The United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) recently issued a final rule withdrawing the Organic Livestock and Poultry Practices (OLPP) Final Rule published in the Federal Register on January 19, 2017. The OLPP rule promised to impose various animal handling and raising requirements on livestock and poultry labeled Organic, but it was never allowed to go into effect during the administration transition. The Trump Administration signaled an interest in revisiting the rule and solicited comments on the OLPP. The recent final rule is noteworthy not only for its withdrawal of the OLPP, but also for the statutory and cost-benefit analyses that USDA cites to justify the withdrawal. In the recent final rule, USDA explains is withdrawing the OLPP Final Rule based on:

  • The agency’s current interpretation of 7 U.S.C. § 6905, under which USDA believes the OLPP final rule would exceed USDA’s statutory authority; and
  • Independent justification based upon USDA’s revised assessments of its benefits and burdens, and USDA’s view of regulatory policy.

The Organic livestock and poultry regulations currently published at 7 CFR Part 205 remain effective.

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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.

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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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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.

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The Federal Trade Commission (FTC) Bureau of Consumer Protection is where the action is when it comes to identifying current and future trends related to consumer protection.  Bureau actions are closely watched to identify enforcement priorities and issuance of key guidance on how the FTC contemplates exercising its authority in key areas, such as social media.  Actions the FTC takes, or elects not to take, provide critical information to marketers committed to legal compliance in a way that does not hamper appropriate business objectives.  The primary protector of consumers against fraud, deceptive advertising, and other practices that prey on unsuspecting consumers has recently updated its previous guidance on the use of endorsements and has taken enforcement action related to endorsements and several other focus areas.  This article touches on a range of topics and is intended as a quick reference guide to recent developments with an eye on what lies ahead.

Click here to read the update.

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.

Today, the European Commission published a new Regulation tightening the restrictions on the use of Bisphenol A (BPA) in food contact materials.

BPA is used in a number of food contact applications, such as polycarbonate plastic produced for articles that are intended to be reused, such as water dispensers, kitchenware, plastic bottles, etc.  BPA is also used to manufacture coatings for food and drink cans.  BPA can migrate into food from the material or article with which it is in contact, resulting in exposure to BPA for consumers of those foods.

Currently a prohibition on the use of BPA in the manufacture of polycarbonate infant feeding bottles is in place in the EU on the basis of the precautionary principle.  The new Regulation extends this ban by also prohibiting the use of BPA to manufacture infant cups as well as the migration of BPA from coated materials containing food intended for infants and children 0–3 year olds.
Based on an updated review of exposure data carried out by the European Food Safety Authority (EFSA), the new Regulation lowers the regulatory limit (specific migration limit or ‘SML’) for BPA and extends this restriction to coating materials, which are used to line food and drink cans.  A specific migration limit of 0,05 mg of BPA per kg of food (mg/kg) has been set for the migration into or onto food of BPA from varnishes or coatings applied to materials and articles. In addition, the new Regulation provides that no migration of BPA is permitted from varnishes or coatings applied to materials and articles specifically intended to come into contact with infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children.

The new Regulation will apply from 6 September 2018.  As from that date, business operators will have to ensure, among other, that varnished or coated materials and articles are in compliance with the new rules and are accompanied by a written declaration of compliance containing:

  • details on the business operator issuing the declaration of compliance;
  • details on the business operator which manufactures or imports the coated material or article;
  • details on the varnished or coated material or article itself;
  • confirmation that the varnish or coating applied meets applicable restrictions; and
  • specifications on the use of the coated material or article (e.g., the type of food with which it is intended to be in contact, the time and temperature of treatment and storage in contact with food, the highest food contact surface area to volume ratio for which compliance has been verified).

At the present time, no total ban on the use of BPA applies as there is insufficient information on replacement substances and more assessment would need to be carried out on their safety and effectiveness before BPA could be fully replaced.  At the same time, the European Commission has mandated EFSA to undertake a full re-evaluation of BPA again on the basis of the results of anticipated new studies and scientific data to address the remaining uncertainties. This work is due to start in spring 2018.  Upon completion,  the Commission will decide what if any further action is necessary to protect consumers as regards BPA in food contact materials.

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.

Click here to read our overview.

The U.S. Food and Drug Administration (FDA) has taken two important steps to launch the Voluntary Qualified Importer Program (VQIP) under the FDA Food Safety Modernization Act (FSMA). First, FDA has started accepting applications for participation in VQIP, a voluntary, fee-based program which offers expedited review and entry of human and animal food into the United States. Second, FDA has recognized the first accreditation body under the voluntary Accredited Third-Party Certification Program created by FSMA, a step needed to implement VQIP. This post discusses both developments.

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