Keeping with spirit of open government and that people deserve to know, Food and Drug Administration took an additional measure to spread knowledge through Adverse Event Report Data.  According to FDA’s press release, “[t]his is information that was once only available through Freedom of Information Act (FOIA) requests, but will now be easily available to researchers, consumers, and health professionals.”  The data comes in the form of .csv file.  From producer’s / distributor’s stand point, the most harmful piece of information comes in the column marked as “PRI_Reported Brand/Product Name.”  While at times overly broad, some line items list in sufficient details the product name and brand.  For example, “POLAND SPRINGS SPRING WATER” is on the list to have allegedly caused “DIARRHOEA, ABDOMINAL PAIN, RIGORS, NAUSEA” to a 29 year old male on December 2, 2003.”  Good question is how it will affect imports or prospective food imports?  FDA’s press release potentially provides answer as follows: The goal of CAERS is to provide indications, or “signals” of potential hazards. FDA uses these adverse event reports to monitor the safety of foods, including conventional foods and dietary supplements, and cosmetics. This information can, and has, led to investigations of specific products,…

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Food and Drug Administration (FDA) continues to brainstorm the regulatory framework surrounding the word “healthy” on food products.  September 2016 guidance advises that the “healthy” nutrient content claim can be used if the food: Meets specific criteria for nutrients to limit in the diet, such as total fat, saturated fat, cholesterol, sodium, as well as requirements for nutrients to encourage in the diet, including vitamin A, vitamin C, calcium, iron, protein, and fiber; The criteria are linked to elements in the Nutrition Facts label and serving size regulations; When used with an explicit or implicit claim or statement about a nutrient (e.g. “healthy, contains 3 grams of fat”), suggests that a food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations. As FDA continues to develop “healthy” definition ingredients, it seeks comments from the public. Federal Register Notice for the Guidance for Industry  Federal Register Notice for the Request for Information Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products Blog: Making Sure ‘Healthy’ Means What It Says on Food Packages “Healthy” on Food Labeling 

Read More When you see “healthy” on food package, what does it mean?