Vermont AG issues memo clarifying scope of GM labeling safe harbor and enforcement discretion.

  • As the July 1 effective date for Vermont’s labeling requirement for genetically modified (GM) foods approaches, many companies have had questions about the scope of the law’s 6-month “safe harbor” for foods that do not bear compliant labeling.
  • On March 24, the Vermont Attorney General (AG) issued a memo clarifying the scope of the safe harbor and the state’s enforcement priorities.  During the 6-month period between July 1 and December 31, 2016, the Vermont AG will not bring an enforcement action or seek fines for products that fail to bear GM labeling unless there is evidence that a manufacturer distributed a mislabeled product after the July 1 effective date.  Starting January 1, 2017, the AG’s position is that all products must bear required GM labeling regardless of their distribution date.  However, even after January 1, 2017, Vermont’s enforcement priority will be willful violations of the labeling law.  The AG does not expect to bring enforcement action based solely on a company’s failure to remove improperly labeled products that were distributed before July 1, 2016.
  • Simply stated, companies may not distribute improperly labeled products in Vermont after July 1, 2016.  However, improperly labeled products that were distributed before July 1, 2016 and that remain on the shelf after January 1, 2017, should be granted enforcement discretion.  To strengthen the argument that enforcement discretion is warranted, companies should consider retaining clear documentation detailing when their products were distributed in Vermont.  This may be of particular significance where products have a long shelf life and are likely to remain on shelves after the 6-month safe harbor ends.

Ninth Circuit puts food labeling challenge on hold pending FDA action.

  • As food industry stakeholders are well aware, “natural” claims invite the risk of consumer class action challenges in the absence of any formal regulatory definition or regime to govern the use of the term.  Similarly, food companies also have faced challenges related to the use of the term, “evaporated cane juice” on product labels, with plaintiffs citing to a 2009 FDA Draft Guidance that states “FDA’s view that the term ‘evaporated cane juice’ is not the common or usual name of any type of sweetener, including dried cane syrup.”
  • On March 24, the Ninth Circuit issued a ruling in a challenge related to the labeling of Chobani yogurt.  Citing the doctrine of primary jurisdiction, the court ordered the challenge to be stayed pending FDA’s completion of “proceedings” regarding the use of the terms, “evaporated cane juice” and “natural” in food labeling.  The court’s reference to “ongoing FDA proceedings” means FDA’s November 2015 solicitation of public comment on the use of the term “natural” in food labeling, and the Agency’s July 2015 statement that it anticipated issuing final guidance on the use of term, “evaporated cane juice” by the end of 2016.
  • Although the Ninth Circuit ruling directly affects only the Chobani case, many believe that it may result in the broader issuance of stays in similar class action lawsuits.  However, in key footnote language, the ruling indicates that the stay need not be permanent if FDA takes too long to act on these matters.  Specifically, the court noted “that the duration of the stay remains within the sound discretion of the district court.  If future events render the FDA’s apparently imminent resolution of the ‘evaporated cane juice’ and ‘natural’ issues illusory, such events should inform the district court’s exercise of its discretion.”  Thus, the reprieve granted by this ruling may be time-limited.  Particularly as many expect future FDA action on “natural” claims (if any) to take several years, it remains to be seen how long trial courts actually may be willing to wait and see.

Recent FDA public meeting addressed FSMA import implications.

  • The FDA Food Safety Modernization Act (FSMA) includes several import-focused components, such as the Foreign Supplier Verification Program (FSVP) and the still-under-development Voluntary Qualified Importer Program (VQIP).  The general compliance date for the FSVP is May 28, 2017.  The VQIP is expected to be open for applications in January 2018.
  • On March 21, FDA hosted a public meeting focusing on the implementation of FSMA’s import-related provisions.  Copies of the meeting materials (agenda and slide presentations) are available here.  To highlight a few substantive notes from the meeting:
    • The Grocery Manufacturers Association (GMA) and the International Dairy Foods Association (IDFA) cited concerns related to 21 C.F.R. § 1.507.  Section 1.507 of the FSVP regulations exempts importers of food from evaluating and verifying a foreign supplier where a particular food cannot be consumed unless its hazards are controlled or where the food’s hazards will be controlled after importation.  GMA and IDFA stated that Section 1.507 imposes documentation burdens to establish the existence of these prerequisites that will prove too onerous in reality.
    • FDA stated that it is making progress with evaluating the food safety systems of Canada and Australia for purposes of determining whether these countries have systems that provide an equivalent level of public health protection as the U.S. system.  FDA also indicated it has recently accepted an application from the European Union (EU) to evaluate the equivalency of the EU food safety system.  Importers of food from countries with food safety systems that are officially recognized by FDA as equivalent are largely exempt from the FSVP requirements pursuant to 21 C.F.R. § 1.513.  Currently, only New Zealand has a food safety system that is recognized as equivalent by FDA.
    • FDA reiterated that food-contact substances (FCS) also are subject to the FSVP requirements, although we anticipate that the Agency will issue further clarification in the coming weeks or months regarding what “FSVP compliance” will look like for FCS importers.
  • Although the FSVP compliance date is not imminent, importers should be familiarizing themselves with the new requirements and assessing the benefits of participation in the VQIP.  Although FDA is anticipated to issue FSVP guidance in the coming months, there is no clear time frame for this action, and the industry should at least begin to prepare for compliance.

Major food companies announce plans to roll out GM labeling.

  • Last week, the Senate voted against advancing a federal labeling solution that would have blocked the implementation of Vermont’s upcoming labeling requirements for genetically modified (GM) foods.
  • In the continued absence of a federal labeling fix, major food companies — including Mars, General Mills, Campbell Soup, and Kellogg — have made announcements regarding their roll-out of GM labeling statements on food products in advance of Vermont’s effective date.  Some products are already on shelves bearing statements such as, “Partially Produced with Genetic Engineering,” with additional roll-outs slated to come in the months ahead.
  • This action by major food companies provides concrete evidence of the difficult situation in which the food industry finds itself.  It remains to be seen how many additional companies will join in publicizing their own labeling compliance strategies, as compared to those companies who will continue to adopt a wait-and-see approach in the hope of swift action when the Senate returns from recess in April.

Training options available in anticipation of upcoming human HARPC compliance date.

  • Under FDA’s hazard analysis and risk-based preventive control (HARPC) requirements  for human food and animal food, a food facility’s compliance strategy must be overseen by a “preventive controls qualified individual.”  Under both rules, a preventive controls qualified individual is defined as someone who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or who must be otherwise qualified through job experience to develop and apply a food safety system.  In Fall 2015, FDA announced its FSMA Training Strategy, indicating the Agency’s plan to facilitate industry training and thus promote effective FSMA implementation.  As the September 2016 general compliance date for the human HARPC requirements approaches, companies have been seeking training opportunities for their potential preventive controls qualified individuals.
  • FDA has collaborated with the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH) to create the “Food Safety Preventive Controls Alliance” (FSPCA) to develop training courses that will help regulated industry comply with the HARPC rule in the months ahead.  In particular, the Alliance represents that its course entitled “FSPCA Preventive Controls for Human Food” is the “standardized curriculum” recognized by FDA, and that successfully completing this course is one way to meet the requirements for a preventive controls qualified individual.  The curriculum for animal HARPC training is still in development, with courses expected to begin in June.
  • Although the HARPC requirements do not require a preventive controls qualified individual to be qualified on the basis of training, many companies likely will find such training useful and instructive as they continue to develop and implement their FSMA compliance strategies.

Children’s Confection Advertising Initiative launched.

  • In the mid-2000s, concerns were raised about the extent to which children’s food marketing focused on products high in salt, sugar, and fat.  In 2006, the food industry formed a voluntary self-regulatory program called the Children’s Food and Beverage Advertising Initiative (CFBAI) with the goal of promoting healthier dietary choices and healthy lifestyles in advertisements to children under 12.
  • Just last week, the Council of Better Business Bureaus (CBBB) and the National Confectioners Association (NCA) announced the launch of a new self-regulatory initiative intended to limit the advertising of confectionery products to children under 12.  The newly-launched Children’s Confection Advertising Initiative (CCAI) is modeled on the CFBAI and its Core Principles.  The CCAI is aimed at small- and mid-sized companies and has fewer administrative requirements than the CFBAI.   “Charter participants” in the CCAI are Ferrara Candy Company; Ghirardelli Chocolate Company; Jelly Belly Candy Company; Just Born Quality Confections; The Promotion in Motion Companies, Inc.; and R.M. Palmer Company.  They join six CFBAI participants (American Licorice Company; Ferrero USA; The Hershey Company; Mars, Incorporated; Mondelez International; and Nestlé) in the pledge to restrict advertising to kids under 12.
  • The Chairwoman of the Federal Trade Commission (FTC) and consumer protection advocates such as the Center for Science in the Public Interest (CSPI) have lauded the formation of the CCAI and express the hope that other candy companies will join in the initiative.

For more information on Keller and Heckman’s consumer protection practice areas — including advertising and promotion, privacy, data security and digital media, as well as product safety— we invite you to visit the Consumer Protection Connection blog.

FDA issues final rule related to BSE risk reduction.

  • Bovine spongiform encephalopathy (BSE) — also called “mad cow disease” — is a fatal and progressive neurologic disease that affects cattle.  BSE poses a risk to humans because people can get a version of the disease called variant Creutzfeldt-Jakob disease (vCJD).  There is no known treatment for vCJD, and it is fatal.  Infected individuals are believed to have contracted the disease from eating food made with cows sick with BSE.  To protect Americans against BSE-related risks, FDA has taken measures to protect the food supply, such as by placing stringent restrictions on the use of high-risk cow parts in animal feed and by restricting the use of material derived from cattle in FDA-regulated products.
  • FDA has issued a final rule prohibiting the use of certain cattle material to minimize the potential risk of BSE in human food (including dietary supplements) and cosmetics.   The final rule designates the following items as prohibited cattle materials:
    • Specified risk materials (SRMs ): brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia (DRG) of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine from all cattle
    • The small intestine from all cattle unless the distal ileum has been properly removed
    • Material from nonambulatory disabled cattle
    • Material from cattle not inspected and passed, or mechanically separated (MS) (Beef).
  • The final rule represents the long-awaited reaffirmation of an interim final rule dating back to 2004, as amended in 2005 and 2008.  As useful clarifying points, the final rule confirms that the category of prohibited cattle materials does not include:  milk and milk products, hide and hide-derived products, tallow that contains no more than 0.15 % insoluble impurities, and tallow derivatives.  The final rule also defines “gelatin” and confirms — consistent with the industry’s general understanding — that gelatin is not a prohibited cattle material provided that it is manufactured using specified customary industry processes.  The rule also provides a process for designating a country as not subject to BSE-related restrictions applicable to FDA regulated human food and cosmetics.  The final rule is effective on April 18, 2016.

Senate rejects Roberts’ amended GM labeling bill.

  • Eyes were on the Senate yesterday as the food industry and consumers anticipated a Senate vote on an amended bill to establish a federal standard for the labeling of genetically modified (GM) foods.  The amended bill took a “hybrid” approach compared to previous measures, proposing a voluntary labeling standard with the potential to become mandatory if there was insufficient industry participation in the voluntary disclosure program.  Many thought the amended bill represented the best chance of federal action in time to preempt the upcoming Vermont GM labeling requirements, which take effect on July 1.
  • To the disappointment of many food industry stakeholders, the amended Roberts bill failed to get the 60 votes needed to move forward in the Senate.  The final vote was 48-49.
  • The potential still exists for this bill to come back up for a vote in the future if an agreement can be reached among the divided camps.  Now that this compromise has failed to bridge the divide, it is even less clear whether or when Congress will be able to come up with a solution to this contentious issue.

Senate expected to vote as early as today on amended GM labeling law.

  • As our readership knows, all eyes are on Congress this week as it prepares to act on proposed legislation to block state laws that would impose labeling requirements for genetically modified (GM) foods.
  • Following up on yesterday’s GM update, the Senate is poised to take action on an amendment to Senator Roberts’ (R-Kansas) previously-introduced voluntary GM labeling bill.  The original bill would have established a voluntary GM labeling standard to be administered by USDA.  The amended bill still would create a USDA-administered standard, but would require rulemaking to consider the extent to which consumers can get information about GM content via sources other than product labels, e.g., via call centers, websites, social media, scannable codes, and other means.  Also, although the amended bill preserves the voluntary nature of the GM labeling standard at the outset, it would give USDA authority to establish a “national mandatory bioengineered food labeling standard” in the event that there is “not at least 70 percent substantial participation” in the voluntary standard 2 years after the promulgation of implementing regulations.
  • Describing the amended bill as a “true compromise,” Senator Roberts indicated that numerous industry groups and companies have shown support for the legislation.  Although some opponents continue to voice concerns that the bill does not go far enough to far enough to require GM disclosures, perhaps the “substantial participation” hook in the amended bill will be enough to persuade voters to give this measure a chance.

Chipotle non-GM claims challenged again in court.

  • As previously covered on this blog, a plaintiffs’ class action lawsuit was filed against Chipotle in connection with its nationwide advertising campaign premised on a pledge to serve only “non-GMO” foods.  In February, the lawsuit was dismissed based on the lead plaintiff’s failure to specify that she had purchased foods served by Chipotle in the categories alleged to be “GM” foods, i.e., meat, dairy, or soft drinks.  As anticipated, the plaintiff has amended and re-filed her complaint to include allegations that she bought chicken and beef burritos with cheese, sour cream, and other condiments.  She also reasserted her position that consumers understand terms such as “non-GMO” and “GMO-free” to mean that products are not sourced from any genetically engineered inputs, a concept broad enough to encompass the GM corn used to produce high fructose corn syrup or that is used to feed cows ultimately slaughtered for beef.

Support for federal GM labeling solution grows.

  • As previously covered on this blog, Congress is considering competing federal GM labeling bills.  The two “frontrunners” are the Biotechnology Food Labeling Uniformity Act — which would establish a mandatory federal GM labeling requirement, to be administered by FDA and the Biotech Labeling Solutions Act — which would establish a voluntary federal GM labeling framework, to be administered by USDA.  As the latter bill heads to the Senate, sponsor Pat Roberts (R-Kansas) reportedly has indicated his willingness to work with senators on both sides of the aisle to strengthen the bill.  Congressional action must happen swiftly if there is to be any meaningful clarity for the food industry prior to the July 1 effective date for Vermont’s GM labeling requirements.