The FDA issued a warning letter to Novartis for their "Facebook Share" functionality on the website for the drug Tasigna. The letter cited that shared posts about Tasigna omitted important risk information and broadened the approved use of the drug. This suggests the FDA considers shared social media posts to be promotional material that requires pre-clearance and balanced risk/benefit disclosures like other promotional content. Marketers must understand how social sharing tools generate messages and ensure compliance with FDA regulations to avoid enforcement actions.