Food & Beverages | New FDA Food Powers
Import Certification Requirement
Under the FSMA, as a condition of granting admission to an article of imported food, FDA can require that the an agent or representative of the government of the exporting country from which the food originates, produce an affidavit declaring that the food complies with the requirements under the Federal Food, Drug, and Cosmetic Act.
If FDA requires an import certificate for an imported food, and the importer does not possess a valid certificate, the food must be refused admission. FDA may refuse an import certificate if FDA determines it is invalid or unreliable. At any time, FDA may require that the certificate be renewed.
In determining whether to require the certificate, FDA must consider:
- the known safety risks of the food;
- the known safety risks of the country, territory, or region of origin of the food; and
- FDA must find that the food safety programs, systems, and standards in the country, territory, or region of origin are inadequate to ensure safety and that certification would assist FDA in making an admissibility determination.
Under the FSMA, effective July 3, 2011, FDA possesses significantly more power to administratively detain foods. Prior to FSMA, FDA needed credible evidence or information that an article of food presents a threat of serious adverse health consequences or death to humans or animals to detain that article of food. FSMA permits FDA the authority to administratively detain an article of food if FDA has reason to believe that the article of food merely is adulterated or misbranded. FDA must issue an interim final rule implementing this amendment by May 4, 2011.
Mandatory Recall Authority
Under the FSMA, FDA has new authority to order a mandatory recall when it believes there is a reasonable probability that a food is adulterated or misbranded, and that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals. The rule requires FDA to give the responsible party an opportunity to conduct a voluntary recall; upon refusal, the mandatory order can issue and the party has an opportunity to participate in an informal hearing within two days after the order has issued.
Inspection-Related Refusal Power
Under the FSMA, FDA may refuse food that derives from a foreign facility (or government) operator that refuses to permit FDA inspectors to inspect the establishment. For purposes of this provision, the refusal is deemed to have occurred if it is not permitted during the 24-hour period after a request is made, or after such other time period as agreed upon by FDA and the factory.