Guidance on gluten labelling of pharmaceutical products

This white paper considers the FDA’s guidance on gluten labelling within the pharmaceutical sector, whilst also reflecting on RSSL’s extensive experience and expertise in allergen management and testing

Sufferers of Coeliac (Celiac) disease have a severe reaction to gluten when consumed in their diet. Currently, approximately 20 people in 100,000 (0.02%) have been diagnosed with this disease.

Grains such as wheat (Triticum species), Rye (Secale species) and Barley (Hordeum species) and all of their cross-breed species contain a set of proteins of the Prolamin and Glutamin families that together are termed ‘gluten’. Gluten is also defined by the FDA as ‘proteins that naturally occur in a gluten containing grain and that may cause adverse health effects in persons with celiac disiease’.

Gluten when ingested triggers the body’s immune system to attack itself leading to damage to the gut lining and therefore reduced absorption of nutrients. For those suffering with the disease the only relief is living a gluten free lifestyle where gluten is avoided in all products consumed or placed directly on the skin. Severe suffers of Coeliac disease extend this life choice to all orally consumed products including drugs.

The food industry has been regulated with regard to gluten labelling for many years. Food labelled as ‘Gluten Free’ is required to have less than 20 mg/kg of gluten to be compliant with the current FDA food labelling regulations. Under these regulations a food product is ‘gluten-free’ if it meets the following criteria;

  1. No ingredient is a gluten containing grain
  2. Any ingredient that is in category (1) that has been processed to remove gluten
  3. If in category (2) then the level of gluten is below 20 ppm (mg gluten per kg of food)

In December of 2017 the FDA issued a guidance document considering the topic of drug labelling requirements with regard to the presence of gluten.

This guidance pertained only to human drug products that were either orally ingested, applied to or near the lips or were applied to the inside of the mouth. The guidance does not cover products that are solely regulated as cosmetics. The guidance document considered the likely ingredients of oral drug products that would be relevant...

Click here to access the full white paper.

Companies