NONOXYNOL-9: BETTER SAFE THAN SORRY?
By Bohdan Zachary
Out Magazine Feb./March 1994
A dispute over the regulation of lubricants reveals a potential hazard for AIDS. Bohdan
Zachary squeezes out the truth.
During the past two years a little-publicized health battle has been waged out
of the glare of the media. It concerns nonoxynol-9, a disinfectant found
in everything from baby wipes to laundry detergent, as well as in sexual
products such as contraceptive foams and gels, condoms, and lubricants.
Invented as a contraceptive, nonoxynol-9 was found to help prevent
sexually transmitted diseases (STDs) such as chlamydia, gonorrhea, and
herpes by killing sperm and cells in the vaginal tract. It also kills the
human immuno-deficiency virus in the test tube, according to laboratory
tests of commercial sexual products. As little as 0.05 percent of
nonoxynol-9 in a solution stops HIV from reproducing, while a 1 to 5
percent concentration may kill cells harboring dormant HIV.
overnight nonoxynol-9 be came a household word, synonymous with safer sex.
By adding nonoxynol-9 to their products, cosmetics and pharmaceutical
manufacturers boosted their already multibillion-dollar sales. It was not
unlike the 1980s boon to skin-care products that contained collagen,
another advertising gold mine.
In the video commercial that helped turn
Wet Personal Lubricant into the best-selling lubricant in the world, porn
star Rex Chandler touches his nipple. "Touch me there." He pours Wet over
his erect penis. Another camera angle. "Tighter," he says,
"longer-hotter-feel it." The camera closes in on his contorted face as he
climaxes. The screen credits end with the words: "Wet, with nonoxynol-9,
aloe vera, and vitamin E."
Unknown to most consumers, however, is
nonoxynol-9's reported toxicity, a downside that since 1990 has caused
several national and international organizations like the U.S. Centers for
Disease Control and the World Health Organization to quietly reconsider
promoting its use. WHO officials had gotten wind of an increasing number
of complaints by women using spermicides and contraceptive sponges with
nonoxynol-9 who experienced vaginal and cervical ulcers, burning
sensations, and recurring yeast infections. Many were Nairobi, Kenya,
prostitutes whose sexual experiences were dismissed by some critics as
unrepresentative of the average woman.
Their complaints also
contradicted an initial 1980 Food and Drug Administration study that had
deemed nonoxynol-9 "safe and effective . . . as a vaginal contraceptive"
on the basis of one animal study of vaginal use and "lack of reports of
significant adverse effect in humans [emphasis added]." But the FDA study
did not base its conclusions on normal daily use of spermicides in women,
nor did it address nonoxynol-9's effectiveness against STDs and HIV.
1991 a very different picture was painted by Dr. Kristina Bird,
information officer at the London-based National HIV Information Service.
In a review of nonoxynol-9 for the journal AIDS, Bird agreed that studies
proved its efficacy against HIV and STDs in the test tube, but she also
found: "The wider literature on these products reveals frequent minor
reference to local toxicity, with rates of reported genital irritation
ranging from 'minimal' to more than 10 percent." She cautioned, "The
protective effects of nonoxynol-9 have not been established in vivo [in
the body] for any of the viral STDs."
More important, Bird posed the
frightening question that gave pause to international health officials:
"Does the ability of nonoxynol-9 to inactivate lymphocytes in the test
tube suggest that it may increase the body's vulnerability to infection in
vivo?" That is, will nonoxynol-9 increase your risk for HIV instead of
AIDS advocates shared a similar concern, worrying that
consumers -- gay men in particular -- were relying on nonoxynol-9 to
protect them and forgetting the main ingredient in safer sex: condoms. "We
get lots and lots of calls from kids, young kids, wondering if they could
get by with just using lubricants instead of condoms," says Michael James
Gong, a former hot-line volunteer at the San Francisco Emergency AIDS
Fund. "That's like putting a loaded gun to your head." Backing Gong's view
are recent reports in the gay and mainstream media suggesting that an
increasing number of gay men have abandoned safer-sex practices, and
'hence condoms. Meanwhile, sales of dildos and lubricants with nonoxynol-9
to lesbians have steadily increased.
Alarmed AIDS activists lobbed
Bird's provocative question to the FDA, only to see it fall into an abyss
of regulatory red tape, where it remains today. Government officials, it
seems, can't agree about how to classify different products containing the
disinfectant. Contraceptive foams and gels are classified as
over-the-counter drugs by the FDA, while condoms are considered medical
devices -- both classes of products used internally and therefore subject
to stringent quality control. Manufacturers must list the exact percentage
of nonoxynol-9 and other ingredients; the minimum concentration for
contraceptives is 3 percent, but some spermicides go as high as 15
Lubricants were initially developed for external use, on the
skin, particularly during sexual intercourse. As long as manufacturers
make no explicit claims for disease prevention or contraception, the FDA
labels lubricants as cosmetics, defined by the Federal Food, Drug, and
Cosmetic Act as articles intended to be applied to the human body for
cleansing, beautifying, promoting attractiveness, or altering the
appearance without affecting the body's structure or functions." Most
lubricant makers do not list the percent age of their ingredients because
of that gray area in FDA guidelines, which do not recognize that the
lubricant is typically an adjunct to a medical device -- a condom. Many
AIDS advocates feel that lubricants in themselves fail the cosmetics
definition since they cause vaginal irritation and yeast
"The situation with lubricants and nonoxynol-9 isn't all
that different from what happened when the FDA did nothing about the
complaints it received from women about silicon-gel breast implants,"
states Brenda Lein of the AIDS information group Project Inform. "It's
business as usual." Lein is technically right: Breast implants, though
placed (like lubricants) inside the body, are intended for cosmetic
purposes not viewed as medically necessary, even for women who have lost
breasts to cancer. But as with the debate over breast implants the real
issue underlying lubricant regulation is not consumer safety but
While the distinction between cosmetics and drugs may appear
minor on paper, it represents millions to manufacturers. Getting FDA drug
approval is a lengthy, money-consuming process, and many products fail the
test. Not so for a cosmetic. Lubricant manufacturers, under fire from AIDS
activists over nonoxynol-9, correctly argued that under FDA guidelines
they are not required to list the ingredient percentages. (The FDA could
use such labeling to reclassify the products as over-the-counter drugs,
subject to stricter controls.) Consumers must rely on the manufacturers'
claims of quality control.
Despite the growing controversy, the FDA has
done little to clear up the inconsistencies in its policy over nonoxynol-9
and has directed concerned consumers to independent state agencies. Since
most lubricant manufacturers are located in California, Bird's question
was directed to Allen Davidson, director of the Food and Drug Branch of
California Health Services. Not surprisingly his agency balked at testing
lubricants with nonoxynol-9 to determine safety in terms of increased
exposure to HIV. "Given our limited resources, we have to deal with those
things that we consider real health hazards," contends Davidson, while
admitting that "nonoxynol-9 has not been shown through well-controlled
scientific studies to prevent STDs; AIDS, and/or HIV."
response frustrates some lubricant manufacturers who worry about harming
consumers and the possibility of future lawsuits if such studies are done
to show nonoxynol-9 is dangerous -- even at 1 percent.
[regulators] don't want to categorize lubricants because they don't know
where it should fall," complains Robin Ogilvie, president of Trimensa
Corporation, maker of the lubricants ForPlay and PrePair. "The FDA is not
creative, just very administrative."
Red tape aside, others have
suggested another reason for the FDA stalemate. One agency official who
requested anonymity says frankly, "Since lubricants are associated with
anal intercourse, they sit very, very low on the totem pole of priorities
at the FDA."
Perhaps ironically, the gay media was the first to alert
the general public to the debate over nonoxynol-9, following the recall of
Wet lubricant batches by its manufacturer, Dynamic Concepts, in February
I992. In a letter to Wet retailers and distributors, company president
Michael Trygstad informed them that "due to problems with our former
manufacturer, Topco Sales," certain shipments failed to meet "our high
standards for providing quality products." He urged them to return
"watery" or "discolored" samples. Trygstad says that he also issued a
similar letter to inform consumers but that the gay press ignored
While regulatory health agencies ducked the issue, three
independent parties -- gay sexologist Dr. Clark Taylor, Condom Sense (a
trade magazine), and the late Dr. Larry Waites (my partner and then
columnist for The Advocate) -- commissioned independent laboratory tests
of Wet Personal Lubricant samples, using FDA standards. All the
conclusions were the same: Prior to batch No. 1170, which was issued March
9, 1993, Wet contained less than the recommended 1 percent concentration
of nonoxynol-9. When Waites published his lab's results in an Advocate
article, Wet's Trygstad protested and a fax war broke out between the two.
The debate spread to other lubricant manufacturers as well, resulting in
bad press for Wet but higher lubricant-industry standards overall.
has contained a minimum of 1 percent nonoxynol-9 since the manufacturing
of lot No. 1170," asserts Trygstad. He confirms that at the time of the
voluntary recall of defective Wet batches in early 1992, "We changed to a
new formulator who has been doing an excellent job. All of the old formula
was replaced by the new formula, at no charge to the retail outlets or
distributors." From February 1992 until March 1993, however -- batches
1148 to 1170 -- Wet contained only 0.1 per cent nonoxynol-9.
most lubricants -- including Wet Personal Lubricant -- contain at least 1
percent nonoxynol-9, the concentration considered protective against HIV.
But buyers still won't be able to read the exact ingredient proportions.
And despite Trygstad's written assurances, no one -- not the manufacturer
nor state or federal officials can absolutely verify that store owners
have removed from their shelves Wet samples issued between February 1992
and March 1993. Nor can anyone say how many people bought and used or
still have those samples.
"The consumer has been left in the dark by
the national health watch dog, and that is unacceptable," fumes Dr.
Taylor. Barbara Garcia, an HIV educator with Planned Parenthood in the Bay
Area who has counseled over 100 HIV-positive women, agrees: "The word is
not out about nonoxynol-9. The only way I learned about the irritation
caused by nonoxynol-9 was by listening to the women I work with."
now the daunting question Bird raised more than two years ago remains
troubling: Can the minor toxicities associated with nonoxynol-9 in sexual
products increase one's risk of HIV infection? At the FDA the anonymous
executive defends his agency's inaction: "When we had people get sick and
die from bad meat, we could put E. coli under the microscope and see it.
With HIV and STDs and lubricants and nonoxynol-9, there's no way to know
something for over 10 years, if someone seroconverted because they used
only a lubricant with nonoxynol-9." Stuck in the gap between a drug and a
cosmetic, he adds, "lubricants with nonoxynol-9, therapeutic doses,
intended uses . . . these are just ethereal concepts in the FDA's
The current demand for a vaginal microbicide may spur government
officials into action. Already a private epidemiologist in Research
Triangle Park, North Carolina, has proposed a clinical trial of
nonoxynol-9 involving 1,000 women to determine its safety in
With the jury still out on nonoxynol-9, AIDS activists
do have a simple word of advice for consumers regarding lubricants: Don't
take a chance. Always use a condom.
Bohdan Zachary is a San Francisco-based journalist and Emmy Award-winning
television news producer.