Proposed Label Warnings for Tablets, Capsules and other solid oral dosage forms

The TGA has published a public consultation, closing 11 July 2024, which includes proposals to introduce NEW labelling requirements. Under the proposal, all Listed Medicines that are: 

  • A large solid oral dosage form; AND 
  • Intended to be swallowed whole; AND 
  • Over a certain size threshold; 

would be required, after a transition period of 2 years, to include on the label for the container, intermediate packaging (if any) and primary pack: 

  • A statement to warn consumers: ‘Warning: large [short name of dosage form]’ such as ‘Warning: Large tablet’ 
  • An image of the dosage unit that is true to size with the words ‘actual size’ (unless at least one entire dosage unit can be seen through the container and primary pack without opening the packaging). 
  • The statement ‘Swallow with water’ in the directions for use. 

The proposal: 

  • Was triggered by serious choking related adverse event reports, mostly related to Glucosamine/chondroitin; Fish/krill oils/omega 3; Calcium with vitamin D3 and Multi-vitamin/minerals; 
  • Follows a targeted stakeholder consultation in August 2023; 
  • Does not propose separate or additional requirements for children’s medicines; 
  • Suggests that the TGA will consider further regulatory changes in future if the new labelling requirements are not enough to address the identified risks, which could include limits on the size of dosage forms. 

HAVE YOUR SAY 

Industry feedback to the TGA will be critical to the outcome. CMA encourages sponsors to: 

a) Respond to the TGA’s public consultation, including: 

    • The percentage of your products affected if the TGA proposed sizes were introduced 
    • What sizes are appropriate 
    • Commercial reasons why the 2 years transition period is insufficient 
    • The regulatory impact on your business 
    • Responding to the consultation questions* 

    b) Contact CMA to help inform the CMA industry response. technical@cmaustralia.org.au . 

    TGA PROPOSED SIZE THRESHOLDS FOR LABELLING INFORMATION   

    If adopted, the new requirements will apply where the size of each dosage unit exceeds the following:  

    • Oral tablets and oral dosage forms, other than capsules, where:  
    • the length or largest dimension is greater than 22mm, or  
    • the width, widest dimension or diameter is greater than 9mm, including round tablets with a diameter greater than 9mm. 
    • Oral capsules where: 
    • the length or largest dimension is greater than 23.3mm, or 
    • the width, widest dimension or diameter is greater than 9mm
    • Listed medicines that are the following solid oral dosage forms and exceed the proposed size thresholds will also be required to display the new information, unless the directions for use on the label are clear enough that if followed by consumers will not result in the dosage unit being swallowed whole. While these dosage forms do not usually include instructions to swallow whole, the TGA provides that in some cases consumers could still attempt to swallow them whole:  
    • lozenge 
    • pastille 
    • tablet, chewable 
    • tablet, dispersible 
    • tablet, effervescent 
    • tablet, orally disintegrating 
    • tablet, soluble 
    • gum, chewing 

    The TGA proposals are more restrictive than those proposed by CMA during the targeted consultation, with the exception of the >22mm length for oral tablets and oral dosage forms other than capsules, and are stated to be based on TGA adverse event data:  

    • 86% (139/161) of reports for tablets involved dosage units that were either >22 mm in length and/or >9 mm wide,  – of these 6% (9/139) involved round tablets with a diameter >9 mm. 
    • 92% (46/50) of reports for capsules involved dosage units that were either >23.3 mm and/or >9 mm wide.   
    • 32% (22/69) serious and 5% (5/92) non-serious33 reports involved tablets ≤22 mm but that were wider than 9 mm. 
    • 17% (4/24) serious and 19% (5/26) non-serious reports involved capsules ≤23.3 mm in length that were wider than 9 mm.  

    Notably only one serious report (and no non-serious reports) involved a long dosage unit (>23.3 mm capsule) that was <9 mm wide. 

    Information received by CMA from sponsor or manufacturers members during 2023 suggest that: 

    • Approximately 45-50% of all products are greater than 22mm long. 
    • Between 37% to 70% of all listed medicines are greater than 9mm wide.  

    Considering the number of products likely to be affected, proposed changes have the potential to have significant impacts, and further information on a regulatory Impact Analysis is currently being sought. 

    Solid oral dosage forms at the above sizes would also be likely to capture a number of OTC and prescription medicines. However, the current consultation will not capture registered medicines – the TGA state that these medicines  typically contain single or a small number of active ingredients at relatively lower doses than those used in listed medicines, so are less likely to be large dosage forms. 

    CMA also noted that, when any policy proposal or action of government, with an expectation of compliance, would result in a more than minor change in behaviour or impact for people, businesses, or community organisations requires a Policy Impact Analysis however, this has not occurred.  

    TGA PROPOSED LABELLING INFORMATION FOR LARGE ORAL DOSAGE FORMS  

    The label information for affected products would be required on the container, intermediate packaging (if any) and primary pack, but would not be required on the front panel where the name of the medicine is most prominently shown: 

    • A statement to warn consumers that the dosage units are large: ‘Warning: large [short name of dosage form]’
    • The TGA are proposing that the full name of the dosage form will not be required, as the message will be clearer to consumers if it is short. The large dosage form warning statement will be required to only include a shortened version of the dosage form name. For example: ‘Warning: large tablet’ or ‘Warning: large pill’. The label will still be required to display the name of the dosage form on the main label in accordance with paragraph 9(1)(d) of TGO 92.  
    • The TGA consider the warning statement for large dosage units is still needed even when they can be seen through the container and primary pack because consumers may not notice that the dosage units are too large for them to swallow unless they are warned by a label statement, which will prompt consumers to look through the packaging before selecting the medicine. 
    • An image of the dosage unit that is true to size with the words ‘actual size’, unless at least one entire dosage unit can be seen through the container and primary pack without opening the packaging. 
    • For dosage forms that exceed the threshold sizes, if at least one entire dosage unit is visible through the packaging, then it is proposed that the label image of a dosage unit is not required. This includes tinted packaging where a dosage unit can still be seen through the packaging around or through the label, or when viewed through the bottom surface.  It does not include packaging where an opaque label takes up most of the space, or where a single whole dosage unit cannot be seen when looking through the bottle around the edges of the label and also cannot be seen through the bottom of the bottle. 
    • If an image is required, it must be positioned next to the large dosage form warning statement. Medicine sponsors can choose where on the label to position these two requirements as long as they are next to each other. 
    • For dosage units that are not symmetrical, the image should show the dimension that exceeds the size threshold. If both length and width dimensions exceed the size threshold, the image should show the longest dimension, with the width shown as accurately as possible. Sponsors can choose to include two images, for example a ‘front’ and a ‘side’ view 
    • In the directions for use, the statement ‘Swallow with water’.  
    • The TGA consider the statement to ‘Swallow with water’ should be in the directions for use section on the label, as this part of the label is most likely to be read by consumers before taking the medicine. Based on CMA feedback via the targeted consultation the TGA have shortened the initially proposed statement to from ‘swallow with a glass of water’ to ‘Swallow with water’ as it can be expected that most consumers would understand that directions to ‘swallow with water’ means to take the medicine with enough water to facilitate effective swallowing.  
    • The TGA is seeking further feedback on whether slightly different statements should be allowed (for example: Take with fluid or liquid, and welcome feedback on whether there should be a list of acceptable directions that sponsors can choose from to display on the label. 

    CMA DRAFT POSITION (BASED ON 2023 INDUSTRY FEEDBACK) 

    Note: CMA’s final position is subject to change by the due date, based on further Member feedback. 

    Dosage form  Nominal sizes Action  
    Chewable tablets, capsules lozenges, pastilles, gum N/A Minimum statement in the Directions for Use:  A statement to the effect to chew or dissolve the tablets/ capsules/ pastilles/ lozenges as appropriate to the product. E.g., ‘Chew before swallowing.’ 
    Tablets – uncoated >22mm (L) AND >9.5mm(W)  OR  >23mm (L)  Minimum label advisory: ‘Large tablet’, and where label space permits, an actual size image of the tablet. (1) Advertising Note AND Minimum statements in the Directions for Use:  ‘swallow with water’ (or words to that effect) Only where suitable to the product: ‘tablet may be crushed’ (or words to that effect)  
    Tablets – film coated  >23mm (L) AND >10mm(W)  OR  >24 mm (L)  Minimum label advisory: ‘Large tablet’, and where label space permits, an actual size image of the tablet. (1) Advertising Note AND Minimum statements in the Directions for Use for film-coated tablets:  ‘swallow with water’ (or words to that effect) Only where suitable to the product: ‘tablet may be crushed’ (or words to that effect) Minimum statements in the Directions for Use for modified release tablets:  ‘swallow with water’ (or words to that effect) 
    Tablets with slippery coating  >23.5mm (L) AND >10.3 mm(W)  OR  >24.4mm (L) Minimum label advisory: ‘Large tablet’, and where label space permits, an actual size image of the tablet.(1) Advertising Note AND Minimum statement in the Directions for Use:  ‘swallow with water’ (or words to that effect) 
    Hard Capsules  0EL, 00EL, 00 or less No mandatory requirements.  
    000 Minimum label advisory: ‘Large capsule’ , and where label space permits, an actual size image of the capsule.(1) Advertising Note AND Minimum statement in the Directions for Use:  ‘swallow with water’ (or words to that effect)  Note: A mandatory statement to the effect that capsules can be opened is unsupportable as it depends on the product ingredients and properties as to whether this is suitable.  
    Soft Capsules  >26mm (L) AND >10.5mm (W);  OR  >27mm (L) (all widths)  OR  >26 Minim size  Minimum label advisory: ‘Large capsule’ , and where label space permits, an actual size image of the capsule.(1) Advertising Note AND Minimum statement in the Directions for Use:  ‘swallow with water’ (or words to that effect)  Note: A mandatory statement to the effect that capsules can be opened, pierced or squeezed onto food is unsupportable as it depends on the product ingredients and properties as to whether this is suitable. 

    Please see CMA’s full 2023 submission at the link below. 

    CONSUMER EDUCATION 

    The TGA has indicated that they intend to provide educational material for consumers on safer swallowing techniques through online forums (for example as a web statement and on social media), and encourage sponsors to provide educational material for consumers on their websites for large dosage units. Schiele et al. (2014) provide information. on techniques to make swallowing pills easier (Figure 1).  

    RESOURCES 

    • Schiele, J. T., Schneider, H., Quinzler, R., Reich, G., & Haefeli, W. E. (2014). Two techniques to make swallowing pills easier. Annals of family medicine, 12(6), 550–552. doi.10.1370/afm.1693 

    *CONSULTATION QUESTIONS (LARGE SOLID ORAL DOSAGE FORMS) 

    Question 12. Do you agree that the proposed dosage unit size thresholds for the labelling requirements are set at the right size? Please explain your answer. If you do not think the proposed size thresholds are set at the right size, do you think they should be smaller or larger than what we have proposed? Please ensure you read Appendix F and provide evidence to support your proposal. 

    Question 13. Is the word ‘Warning’ needed as part of the proposed label statement to alert consumers that the dosage unit is large and presents a risk? Please explain your answer. Please ensure you read Appendix F and submit evidence to support your proposal. 

    Question 14. Please tell us if you have any other comments about the proposed required warning statement.  

    Question 15. For large oral dosage forms, should alternatives to the directions ‘Swallow with water’ be allowed if they have a similar meaning? For example: ‘Take with fluid’. 

    Please explain your answer. If you think similar directions should be allowed, do you think there should be a list of acceptable directions that sponsors can choose from to display on the label? Please see Appendix F for further discussion about this. 

    Question 16. For large dosage forms, would dimensions of the dosage unit in millimetres (mm) in place of an ‘actual size’ image on the label be enough to inform consumers about size if dosage units can’t be seen through the packaging? Please explain your answer. Please refer to Appendix F for further discussion about this. 

    Question 17. Do you think the proposed guidance in Appendix G to support the proposed new requirements for large dosage forms is clear and easy to understand? Please explain your answer. 

    Question 18. Please tell us if you have any other comments about the proposed new labelling requirements for large solid oral dosage forms intended to be swallowed whole. 

    Please also refer to Appendices F and G of the consultation paper: Large solid oral dosage forms – Considerations for proposed new labelling rules   

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