The Office of Inspector General (OIG/HHS) recently released a report detailing its review of FDA inspections of domestic food facilities. Among other things, OIG reported that between fiscal years 2004-2008, FDA inspected on average less than a quarter of food facilities each year, and that 56 percent of facilities have gone five or more years without a FDA inspection. This report has provided Senators with additional evidence of the need for quick movement on S. 510, the FDA Food Safety Modernization Act, currently awaiting floor time in the Senate. We anticipate the release of a manager's package any day now, as staff work to finalize bill language. Senators are also beginning to seize upon the legislation as a vehicle for various proposals. Proposals gaining momentum include those relating to dietary supplements and bisphenol A, among others.  

  • Dietary Supplements. Sen. McCain (R-AZ) introduced a bill earlier this year (S. 3002) that would tighten the regulation of dietary supplements. McCain's proposal would (1) require registration of all dietary supplement facilities and listing of all products manufactured, packed, held, distributed, labeled or licensed by the facility; (2) require FDA to publish an "Accepted Dietary Ingredients" list, effectively directing the codification of an "Old Dietary Ingredients" list (i.e., list of ingredients exempt from 75-day prior notifications); (3) require annual compilation of non-serious adverse events; and (4) provide for broad and sweeping authority to issue "cease distribution" orders (onto which recall authority may be tacked) upon "reasonable probability" that a supplement would cause serious adverse health consequences or death, or is adulterated or misbranded by statute. There is no equivalent provision in the House food safety bill that passed last summer (H.R. 2749). As such, it is uncertain whether McCain's provisions, if included in the Senate bill as rumored, would be upheld in conference.  
  • Bisphenol A. Sen. Feinstein (D-CA) introduced a bill last month (S. 593) that proposes a ban on bisphenol A (BPA) in food and beverage containers where the container is composed, in whole or part, with BPA or can release BPA into food. The proposed effective date of this ban for reusable food containers that do not contain food when placed into commerce, as well as food containers that are packed with food when introduced into commerce, is 180 days after the date of enactment of Sen. Feinstein's bill (i.e., the Ban Poisonous Additives Act of 2009). The insertion of Sen. Feinstein's ban into the Senate bill is likely to draw strong industry opposition since BPA is used in so many food containers and since alternative additives are not likely to be available to industry in this narrow window.

Whether these and other provisions will make it into the bill on the Senate floor remains to be seen. What was expected to be a quick vote on the floor of the Senate now appears as though it could involve lengthy debate.