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“Gluten-Free” – FDA Recently Defined the Term, So What Does that Mean for Manufacturers?

The sale of gluten-free foods is big business.  In fact, Americans spent more than $4 billion on gluten-free foods alone last year.  Whether an individual is diagnosed with celiac disease (an autoimmune digestive condition that can be effectively managed by eating a gluten-free diet), is gluten-sensitive, or has chosen to eliminate gluten as a trendy diet option, the gluten-free movement is a booming industry.

Until recently, there has been no regulatory definition of “gluten-free” in the United States and manufacturers have been able to use their discretion with regard to how much gluten they include in their food and dietary supplement products.

In early August, the Food and Drug Administration (FDA) at last defined what a “gluten-free” label on a food or dietary supplement package means, after more than six years of consideration.  According to the FDA, products labeled “gluten-free” will either have to be free of wheat, rye and barley or contain less than twenty parts per million of gluten.  The FDA considers the statements “no gluten,” “free of gluten,” or “without gluten” to be equivalent to a “gluten-free” claim.  According to the FDA, a food or dietary supplement that bears any of the foregoing claims in its labeling and fails to meet the requirements for a “gluten-free” claim will be deemed misbranded under the Federal Food, Drug and Cosmetic Act. The FDA also discourages the use of statements in labeling about the gluten content in foods or dietary supplements other than “gluten-free,” such as “low-gluten” or “very-low gluten,” because, according to the FDA, there is no scientific basis for these claims.

Requirements related to “gluten-free” labeling on drugs and cosmetics are outside the scope of the FDA’s rule, but the FDA is evaluating whether to address ingredients in human drug and cosmetic products that currently are derived from wheat, rye, or barley.

Manufacturers have until August 5, 2014 to review their food and dietary supplement products to ensure that they comply with the FDA’s rule, or to remove “gluten-free” or similar claims from their labels.

 The Way I See It

  •  I see that manufacturers should take note of this important rule, and begin the process of labeling revisions, or in some cases reformulation, as soon as possible in order to ensure compliance by the deadline.
  •  I see that the FDA is likely to issue further guidance on “gluten-free” labeling and that companies who fall outside the scope of the current rule, such as beer manufacturers and drug or cosmetic companies, should be cautious about making “gluten-free” claims.
  •  I see this decrement as part of a trend of special provisions relating to select ingredients.