By Len Monheit
This week’s FDA introduction of regulations which will become part of the implementation of the Public Health Security and Bioterrorism Preparedness and Response Act, confirms that businesses operating in the food sector will have new procedures to deal with later this year. The two proposed regulations introduced for comment this past week are ‘Prior Notice of Imported Food Shipments Proposal’and ‘Regulation for Registering Food Facilities’.
In both cases, a consultative process exists, in the case of the Facility Registration regulation, until October, with a proposed effective date for both pieces of December 12, 2003. In the case of ‘Notification of Imported Food Shipments’, estimates place the number at approximately 20,000 per day, and for ‘Facility Registration’, approximately 400,000 facilities.
Dietary supplements, for the most part regulated as food products, and the companies which manufacture and supply these products, will fall squarely in the sector covered by the regulations designed to ensure safety in food supply.
While retail and health store operators will not be impacted by the second piece, the impact on the natural product and supplement industry by the 2002 Act as a whole could be significant. Its scope (and the possible interpretation of rather broad, sweeping powers), and the resources FDA will deploy in its implementation, means that it needs to be taken very seriously for our industry, both domestically and internationally. The responsibilities of domestic importers, both in the facility registration process (especially if they are registering facilities for their foreign suppliers), as well as the prior notice required for incoming shipments, puts a burden on many organizations. In fact, it is quite conceivable that the regulation will place some industry organizations on FDA radar for the first time, whether as importers or food facilities.
Being on the radar itself may not be a bad thing. The process of facility registration and the identification of company trade-names and food categories offered, at the very worst, help to create a small but previously lacking barrier to industry entry. The identification of US agents for foreign facilities also puts on ‘paper’ a relationship and implied responsibility between the two groups. The exclusion of retail operations is practical.
Prior notification forces logistics management and controls where they may presently not exist, and ultimately, could lead to better planning and inventory management. On the other hand, if an undue volume of shipments are stopped and inspected, with resulting delays and unpredictable delivery implications, then organizations could lose efficiency and flexibility in a tough market. And the level of information required for each product and shipment is significant.
As with any rule or regulation, so much is in the interpretation and administration. The powers provided to the FDA under this Act are significant. A lot will depend on how smoothly the system operates, and the focus of FDA inspections. The National Food Processors Association has already gone on the attack, claiming the proposed rules to be impractical, burdensome and potentially costly, especially for perishable items. While the exact effects remain the subject of speculation we can be sure of a few things: Less scrupulous suppliers will be challenged, and the cost of doing business in the US will certainly go up.