NGO Seeks FDA Guidance On Colorant Use In Feminine Cleansers

Women's Voices for the Earth asks FDA to issue guidance regarding appropriate use of color additives in feminine personal-cleansing products following research indicating that certain colorants may pose health risks to women if the products are used as marketed.

Inconsistencies in labeling and marketing for feminine personal-cleansing products could be subjecting users to potentially hazardous color-additive exposure, according to NGO Women's Voices for the Earth, which wants FDA to weigh in on appropriate color use.

In a citizen petition filed Aug. 18 and posted Aug. 19 on Regulations.gov, Women's Voices asks the agency to issue guidance to direct manufacturers on which colorant ingredients and specific amounts are suitable for use in feminine-wash products.

Feminine-wash products for cleansing purposes – as opposed to treatment of fungal or yeast infections, for example – are regulated as cosmetics under the Federal Food, Drug and Cosmetic Act, requiring them to be safe but not subject to premarket approval.

On the other hand, color additives in such offerings, among other cosmetics, are required to undergo FDA review, which dictates whether and how they can be used in marketed products.

The problem, according to Women's Voices, is that certain color additives permitted by FDA for external use only are present in feminine-cleansing products, which intuition, labeling instructions and product marketing suggest should be used in ways that lead to internal exposure.

"Feminine-hygiene products like feminine wash are not used externally because of the nature of a woman’s anatomy," the group asserts. Therefore, it reasons, colorants restricted as such should not be used in the products.

Specifically, Women's Voices cites D&C Red No. 33 and Ext. D&C Violet No. 2 as colorants approved exclusively for external-use products, which the FDCA defines as "drugs or cosmetics applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane.”

Feminine washes containing the colorants "are undoubtedly used on the vaginal area – an area of the body 'covered by mucous membrane,' which the definition of 'externally applied cosmetics' prohibits," the NGO says.

FD&C Yellow No. 5 is another colorant listed in labeling for feminine personal cleansing products, according to Women's Voices. While prescription drug products containing the additive must carry a warning statement about sensitization risks if they are administered "orally, nasally, vaginally or rectally," among other routes of exposure, no warning is required by FDA for cosmetic feminine washes, the group notes.

Women's Voices acknowledges that most feminine-cleansing products are labeled as "For External Use Only," but conflicting language in labeling and marketing implies that exposure to vaginal mucous membranes is expected, it says.

The NGO points to claims promoting vaginal pH balance, in particular, which signal that "internal contact is inevitable."

"The feminine washes that contain these colorants are thus clearly unsafe for the use intended by their manufacturer and are produced in violation of the standards and principles for products safety that the FD&C Act requires," Women's Voices says.

Further zeroing in on brands' marketing language, the group points to statements about use on the "vaginal area" or "intimate area," which it argues is misleading if the intent is for the product to be used externally.

"Clearly, the manufacturers of these feminine washes intend for their product to have internal vaginal exposure to reach the desired effect."

Consumer Complaints Signal Possible Correlation

In its petition, Missoula, Mont.-based Women's Voices provides consumer product reviews culled from the web to suggest that improper use of colorants in feminine-cleansing products could be responsible for reported adverse reactions.

Specifically, colorants approved for external use may be linked to rashes in the vaginal area where the wash is generally applied, according to the NGO.

"Though we understand that correlation of harm is not necessarily causation, the plethora of negative reviews is strong evidence that use of these products containing prohibited ingredients can lead to severe harm," Women's Voices says.

Consumer complaints in online reviews of feminine cleansing products include statements such as:

• "I did nothing but itch and burn ALL DAY when I used this wash";
• "It gave me the worst allergic reaction I've had in my entire life";
• “Totally ruined my perfect vagina! It became itchy and bumpy and so uncomfortable after the first use! Very disappointed";
• “Buy this product if the thought of cleansing your intimate parts with battery acid appeals to you."

The reviews were pulled from major brand and retailer websites, including a leading player's website where 130 of 500 reviews for its cleansing wash were negative, according to Women's Voices.

"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," Women's Voices concludes.