1. 1 Lubricant Safety Update: Current Research and Advocacy Efforts Global Regulatory Issues IRMA Global Teleconference January 24, 2011 Marc-André LeBlanc IRMA Secretary, Lube Wrangler

2. Regulation 2

3. Regulators in various countries classify lubes differently, depending on claims made by manufacturers Application of different sets safety criteria for exact same product in different countries U.S. classifies lubes as medical devices Canada classifies them as cosmetics 3 IRMA Lube Safety Working Group

4. Regulation Safety criteria for medical devices usually stricter than cosmetics criteria IRMA – current criteria insufficient based on info from lube studies to date U.S. simply requires data from studies that test whether lubes irritate rabbit vaginas Insufficient re: safety in human rectums 4 IRMA Lube Safety Working Group

5. Regulation In some contexts, some lubes are on the market w/out any regulatory approval Some regulatory agencies have little to no power or resources to: force manufacturers to seek regulatory approval take action regarding products that may not be safe 5 IRMA Lube Safety Working Group

6. Regulation Even in jurisdictions where : Regulatory agencies have very clear and stringent safety criteria Power and resources to enforce rigorously May still be no requirement to demonstrate safety for rectal use Manufacturers rarely indicate product intended for that use 6 IRMA Lube Safety Working Group

7. Regulation – lack of clarity moment #1 No clarity around safety tests to recommend, even if regulations demanded them Regulators likely to be hesitant to enforce tests that would yield limited safety info Here’s the rub 7 IRMA Lube Safety Working Group

8. Lack of clarity moment #2 Even if/when we know which lubes are better than others… How does that translate into HIV/STI risk? 8 IRMA Lube Safety Working Group

9. What is IRMA doing? Urge researchers to test lubes for rectal safety and to share findings Facilitate dialogue leading researchers/advocates in Lube Safety Working Group (wanna join?) Compile articles, studies maintain background document 9

10. What is IRMA doing? Make IRMA’s list of most widely- used lubes available to anyone interested in testing lubes Monitor how regulatory agencies in various countries address lube safety Engage with lube manufacturers Keep IRMA membership updated 10

11. Conclusions Water-based lubes don’t look great BASED ON THE TESTS CONDUCTED TO DATE We don’t know how this translates into real-world use, real-world risk Is there a commitment to find out? Can we ever imagine advocating for AI without lubricant? 11

12. 12 o Safety of lubricants for rectal use: Safety of lubricants for rectal use: A fact sheet for HIV educators and advocates o Safety of lubricants for rectal use: Questions & Answers for HIV educators and advocates Safety of lubricants for rectal use: Questions & Answers for HIV educators and advocates rectalmicrobicides.org irma-rectalmicrobicides.blogspot.com

13. 13 IRMA Lube Safety Working Group

14. Questions? 14

15. Thank you Marc-André LeBlanc maleblanc27@yahoo.ca 15