Gluten-Free Claims on Dietary Supplements and OTC Drugs

In the past decade there has been an increasing awareness of, and questions about, gluten.  What is this substance?  Why are so many people concerned about its presence in foods, medicines and dietary supplements?

Gluten is a protein found in cereal grains. While present in all grains, it is the gluten in wheat, barley, rye (and, to a lesser extent, oats) that triggers an autoimmune response in people with a condition called celiac disease.  Not a typical food allergy, celiac disease patients are unable to digest gluten, resulting in inflammation of the small intestine such that nutrients from the food cannot be properly absorbed.

Once the condition is diagnosed, the management of the disease sounds simple; just avoid ingesting any product that contains gluten.  But this is not so easy when it comes to drugs and dietary supplements in which the list of ingredients may be long and unfamiliar. Questions from consumers pertaining to gluten content are therefore very common to companies manufacturing these products.

While many products on the market are labeled as “gluten-free”, the actual requirements to make this claim had not been defined by the FDA until recently.  The final rule (implemented as part of the Food Allergen Labeling and Consumer Protection Act) was published last year and became effective August 5, 2014.  It is currently applicable only to foods and dietary supplements.  For drug products (prescription, non-prescription, biologic and homeopathic) the FDA is currently evaluating responses received to a December 2011 Federal Register notice requesting public comments.

The use of the term “gluten-free” on product labeling is strictly voluntary.  However, if a dietary supplement company is making this claim, it now means that the product does not contain any ingredient that is: 

1.    a gluten-containing grain
2.    derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 
3.    derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food

In addition, any unavoidable presence of gluten in products labeled as gluten-free, whether manufactured as such or that are inherently free of gluten, must be below 20 ppm.

The rule does not require companies to test their products for the presence of gluten but, if the gluten-free claim is made on any item, the company is responsible for ensuring that it contains less than 20 ppm of gluten.  This can be accomplished through:

•    testing the ingredients for gluten content using a scientifically valid method
•    requesting certificates of analysis from raw material suppliers, indicating gluten testing has been performed
•    participating in a third-party gluten-free certification program

Whichever method is chosen, appropriate records should be maintained, as always, in accordance with applicable regulation.  Also, companies should ensure that their responses to gluten content enquiries from consumers take into account the 20 ppm threshold.  While these responses would not fall under FDA’s definition of a label claim, this new requirement should be applied consistently in all product communications to avoid confusion.

For industry, this ruling provides a single definition and standard for ensuring product labeling is in compliance.  For consumers with celiac disease, or others who just want to avoid gluten in their diet, it provides confidence that such claims mean the same thing for all dietary supplements they may be using.