Sen. Roberts expresses confidence that Congress will pass GM labeling bill in June.

  • As previously covered on this blog, Congress has repeatedly failed to agree on legislation to establish a federal standard for the labeling of genetically modified (GM) foods.  In March, many thought a “hybrid” bill modeled on Senator Roberts’ (R-Kansas) voluntary GM labeling 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, that measure was defeated.
  • On May 24, Sen. Roberts told reporters that he and Debbie Stabenow (D-Michigan) were actively working on a deal to move federal GM legislation forward.  He reportedly stated that he still expects Congress to pass a national labeling standard before Vermont’s requirements take effect.
  • Once Congress returns from recess on June 6, they will have only 19 working days to resolve the issue before July 1.  Particularly as many food companies have moved ahead with developing compliance strategies in anticipation of Vermont’s deadline, Congressional action may be too late to provide immediate relief.  Nevertheless, a standardized nationwide approach to GM labeling would be welcomed by many.

Appeals court gives NYC the go-ahead to enforce sodium warning requirement.

  • As previously covered on this blog, New York City (NYC) health officials have adopted the nation’s first sodium warning requirement.  The rule requires restaurants that are part of chains with more than 15 locations nationwide to post warning statements about high sodium consumption levels and to display a salt shaker icon on menus and menu boards next to any food item with a high sodium content (>2,300 mg of sodium) or on tags next to any food on display that is a food item with a high sodium content.  The rule took effect on December 1, 2015, although implementation delays resulted when the National Restaurant Association challenged the rule in court.  In February 2016, a New York Supreme Court judge upheld the warning requirement.
  • On May 26, 2016, an NY appeals court lifted a prior interim order that had temporarily stopped NYC from enforcing the sodium warning requirement.  With this legal obstacle removed, NYC has announced its intent to begin enforcing the requirements on June 6.  Violations are subject to a $200 penalty.
  • Although the National Restaurant Association may continue to pursue its legal challenge to the rule, there is nothing left to protect non-compliant restaurants from enforcement action and penalties pending resolution of the case.

 

FDA releases final rule to implement FSMA intentional adulteration provisions for human food.

  • On May 26, 2016, FDA released its final rule to implement the intentional adulteration (or “food defense”) provisions of the FDA Food Safety Modernization Act (FSMA).  Click here for a pre-publication copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule.
  • The final rule establishes various food defense measures that registered facilities are required to implement to protect against the intentional adulteration of food.  As a general matter, facilities must prepare and implement a written food defense plan that identifies significant vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions, and verification.  Facilities also have new training and recordkeeping requirements under the final rule.  Several types of facilities and activities are exempt from compliance.  Specifically, the new requirements do not apply to:  (i) very small businesses; (ii) the holding of food, except the holding of food in liquid storage tanks; (iii) the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact; (iv) activities that fall within the definition of “farm”; (v) animal food; (vi) alcoholic beverages under certain conditions; and (vii) certain on-farm food/activity combinations performed by small or very small businesses.
  • The rule is scheduled for publication in the Federal Register on May 27, 2016 with an effective date 60 days thereafter.  Companies generally have 3 years after the effective date to comply with the new requirements (i.e., July 2019).  Small businesses will have an additional year to comply (i.e., July 2020).

With the issuance of this final rule, FDA has met its final court-imposed deadline under its settlement agreement to end a lawsuit premised on the Agency’s prior delay in issuing seven major rules to implement the core of FSMA.  Keller and Heckman is preparing a full analysis of the final rule.

FDA releases final guidance regarding use of the term “evaporated cane juice” on food labeling.

  • As previously covered on this blog, food companies have been grappling for years with the use of the term “evaporated cane juice” 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 ‘evaporated cane juice’ is not the common or usual name of any type of sweetener, including dried cane syrup.”  In response to repeated inquiries related to this issue, FDA promised a California court last year that the Agency would issue final guidance on this topic before the end of 2016.
  • On May 25, 2016, FDA released final guidance reaffirming the Agency’s view that sweeteners derived from sugar cane should not be declared on food labels as “evaporated cane juice.”  According to the guidance, the term is “false or misleading because it suggests that the sweetener is ‘juice’ or is made from ‘juice’ and does not reveal that its basic nature and characterizing properties are those of a sugar.”  FDA advises regulated industry that the ingredient “should instead be declared on food labels as ‘sugar,’ preceded by one or more truthful, non-misleading descriptors if the manufacturer so chooses (e.g., ‘cane sugar’).”
  • Many food industry stakeholders have long urged FDA to accept and endorse the use of the term “evaporated cane juice” based on the manufacturing process and the characterizing properties of this ingredient.  The final guidance is likely to be met with industry criticism and will not improve food companies’ position with respect to litigation surrounding this term.

USDA’s new labeling requirements for mechanically tenderized beef take effect.

  • As previously covered on this blog, in 2015, USDA’s Food Safety and Inspection Service (FSIS) issued new labeling requirements for raw or partially cooked beef products that have been mechanically tenderized.
  • Under the new requirements, raw or partially cooked beef products must bear labels stating that they have been mechanically, blade, or needle tenderized.  Cooking instructions also must appear on product labels to facilitate safe preparation by consumers.  According to FSIS, the need for new labeling requirements arises because the tenderizing of meat by mechanical means can introduce pathogens from the surface of the cut to the interior, making proper cooking very important.  Mechanically tenderized products are indistinguishable in appearance from intact product, which makes labeling the only way to convey the importance of safe preparation to consumers.
  • The new requirements took effect on May 17, 2016.

Canada approves genetically modified salmon for sale.

  • As previously covered on this blog, in November 2015, FDA issued its first approval for a genetically engineered (GE) animal intended for direct human consumption.  The AquAdvantage Salmon is an Atlantic salmon engineered to grow twice as fast as its natural counterpart.  Since FDA’s approval, the GE salmon has been mired in controversy.  A provision in the omnibus spending bill passed in December 2015 blocks the sale of GE salmon until FDA publishes labeling guidelines to inform consumers of the product’s GE content.  FDA also has been sued over whether it exceeded its authority in approving the GE salmon in the first place.
  • Canada now has approved the AquAdvantage salmon for sale as food, making it the nation’s first GE approval that is not a crop.  The AquAdvantage salmon underwent separate safety and nutrition assessments by Health Canada for use as food and by the Canadian Food Inspection Agency (CFIA) for use as livestock feed.  These reviews both found the salmon to be as safe and nutritious as conventional salmon.  The AquAdvantage salmon will not be required to bear any special GE labeling at retail.
  • Considering the aftermath of FDA’s approval of AquAdvantage, it remains to be seen whether the product will face similar controversy and challenge in the Canadian market.

Congress introduces bills to create a national standard for date marking of food.

  • As previously covered on this blog, food waste is a major issue in the United States.  Government estimates indicate that Americans waste between 30 and 40% of the overall food supply on an annual basis.  According to the National Resources Defense Council (NRDC), confusion associated with the use of arbitrary “expiration” dates on food packages leads to 90% of Americans throwing away food before actual deterioration or spoilage has occurred.  NRDC and others have been advocating revisions to the nation’s food dating system, including the creation of a standardized approach.
  • Last week, the U.S. Senate and House of Representatives introduced bills (S.2947 and H.R.5298) that would standardize the date marking system for foods.  Specifically, The Food Date Labeling Act would establish a uniform national system that distinguishes between foods bearing a label indicating peak quality from foods bearing a label that indicates a potential safety risk if they are consumed after the listed date.  The bill also would ensure that food is allowed to be sold or donated after a quality-based date.
  • This is by no means the first attempt by Congress to create a standardized date marking system for foods in the U.S.  Considering the commitments made just last year by industry and by the federal government to cut back on food waste, it remains to be seen whether there is enough shared interest and political momentum to give this latest measure a realistic chance of becoming law.

FDA releases final rules to revise nutrition labeling requirements.

  • In 2014, FDA issued proposed rules that would revise the Nutrition Facts label requirements.  The proposals included amendments to the Nutrition and Supplement Facts labels and to longstanding reference amounts customarily consumed (RACCs), which are used to determine serving sizes.  In 2015, FDA issued a supplemental proposed rule that would require inclusion of the percent daily value (% DV) for added sugars and change the current footnote of the Nutrition Facts label.
  • On May 20, 2016, FDA issued its final rules to implement changes to nutrition labeling requirements in the U.S.  The rules are scheduled for publication in the Federal Register on May 27, 2016.
    • Click here for the final rule revising the Nutrition and Supplement Facts labels (pre-publication version).
    • Click here for the final rule related to various aspects of the serving size regulations, including updates to the RACCs (pre-publication version).
    • Click here for FDA’s press release announcing the availability of the final rules and summarizing the changes therein.
  • The compliance date for both rules is July 26, 2018 for manufacturers with $10 million or more in annual food sales, and July 26, 2019 for manufacturers with <$10 million in annual food sales.

Keller and Heckman LLP will be analyzing the rules in detail and will provide further information related to their implications for the industry in the near future.

San Francisco sugar-sweetened beverage warning set to take effect in July.

  • As previously covered on this blog, the City of San Francisco passed legislation in June 2015 that requires health warnings to be placed on advertising for sugar-sweetened beverages (i.e., nonalcoholic beverages with caloric sweeteners that contain more than 25 calories per 12 oz.).  Specifically, the warning will read:  “WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San Francisco.”  In July 2015, trade associations filed a lawsuit challenging the legislation on First Amendment grounds.
  • On May 17, 2016, a California federal judge ruled against the plaintiffs, finding that “[t]he warning required by the City ordinance is factual and accurate, and the City had a reasonable basis for requiring the warning given its interest in public health and safety.”  Although the plaintiffs sought review of their First Amendment claims under strict scrutiny, the judge found this to be unwarranted under Zauderer because the ordinance “requires disclosure rather than suppression of speech.”  In denying the motion for a preliminary injunction, the court found that plaintiffs were “not likely to succeed on the merits of their First Amendment claim” and that it was “unlikely that they would suffer irreparable harm if the ordinance were to go into effect.”  The ruling further stated that even if the plaintiffs “had established serious questions going to the merits, balancing of hardships does not tip sharply in their favor.”
  • The ruling paves the way for San Francisco’s sugar-sweetened beverage warning to take effect on July 25, 2016.

 

Vermont relaxes enforcement of GM labeling requirements for the first year.

  • As the food industry is well aware, Vermont’s labeling requirements for genetically modified (GM) foods are set to take effect on July 1 of this year, with a six-month “safe harbor” provision thereafter.  In recent weeks, the Vermont Senate had been considering a legislative amendment to delay the private cause of action under the GM labeling law until 2017.
  • The Vermont Attorney General’s (AG) office has just issued updated GM labeling law resources — an annotated version of the GM labeling rule and a memo regarding enforcement priorities.  The annotated version of the rule contains several new comments or revisions to prior comments.  Further, the updated memo confirms the following:
    • Between July 1, 2016 and June 30, 2017, upon receipt of a written complaint alleging that food offered for sale does not bear appropriate GM labeling, the AG’s office will provide the manufacturer of the product with a notice of alleged violation and a copy of the complaint.  Between July 1, 2016 and June 30, 2017, no enforcement action will be commenced unless the manufacturer continues to be in violation of the law 30 business days after the date of the notice.
    • The private right of action has been delayed by legislative amendment until July 1, 2017.
  • In a nutshell, for the first full year in which the requirements will be effective, companies will have a 30-day “grace period” to correct violations without penalty and will be free from pursuit by private “bounty hunters.”  It is less clear how the AG’s office intends to treat situations in which an alleged violation is brought to their attention in a manner other than a “written complaint,” although one expects that a similar grace period should apply.  Thus, although this new development does not change the effective date of the GM labeling requirements themselves, it does give the food industry somewhat more “breathing room” on the enforcement front.

 

 

FDA pet jerky update indicates decline in reported incidents, but still no identifiable cause.

  • Since 2007, FDA has been investigating a series of complaints of illnesses in pets associated with the consumption of jerky pet treats.  Many of the reports involve products imported from China.  As of December 31, 2015, FDA has received approximately 5,200 complaints of illnesses associated with pet jerky consumption, including more than 1,140 canine deaths.  Over the years, FDA has been issuing updates regarding the status of the investigation.
  • In FDA’s most recent update, the Agency indicates that reported cases have been on the decline in recent years.  Unfortunately, FDA still has not identified the root cause of these illnesses.
  • FDA has explained the challenges associated with its ongoing investigation into the pet jerky problem, which include the lack of a centralized outbreak database for pets, breed-specific variables, and the lack of adequate post-mortem information in many cases.  Despite these challenges, FDA continues to devote resources to its investigation.  In the meantime, the Agency continues to caution pet owners that jerky pet treats are not required for a balanced diet and encourages pet owners to consult with veterinarians if they notice certain symptoms in their pets.