FDA states that it will issue “evaporated cane juice” guidance by the end of 2016. 

  • For the past several years, food companies have faced putative class action lawsuits related to the use of the term “evaporated cane juice” (ECJ) on product labels.  Various lawsuits have alleged that the term violates federal and state laws, citing as support a 2009 FDA Draft Guidance that states “FDA’s view that the term [ECJ] is not the common or usual name of any type of sweetener, including dried cane syrup.”  Judges presiding over ECJ-related cases have looked to FDA for guidance on the lawfulness of the term as used on product labels.
  • On July 13, 2015, FDA issued a letter to a judge in the Northern District of California, indicating that the Agency is “actively working on a final guidance” to address the use of the term and “currently anticipates that a final guidance will issue before the end of 2016.”  In March 2014, FDA re-opened the comment period on its guidance and sought information about the basic nature and characterizing properties of the ingredient declared on labels as ECJ.  The Agency notes that it received “a substantial number of comments and extensive amounts of supporting materials,” which FDA now must consider.
  • Food industry stakeholders — including the Grocery Manufacturers Association (GMA) — have criticized FDA’s 2009 Draft Guidance for exposing the industry to litigation risks and causing chaos for manufacturers.  Many urge FDA to accept and endorse the use of the term ECJ, which they state is a defensible term based on the manufacturing process and the characterizing properties of the substance.  It remains to be seen whether FDA’s final guidance will improve the situation for the food industry.

Lawsuit proceeds on the premise that the use of PHOs in foods may violate California law. (subscription to Law360 required)

  • As previously covered on this blog, FDA recently issued a final determination stating that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs) are generally recognized as safe (GRAS) under any conditions of use in food.  Although FDA provided a “compliance date” of June 18, 2018 — ostensibly giving the food industry three years to remove PHOs from food or to seek regulatory clearance for low-level uses — the status of PHO use under state law during the interim time period is not clear.
  • In a recent ruling on a motion to dismiss before the “Food Court” (Northern District of California), the judge permitted a plaintiff’s case to proceed on the premise that the presence of PHOs in defendant’s noodle products may violate California law.  Specifically, the judge found “plausible allegations” under:
    • the Unfair Prong of California’s Unfair Competition Law (based on allegations that the use of trans fats in foods poses risks to public health and that the only utility of such use is that it is less expensive than safe substitutes) because the law applies a balancing test of harm and utility; and
    • the breach of implied warranty of merchantability (based on allegations that foods containing trans fats are not fit for human consumption due to the associated health risks).
  • In the ruling, the judge cited FDA’s recent statement that “no form of partially-hydrogenated oil was ‘generally recognized as safe'” and noted the lack of any federal “safe harbor protecting the use of [PHOs] from the reach of California law.”  Although the case still poses key questions of whether the presence of PHOs actually violated California law, as well as issues of class certification, standing, and damages — and other courts might take a different position on such issues — this early ruling illustrates the reasons for anxiety in the food industry during the immediate aftermath of FDA’s PHO determination.

Senate Appropriations Committee nixes amendment that would have increased funding allotted to FSMA implementation.

  • Congress has been considering the agriculture appropriations bill for fiscal year 2016.  Among the issues under discussion has been the adequacy of funding available to FDA to implement the FDA Food Safety Modernization Act (FSMA).
  • On July 16, 2015, the Senate Appropriations Committee approved the FY 2016 appropriations bill, rejecting a proposed amendment by Senator Dick Durbin (D-Illinois) that would have increased FSMA funding.  According to Durbin’s remarks, FDA requested an additional $276 million to support adequate FSMA implementation, but ultimately the Committee allotted only another $45 million to food safety.
  • Particularly as the industry anticipates major final FSMA implementation rules in the next few months, it remains to be seen how FDA will allocate its lean budget to food safety regulation and enforcement in the year ahead.

Canada considers changes to its policy regarding GM imports.

  • Currently, food containing genetically modified (GM) organisms may be imported into Canada only if Health Canada has performed a pre-market safety assessment of the products.  According to Health Canada, it is a “seven to ten year process to research, develop, test and assess the safety of a new GM food” before it can be approved.  As the food industry is well aware, once a GM crop is authorized for use in a jurisdiction, trace amounts of GM material may become mixed with conventional crops during the course of commercial production.  This “cross-contamination” may happen during cultivation, harvest, transportation, and storage of the crops.  Even where best practices are followed, it is difficult to avoid inadvertent cross-contamination.  Under Canada’s strict GM policy, the presence of any unauthorized GM constituents in a food shipment constitutes non-compliance and triggers a risk-based enforcement response which may result in the entire shipment being denied entry into Canada.
  • After years of discussion and debate, Canada is close to finalizing a new policy on GM foods that would permit some GM imports without approval by Health Canada.  The new policy would permit a “low level presence” (specifically, 0.2%) of GM constituents in food imports where the GM materials have not yet undergone a safety assessment in Canada if the products are authorized for sale in a foreign jurisdiction that Health Canada deems to have an adequate pre-market safety review process.
  • If finalized, Canada’s new policy would eliminate the “zero-tolerance” approach to the importation of foods with low levels of inadvertent GM cross-contamination.  The policy is aimed at eliminating trade barriers while remaining protective of health and safety, as well as providing a global model that may facilitate the adoption of reciprocal policies by Canada’s trading partners.

House Committee on Agriculture approves Safe and Accurate Food Labeling Act of 2015.

  • As previously covered on this blog, Reps. Mike Pompeo (R-KS) and G. Butterfield (D-NC) co-sponsored the Safe and Accurate Food Labeling Act of 2015, which would prohibit states from mandating the labeling of genetically modified (GM) foods.  The bill also would create a voluntary certification process for companies that want to claim that their products are “non-GM.”
  • On July 14, 2015, the House Committee on Agriculture engaged in a markup and approved an amended bill that included changes intended to enhance coordination between FDA and USDA in the GM regulatory approval process.  The amended bill also would establish a public website (administered by USDA) to list all GM crops intended for use in food applications.  USDA would administer the voluntary certification program to permit the use of “non-GM” claims on food labels.
  • As anticipated, industry members and groups such as the Grocery Manufacturers Association (GMA) have praised the House Committee’s action, maintaining that such legislation will prevent the creation of a 50-state patchwork of GM labeling laws that could create widespread confusion and add significant costs to food production.  Consumer groups such as the Center for Food Safety (CFS) continue to oppose the bill, stating that the measure will block consumer access to information about the composition of their food.  The bill now moves to the House floor for a vote, although it remains to be seen whether this will occur before the August recess.

New York City mandates freezing of fish intended to be served raw or undercooked.

  • Section 3-201.11(D) of FDA’s 2013 Food Code recommends that most fish intended for consumption in raw or undercooked form be offered for sale or service only if they are obtained from a supplier that freezes the fish or if they are frozen on the premises prior to sale or service.  Published by FDA, the Food Code serves as a model for retail and food service regulations nationwide.  FDA urges state, local, tribal, and territorial regulatory bodies to adopt the latest version of the Food Code.
  • Beginning in August 2015, New York City will require fish served raw or undercooked in restaurants to be frozen prior to serving, in alignment with the Food Code recommendation.  Under new rules promulgated by the NYC Department of Health and Mental Hygiene, fish must be stored in a freezer for a minimum time period ranging from 15 hours to one week, depending on the temperatures used in freezing and storage.  Certain seafood is exempt from the rule, e.g., shellfish, farm-raised fish, and certain types of tuna.  These exemptions also exist in Section 3-402.11(B) of the Food Code.
  • The new food safety regulations are intended to eliminate the threat of parasites and harmful pathogens, such as bacteria, that may be present in seafood products.  The regulations also serve to illustrate a practical example of how localities may take action to give legal effect to provisions of the Food Code.

FDA warning letter causes confusion about “natural” claims for HFCS.

  • FDA’s informal policy regarding the use of the term, “natural” is that nothing artificial (including artificial flavors) or synthetic (including all color additives regardless of source) has been included in or has been added to a food that would not normally be expected to be in the food.  Although FDA has not codified an official definition for “natural” and does not issue determinations regarding the “natural” status of specific ingredients, the Agency issued an informal opinion letter in 2008 stating that it would not object to the use of the term “natural” on a product containing high fructose corn syrup (HFCS) where the ingredient had been produced by a specific manufacturing process that did not involve synthetic fixing agents.
  • In a recent FDA Warning Letter, the Agency caused confusion by including a paragraph alleging the impropriety of “100% Natural” and “all natural” claims where the finished product contained HFCS.  Restating its informal policy on “natural” claims, FDA concluded that the term, “‘natural’ may not be used in association with this product,” ostensibly due to the presence of HFCS.  When asked about the significance of this unusual — and seemingly self-contradictory — Warning Letter language, an FDA spokesperson confirmed that the letter would be re-posted without the section on HFCS “to avoid any confusion with the agency’s policy.”  Therefore, despite the earlier alarm, it appears that FDA did not intend to signal a new or official policy on the “natural-ness” of HFCS.
  • The food industry has grappled for years with how to apply FDA’s informal policy in practice.  Numerous class action lawsuits continue to be filed in California and in other jurisdictions challenging the propriety of “natural” or “all-natural” claims for food products that contain processed ingredients and/or genetically modified ingredients.  Although Warning Letter language is not legally binding, plaintiffs’ lawyers seize upon the Agency’s statements to support allegations of false advertising.  In the absence of an official policy on “natural” claims, the industry must remain attuned to FDA’s unofficial statements in this arena.

House Appropriations Committee approves bill amendment aimed at protecting food industry from PHO-related litigation until 2018.

  • As recently covered on this blog, FDA issued a final determination stating that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs) are generally recognized as safe (GRAS) under any conditions of use in food.  FDA specified a compliance date of June 18, 2018, suggesting that the Agency does not plan to take enforcement action against the continued presence of PHOs in the food supply for the next three years.  However, because FDA’s determination that PHOs are not GRAS took immediate effect, the food industry understandably is concerned about potential consumer litigation regarding PHOs present in foods even during the three-year “phase out” period.
  • During the House Appropriations Committee’s markup of the FY 2016 Agriculture Appropriations Bill, Rep. Andy Harris (R-MD) introduced an amendment intended to protect the food industry from litigation until June 18, 2018.  Specifically, the amendment would require FDA to publish a notice in the Federal Register clarifying that “until the compliance date specified [in FDA’s PHO determination], partially hydrogenated oils shall be considered generally recognized as safe within the meaning of section 201(s) of the [FD&C Act].”  The Committee approved this amendment.
  • If the amendment is enacted — and if FDA actually publishes the notice — FDA’s action would preserve the lawful use of PHOs in the food supply until June 18, 2018, thus potentially discouraging plaintiffs’ lawsuits premised on the allegation that food products contain an unapproved food additive.  This approach represents an interesting attempt by Congress to insulate the food industry from the litigation consequences of FDA’s recent determination.  The eventual effectiveness of this approach remains to be seen, however, particularly if FDA fails to publish the Federal Register notice in a timely manner, if someone challenges Congress’ authority to act this way, or if plaintiffs’ lawyers challenge the scientific and factual inconsistencies between the two notices.

FDA extends compliance date for menu labeling rule to December 1, 2016.

  • On December 1, 2014, FDA published a final rule to implement the menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Affordable Care Act. Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar menu items) must provide calorie and other nutrition information for standard menu items. In March 2015, FDA released a small entity compliance guide to help the industry understand the scope and coverage of the rule and compliance dates, as well as specifics of the new requirements. The menu labeling requirements originally were scheduled to take effect on December 1, 2015.
  • On July 9, 2015, FDA announced that it will extend the compliance date for the menu labeling rule to December 1, 2016. In explaining the reason for the extension, FDA noted its extensive dialogue with covered entities and requests from industry, trade, and other associations to grant additional time for compliance. FDA agreed that additional time is necessary for the Agency to provide further clarifying guidance and to help facilitate efficient compliance.
  • FDA plans to issue a draft guidance document in August 2015 that is intended to provide answers to frequently asked questions about how covered establishments should comply with applicable requirements. The Agency encourages companies to consider the information in the draft guidance as they prepare for compliance by December 2016.

Major food manufacturer pledges to use only cage-free eggs.

  • While concern for animal welfare is not a new concept, recent years have ushered in new marketplace opportunities and strategies for companies to indicate their continued commitment to the ethical treatment of livestock.
  • Major food manufacturer, General Mills, has announced a pledge to purchase eggs exclusively from cage-free suppliers.  The company joins a list of other major food industry players — such as Wal-Mart, Costco, Kraft Foods, Sara Lee, Safeway, and Starbucks — who have made similar commitments in this area.
  • Although no conclusive food safety benefits are linked to the consumption of cage-free eggs (versus battery cage eggs), the continuing shift toward cage-free buying practices indicates the market interest and potential benefits associated with food production and retail practices that focus on broader concepts such as sustainability and ethics.