Proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions

Also include egg shell - there are some products (a Clinicians hay fever one comes to mind) that are made from different bird egg shells.

Also need to be very clear whether this covers only chicken eggs, or other birds. I don’t know whether allergies to other bird eggs are common, we avoid all types of egg because my son is allergic to chicken egg.

I think it is important to ensure the statements differentiate between products that actually contain egg, and those which are cultured/manufactured in egg I.e. don’t let the manufacturer just take a conservative position and put ‘contains egg’ in all cases. An example of why this is important - I can’t give anything that contains actual egg to my son, but he is fine with vaccinations that had egg in the process. It would be a bad outcome if I avoided vaccinations or other medication due to a generic statement about the product containing egg.

I don’t know the reasons for the 3% limit, but as a consumer I’d prefer a lower threshold

Should have a ‘contains milk product (lactose)’ statement - if this is genuinely intended to make life easier for consumers, then think of it from a consumer point of view - we look for the high level statement first (i.e. milk) and then the specifics in the detailed ingredient list

I’m unsure about lactose - I think it should probably be included as well

Important to ensure manufacturers don’t take an overly conservative stance, and include an allergen statement when the specific product doesn’t in fact contain it. This often happens in food labelling, but the consequences of not being able to eat an item of food are substantially lower than those of unnecessarily avoiding a medicine.

It’s unclear why you wouldn’t just put this on all classifications - if the argument is that it’s generally not used in skin and mucous membrane applications then surely that’s a moot point? My concern is that any boundary like this creates grey areas, so unless there is a very strong case for the boundary it is better to include all applications.

I don’t understand the technical names, but I know that in food, we have reactions to soy lecithin as well as soy oil and soy bean products

The specifics are fine, but I would want to have confidence that manufacturers are incentivised/audited to ensure they meet some kind of standard for full refined soy oil for example - I know that even an incredible small amount of protein making it into my son’s food will make him very sick, so I would be very nervous of manufacturers self certifying, or even having contamination risk, without a requirement to declare that risk.

This statement is ok, but it would be better if they were also required to declare the actual component - many people are allergic to soy bean for example but can tolerate soy oil or lecithin. Specificity in the declaration would help avoid unnecessary restriction.

I don’t know what these are, but I assume they follow the inclusions for sulphites I’m food labelling. If not, it would be good to clarify this so consumers know what is different.

I would prefer if they had to specify which product it contains I.e. ‘contains tree nuts (almond oil)’ as many people are allergic to some but ok with others.

1. Important to ensure manufacturers don’t take an overly conservative stance, and include an allergen statement when the specific product doesn’t in fact contain it. This often happens in food labelling, but the consequences of not being able to eat an item of food are substantially lower than those of unnecessarily avoiding a medicine.

2. Include a mandatory review in the legislation 5 years post implementation, to ensure that regardless of politics or departmental prioritisation at the time, a review happens and ensures that this labelling actually does meet consumers needs.

3. Consider whether manufacturers will/should also use ‘may contain’ labelling, where there is a risk of cross contamination, and whether this should be regulated or some guidance provided. In food labelling, ‘may contain’ statements seem to be used very conservatively and as a result people avoid foods that may be safe. As per my first point, that’s ok with food as there are alternative choices, but wouldn’t be a good outcome for medicines.

4. Need to ensure there is significant resourcing to work with manufacturers/distributors to ensure labelling is applied correctly. Otherwise this is at best a waste of time and at worst it would cause people to doubt products that could actually be safe.

5. It is crazy that dietary supplements etc are not included in the required labelling. This should change.