December 3, 2010 — In the first substantive vote in the lame-duck session of the 111th Congress, the Senate voted today to pass sweeping legislation to address food safety.
The bill approved by the Senate, the FDA Food Safety Modernization Act (S. 510), was initially introduced by Sen. Dick Durbin (D-IL) in March 2009. The original bill has been revised on several occasions, most recently with an amendment by Sen. Jon Tester (D-MT) to exempt small farming operations.
Among other details, the bill would, for the first time, give the Food and Drug Administration 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 American Herbal Products Association has expressed support for this expanded recall power.
Under S. 510, FDA would also be provided with enhanced authority on records inspections, administrative detention, imported foods, and in numerous other areas. This legislation would also set a minimum schedule for FDA inspections of all food and supplement manufacturers.
The legislation would also directly affect the practices of food and supplement companies in several ways. For example, while current law mandates that all food facilities be registered with FDA, S. 510 would require registrations to be renewed biannually. Companies would also be held accountable for any expenses borne by FDA related to facility reinspections. And conventional food companies and dietary ingredient firms (not included in FDA’s recently established cGMP rule for dietary supplements, and therefore regulated as food manufacturers) would be required to 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.
The House of Representatives passed its version of food safety legislation in July 2009, but that legislation (H.R. 2749, The Food Safety Enhancement Act) differs significantly from the bill passed today by the Senate. It has been reported that there may not be enough time in the few weeks left in the current Congress for a conference to agree to a House-Senate consensus food safety bill.
Given this time constraint, it appears likely that the House will discard its earlier version – generally viewed as more onerous on industry – and simply adopt the Senate’s legislation. House consideration of the Senate-passed food safety bill could happen as early as this week.
Source: American Herbal Products Association, www.ahpa.org