In early July 2011, FDA provided an update in which the agency said that it has made progress toward implementing the US Food Safety Modernization Act (FSMA), which was enacted in January 2011. In addition to clarifying expectations for new dietary ingredients through new draft guidance, the agency has issued an antismuggling strategy.
FDA worked with the US Department of Homeland Security to create the strategy, which aims to “identify and prevent smuggled foods from entering the United States and posing a threat to national security and consumer safety,” according to an agency press release. Although the strategy, like many portions of FSMA, focuses on food safety, many components and directives within the act also pertain to pharmaceuticals. Food-safety actions taken now may provide guidance for drug-safety issues in the future (see “FDA Gains Food Recall Authority, Drugs Could be Next”).
“This new system, overall, will better leverage the resources of federal agencies and it will make industry an important partner in safeguarding the health of US consumers,” said Deputy Commissioner for Foods Michael R. Taylor in the press release.
As part of the strategy, FDA will work with US Customs and Border Protection (CBP) to review historical data and better identify products, firms, and countries of origin to target potential food smuggling and smugglers. FDA and CBP also will share information on import shipments and conduct joint examinations to identify shipments that may contain smuggled food. FDA has been increasing its focus on drug imports at the borders as well with its Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) computer system and its new spectral library system aimed at identifying excipients.
The agency also issued draft guidance regarding new dietary ingredients as part of FSMA implementation. The document aims to prevent consumers from being exposed to “unnecessary public-health risks from new ingredients with unknown safety profiles,” says the press release. Specifically, dietary-supplement manufacturers are required to notify FDA before adding a new dietary ingredient to their products, except when the ingredient has been part of the food supply and has not been chemically altered for use in supplements.
FDA has a website devoted to FSMA implementation and updates for more information.