On Friday FDA announced the approval of a drug to mitigate allergic reactions to accidental peanut exposure in children. Manufactured by Aimmune Therapeutics, Palforzia is intended for use in children who are four years through 17 years old. FDA points out that there is no cure for a peanut allergy and so peanuts must continue to be avoided.
Palforzia is a powder made from peanuts and administered in capsule and sachet form via three phases, the first of which occurs under the supervision of a healthcare professional. This first phase, called “initial dose escalation”, involves administration of a single capsule. The second phase, “up-dosing”, is a phase of 11 increasing dose levels over a period of several months (the first dose of this phase is also administered under watch by a healthcare professional, while the remaining doses can be taken daily at home). Following completion of the second phase, a patient begins the “maintenance” treatment, which is delivered via a sachet (the powder can be mixed with foods such as applesauce and yogurt).
“Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research in an agency press release.
Palforzia is available through healthcare providers, healthcare settings and pharmacies that receive special certification and are educated on the risk of anaphylaxis in using the drug. Patients interested in receiving the drug must be part of FDA’s risk evaluation and mitigation strategy program.
The Import Alert for FSVP noncompliance is applicable to any human and animal food subject to the FSVP regulation, and allows FDA to detain imported foods at the port of entry under the protocol for Detention Without Physical Examination (DWPE). DWPE is a standard enforcement tool for FDA.
July 31, 2019: FDA issued Import Alert #99-41, the first Import Alert based on noncompliance with the Foreign Supplier Verification Program (FSVP) regulation.
The FSVP Import Alert contains the following reason for the alert and the relevant charge.
“Section 805 of the FD&C Act (21 U.S.C. 384a) requires each importer of food to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer is produced in compliance with the requirements of section 418 (21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive controls) or section 419 (21 U.S.C 350h)(regarding standards for produce safety) of the FD&C Act, as appropriate; and that the food is not adulterated under section 402 or misbranded under section 403(w).” – FDA
“The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805.” – FDA
Join Trish Wester for the closing plenary 2019 Food Safety Consortium panel discussion FDA Presentation on The Third-Party Certification Program | Thursday, October 3, 2019“Import alerts inform the FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information,” states FDA on its webpage about import alerts.
A Trend of Increased Import Enforcement?
FDA enforcement actions in this area have recently seen a dramatic increase. Only one alert was posted in the first quarter, and less than 10 food-related alerts were posted prior to June. July 2019 saw eight food alerts, including one on radionuclides and the FSVP. FDA posted more than 30 food-related import alerts in August, and September is on a similar pace currently showing 21 food-related alerts, indicating this may be an ongoing focus for the agency.
The information in this update is provided by AFSAP, the Association for Food Safety Auditing Professionals. Please contact Patricia Wester @ firstname.lastname@example.org if you have any questions regarding DWPE, or to request a complete copy of the alert.
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