376 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS Human odors and their effects on the menstrual cycle George Preti and Winnifred B. Cutler, Monell Chemical Senses Center, 3500 Market Street, Phil- adelphia, PA 19104, and Department of Obstetrics and Gynecology, School of Medicine, University of Pennsylvania, Philadelphia, PA 19104 The possibility that human odors affect our repro- ductive biology has been discussed at some length in both the scientific and popular press however, much of this discussion has centered on the possible existence of releaser pheromones or "sex attractant"- type effects. Our studies examined the thesis that human odors act in a primer pheromone fashion and alter the endocrinology of the menstrual cycle. Pre- vious studies have shown that (a) menstrual cycle lengths of 29.5 + 3 days ("normal cycles") are more frequent in women who have weekly coital activity than in women who do not and (b) women who spend time together are likely to show synchrony in the onset of their menstrual bleeding. To deter- mine whether chemical substances from the axillae are involved in these phenomena, the menstrual cycle length of nulliparous women was evaluated following regular application of extract from either donor males or femal'es. Female subjects who re- ported having a history of aberrant length cycles (26 days and 33 days) received extract from male donors, while those subjects who reported having normal cycle lengths received extract from female donors. Women receiving the male extracts for 13.5 + 1 weeks experienced more regular cycles com- pared to controls receiving only placebo applications in addition, subjects receiving female extracts showed a significant shift towards menstrual syn- chrony with the donor females. These studies dem- onstrate that axillary constituents can shift the length and onset of the direct social contact. Both male and female extracts have also been examined by gas constituents. Secretions of both male and females contain a number of steroid constituents including the volatile steroids androstenone and an- drostenol. The concentrations of these components is being determined to see if there is menstrual or seasonal variation in female or male samples, re- spectively. CONCURRENT SESSION ARRANGED BY CTFA MICROBIOLOGY COMMITTEE Report of a cosmetic industry survey con- cerning correlation of preservative challenge and consumer use test results Ronald J. Spielmaker, Amway Corporation, 7575 East Fulton Rd., Ada, MI 49355 Results are presented of a cosmetic industry survey generated by the CTFA Microbiology Committee and distributed by CTFA. The survey requested in- formation concerning •orrelation of preservative challenge and consumer use test results. The survey dealt with three product areas: water-based mas- caras solvent-based mascaras and creams/lotions. Validation of the microbiological integrity of cosmetic products through consumer use testing Susan M. Lindstrom, and Patricia Imig Bowman, Ph.D., Avon Products, Inc., Division St., Suffern, NY 10901 To ensure the development of microbiologically safe cosmetics, Avon Products, Inc. has developed an in vitro microbial challenge test which accurately pre- dicts the preservative efficacy of a product after long-term consumer use. Over the past five years, 186 products which had met the in vitro challenge test criteria, were subjected to consumer testing. These products included mascaras, creams, lotions, liquid makeup, eyeshadows, eyeliners, and batch and hair preparations. Criteria for formula accept- ability after use included: no recovery of Pseudomonas sp., E. coli, or S. aureus, and recovery of 100 cfu/ g followed by no recovery of organisms upon a retest of the product. Over 99% of the products met these requirements. Only five out of approximately 4000 samples tested did not meet these test criteria, and were reformulated with increased preservative con- centrations before release for sale. As a result of the failures, our in vitro challenge test was made more stringent by including a higher concentration of challenge organisms, a greater number of preser- vative-resistant product isolates, and more stringent inoculum reduction requirements. These procedures have resulted in an in vitro test which accurately predicts preservative efficacy of a cosmetic product after consumer use. Correlation of in vitro challenge testing with in- use consumer testing for cosmetic products D. K. Brannan, J. C. Dille, and D. J. Kaufman, Procter & Gamble Co., 1 Procter & Gamble Plaza, Cincinnati, OH 45202 The cosmetic and drug industries use microbial challenge testing as an indicator of a product's ability to withstand microbial insults. The ability of a cosmetic product to withstand microbial insults experienced during consumer use is of particular interest to the regulatory agencies. The FDA, for example, has issued a contract to develop an in vitro test method that predicts whether or not a cosmetic will become contaminated during consumer use. This paper presents an in vitro challenge method for assessing the preservative efficacy of cosmetic products under typical consumer use conditions. Two products were used, an anionic shampoo and

ABSTRACTS 377 a hand and body lotion. Three preservative condi- tions were investigated to give unpreserved, mar- ginally preserved, and preserved products. The in vitro challenge test was based on the CTFA proce- dure but is modified to include product dilutions at four levels (30%, 50%, 70%, 100%). This mod- ification aided in classifying the preservative efficacy of the formulae. The preserved formulae passed the challenge test at all product concentration levels including the most stringent 30% level (Pass 30%). The marginally preserved formulae passed the chal- lenge test at only the 100% product concentration level (Pass 100%). The unpreserved formulae failed the challenge test. Data will be presented to show that the modified CTFA challenge procedure is pre- dictive of the potential for product contamination after consumer use. SESSION II PLAQUE AND GINGIVITIS CLAIMS FOR ORAL HYGIENE PRODUCTS Guidelines for the evaluation of products for the control of plaque and gingivitis Edgar W. Mitchell, Ph.D., American Dental As- sociation, 211 East Chicago Avenue, Chicago, IL 60611 The Council on Dental Therapeutics has reviewed laboratory and clinical studies on products for their safety and efficacy in the control of dental plaque and gingivitis. In its review of data from these studies the Council and its consultants concluded that there is considerable disagreement about the information necessary to conclusively demonstrate product efficacy. There is also disagreement re- garding the design of studies to evaluate these prod- ucts. In an attempt to resolve these issues, the Council developed, in consultation with more than 90 individuals and organizations, guidelines which will be used in reviewing these products in its ac- ceptance program. Products which meet the criteria in these guidelines will be eligible to receive the Seal of Acceptance of the Council. The guidelines and the rationale for their development will be pre- sented. Specific commercial products which have received the Seal of Acceptance and the studies which demonstrated their efficacy will be discussed. FDA and the regulation of prescription drug advertising and promotion Lloyd G. Millstein, Ph.D., Division of Drug Ad- vertising and Labeling, Food and Drug Adminis- tration, Rockville, MD 20857 Disclosures before the Kefauver Subcommittee in 1960-61 led committee members to conclude that advertising to the medical profession had resulted in serious abuses and required new specific controls for the protection of the public. Congress had de- cided that reforms in prescription drug advertising practices were needed because usually favorable fea- tures about a drug were presented in advertising, but side effects, contraindications, warnings, and other limitations regarding usefulness of the drug, as well as other defects that needed regulatory con- sideration, were somehow forgotten or deempha- sized. The Drug Amendments of 1962 corrected some of the prior deficiencies and later drug adver- tising regulations and administrative concepts pro- vided further authority to overcome continued abuses. The 70's began a new era in advertising compliance activities and management. With the evolution of new methods to provide information to the health community, the FDA has entered the 80's with new priorities to examine in the field of promotion and advertising. It continues to exercise oversight in 1) the growing interest to promote products, concepts, and procedures well in advance of their approval, 2) the emerging technologies in electronic communications that have provided mar- keters with more outlets from which to promote their wares to health providers, and 3) the interest in promoting prescription products directly to con- sumers. Because of these and other current issues, the FDA is concerned about turmoil in the mar- ketplace and whether further sanctions on current advertising practices will be necessary. Influence of mechanical aspects of dentifrice and toothbrush in plaque control L. P. Cancro, Morton Pader, Ph.D., Shirley S. Birenz, and Patricia Pretara Spanedda, Lever Brothers Co. Research Center, 45 River Road, Edgewater, NJ 07020 The toothbrush is the most popular mechanical de- vice for cleaning teeth. The efficiency of tooth- brushing is assessed in regard to varying brushing times, toothbrushing frequency, dentifrice load, and dentifrice abrasivity. Studies of the duration of toothbrushing time involving children and adults suggested that the average "scrub" time for children as well as adults is approximately 20 seconds. The wearout rate of toothbrushes is directly related to the number of filaments in a tuft and filament di- ameter, whereas cleansing features appear to have an inverse relationship to filament diameter: thicker filaments last longer but fail to clean as well as thinner filaments. Toothbrush configuration, shape, and size have not been clearly demonstrated to be dominant factors associated with toothbrush efficacy. A system facilitating plaque removal via com- bination of chemical and mechanical proce- dures