Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA responds to BPA review

This article was originally published in The Tan Sheet

Executive Summary

Norris Alderson, FDA's associate commissioner for science, says in a Dec. 3 letter the agency and its Science Board agree that the draft assessment of bisphenol A use should focus on "dietary sources relevant to infants," including exposure from epoxy used in formula packaging. The letter, addressed to Barbara McNeil of the Science Board and Harvard Medical School, says that the board's peer review report recommends additional work relating to BPA exposure, health effects and proposed research. Alderson adds that FDA will work with the Centers for Disease Control and Prevention and other parties to develop additional biomonitoring data for infants and exposure assessments for infant formula packaging. The agency previously was criticized for suggesting that low levels of BPA transferred from food packaging are safe in children (1"The Tan Sheet" Nov. 10, 2008, In Brief)

You may also be interested in...

FDA responds to Science Board’s BPA review

The agency is formulating a response to its Science Board's review of FDA's draft assessment of bisphenol A's safety in food contact applications. Associate Commissioner for Science Norris Alderson initially replied to the board in a December 2008 letter, agreeing that FDA should focus on BPA applications that might impact infants, including formula packaging (1"The Tan Sheet" Jan. 5, 2009, In Brief). According to a Feb. 9 release, FDA and Health Canada officials held a forum Jan. 30 with manufacturers from both countries to discuss ongoing BPA reduction efforts. FDA says an international regulatory consensus holds that BPA exposure through food packages does not pose a risk to the general population, but the agency continues to review research on the potential low-dose effects of BPA

FDA regroups on BPA

FDA says Oct. 28 it plans to research and address the potential low-dose effects of bisphenol A, which is used in packaging for some infant formula and food products. The Science Board on Oct. 31 asked the agency to reconsider its finding that current levels of BPA that transfer to foods and are absorbed by children are safe. The board recommended this after its BPA subcommittee reported FDA overlooked multiple studies that it should have considered. Before FDA's advisory board rendered its opinion, a Journal of American Medical Association study concluded higher concentrations of BPA in human urine are associated with cardiovascular disease, diabetes and liver-enzyme abnormalities. The JAMA study prompted Congress to criticize FDA's conclusion (1"The Tan Sheet" Oct. 13, 2008, In Brief)

Pulling In 10 Different Directions – The Challenge Of Harmonizing Asia’s VMS Market

A lack of regulatory harmonization for dietary supplements in Asia is a big challenge facing companies operating in the region, according to experts from the Asia Regulatory Professionals Association. The ARPA is looking to start a conversation on the issue which the association hopes will lead to regulatory change.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts