TGA
We initiated targeted compliance reviews of selected listed medicines containing Lysine Hydrochloride to verify whether sponsors had appropriate evidence to support their cold sore-related claims.
We found that the evidence provided by the sponsors was inadequate to support the cold sore-related claims. Consequently, all sponsors removed the unsupported claims from their medicines and their advertisements.
If you are a sponsor of a listed medicine containing Lysine Hydrochloride that makes claims regarding cold sores, you are encouraged to:
- review your supporting evidence using the Evidence Guidelines; and
- re-assess how your product is presented and ensure all claims-especially those related to cold sores-are accurate, truthful, and not misleading.
For more details, please visit the Compliance and education for listed medicines page.
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