Report highlights concerns over lupine; other food additives

Lupin or Lupini BeansA new report is raising concerns surrounding GRAS (generally recognized as safe) food additives, the controversies associated with how they are determined, and the barriers to regulating them.

In particular, a peanut-related legume called lupine, sometimes added in gluten-free products, is the main area of focus as it is often added without an allergen warning label and can cause a life-threatening reaction in peanut-allergic consumers.

“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 lupine is or whether it is an ingredient that could cause their child harm,” Dr. Stefano Luccioli, the Food and Drug Administration’s senior medical advisor, said in a recent article.

The report published by the Center for Public Integrity (CPI), states that lupine, sometimes also spelled “lupin,” is considered a “major food allergen” in Europe where it must be labeled accordingly on packaged foods. However, it is relatively new to the U.S. market and less commonly used, so there is no such requirement.

Lupine was brought to the attention of the FDA in 2008 when an Australian food company sought its permission for adding lupine flour, protein and fiber to breads, pastas and cereal.  According to the article, the federal agency said that simply listing lupine on ingredient labels would not be enough of a warning to allergy sufferers, so the company decided not to sell their products in the U.S. The article also notes that other “companies that make and supply these ingredients have never sought the FDA’s opinion on safety, nor informed the agency that it was including lupine in products sold in the U.S.”

Michael Taylor, FDA’s Deputy Commissioner for Foods, has said the FDA has acknowledged the shortcomings of the GRAS program adding that the agency lacks the information needed to vouch for the safety of many GRAS food additives.

The report states that lupine is just one of thousands of ingredients companies have added to foods with little to no oversight from the FDA, noting that there is a loophole in a decades-old law that allows companies to deem an additive to be “generally recognized as safe” without the agency’s blessing, or even its knowledge.

Critics also say that companies regularly introduce new additives without ever informing the FDA, meaning people are consuming foods with added flavors, preservatives and other ingredients that are not always reviewed by regulators for immediate dangers or long-term health effects.

A 2010 report by the Government Accountability Office (GAO) made a total of six recommendations to the FDA to help ensure the safety of GRAS substances. These included: 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, 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.

As stated in the article, the 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.

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Neogen offers screening and quantitative food allergen test kits to detect a variety of allergens, including lupine. For more information, click here.

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