The Food and Drug Administration (FDA) has issued a final rule extending the compliance date for the final rules revising the requirements for the nutrition and supplement facts labels and the declared serving sizes and reference amounts customarily consumed (RACCs). The final rule extends the compliance date for manufacturers with $10 million or more in annual food sales from July 26, 2018 to January 1, 2020, and for manufacturers with less than $10 million in annual food sales from July 26, 2019 to January 1, 2021.
On September 8, 2017, Ocean Spray Cranberries, Inc. (Ocean Spray) originally submitted a health claim petition to the Food and Drug Administration (FDA) for approval of a health claim tying together the consumption of cranberry products and the reduced risk of urinary tract infections (UTIs) in healthy women. More recently, on February 20, 2018, the FDA sent a letter to Ocean Spray stating that it is proceeding to review the petition as one for a qualified health claim. All of this information has now been posted in the agency docket. Comments on this qualified health claim petition will be accepted until May 7, 2018, and the FDA expects to issue a final decision on the claim by October 5, 2018.
This post summarizes Ocean Spray’s petition, the studies cited in support of Ocean Spray’s claim, the discussion concerning cranberry as an eligible “substance,” and the FDA’s response.
On March 29, 2018, Food and Drug Administration (FDA or the agency) Commissioner Scott Gottlieb, M.D., delivered a nutrition-related policy address. The Commissioner emphasized FDA’s role in helping Americans improve their nutrition as a step towards reducing chronic disease, with a particular focus on sodium reduction. The Commissioner’s address provides important insight into the shape that FDA nutrition and health policy can be expected to take in the next few years.
The Food and Drug Administration (FDA) has released an Excel file that lists all general inspection citations included on every FDA Form 483 (Inspectional Observations) issued for almost the past ten years, from October 2008 through February 2018. The information is specific to each establishment that has been inspected by FDA across all areas of the agency’s jurisdiction, including food facilities. We encourage all food companies to review their data so that they are aware of the information that is now readily available for review by the public.
The release of these inspection citations is connected to the Open Government Initiative issued by President Obama on January 21, 2009. Pursuant to this initiative, the agency’s stated purpose for now releasing this data set is to “improve the public’s understanding of how the FDA works to protect the public health, provide the public with a rationale for the Agency’s enforcement actions, and to help inform public and industry decision-making.” Pursuant to this initiative, the data set provides information on general inspection citations under all areas of FDA jurisdiction.
The Food and Drug Administration (FDA) recently posted a document on its website that lists all importers that have been identified at entry in connection with the Foreign Supplier Verification Programs (FSVP) regulation. As discussed in the link below, this posting is a statutory requirement under the FDA Food Safety Modernization Act (FSMA). The list simply provides all of the FSVP importer names that have been declared at entry, which means that some companies are listed multiple times with slight variations in their name. We expect the list is too general to help most companies determine whether there are any entries for which they have been declared as the FSVP importer without permission. However, the list could be helpful to companies that have never knowingly been declared as an FSVP importer so they can become aware they were declared and therefore may be subject to an FSVP inspection.
Join us in London for a food seminar, “New U.S. food manufacturing, labeling, and inspection requirements – What you need to know to export foods ”
On 19 April, Hogan Lovells will offer a seminar on recent developments in U.S. food law that affect all food companies exporting food to the U.S.
U.S. partners Maile Hermida and Elizabeth Fawell will be visiting London from Washington, DC to discuss the latest U.S. food law developments that affect foreign companies that sell food in the U.S. This session will address recent changes for food safety, nutrition labeling, import filings, and facility inspections, addressing what these developments mean for exporters and how they are affected by the political climate in the United States. Both Maile and Elizabeth have extensive experience helping companies navigate these new requirements and developing effective business solutions for managing compliance.
Topics for this two hour seminar include:
— New U.S. Food Safety Requirements (FSMA)
— New Nutrition Labeling Rules
— Impacts from and Forecast for Trump Administration
— Inspections and Enforcement
On March 1, 2018, Food and Drug Administration (FDA or the agency) Commissioner Dr. Scott Gottlieb, M.D., announced new efforts to advance implementation of the new consumer Nutrition Facts label for foods, and with it a plethora of guidance documents on dietary fiber, Reference Amounts Customarily Consumed (RACCs) for product categories, declaration of added sugars on honey and similar products, and proper labeling of honey and honey products. We briefly discuss each of the following guidance documents further below:
- Final Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category
- Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Small Entity Compliance Guide
- Final Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30)
- Draft Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products
- Final Guidance for Industry: Proper Labeling of Honey and Honey Products
The deadline for submitting comments on the Draft Guidance concerning the declaration of added sugars for honey, maple syrup, and certain cranberry products is May 1, 2018. Comments should be submitted to Docket No. FDA-2018-D-0075. The other documents are Final Guidance, on which comments can be submitted at any time.
As seen in news reports, two recent Department of Justice (DOJ or Department) memoranda address the role of guidance documents in civil enforcement actions. Taken together, the two memoranda greatly limit the Department’s use of DOJ and other agencies’ guidance documents to support civil enforcement actions, as guidance documents do not impose binding standards on private parties. However, for the reasons set forth below, the memoranda are not expected to have a significant impact on enforcement actions initiated by the Food and Drug Administration (FDA) in food-related matters.
On February 9, 2018, the U.S. Cattlemen’s Association (USCA) submitted a petition requesting the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) to establish labeling requirements that would exclude synthetic products made from alternative proteins and lab-grown meat from animal cells from being marketed as “beef” and/or “meat.” The petition requests that new regulations be adopted limiting the term “beef” to describe the tissue or flesh from animals born raised, harvested, and processed in the “traditional” way, and limiting the term “meat” to the tissue or flesh of animals that have been harvested in the “traditional” manner.
On January 11, 2018, the Food and Drug Administration issued its 2018 Strategic Policy Roadmap (the Roadmap) in an effort to provide transparency about the FDA’s policy undertakings. The Roadmap outlines key priorities that the Agency will pursue in 2018 to advance its public health mission. The Roadmap covers all FDA-regulated product areas and includes the following priorities related to food:
- Empower consumers to make better and more informed decisions about their diets and health; and expand the opportunities to use nutrition to reduce morbidity and mortality from disease
- Strengthen FDA’s scientific workforce and its tools for efficient risk management
FDA notes that there are areas of overlap both between all priorities mentioned as well as with other aspects of work at FDA. Importantly, for food regulation, FDA outlined how it will continue to focus on implementing the new Nutrition Facts Panel and menu labeling regulations and associated guidance, as well as continuing to implement FSMA and the associated field realignment that now
has a dedicated cadre of food (and feed) inspectors. Other noteworthy inclusions on the nutrition and labeling side are revisions to the “healthy” claims regulations, updating food standards to promote public health, providing new opportunities to make ingredient information more helpful to consumers, and advancing guidance on dietary sodium reduction. On the food safety side, FDA will
continue to build its pathogen database networks and, under FSMA, implement preventive controls rules and pay particular attention to implementing the produce safety rule through increased training and collaboration with the states.
We provide an overview of FDA’s priority areas, and the corresponding goals and action items, most relevant to food policy.