U.S. Senate & House of Representatives Succeeds on Second Attempt to Pass "Food Safety Modernization Act"

On Tuesday, December 21, the House of Representatives agreed with the U.S. Senate vote held on Sunday, December 19 passing S. 510, the FDA Food Safety Modernization Act. The Senate's move put an end to much of the uncertainty that had surrounded the bill following its invalidation immediately after its passage weeks ago based on a disallowed revenue-raising measure.

The bill is now expected to be signed into law by President Barack Obama and will give the Food and Drug Administration (FDA) authority to mandate a recall of any food (including a dietary supplement) when there is a "reasonable probability [of] serious adverse health consequences or death" associated with such food. The International Aloe Science Council has expressed support for this expanded recall power.

Under S. 510, FDA will also be provided with enhanced authority on records inspections, administrative detention, imported foods, and in numerous other areas. Other features of the legislation include:

a minimum schedule for FDA inspections of all food and supplement manufacturers;
a requirement that food facilities re-register biannually;
accountability of companies for expenses borne by FDA related to facility re-inspections, and
a requirement that food companies and dietary ingredient firms establish hazard analysis and risk-based preventive controls.
Supplement companies would be exempt from this last requirement in recognition of their obligation to comply with the new dietary supplement cGMP regulation.

"IASC appreciates that the Food Safety bill exempts dietary supplement manufacturers from the HACCP portion of the law, but is reviewing the final language to determine its full effect on ingredient manufacturers," observed IASC executive director Devon Powell. IASC will continue to observe and report on progress related to its final passage.