There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA). The below post summarizes the following topics:

  • Guidance on application of the Foreign Supplier Verification Programs (FSVP) regulation to the importation of certain live animals;
  • Draft Guidance on the definition of “small business” for purposes of the Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) regulations;
  • A letter to the winegrape and hops growing industries regarding possible modifications to written assurances in the Produce Safety Rule; and
  • A report from the Government Accountability Office (GAO) scrutinizing FDA’s progress and implementation of key food safety-related activities.

Also, as a reminder, March 19, 2018 was the compliance date for supplier verification under the PCHF (Subpart G) and FSVP regulations when a supplier is a “small business” required to comply with the PCHF regulation. Additionally, April 6, 2018 is the compliance date for small businesses for the Sanitary Food Transportation regulation.

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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

 Click here for more information and to register.

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.

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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.

Read the update.

On 1 February 2018, the European Commission issued a notice on the impact of Brexit for food products originating from the UK. The Commission confirmed that, in the absence of a transitional agreement, the UK will become a ‘third country’ from the date of its withdrawal from the EU. This will impact a number of key areas of EU food regulation, including:

  • Food labelling: changes will need to be made to labels of food products originating from the UK. An EU-based importer must be named on the product, and mandatory references to the origin of products will need to be changed from “EU” to “UK” or “non-EU”.
  • Food composition, contaminant levels and food contact materials: UK-produced food sold in the EU will remain subject to EU rules including requirements for certain ingredients to be authorised by the Commission (e.g. additives and flavourings and novel foods), maximum permitted levels of contaminants and residues in foodstuffs, and rules on food contract materials. These apply to all foods placed on the EU market, irrespective of the place of production.
  • EU establishment requirements and submission of EU authorisations: some products such as genetically modified food must have a food business operator, authorisation holder or a representative that is established in the EU. Establishments in the UK will no longer comply with this requirement. The Food Standards Agency, the UK’s competent authority, will also no longer be able to accept applications for EU authorisations such as for the cultivation and placing on the market of genetically modified materials, and for use of new materials in food contact materials.
  • Food of animal origin: the import of food of animal origin from the UK into the EU will be prohibited, unless certain requirements are met. These include:
    • the UK must be listed by the Commission as an approved third country for the export of each category of food of animal origin. The Commission has not addressed whether the UK will automatically be approved post-Brexit or whether the UK will need to apply for authorisation as a third country;
    • the establishment from which the food is dispatched and obtained or prepared must further be approved for the export of the specific category of food of animal origin;
      the imported food satisfies all EU food hygiene requirements; and
    • the product will be subject to mandatory border checks and must enter the EU through approved border inspection posts of a remaining Member State.
  • Organic products: UK-originating organic foods will be subject to the same regulation as organic foods entering the EU from other third countries. In particular, all consignments of organic products must be accompanied by a certificate of inspection on import to the EU. These certificates can be issued by an authorised EU organic control body or authority or a non-EU control body or authority recognised as having equivalent standards as the EU. Certificates issued by UK bodies will no longer be valid.

The full notice published by the Commission is available here. 

The Proposition 65 Interim BPA warning regulation that allows companies to rely on a generic warning posted in California retail establishments will sunset on December 30, 2017. Food and beverage companies that have BPA containing packages in California and that have been relying on the interim BPA warning regulation for compliance should reassess their Proposition 65 warning obligations prior to December 31, 2017.

By way of brief background, effective May 11, 2016, OEHHA started requiring warnings for consumer products containing BPA under the Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65 or Prop 65). Due to the high percentage of the canned and bottled food and beverages that were packaged with BPA-containing materials in California at that time, OEHHA adopted an emergency regulation that allowed the temporary use of a standard point-of-sale warning message (e.g., posting of warnings at checkout stands in retail stores) for BPA. In July 2016, OEHHA proposed an interim rule that essentially extended the temporary regulation through December 30, 2017. The interim regulation also required food companies that exercised this option to provide OEHHA with a list of all food products in which BPA was intentionally used in the manufacture of the can lining or jar or bottle seals.

As of today, there are a total of over 23,000 entries of canned or bottled food products listed in the publicly-accessible OEHHA database for products packaged with BPA-containing materials. The sheer number of listed products in the database suggests that many food and beverage companies have been relying on the interim BPA warning regulation for compliance. On December 31, 2017, those food and beverage companies with products listed in the OEHHA database that have not phased out the use of BPA in their packaging should assess their options for compliance with Proposition 65. Companies should consult with legal counsel when assessing whether they will have an obligation to provide a Prop 65 warning and if so, the type of warning that should be required.

Click here to read more.

After three years of negotiations, the European Union is nearing the end of a long process to simplify and harmonize the rules for organic food production and the labeling of organic products. Council Regulation (EC) 834/3007 currently defines the minimum standards for organic products that are produced, manufactured, imported into, sold or traded within the EU, as well as the national inspection and certification systems that ensure that these requirements are met.

However, the past decade has seen a 125% growth in the value of the organic food market, with the amount of land used for organic farming growing at around 400,000 hectares per year. The European Commission has now recognized that the current rules need to be updated to support the long term development of organic production in the EU.   One of the key aims of the new regulations will be to ensure that the EU organic logo offers consumers the same guarantee of quality across Europe, including in respect of products imported from outside the EU.

The new rules will:

  • Create an EU-wide set of rules for all organic producers and products. Any necessary exceptions will be limited in time, regularly assessed and applied to all producers to ensure fair treatment.
    Apply equally to non-EU farmers who export their goods to the EU, phasing out the 60+ different “equivalence” standards currently applying to imported organic foods and levelling the playing field between EU and non-EU producers.
  • Enable farmers to apply for group certification for their products, thereby reducing costs and making it easier to join the organic scheme.
  • Apply to new products like salt, cork and essential oils and enable further products to be added in response to consumer demand.
  • Allow national authorities the discretion to reduce controls and inspections on farms from every year to every two years for producers with no record of non-compliance after three consecutive controls.
  • Reinforce the rules on precautionary measures to avoid accidental contamination by pesticides, giving consumers confidence that no pesticides have been used in the production of organic foods.

Following the European Parliament’s first reading, the proposed regulations will come into force on 1 January 2021, repealing Council Regulation (EC) 834/3007.

Please see here for more information on the new proposals.

The Food and Drug Administration (FDA) has issued a proposed rule to extend 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). Under the proposed rule, the compliance date would be extended by about 18 months – from July 26, 2018 until January 1, 2020 for large manufacturers and from July 26, 2019 until January 1, 2021 for manufacturers with $10 million or less in annual food sales. If FDA finalizes the proposed extension, it will result in a total compliance period of about 3.5 years from the date the final rules were initially published (May 27, 2016). In comparison, a number of food industry trade associations requested a 5-year compliance period – i.e., a May 2021 compliance date – that would have allowed for harmonization with the mandatory disclosure standards for bioengineered foods that are being developed by the U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS).

Read more.

On May 1, 2017, the Food and Drug Administration (FDA) issued an interim final rule (IFR) extending the compliance date for the final rule on menu labeling by one year, to May 7, 2018. FDA is also seeking comment on how FDA “might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives to provide consumers with nutrition information so that they can make informed choices for themselves and their families.” Interested parties affected by this rule should consider the comment period an opportunity to highlight for FDA specific requirements that are difficult to implement or otherwise unduly burdensome.

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On March 9, 2017, FDA held a public meeting to discuss the use of the term “healthy” on the labeling of food products. This meeting was a continuation of the public process initiated by FDA to update the criteria for making a “healthy” nutrient content claim. Companies that use or may consider use of “healthy” claims in the future should pay close attention to the issues raised at the meeting and FDA’s request for information, and should consider submitting comments to FDA, due April 26, 2017. In this update we provide a high-level summary of the issues that were raised at the public meeting.

Click here to read more.