FDA Food Safety Modernization Act: Six Month Update

July 5, 2011

Dear International Colleagues:

Upon passage of the FDA Food Safety Modernization Act (FSMA), I made a commitment to keep you updated regarding the U.S. Food and Drug Administration’s (FDA) progress towards implementing this new food safety legislation in the United States. I am writing today to tell you about several new implementation accomplishments and to update you on various other issues regarding this legislation. We appreciate your continuing interest in these activities and are grateful for your thoughts and perspectives on our initiatives. I hope this letter will be part of that continuing dialogue.

We continue to meet the implementation requirements that this law imposed on us. The newest deliverables we have accomplished since my last update to you on 5 May 2011 are summarized below:

• The U.S. Department of Health and Human Services and the U.S. Department of Homeland Security jointly developed an anti-smuggling strategy to prevent smuggled foods from entering the United States. This strategy will assist FDA and Customs and Border Protection - which fall organizationally under HHS and DHS, respectively - in establishing targeting criteria to better identify and prevent smuggled foods from entering the United States and posing a threat to national security and consumer safety. When possible, the agencies will also work together to publicize food smuggling enforcement actions. For additional information on the anti-smuggling strategy, please visit:
  http://www.fda.gov/downloads/ForIndustry/ImportProgram/UCM261739.pdf.  
• FDA issued draft guidance for the dietary supplement industry on assuring the safety of new dietary ingredients. The draft guidance clarifies our agency’s expectations on new dietary ingredients for industry and is an important preventive control to ensure that consumers are not exposed to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 dietary ingredients with unknown safety profiles. Dietary supplement manufacturers are required to notify 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 The draft guidance is intended to inform and assist manufacturers, distributors, and others in deciding when a premarket safety notification for a dietary supplement containing a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. To view the draft guidance on new dietary ingredients please visit:
  http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/
  GuidanceDocuments/DietarySupplements/ucm257563.htm.  
• FDA announced that its authority is now effective to suspend the registration of a food facility in certain circumstances to prevent the importation of food into the United States or the intrastate or interstate distribution of food within our borders. FDA expects individuals responsible for registered food facilities to take steps to produce safe products. If those efforts fail, the facility should take appropriate steps to keep such 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. 
• FDA announced that the interim final rule published on 4 May 2011 is now effective. This new rule allows FDA to administratively detain food products within the United States that it has reason to believe are adulterated or misbranded for up to 30 days, if needed, to ensure they are kept out of the marketplace. Under this rule, these products will not be sold or distributed in the domestic marketplace while the agency determines whether an enforcement action such as a federal seizure or injunction is warranted through the U.S. judicial system to prevent the distribution of the product throughout the United States. To view the interim final rule published on 04 May 2011, please visit:
  http://www.gpo.gov/fdsys/pkg/FR-2011-05-05/html/2011-10953.htm. 

I would also like to take this opportunity to remind you that FDA is seeking comments on preventive control measures for food facilities through a public docket that opened on 23 May 2011 and which will remain open until 22 August 2011. FSMA requires food facilities, domestic and foreign, that are supplying the U.S. market to implement a written preventive control plan to prevent food-borne hazards from occurring in food products during processing and production. Preventive control plans must include information about evaluating those hazards that could affect food safety, specifying what preventive steps or controls will be put into place to significantly minimize or prevent the hazards, identifying how the facility will monitor these controls to ensure they are working, maintaining routine monitoring records, and specifying what actions a facility will take to correct problems that arise. Under FSMA, FDA is required to issue a rule on preventive controls for all food facilities that are registered in accordance with our laws. Our agency opened the public comment docket to solicit specific recommendations from stakeholders on what preventive control measures are appropriate and any other pertinent information and recommendations. We greatly value the experiences of our international colleagues in this area, and I encourage you to submit comments either electronically or in writing to the public docket so that our final rule can be better informed by these perspectives.

You may submit electronic comments at: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0238-0001.

You may submit written comments to:
The Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

As for specific outreach activities, we have now held three public meetings on the new law that I hope many of you or your staffs were able to attend. The first, held on 29 March, focused on key importation provisions of the new law; the second, held on 20 April, focused on preventive controls in facilities; and the third, held on 6 June, focused on the inspection and compliance provisions of the new law. We especially thank those of you who were able to attend and who have provided comments and perspectives on these provisions of the new law.

We continue to update our FSMA web site at:

http://www.fda.gov/Food/FoodSafety/FSMA/default.htm

It contains what we hope are many useful items such as FSMA requirements we have met, frequently asked questions, translations of key FSMA documents into eleven languages, recent speeches, and upcoming events.

Specifically, new items on our website that may be of specific interest to you and your colleagues include:

• A six month Progress Report that provides additional details about the items mentioned in today’s communication. The Progress Report is available in both a web and PDF format at:
  http://www.fda.gov/Food/FoodSafety/FSMA/ucm255893.htm. 
• A timeline that illustrates the specific FSMA deadlines that FDA has already met is located at:
  http://www.fda.gov/Food/FoodSafety/FSMA/ucm250568.htm. 

In addition, I hope you have signed up for the subscription service on our website at the following link that allows you to get automatic emails when something new has been added: https://service.govdelivery.com/service/subscribe.html?code=USFDA_206.

Your input is essential as we continue our efforts to implement our new law. Therefore, if you or your colleagues have general comments or questions regarding how FDA will implement FSMA, please continue to forward them electronically to: FSMA@fda.hhs.gov.

Also, if your government wishes to comment formally as part of the World Trade Organization notification process for FSMA, document SPS/N/USA/2156, please send those comments electronically to FSMAWTO@fda.hhs.gov or by fax to +1 201-436-2618.

I will also continue to keep you apprised of our progress through letters, such as this one. In closing, FSMA calls for strengthening collaboration among all food safety agencies, including our foreign counterparts, and FDA believes that building and leveraging the capacity of our foreign food safety partners will help promote, to the benefit of all of our citizens, a well-integrated, coordinated global food safety system focused on prevention and that is as effective and efficient as possible. On behalf of FDA, please accept my most sincere gratitude for your commitment to enhancing the safety of our global food supply and for your ongoing support as we continue to fully implement FSMA.

Sincerely,

---/s/---

Murray M. Lumpkin, M.D., M.Sc.
Deputy Commissioner
International Programs

International Outreach to Foreign Embassies