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Gluten-Free Food Labels

On Aug. 2, 2013, the FDA issued a final regulation defining the use of the term “gluten-free” on food labeling, finalizing a rule first proposed on Jan. 23, 2007. The rule has an effective date of Sept. 4, 2013 and a compliance date of August 5, 2014 (almost nine years after a public meeting on gluten-free food labeling that was held on Aug. 19, 2005). The rule will help the estimated three million American suffering with celiac disease choose appropriate food items. The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 required that food products containing wheat be identified and that the FDA determine an appropriate label for gluten-free food products.

One of the first (recent) “popular” books about the benefits of a gluten-free diet was Against the Grain, written in 1996 by Jax Peters Lowell, who has been gluten-free since 1981. Her follow-up book, The Gluten-Free Bible, was published in 2005. (The second book has received mixed reviews on Amazon.) Wheat Belly (2011) and Gluten-Free Cooking for Dummies (2013) are more recent popular books on the topic. Earlier works include Charlotte Baum Sheedy’s and Norman Keifetzthere’s cookbook for parents of children with celiac disease, published in 1969, and a 1951 book (available in digital format via the Hathi Trust) on the management of celiac disease. According to Amazon reviews, the latter book advises a different dietary approach — the Specific Carbohydrate Diet (SCD).

The gluten-free labeling rule epitomizes several administrative-law topics mentioned in previous blog entries: promulgation of a regulation consistent with the FDA’s enabling statute and as directed by subsequent federal legislation (FALCPA); a period designated for public comments; and agency discussion of substantive comments (totally gluten-free vs. minimal amounts, what about oatmeal?, should an existing or new label be adopted?, etc.)

There are a couple additional interesting elements of this rule-making process that are also often elements of administrative rule-making in general. While not as drastic as the pricing of (premature) human death which is part of the cost/benefit evaluation of major environmental regulations, the FDA estimated a net benefit of over $103 million in “health gains for individuals with celiac disease” — after deducting estimated costs of $1 million for relabeling and $5.8 million for food testing. Also, The FDA considered existing regulations and scientific studies from Canada and the European Union while deciding the appropriate level of gluten that should be present in foods that are labeled “gluten-free.”