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In the past year, FDA has made considerable progress (in most cases), fine-tuning the regulations on foods and dietary supplements, including the updates and changes to the Nutrition Facts Panel, the promulgation of the Generally Recognized As Safe (GRAS) final rule, release of the New Dietary Ingredient (NDI) draft guidance, etc. Though none of these listed above directly relates to claims, FDA  has signaled its tightening stance on claims through warning letters and other w

Demand for dietary and nutritional supplements worldwide continues to increase, with steady growth in the established markets and more rapid growth in emerging markets. The annual growth rate of dietary supplements in the U.S. was 7.1% between 2008 and 2012. According to one survey, the U.S. and Asia lead the world in supplement usage, with 54% of North Americans consuming a supplement and 43% of Asians consuming a supplement. In another survey, the U.S. was the largest marke

In November 2015, the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) released new guidance on fortification of foods.[1] The purpose of the guidance document is to help the food industry better understand and comply with the fortification policy for various food products. In this article, we focus on five important elements of the updated guidance, providing additional information to help clarify FDA’s fortification policy. Is my for

A recent United States District Court (New Jersey) decision has scored a small but significant win in a battle between Bayer and the federal government. As was described in the Court’s opinion[1], Bayer was the defense in a case brought by the Federal Trade Commission (FTC), although Bayer was the ultimate victor in the courtroom battle. This case illustrates that the government can be found to be unconvincing in its arguments against a manufacturer, if the manufacturer has h

According to Food Business News, sales of “gluten free” foods have exploded over recent years, into a $9 billion dollar market in 2014. It is estimated that within the next three years these numbers will increase by 60%.[1] Why are so many people going gluten free? Recent reports claim that diets high in gluten are linked to diseases such as depression, anxiety, arthritis, autism and obesity[2]. Also, recent polls also show that a high percentage of people think that followin

Study Implies Reaffirmed Health Claims for Oatmeal In 1997, the FDA approved a health claim statement for food labels that indicated a link between eating oatmeal and lower cholesterol. In 2008, a scientific review of current research shows that link to be even stronger. Recent studies suggest that eating oatmeal may: 1) Reduce elevated blood pressure risk, Type 2 diabetes and weight gain 2) Reduce LDL cholesterol during weight-loss 3) Provide positive changes in the physical