“Gluten in Drug Products and Associated Labeling Recommendations: Guidance for Industry”
The Gluten Intolerance Group of North America, Washington nonprofit corporation (“GIG”), has been empowering the gluten-free community through consumer support, advocacy, and education for over four decades. GIG appreciates all of the FDA’s efforts to provide consumers with clarity around the gluten content of certain foods and beverages, including the FDA’s recent efforts to clear up uncertainty regarding the presence of gluten in drug products. However, GIG fears that the FDA’s current draft guidance is counterproductive and that industry adoption of its recommendations would create more confusion than it would prevent. Accordingly, GIG has two specific concerns with the draft guidance as currently written and one suggestion for increasing consumer awareness.
1. The draft guidance would create a wholly separate FDA “gluten-free” standard for drug products, creating consumer confusion about what “gluten-free” actually means for goods under the FDA’s purview.
The FDA’s food labeling regulations currently provide that a product may be labeled as “gluten-free” if that product contains 20 ppm or less of gluten. 21 C.F.R. 101.91. In the years since the FDA promulgated that rule, consumers have become aware of the rule’s significance and meaning. Consumers, particularly those with strict gluten sensitivity, understand that food product labeled with “gluten-free” means that the product has less than 20 ppm gluten. Consumers are also aware that the “gluten-free” statement encapsulates both ingredient and manufacturing controls.
Now, however, the FDA seeks to encourage a parallel labeling system whereby some FDA regulated goods contain the statement “Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).” Upon reading this statement, consumers would be left wondering what practical difference exists between that statement and a “gluten-free” statement on other FDA regulated products. Does this statement mean that there is less than 20 ppm gluten? More? What does the lack of a gluten-containing grain mean for the ultimate gluten content of the food?
There are more informative and less confusing labeling options to encourage, such as “gluten-free ingredients.” Such a statement would be more consistent with the FDA’s food labeling requirements and be more accessible to consumers. The FDA should seek to promote, where possible, a consistent system of gluten-free labeling across all product groups. Adopting two inconsistent standards increases, not decreases, consumer confusion. GIG encourages the FDA to adopt guidance which encourages a consistent and easy to understand standard across product groups.
2. If industry groups adopted the proposed guidance, certification marks such as GIG’s, which provide valuable and necessary information to consumers, would not be allowed on packaging.
If industry groups were to follow the recommended labeling provided by the proposed guidance, certification marks such as GIG’s, which consumers nationwide have come to rely upon, would not be allowed on drug product labeling. To be sure, consumers have come to rely on GIG’s certification program, the Gluten-Free Certification Organization (“GFCO”). GFCO currently certifies over 45,000 products in 29 different countries. The GFCO allows certified products to affix the following certification mark to their packaging:
Members of the gluten-free community have come to know and understand that a product, regardless of if it is a food product, beverage, supplement, or personal care product, which features the GFCO certification mark is subject to GFCO’s strict certification requirements. Among other things, consumers who observe GFCO’s mark understand that the certified product is subject to:
This information is precisely the kind of information that the FDA is seeking to provide to consumers. Unfortunately, however, if drug manufacturers were to follow the proposed guidance, it is precisely the kind of information which would be banned from drug labels. The result would be a less, not more, informed consumer base.
Alternatively, GIG requests guidance which would enable a drug manufacturer to place a certification mark which clearly identifies the source of the certification, further eliminating any sort of potential for consumer confusion or misbranding concerns under Section 502(a) of the GF&C Act, 21 U.S.C. §352(a). GFCO currently uses the following certification mark on products subject to USDA labeling:
If the FDA believes that the statement “gluten-free” has the tendency to mislead consumers in the context of drug packaging, such a logo clearly identifies that the product in question is certified by GFCO and GFCO alone. Consumers, if not already aware of GFCO’s labeling standards, can access those standards easily online. GIG requests that the FDA issue guidance which allows drug manufacturers to, at the very least, be able to provide this information to consumers.
3. The FDA could greatly increase consumer awareness by issuing proposed rulemaking requiring drug manufacturers to identify all ingredients which contain gluten.
In the proposed guidance, the FDA notes that under current rules the FDA is only able to require drug manufacturers to label ingredients containing gluten in limited circumstances. GIG suggests that the FDA issue proposed rulemaking requiring drug manufacturers, prescription and non-prescription alike, to list all ingredients which contain gluten on the outside of the drug’s packaging. The labeling should be done in a way that allows gluten sensitive consumers to identify ingredients containing gluten quickly and easily.
Such a solution would increase consumer awareness. It would allow those consumers that the FDA worries are skipping their medications on account of the potential gluten content of medications to unquestionably know that there is no gluten in the medication. It would further be able to be consistent with the FDA’s requirements with regard to food labeling, increasing consumer awareness across product groups.
In sum, the guidance as currently constructed would only serve to increase consumer confusion regarding the potential gluten content of drug products. GIG sincerely requests that the FDA issue proposed guidance that allows more, not less, information to be present and accessible in drug product labeling. GIG further requests that the FDA endeavor to provide a uniform standard for gluten-free goods among all goods under its regulatory purview.