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FDA Issues Guidance on Gluten Labelling of Certain Drug Products

The FDA has issued a draft guidance document on gluten in drug products and associated labelling recommendations. While the guidance does not establish any legally enforceable responsibilities, it conveys to drug manufacturers the FDA’s recommendations on how certain oral drug products should be labelled regarding gluten, which is a matter of interest to individuals with celiac disease. The guidance encourages manufacturers to have accurate information about their products’ gluten content available so that they can respond to questions from consumers and health care professionals.

The FDA’s food labelling regulations define gluten as proteins that naturally occur in wheat, barley and rye, or their cross-bred hybrids, and that may cause adverse health effects in persons with celiac disease (e.g., prolamins and glutelins). The guidance is limited to oral drug products because gluten is not believed to harm individuals with celiac disease through routes of exposure other than oral or enteral ingestion.

According to the FDA, if a drug includes an ingredient derived from wheat, barley or rye, the ingredient would most likely be wheat-derived. The amount of gluten potentially contributed by a wheat-derived ingredient to a unit dose of an oral drug product (unless that ingredient is wheat gluten itself or wheat flour) is expected to be less than 0.5 milligrams as a high estimate. Most oral drug products are not expected to contain ingredients derived from wheat, barley or rye, however, and the likelihood of them including more than one such ingredient is even less. Thus, it is expected that the amount of gluten potentially present in a unit dose of an oral drug product is less than the amount of gluten that could potentially be found in a single serving of a cookie (30 grams) labelled gluten-free in accordance with FDA regulations. Moreover, the amount of gluten estimated to be potentially present in a unit dose of an oral drug product (less than 0.5 mg) is significantly less than the range at which gluten is estimated to be present in a gluten-free diet (5 to 50 mg).

In light of all of this, the FDA believes that individuals who respond well to a gluten-free diet are at low risk of experiencing problems as a result of the possible presence of gluten in a drug product. However, the agency expects that they might choose to avoid using oral drug products labelled as containing wheat gluten or wheat flour as an ingredient in the absence of more information about the product’s actual gluten content. Accordingly, the FDA recommends that drug manufacturers that wish to make statements about gluten anywhere on oral drug product labels or in required labelling use the following statement, when it is truthful and substantiated: “Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).”

The FDA would interpret such a statement to mean that the manufacturer knows that no ingredient in  the product was derived directly or indirectly from wheat, barley or rye, or their cross-bred hybrids. This would preclude, for example, the use of ingredients derived from wheat starch or from starch of unknown botanical origin. It would also preclude the use of ingredients produced through a fermentation process if the fermentation medium is not known to be free of ingredients derived from wheat, barley or rye, or their cross-bred hybrids.

The FDA encourages the use of this recommended labelling statement to provide health care professionals and consumers with consistent, clear, accurate and readily understood information about the gluten content of the pharmaceutical products they use. Moreover, this phrase allows easy searching for terms such as gluten and wheat. This recommended labelling statement does not describe a drug as gluten-free because the FDA has not established criteria for gluten-free statements on oral drug products and it may be difficult to substantiate that a drug product is free of gluten.

The FDA adds that firms are responsible for the truthfulness of their gluten-related labelling statements and for ensuring that the information related to their oral drug products supports the use of such statements. Firms should also have supporting information available, including information from ingredient suppliers about their processes and raw materials. For firms wishing to use the recommended labelling statement, substantiation for such a statement should include a written commitment from ingredient suppliers that, for each ingredient potentially derived from wheat, barley, rye or their cross-bred hybrids or produced through fermentation, these grains are not used in the production of the ingredient.

For statements other than the recommended labelling statement, the supporting information could vary by product. For example, firms may be able to test individual wheat-derived ingredients for the absence of nitrogen (indicating an absence of all protein, including gluten) or they may be able to provide information demonstrating that the processing of such ingredients removes the gluten.

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