David C. Steinberg - Comment

The manufacturer's of preservatives used in cosmetics support the FDA in their role to ensure safe cosmetics for consumers. In my presentation of 11/30 , I spelled out the types of preservatives used in cosmetics, the consumer issues and self-destructive attacks against all preservatives even though the two major independent scientific review organizations (the Cosmetic Ingredient Review in the US and the Scientific Committee Consumer Safety of the EU) have reviewed and published their conclusions on the safety of preservatives. A strong position expressed publicly by the FDA to the mass media may help set the record straight instead of allowing the "junk science" to destroy the safety record of preservatives and their critical role in ensuring the safety of cosmetics. There are several areas that the FDA should address: 1. Acceptable release levels for cosmetics excluding products which are self preserving, have water activity levels below the level needed for microbial growth or cannot be contaminated. 2. Define what pathogens should be absent from cosmetics. 3. In establishing release levels based on micro testing, the industry accepts the result of less than 10 cfu's/mL as being absentof contamination. This is not to suggest this level as the requirement, currently less then 1000 cfu's per mL or less then 100 cfu's perr ml are used. Testing for levels below 10 is costly and based on conversations with independent testing labs, very inaccurate often having false "positives". I would suggest a much simpler and cost effective approach: After production of a batch of cosmetics and before release, run a plate count like I described in my presentation. If it meets the levels established in 1 & 2; then wait 24 hours and retest. 24 hours is sufficient time to see if trace levels possibly present will either grow out (and rejection of the batch) or pass and be released.