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Lubricant Safety Update: Current Research and Advocacy EffortsGlobal Regulatory Issues
IRMA Global TeleconferenceJanuary 24, 2011Marc-André LeBlancIRMA Secretary, Lube Wrangler
Regulation
Don’t regulators have to review
safety data before lubes are on the
market?
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Regulation
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
3IRMA Lube Safety Working Group
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 4IRMA Lube Safety Working Group
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
5IRMA Lube Safety Working Group
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
6IRMA Lube Safety Working Group
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
7IRMA Lube Safety Working Group
Lack of clarity moment #2
Even if/when we know which lubes are better than others…
How does that translate into HIV/STI risk?
8IRMA Lube Safety Working Group
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
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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
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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?
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oSafety of lubricants for rectal use: A fact sheet for HIV educators and advocates
oSafety of lubricants for rectal use: Questions & Answers for HIV educators and advocates
rectalmicrobicides.org
irma-rectalmicrobicides.blogspot.com
THE BOTTOM LINE:MORE RESEARCH IS URGENTLY NEEDED TO EXPLORE IF THERE IS A LINK BETWEEN LUBE USE AND ACQUIRING HIV AND /OR RECTAL STIS
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Questions?14
