Colorants in Feminine Washes May Be Violating FDA Use Restrictions

‘For External Use Only’ – This language-loophole on feminine care product labels may be putting women’s health at risk

MISSOULA, MT — Today, national women’s health non-profit, Women’s Voices for the Earth (WVE), filed a citizen’s petition to the FDA regarding clear safety guidelines on the use of colorants in feminine care products. The petition argues that colorants found in some feminine washes come in contact with vaginal mucous membranes –violating the FDA’s use restrictions, and may adversely affect the health of women using these products.

WVE’s research identified several feminine wash products currently on the market that contain the colorants FD&C Red 33, Ext Violet #2 and Yellow #5.

Under FDA guidelines, colorants FD&C Red 33 and Ext Violet #2 are not authorized for use in products which come into contact with mucous membranes. The use of Yellow #5 requires a specific safety warning regarding allergic reactions when used in drugs that are applied vaginally. Yet these colorants are ending up products that are specifically designed for vaginal use.

“While most feminine wash products have the words ‘For external use only’ on their labels, it’s undeniable that even manufacturers expect both the internal and external use of their products,” said Alexandra Scranton, Director of Science and Research at Women’s Voices for the Earth. “For example, many feminine wash brands make claims such as ‘pH balanced’ or ‘helps maintain a healthy pH balance’. A product could only affect vaginal pH if it is applied to internal vaginal tissue.”

Studies show that there are many potential chemicals of concern found in feminine care products, but there are few for which the FDA has specifically identified use restrictions. Colorants, however, are one of the few exceptions.

“What’s more, aside from aesthetics, the use of colorants in feminine wash serves no purpose in these products,” said Executive Director of Women’s Voices for the Earth, Erin Switalski. “Instead, they are exposing women to unnecessary, additional health risks — risks already recognized by the FDA.”

In support of their petition to the FDA, WVE also identified and documented numerous consumer reports of adverse reactions including rashes, bleeding and vaginal discomfort resulting from the use of these products.

“We are strongly in support of WVE’s campaign for better safety warnings on feminine washes. It is unacceptable that women are suffering from itching, bleeding and soreness in their most intimate parts, all because of completely unnecessary colorants, which are already known by the FDA to be potential allergens,” said Jessica Gitsham of Natracare feminine care products.

The fact that manufacturers are putting chemicals like these colorants into feminine care products, further illustrates the need for greater research, attention and scrutiny from the FDA regarding chemicals used in products that come in contact with one of the most sensitive and absorbent parts of a woman’s body.

Just as a recent study identified disproportionate health risks to African American women due to higher exposure to chemicals in douche, colorants in feminine washes also represent an unaddressed risk to women of color.

“We’re especially concerned about feminine washes as they may disproportionately affect black and Latina women since they tend to be greater users of these products,” said Cristina Aguilar, Executive Director of Colorado Organization for Latina Opportunity and Reproductive Rights (COLOR). “Many Latinas who already have health disparities also face financial, economic, and geographic barriers to accessing safe alternatives. That’s why the FDA must do its job and ensure that all washes on the market are safe. This is a reproductive justice issue, and a fundamental human rights issue that we must expose.”

“Our petition asks the FDA to close the language-loophole that manufacturers are using to include harmful chemicals into their products,” said Switalski. “The guidelines need to be clear. And, most importantly, they need to protect women’s health.”

Feminine washes on the market that contain colorants FD&C Red 33, Ext Violet #2 and Yellow #5 include well-known brands including Vagisil, CVS and Summer’s Eve. Click here, for a complete list of these products.

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About Women’s Voices for the Earth
Founded in 1995, Women’s Voices for the Earth amplifies women’s voices to eliminate the toxic chemicals that harm our health and communities. With thousands of members across the United States, WVE changes corporate practices, holds government accountable, and works to ensure a toxic-free future for all. www.womensvoices.org.

WVE has published various factsheets on toxic chemicals and feminine care products, including their ground-breaking report, Chem Fatale.

Media Contacts:
Alexandra Scranton, Director of Science & Research at Women’s Voices
alexs@womensvoices.org, 406-543-3747, office.
Beth Conway, Communications & Outreach Manager at Women’s Voices
bethc@womensvoices.org, 406-543-3747, office.