The Center for Public Integrity (CPI) published a lengthy investigative report on Tuesday summarizing the safety concerns associated with GRAS (generally recognized as safe) food additives, the controversies surrounding how they’re determined, and barriers to regulating them. The report’s key illustration of the concerns about GRAS was a peanut-related legume called lupin — sometimes spelled “lupine” — which is relatively new to the U.S. market and frequently used in gluten-free products. Lupin can cause “life-threatening reactions” in peanut-allergic consumers, but lupin products are used in food as GRAS without an allergen warning label. “While many parents know to look for and avoid peanut ingredients in the diet of their peanut-allergic child, they may have no idea what lupin is or whether it is an ingredient that could cause their child harm,” said Dr. Stefano Luccioli, the Food and Drug Administration’s senior medical advisor, in an agency Q&A about the food item. According to the CPI report, George Weston Foods sought FDA’s agreement in 2008 that its lupin flour, protein and fiber were safe to add to breads, pastas and cereal. However, the federal agency said that simply listing lupin on ingredient labels would not be enough of a warning to allergy sufferers. While the Australian company decided not to sell the additive in the U.S., the report notes that other “companies that make and supply these ingredients never had to seek the FDA’s opinion on safety, or even inform the agency that it was including lupin in products sold in the United States.” FDA has acknowledged the shortcomings of the GRAS program. Michael Taylor, FDA’s Deputy Commissioner for Foods, has said publicly on multiple occasions that the agency lacks the information needed to vouch for the safety of many GRAS food additives. A 2010 report by the Government Accountability Office (GAO) recommended that FDA do more to ensure the safety of GRAS substances such as requiring companies to provide basic information of any GRAS determinations, developing a strategy to minimize the conflicts of interest in companies’ determinations, monitoring the appropriateness of determinations through random audits or some other means, finalizing the rule that governs the voluntary notification program, conducting reconsiderations of the safety of GRAS substances in a more systematic manner, and ensuring the safety of engineered nanomaterials that companies market as GRAS substances without the agency’s knowledge. FDA has responded to two of GAO’s six recommendations by issuing guidance on nanotechnology and agreeing to finalize its 1997 proposed rule on GRAS.