FDA to Make Admin Detention of Food More Likely
The Food and Drug Administration has issued an interim final rule, effective July 3, 2011, that will amend its regulations to lower the threshold for ordering administrative detention of food for human or animal consumption, as required by the Food Safety Modernization Act1. FDA states that with the new criteria, the number of administrative detentions2 for food is likely to increase.
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FDA invites public comment on this interim final rule by August 3, 2011. FDA states that it will consider modifications to it based on comments made during the comment period.
Ordering Admin Detentions Will be Based on “Reason to Believe”
Under the new criteria, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. Decisions regarding whether FDA has a “reason to believe” a food is adulterated or misbranded would be made on a case by case basis because such decisions are fact specific.
Admin Detentions Currently Based on “Credible Evidence”
Currently, FDA has the authority to order the administrative detention of an article of food if a FDA officer or qualified employee finds there is credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals. The new criteria will provide FDA enhanced authority to detain articles of food that may be adulterated or misbranded.
(A FDA official previously stated that the “credible evidence” standard is too high and impedes FDA’s ability to detain food it suspects. See ITT’s Online Archives or 04/14/11 news, 11041415, for BP summary.)
21 CFR to be Amended to Provide for New Criteria
The interim final rule will amend 21 CFR 1.378 and 1.393(a) as follows (new text italicized, deleted text has strikethrough):
21 CFR 1.378: What criteria does FDA use to order a detention?
An officer or qualified employee of FDA may order the detention of any article of food that is found during an inspection, examination, or investigation under the act if the officer or qualified employee has reason to believe that the article of food is adulterated or misbrandedcredible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.
21 CFR 1.393(a): What information must FDA include in the detention order?
(a) FDA must issue the detention order in writing, in the form of a detention notice, signed and dated by the officer or qualified employee of FDA who has reason to believe that the article of food is adulterated or misbrandedcredible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.
FDA Has Not Used Admin Detention Authority for Food, Expects That to Change
FDA notes that since the agency has had administrative detention authority, it has never administratively detained an article of food. Under the new criteria, FDA believes that the agency is more likely to use administrative detention against articles of food in situations which include, among others, where the use of, or exposure to, a violative product may cause (i) temporary or medically reversible adverse health consequences or (ii) where the probability of serious adverse health consequences is remote.
By changing the criteria under which FDA can order administrative detention, FDA expects that it could use the administrative detentions up to 195 times during any given year.
1The FSMA (Public Law 111-353) was signed into law on January 4, 2011. The law provides FDA with new enforcement authorities to help it achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA new tools to better ensure the safety of imported foods and directs FDA to build an integrated national food safety system in partnership with State and local authorities.
2FDA’s authority to detain food administratively under section 304(h) of the Federal Food, Drug, and Cosmetic Act is separate and distinct from its authority to refuse admission of imported food under section 801(a) of that Act (aka import detention), even though refusal under section 801(a) is preceded by an action referred to as "detention and hearing."
FDA's evaluation of imported foods under section 801(a) largely focuses on whether the article of food appears to have been safely produced, packed, and held; contains no contaminants or illegal additives or residues; and is properly labeled.
(See ITT’s Online Archives or 05/04/11 news, 11050432, for BP summary announcing this rule was available.
See ITT’s Online Archives or 04/25/11 news, 11042529, for BP summary of FDA’s Q&A on FSMA provisions.
See ITT’s Online Archives or 03/07/11 news, 11030720, for BP summary of FDA’s overview of the FSMA.
See ITT’s Online Archives or 01/04/11 news, 11010426, for a comprehensive BP summary of the FSMA.)
FDA press release is available here.
FDA contact- William Correll, Jr. (301) 436-1611