FDA Seeks Comments on Bisphenol - A in Medical Devices, Drugs, Cosmetics, and Their Packaging, Etc.
The Food and Drug Administration is requesting assistance in identifying the types of FDA-regulated products (other than food contact materials) that contain Bisphenol A (BPA), whether as a component of the product or its packaging, and any information relating to the leaching of BPA from the packaging to the product and/or from the product following human administration.
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(The FDA is involved in a review of current research and new information on BPA for all FDA-regulated products, and has already completed an assessment of the potential exposure to BPA due to leaching from food contact materials.
This FDA review follows a National Toxicology Program report which indicated that the leaching of BPA to food from plastic baby bottles and the linings of certain baby food containers could be linked to developmental problems of the endocrine system in infants and young children.)
BPA is Used in Polycarbonate Plastics and Epoxy Resins
BPA is a chemical commodity used primarily in the production of polycarbonate plastics and epoxy resins. Such plastics and resins have many applications including as components of packaging for food and drink, and as components of certain medical products and their packaging. Consequently, low levels of residual BPA may be present in such products.
FDA Seeking Comments on Medical Devices, Drugs, Cosmetics, Etc.
The FDA is now interested in additional information on BPA in products other than food-contact materials, specifically medical devices, biological products (including blood, blood products, vaccines, and cell and gene therapies) and drugs, as well as BPA in the packaging that comes into contact with such products.
In addition, FDA is soliciting any relevant information on the use of, and potential exposure to, BPA from any other FDA-regulated products, including cosmetics.
- Written or electronic comments and information due by December 29, 2008
FDA contact: Norris Alderson 301-827-3340
FDA notice (D/N FDA-2008-N-0523, FR Pub 10/15/08, available at http://edocket.access.gpo.gov/2008/pdf/E8-24506.pdf