Wednesday, June 16, 2010

"Generally Recognized as Safe"

The Corn Refiners Association's website, Sweet Surprise, cites the designation GRAS from the U.S. Food and Drug Administration (FDA) as proof that high fructose corn syrup should be considered a safe food ingredient.
Yes. In 1983, the FDA listed high fructose corn syrup as “Generally Recognized as Safe” (known as GRAS status) for use in food and reaffirmed that ruling in 1996.

Well,  GRAS, which (as stated above) means “Generally Recognized as Safe,” doesn't exactly sound to me like a resounding endorsement.  Whatever you may think GRAS means and whatever you read into that designation, there's something else to consider:

A recent Government Accountability Office (GAO) report suggests that the FDA designation GRAS is not a problem-free designation.  The report, "Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) GAO-10-246 February 3, 2010," suggests that the "FDA has not taken certain steps that could help ensure the safety of GRAS determinations."  So, in plain English: GRAS may not really mean “Generally Recognized as Safe.”  Instead, according to the GAO report, there may be examples of conflicts of interest, examples of procedures not followed, and instances in which the FDA has simply taken a manufacturer's word about whatever it is.  
The Food and Drug Administration (FDA), which is responsible for ensuring the safety of most of the U.S. food supply, does not review many of the substances added to food that manufacturers determine to be generally recognized as safe (GRAS) under the conditions of their intended use. Manufacturers add these substances—hundreds of spices and artificial flavors, emulsifiers and binders, vitamins and minerals, and preservatives—to enhance a food’s taste, texture, nutritional content, or shelf life. GRAS substances can be marketed without FDA’s approval or even its knowledge because such substances are generally recognized among qualified experts as having been shown, through scientific procedures or experience based on common use, to be safe. Some consider GRAS substances to warrant less oversight because they generally pose a relatively low level of threat to public health. However, a few substances previously assumed to be GRAS, such as cyclamate salts, have later been banned; and more recently, consumer groups have raised concerns about the safety of certain other GRAS substances, such as salt and trans fats in partially hydrogenated vegetable oils. (page 1)
so, what did the GAO recommend as a way ahead?
GAO Recommendations

To better ensure FDA’s oversight of the safety of GRAS substances, we recommend that the Commissioner of FDA take the following six actions:
•    develop a strategy to require any company that conducts a GRAS determination to provide FDA with basic information—as defined by the agency to allow for adequate oversight—about this determination, such as the substance’s identity and intended uses, and to incorporate such information into relevant agency databases and its public Web site;
•    develop a strategy to minimize the potential for conflicts of interest in companies’ GRAS determinations, including taking steps such as issuing guidance for companies on conflict of interest and requiring information in GRAS notices regarding expert panelists’ independence;
•    develop a strategy to monitor the appropriateness of companies’ GRAS determinations through random audits or some other means, including issuing guidance on how to document GRAS determinations;
•    develop a strategy to finalize the rule that governs the voluntary notification program, including taking into account the experience of the program to date, incorporating input from a new public comment period, and reporting to Congress and the public the agency’s timeline for making it final;
•    develop a strategy to conduct reconsiderations of the safety of GRAS substances in a more systematic manner, including taking steps such as allocating sufficient resources to respond to citizen petitions in a timely manner, developing criteria for the circumstances under which the agency will reconsider the safety of a GRAS substance, and considering how to collect information from companies on their reconsiderations; and
•    develop a strategy to help ensure the safety of engineered nanomaterials that companies market as GRAS substances without the agency’s knowledge, including taking steps such as issuing guidance recommended by the agency’s nanotechnology taskforce, developing an agency definition of engineered nanomaterials, and requiring companies to inform FDA if their GRAS determinations involve engineered nanomaterials. (pages 34-35)
Sounds reasonable, doesn't it?   I guess we now understand better how the FDA could judge that HFCS is "natural."

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