On January 29, 2016, the U.S.A. Food and Drug Administration (FDA) published a new import alert preventing all genetically modified (GMO) salmon from entering the United States. The alert was prompted by the FY 2016 Omnibus Appropriations Act, which directs FDA not to allow food containing GMO salmon into interstate commerce until the agency publishes final labeling guidelines. Currently only draft guidance on voluntary labeling is available.
Products on import alert are subject to detention without physical examination (DWPE) upon arrival to the United States. In other words, all shipments of GMO salmon exported to the US will be detained by FDA. Usually facilities can petition FDA for exemption from an import alert by proving their shipments are continuously non-violative. It’s likely, however, that FDA will not allow exemptions from this new alert because there is no regulation with which to prove compliance. While most import alerts offer instruction for requests for removal, the GMO salmon alert states “Under no conditions should the entry be released without concurrence from both DIO and CFSAN OC/DE for human food or DIO and CVM/OSC/DC/ for animal food.”
The Omnibus Appropriations Act encompasses GMO salmon manufactured in the US as well. Just two months ago, FDA approved AquAdvantage’s GMO salmon for distribution in the United States. After scientific review, the agency determined the GMO salmon was equally as safe and nutritious as non-GMO salmon. Despite the recent approval, the act will prevent the salmon from going to market.
It’s important to be aware of whether a product is on an FDA import alert before exporting or importing it into the United States. Products and facilities are added and removed from import alerts on a daily basis. The Registrar Corp FDA Compliance Monitor allows users to monitor food facilities’ FDA compliance statuses, including whether they are subject to an FDA import alert. For facilities that are subject to an import alert, Registrar Corp can help petition FDA for removal or exemption.
For more information about FDA import alerts, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.