scale up its business – and mission – of nourishing people around the globe. In fact, the scientific and technological advances in research and development, such as those that that led to the first food-specific health claim 15 years ago, continue today and serve as the innovation engine for consumer-centered solutions demonstrating that what is good for the consumers’ health can also be good for business. Best wishes for a happy and special 15th anniversary celebration to Quaker!
Selected References
- Food and Drug Administration. Food Labeling: Health Claims; Oats and Coronary Heart Disease; Final Rule. Fed Regist 1997 January 23;62(15):3583-601.
- United States Congress. Pure Food and Drug Act of 1906. United States Statutes at Large (59th Cong , Sess I, Chp 3915, p 768-772; cited as 34 U S Stats 768) 1906;Available at: URL: http://www.ncbi.nlm.nih.gov/books/NBK22116/pdf/purefood.pdf
- Fitzsimmons R. Oh, What Those Oats Can Do. Quaker Oats, the Food and Drug Administration, and the Market Value of Scientific Evidence 1984 to 2010. Compr Rev Food Sci Food Safety 2012; 11:59-99.
- Food and Drugs Administration. Claims That Can Be Made for Conventional Foods and Dietary Supplements. http://www.fda.gov/food/labelingnutrition/labelclaims/ucm111447.htm
- Food and Drugs Administration. Guidance for Industry: A Food Labeling Guide http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/ucm064919.htm
- Food and Drugs Administration Qualified Health Claims http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm072756.htm
- Khan M. PepsiCo’s new Global Nutrition Group. http://foodfrontiers.pepsicoblogs.com/2010/10/pepsico%E2%80%99s-new-global-nutrition-group/
