Sanitary pads for menstrual hygiene have a layered design consisting of a fluid permeable surface (topsheet), an absorbent core, and an impermeable backing with adhesive. Most sanitary pads employ cellulose-based cores. This describes the safety evaluation of a menstrual pad with an emollient-treated topsheet and a novel polymeric foam core. A quantitative risk assessment was performed, which included: (1) toxicological evaluation of the raw material components; (2) quantitative exposure assessments of pad constituents, accounting for the fluid handling properties of the product and pertinent conditions of use; and (3) risk characterization for exposure to raw materials (e.g., potential for skin irritation, contact sensitization, or systemic effects, if relevant) and to the physical article itself (potential effects on skin friction, etc.). No significant risk of adverse effects was found. Five years of post-market surveillance substantiates that the product is well-tolerated (1 health complaint reported per 2 million products shipped to market) and surpasses women's expectations for menstrual protection and overall comfort and dryness. This report illustrates how the classical risk assessment paradigm, informed by the impact of product design, functionality and pertinent use conditions, allowed the systematic safety evaluation of a personal hygiene product with a novel, non-cellulosic absorbent foam core technology.

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OBJECTIVES(1) To determine whether advertising nighttime tampon use for up to eight hours was understood to be consistent with label recommendations and (2) to determine whether television and print advertising with this message affected tampon wear times in adults and teens.METHODS(1) A comprehension study (online advertising and follow-up questionnaire) among women aged 14–49 years (300 per group) who viewed either the test or a control advertising message; (2) Diary-based surveys of tampon wear times performed prior to (n = 292 adults, 18–49 years, 74 teens, 12–17 years) and after (n = 287 adults, 104 teens) the launch of national advertising.RESULTSSignificantly more test message viewers than controls stated tampons should be worn less than or equal to eight hours (93.6% vs. 88.6%, respectively, P = 0.049). A directionally higher percentage of test message viewers said they would use a pad if sleeping longer than eight hours (52% vs. 42% of controls). Among the women who used tampons longer than eight hours when sleeping, 52% reported they would wake up and change compared with 45% of controls. No significant difference between baseline and follow-up diary surveys was found among teens or adults in various measures of tampon wear time (mean wear times; usage intervals from less than two hours to more than 10 hours; percentage of tampons used for more than or equal to eight hours; frequency of wearing at least one tampon more than eight hours).CONCLUSIONSAdvertising nighttime tampon wear for up to eight hours effectively communicated label recommendations but did not alter tampon wear times. The informational intervention had limited impact on established habits.

IntroductionWe illustrate a comprehensive tampon safety assessment approach that assures products can be used safely. Material biocompatibility, vaginal mucosa assessment, vaginal microbiome evaluation, and in vitro assessment of potential risk of staphylococcal toxic shock syndrome expressed through growth of Staphylococcus aureus (S. aureus) and production of TSST-1 are the four essential portions of the approach. Post-marketing surveillance informs of possible health effects that warrant follow up. The approach meets or exceeds US and international regulatory guidance and is described through the example of four tampon products.Methods/ResultsEach product is comprised mostly of large molecular weight components (cotton, rayon, polymers) that cannot pass the vaginal mucosa, are widely used across the industry, and replete with a vast body of safety data and a long history of safe use in the category. Quantitative risk assessment of all small molecular weight components assured a sufficient margin of safety supporting their use. Vaginal mucosa assessment confirmed that pressure points, rough edges and/or sharp contact points were absent. A randomized cross-over clinical trial (ClinicalTrials.gov Identifier: NCT03478371) revealed favorable comfort ratings, and few complaints of irritation, burning, stinging, or discomfort upon insertion, wear, and removal. Adverse events were few, mild in severity, self-limited and resolved without treatment. Vaginal microbiota assessment in vitro presented no adverse effect on microbial growth. Culture-independent microbiome analyses from vaginal swab samples obtained during the clinical trial showed no differences attributable to tampon usage, but instead due to statistically significant subject-to-subject variability. Growth of S. aureus and TSST-1 toxin production in the presence of any of the four products in vitro were statistically significantly reduced when compared to medium control alone.DiscussionThe data from the four elements of the comprehensive safety assessment approach illustrated herein confirm that tampons evaluated using this system can be used safely for menstrual protection. A post-marketing surveillance system that monitors and responds to in-market experiences indicated in-use tolerability of the product among consumers, thus confirming the conclusions of the pre-marketing safety assessment.