The new edition of Food Regulation: Law, Science, Policy, and Practice has published

The third edition of Food Regulation: Law, Science, Policy, and Practice has been published. The book presents an appetizing menu of all key aspects of United States food regulation.  Incomparably comprehensive yet remaining accessible to all readers, the text connects legal theory to practical application. The third edition is fully updated to reflect significant changes in US food law. 

For more information, visit: www.foodregulation.us 

Extension of Comment Period on FDA's Guidance for NDI Notifications

Today FDA published in the Federal Register a notice granting a 60-day extension (until December 2, 2011) for comments on the FDA's draft guidance on New Dietary Ingredient ("NDI") notifications, which the Agency issued on July 5, 2011. More information is available here.

FDA Commissioner Eschenbach to Resign

Alicia Mundy, Wall St. Journal (Dec. 15, 2008).

“Food and Drug Administration Commissioner Andrew von Eschenbach has told his staff that he plans to resign effective Jan. 20, 2009. “In an internal message sent Monday to FDA officials, Dr. von Eschenbach said he would work closely with President-elect Barack Obama's transition team "to ensure a seamless change in political leadership at the agency. As with any transition, there will likely be changes for other senior managers as well, although all current Deputy Commissioners and the Chief of Staff are career civil servants who have served me and FDA well." . . .

For “The Onion” style humor at the Pharma Marketing Blog: Eschenbach Announces Resignation, FDA Staffer Throws Shoes in "Farewell Kiss".

FDA Amending Health Claim for Calcium and Osteoporosis

The Food and Drug Administration (FDA) is amending its labeling regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to:

1) Include vitamin D so that, in addition to the claim for calcium and osteoporosis, an additional claim can be made for calcium and vitamin D and osteoporosis;
2) Eliminate the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis;
3) Eliminate the requirement that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis;
4) Eliminate the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional;
5) Eliminate the requirement that the claim include a statement that a total dietary intake greater than 200 percent of the recommended daily intake (2,000 milligrams (mg) of calcium) has no further benefit to bone health when the food contains 400 mg or more of calcium per reference amount customarily consumed or per total daily recommended supplement intake; and
6) Allow reference for the need of physical activity in either of the health claims to be optional rather than required.

This final rule is effective January 1, 2010. For more information, visit 73 Federal Register 56477–56487 (Sept. 29, 20008), which is available here: [TEXT] [PDF]