YOUR SOURCE ON FOOD LITIGATION AND REGULATION

The current unsettled status of restaurant menu labeling rules may be headed toward some form of resolution. FDA first promulgated a final federal menu labeling rule in December 2014 requiring that calorie information be posted on menu labeling boards in covered food retailers. The agency subsequently delayed the compliance date to December 2016, and again to May 2017. On May 4, 2017, the day before the rule was to take effect, FDA delayed the rule again, this time to May 7, 2018.[1] In response, on May 18, New York City announced it would begin to enforce its own local menu labeling rule.[2] Current circumstances have left retailers uncertain about how to proceed. Can a federal agency delay a final federal regulation for an indefinite period? Does a delayed federal regulation have preemptive effect over a local or state rule?

USDA’s Agricultural Marketing Service (AMS) posted 30 questions for stakeholder input regarding the establishment of a national disclosure requirement for identifying bioengineered foods and food ingredients. The legislation requiring the disclosure of bioengineered foods was enacted on July 29, 2016, and gave AMS two years to establish a national standard and the procedures necessary for implementation (see our LawFlash, New GMO Legislation Signed Into Law, for more information on the legislation). AMS is now seeking input from stakeholders in order to issue a proposed rule this fall, such that it may promulgate a final rule by the mandated July 2018 deadline.

On May 18, 2017, New York City announced plans to begin enforcing its updated local menu labeling rule,[1] just weeks after FDA announced the postponement of the compliance date for a similar federal menu labeling rule, from May 2017 until next year.[2] These two actions potentially raise novel and significant issues of federal preemption.

More specifically the city’s planned enforcement measures could well be in conflict with an express federal preemption clause at 21 U.S.C. § 343-1, which states that “no State or political subdivision of a State may directly or indirectly establish . . . any requirement for nutrition labeling of food that is not identical to the requirement of section 343 (q) of this title [which contains restaurant menu labeling requirements].” On its face, the NYC menu labeling requirements differ in at least some material respects from those specified in the federal rule. For example, the city’s rule affects food service establishments that are part of chains with 15 or more locations in the United States, whereas the federal rule applies to chains with 20 or more locations. But more fundamentally, NYC will quite arguably be enforcing rules that Congress has determined should fall within the exclusive province of FDA.

Continuing the pattern of delays in the implementation of a compliance date for the menu labeling final rule requirements (previously covered in our posts, FDA Delaying Enforcement (Again) for Menu Labeling Final Rule (March 2016) and LawFlash: FDA Issues Menu Labeling Final Guidance (May 2016)), FDA has issued an interim final rule (to be published on May 4, 2017) again extending the compliance date for menu labeling requirements by one year—from May 5, 2017 to May 7, 2018.

On March 31, FDA published a final guidance document on acceptable unique facility identifiers (UFIs) for Foreign Supplier Verification Programs (FSVPs).[1] FDA states in the guidance that it now formally recognizes the Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number as an acceptable UFI for FSVP.

On December 1, the US Department of Agriculture's (USDA’s) Food Safety and Inspection Service (FSIS) issued a proposed rule to amend the nutrition labeling regulations for meat and poultry products (Proposed Rule). The revisions in the Proposed Rule are meant to parallel, to the extent possible, the US Food and Drug Administration’s (FDA’s) two similar final rules concerning nutrition fact labels (Nutrition Labeling Rules).1

Some notable similarities between provisions in the Proposed Rule and FDA’s Nutrition Labeling Rules include, but are not limited to, the following:

  • Updating the list of nutrients required or permitted to be declared (e.g., no longer requiring declaration of Vitamins A and C but requiring declarations for Vitamins D and Potassium) and updating Dietary Reference Values (DRVs) and Reference Daily Intakes (RDIs) that are based on current dietary recommendations2
  • Requiring the declaration of trans fat in the Nutrition Facts label
  • Requiring the declaration of added sugars
  • Establishing a new definition of “dietary fiber”
  • Modifying the nutritional labeling format for certain nutrition information (e.g., calories, serving size, and servings per container) prominence, and changing the order of the “Serving Size” and “Servings Per Container” declarations
  • Requiring mandatory dual-column labeling on certain packages of meat and poultry products (i.e., products that contain 200–300% of the applicable reference amounts customarily consumed (RACC))
  • Amending the requirements for foods represented or purported to be specifically for children under the age of four years, and pregnant and lactating women

The Final Rules implementing the Food Safety Modernization Act (FSMA) issued over the last several years contain numerous requirements, compliance dates, definitions, applicability guidelines, extensions, and related guidance. For your comprehensive reference, we’ve drafted a summary of the Final Rule information and requirements. We are continually monitoring FSMA developments and can assist you with questions regarding the items in the summary.

Read the Final Rule summary.

As part of its continuing implementation of the Food Safety Modernization Act (FSMA), on October 31, the FDA announced the availability of a draft guidance document titled “Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA” (Guidance).

The Guidance is meant to provide industry with more information on the content of the disclosure statements required by four of the seven foundational FSMA rules. Additionally, it identifies the types of documents that would and would not be appropriate vehicles for such disclosure statements.

The four relevant foundational FSMA rules are:

  1. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Human PC Final Rule)[1]
  2. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Animal PC Final Rule)[2]
  3. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Product Safety Final  Rule)[3]
  4. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (FSVP Final Rule)[4]

On August 17, the US Food and Drug Administration (FDA) published a Final Rule on the Generally Recognized as Safe (GRAS) notification program, a voluntary premarket notification program for products used in food substances. This Final Rule comes 19 years after the FDA proposed the GRAS notification program in a Proposed Rule, which was intended to shift the premarket program from the GRAS petition process, which involved formal rulemaking, to the less burdensome GRAS notice process. Although the Final Rule is extensive, human food manufacturers can rest assured that the changes to the GRAS notice are not.

Recently, the US Food and Drug Administration (FDA) announced its plan to redefine the implied nutrient content claim “healthy” by issuing a new guidance document—Use of the Term “Healthy” in the Labeling of Human Food Products1 (Guidance).

The Guidance is effective immediately and states that FDA will exercise enforcement discretion when the claim “healthy” is used on the labeling of certain food products. Specifically, FDA will exercise enforcement discretion for food labels that display the “healthy” implied nutrient content claim and that

  • are not low in fat, provided that the amounts of mono and polyunsaturated fats are declared on the label, and the amounts declared constitute the majority of the fat content; or
  • contain at least 10% of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.