Food Labeling

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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.

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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).

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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.

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Following the release of the Food and Drug Administration’s (FDA’s) nutrition labeling revisions in May 2016, the U.S. Department of Agriculture’s (USDA’s) Food Safety Inspection Service (FSIS) is proposing to amend the nutrition labeling requirements for meat and poultry products. The proposed revisions parallel almost exactly FDA’s final nutrition labeling revisions.  Comments are due 60 days from the date the proposed rule is officially published in the Federal Register.
This rule proposes several significant changes for many meat and poultry product labels. As with the FDA final rule, the FSIS proposed rule would (1) require the declaration of “Added Sugars,” vitamin D, and potassium and remove the requirement to declare “Calories from Fat”; (2) revise the definition of dietary fiber; (3) revise the format of the Nutrition Facts Panel (NFP); (4) require dual-column labeling for certain containers; (5) update the reference amounts customarily consumed (RACCs) for several product categories; (6) consolidate some RACCs across meat and poultry products; and (7) create several new RACCs. The new and updated RACCs include those for appetizers and candies with meat or poultry. Additionally, the proposed rule would consolidate the nutrition labeling regulations (which are currently separate for meat and poultry products) into a single part at 9 CFR part 413. FSIS proposes a two-year compliance period for large companies and a three-year period for small companies.

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The Food and Drug Administration (FDA) announced yesterday that it has started a public process to update the criteria for making a “healthy” nutrient content claim in food labeling. To initiate that process, FDA issued a request for information, with comments due January 26, 2017.  FDA also announced that while the rulemaking process is ongoing, the agency will exercise enforcement discretion to allow healthy” claims on foods that:

(1) are not low in fat, but the amounts of mono- and poly-unsaturated fats constitute the majority of the fat content and the mono- and poly-unsaturated fat content is declared on the label; or
(2) do not contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, iron, calcium, protein, or dietary fiber, but do contain at least 10 percent of the DV per RACC of potassium or vitamin D, and whichever nutrient is being used as the basis for eligibility is declared in the label.

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The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has announced the beginning of its “Generically Approved Label Record Assessment Pilot Project.”  This project is the pilot phase of FSIS’s inspectional program to assess the effectiveness of the expanded generic approval program in ensuring meat and poultry labels comply with FSIS regulations. The pilot program will take place through the end of September and will begin with five establishments. Although the pilot project affects only a few establishments, it signals that FSIS plans to begin reviewing generically approved labels more closely in the relatively new future and shows how the Agency plans to do so. Companies operating under FSIS inspection might use this opportunity to review their generic approval compliance programs and prepare for closer Agency scrutiny.

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The House of Representatives voted today to approve compromise legislation sponsored by Senate Agriculture Committee Chairman Pat Roberts (R-Kan.) and Ranking Member Debbie Stabenow (D-Mich.) that will preempt the Vermont and other state labeling laws relating to genetically engineered (GE) foods. The bill creates a national, uniform disclosure standard for GE foods that will consist of a text, symbol, or digital or electronic link. It now awaits President Obama’s signature before becoming law. Passage of the law marks a major victory for industry, but the GE labeling issue will remain active for many years to come as the U.S. Department of Agriculture (USDA) works to implement the disclosure standard in the next two years. We expect that USDA will aim to issue its final rule by July 2018, with additional time for companies to come into compliance with that disclosure standard.

In this post we summarize the key components of the disclosure standard and the bill’s likely effect on state labeling laws.

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The Food and Drug Administration (FDA) has published its final guidance on the menu labeling final rule. This development is significant because it triggers the compliance date for the law, which will be one year from the date that FDA publishes a notice in the Federal Register advising the public that the guidance is available.  FDA expects to publish this notice in early May, meaning the compliance date for the final rule would be in early May 2017.

The guidance document is comprised of questions and answers, with many of the questions having been submitted to the agency by the food industry. FDA is providing additional flexibility in a few areas, particularly for “grab and go” items sold in grocery stores; and for declaring calories for combination meals based on the individual components of the meal, where they are specifically listed, rather than using a range with the total possible calories. The below post summarizes some of the key highlights of the guidance, particularly where the guidance provides clarifications not offered in the final rule or preamble.

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