Wednesday, August 15, 2018
 Six-Month Milestone in the Implementation of FSMA  

July 3 marks the six-month anniversary of the signing of the FSMA. On this date, FDA met two additional milestones required under the new law.

Joint Anti-Smuggling Strategy
FDA issued on July 3, a joint anti-smuggling strategy developed with the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS). The anti-smuggling strategy will help to identify and prevent smuggled foods from entering the United States and posing a threat to national security and consumer safety. The FDA will work with U.S. Customs and Border Protection (CBP) to review historical data and better identify products, firms, and countries of origin to establish food smuggling targeting criteria. The FDA and CBP also will share information on import shipments and conduct joint examinations, when appropriate, to identify shipments that may contain smuggled food. When possible, the agencies will work together to publicize food smuggling enforcement actions to deter others from attempting similar acts.

Draft Guidance for Dietary Supplement Industry
FDA issued on July 3, draft guidance for the dietary supplement industry on assuring the safety of new dietary ingredients. The draft guidance clarifies agency expectations on new dietary ingredients for industry and is an important preventive control to ensure that consumers are not exposed to unnecessary public health risks from new ingredients with unknown safety profiles. Dietary supplement manufacturers are required to notify the FDA in advance when they intend to add a new dietary ingredient to their products, except in certain situations when the ingredient has been part of the food supply and has not been chemically altered for use in supplements. The notifications must identify the new dietary ingredient and be accompanied by evidence on its safety. The draft guidance is intended to inform and assist manufacturers, distributors, and others in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient is necessary and in preparing premarket safety notifications.

Authority to Suspend the Registration of Food Facilities
On July 3, the agency’s authority to suspend the registration of food facilities to prevent the import and export into the United States, or other intrastate or interstate distribution of food became effective. The FDA expects individuals responsible for registered food facilities to take steps to produce safe products. If those efforts fail, the facility should file a food report with FDA, voluntarily recall the affected product, and take action to keep products from reaching consumers. FDA may suspend the registration of a facility in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

Administrative Detention of Foods
This rule, issued in May, allows the FDA to administratively detain food products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed, and went into effect on July 3. Under this rule, these products will not be sold or distributed while the agency determines whether an enforcement action such as seizure or federal injunction against distribution of the product, is warranted.

MOU Signed with USDA
On July 1, FDA and United States Department of Agriculture (USDA), National Institute of Food and Agriculture (NIFA), entered into an agreement to collaborate on the establishment of a competitive grant program for food safety training, and other projects, as part of a Memorandum of Understanding with USDA’s Research, Education and Economics Agencies.

Source: FDA

View Complete Progress Report and Supporting Documents:

Posted on Thursday, July 28, 2011 (Archive on Thursday, August 04, 2011)
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