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

Response 930761831

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Your details

3. Are you providing feedback:

Please select one item
As an individual
Ticked On behalf of an organisation or group

4. Where are you or your organisation based?

Please select one item
Ticked New Zealand
Australia
Other

5. Which of the below options best describes you in the context of this consultation?

Please select one item
Healthcare professional
Member of the public
Sponsor
Manufacturer
Supplier
Importer
Government organisation
Researcher
Professional body
Ticked Industry organisation
Consumer organisation
Institution (eg, university, hospital)
Regulatory affairs consultant
Laboratory professional
Other

Antibiotics

1. Should labels include a warning statement for antibiotics?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for antibiotics?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for antibiotics?

Please select one item
Ticked Yes
No

Aspartame

1. Should labels include a warning statement for aspartame?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for aspartame?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for aspartame?

Please select one item
Ticked Yes
No

Benzoates

1. Should labels include a warning statement for benzoates?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Benzoic acid, Sodium benzoate)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for benzoates?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for benzoates?

Please select one item
Ticked Yes
No

Crustacea and crustacean products

1. Should labels include a warning statement for crustacea and crustacean products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Crab, Crayfish, Lobster, Prawn, Shrimp)?

Please select one item
Ticked Yes
No
If no, please suggest alternative inclusions
Krill should also be included as a crustacean

3. Do you agree with the proposed conditions for crustacea and crustacean products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for crustacea and crustacean products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Contains Shellfish - Crustacea.
Consumers may be more familiar with the terms "shellfish", rather than crustacea. This may also prompt those with allergies to molluscs to ask questions to determine whether the medicine is safe for them.

Egg products

1. Should labels include a warning statement for egg products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Dried egg yolk, Egg, Egg lecithin, Influenza vaccine, Products manufactured in eggs)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for egg products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement?

Please select one item
Ticked Yes
No

Ethanol

1. Do you agree with the proposed conditions for ethanol?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed warning statement for ethanol?

Please select one item
Ticked Yes
No

Fish and fish products

1. Should labels include a warning statement for fish and fish products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Cod, Cod liver oil, Halibut, Shark, Tuna)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for fish and fish products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for fish and fish products?

Please select one item
Ticked Yes
No

Galactose

1. Should labels include a warning statement for galactose?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for galactose?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for galactose?

Please select one item
Ticked Yes
No

Gluten

1. Should labels include a warning statement for gluten?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Ingredient derived from gluten-containing grain, Wheat starch)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for gluten?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for gluten?

Please select one item
Ticked Yes
No

Hydroxybenzoic acid esters

1. Should labels include a warning statement for hydroxybenzoic acid esters?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Ethyl hydroxybenzoate, Methyl hydroxybenzoate, Propyl hydroxybenzoate, Sodium ethyl hydroxybenzoate, Sodium methyl hydroxybenzoate, Sodium propyl hydroxybenzoate)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for hydroxybenzoic acid esters?

Please select one item
Ticked Yes
No

Lactose

1. Should labels include a warning statement for lactose?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for lactose?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for lactose?

Please select one item
Ticked Yes
No

Milk and milk products

1. Should labels include a warning statement for milk and milk products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Casein, Hydrolysed milk protein, Non-fat dry milk, Whey powder, Whole dry milk)?

Please select one item
Ticked Yes
No
If no, please suggest alternative inclusions
Include colostrum

3. Do you agree with the proposed conditions for milk and milk products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for milk and milk products?

Please select one item
Ticked Yes
No

Peanuts and peanut products

1. Should labels include a warning statement for peanuts and peanut products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Arachis hypogaea, Arachis (peanut) oil)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for peanuts and peanut products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for peanuts and peanut products?

Please select one item
Ticked Yes
No

Phenylalanine

1. Should labels include a warning statement for phenylalanine?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for phenylalanine?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for phenylalanine?

Please select one item
Ticked Yes
No

Pollen

1. Should labels include a warning statement for pollen?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for pollen?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for pollen?

Please select one item
Ticked Yes
No

Potassium salts

1. Should labels include a warning statement for potassium salts?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Potassium bicarbonate, Potassium chloride)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for potassium salts?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for potassium salts?

Please select one item
Ticked Yes
No

Propolis

1. Should labels include a warning statement for propolis?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for propolis?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for propolis?

Please select one item
Ticked Yes
No

Royal jelly

1. Should labels include a warning statement for royal jelly?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for royal jelly?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for royal jelly?

Please select one item
Ticked Yes
No

Saccharin

1. Should labels include a warning statement for saccharin?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Saccharin calcium, Saccharin sodium)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for saccharin?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for saccharin?

Please select one item
Ticked Yes
No

Sesame and sesame seed products

1. Should labels include a warning statement for sesame and sesame seed products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Sesame seed, Sesame oil, Sesamum indicum)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sesame and sesame seed products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sesame and sesame seed products?

Please select one item
Ticked Yes
No

Sodium salts

1. Should labels include a warning statement for sodium salts?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Sodium bicarbonate, Sodium chloride)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sodium salts?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sodium salts?

Please select one item
Ticked Yes
No

Sorbic acid and sorbic acid salts

1. Should labels include a warning statement for sorbic acid and sorbic acid salts?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusion (Potassium sorbate)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sorbic acid and sorbic acid salts?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sorbic acid and sorbic acid salts?

Please select one item
Ticked Yes
No

Soya beans and soya bean products

1. Should labels include a warning statement for soya beans and soya bean products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Glycine max, Soya bean, Soya oil)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for soya beans and soya bean products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for soya beans and soya bean products?

Please select one item
Ticked Yes
No

Sucralose

1. Should labels include a warning statement for sucralose?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for sucralose?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for sucralose?

Please select one item
Ticked Yes
No

Sugar alcohols

1. Should labels include a warning statement for sugar alcohols?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Erythritol, Isomalt, Lactitol, Maltitol, Mannitol, Polydextrose, Sorbitol, Xylitol)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sugar alcohols?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sugar alcohols?

Please select one item
Ticked Yes
No

Sugars – monosaccharides and disaccharides

1. Should labels include a warning statement for sugars (monosaccharides and disaccharides)?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Fructose, Glucose, Honey, Invert sugar, Lactose, Maltose, Sucrose)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sugars?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sugars?

Please select one item
Ticked Yes
No
If no, please suggest an alternative statement
A statement of "Contains xxx mg total sugars per tablet/capsule/etc" may be more useful especially for those patients who are monitoring sugar levels.

Sulfites

1. Should labels include a warning statement for sulfites?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Potassium metabisulfite, Sodium bisulfite, Sodium metabisulfite, Sodium sulphite, Sulfur dioxide (including residues))?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sulfites?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sulfites?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The threshold for sulfite inclusion should align with the Food Code of 10mg/kg. Sulfites are found in common excipients such as gelatin and maltodextrin. If a "0" level is set as the threshold, many medicines will require this proposed statement, whereas foods which contain much more of this allergen will not be labelled.

Tartrazine

1. Do you agree with the proposed conditions for tartrazine?

Please select one item
Ticked Yes
No

Tree nuts and tree nut products

1. Should labels include a warning statement for tree nuts and tree nut products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Almond oil, Brazil nut, Cashew, Chestnut, Juglans nigra, Macadamia nut oil, Macadamia ternifolia, Prunus dulcis, Walnut)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for tree nuts and tree nut products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for tree nuts and tree nut products?

Please select one item
Ticked Yes
No

Implementation date

1. Do you agree with the proposed implementation date of 1 September 2020 (1/09/2020)?

Please select one item
Yes
Ticked No
If no, please suggest an alternative date
TGO92 and its new warning statements came into force on 15/8/2017, with the aim of full compliance by September 2020. This is a 3 year transition for sponsors to amend their labels and become compliant. If this same implementation date is required for NZ medicines, then this transition period will be less than one year, and may result in significant packaging write-offs. A 3 year transition for full compliance is recommended.

Other comments

1. Do you have any other comments about this consultation?

Do you have any other comments?
We agree that allergen identification is important for the consumers of Medicines, and all other consumed products to reduce the risk of undesirable reactions. A general alignment of Medicine warning statements with TGO92 in Australia is supported.

We appreciate the opportunity to comment on this consultation, and also welcome the opportunity to be further involved in this process.