Save the date!

Please mark September 29-October 1, 2015 on your calendars to join experienced Keller and Heckman attorneys at our Practical Food Law Seminar in Washington, D.C.  The Practical Food Law seminar provides members of the food industry with a comprehensive presentation of the applicable statutory and regulatory framework for foods (including dietary supplements).  The course will focus on food safety as well as labeling and advertising.  Registration will open soon, so please stay tuned.

White House issues Spring 2015 Regulatory Plan.

  • Each year, federal agencies publish agendas of the regulatory and deregulatory activities that they plan to undertake.  The White House publishes these agendas in the form of a “Unified Agenda and Regulatory Plan,” which enables stakeholders to review planned agency actions for the coming year.
  • On May 21, 2015, the White House issued its 2015 Spring Agenda.  As anticipated, FDA’s docket includes finalization of the major rules to implement the FDA Food Safety Modernization Act (FSMA).  The agenda also includes a proposed rule to implement user fees for FDA’s third-party accreditation program for food and feed (anticipated May 2015); a proposed rule to update standards for the labeling of pet food (anticipated September 2015); a final rule to implement revisions to the nutrition and supplement facts labels (anticipated March 2016); and a final rule to implement revisions to serving size requirements (anticipated March 2016).  The Food Safety and Inspection Service (FSIS) docket includes a proposed rule regarding the use of the voluntary claim, “natural” on the labeling of meat and poultry products (anticipated December 2015) and a proposed rule to revise reference amounts customarily consumed and the nutrition facts panels for meat and poultry products (anticipated December 2015).
  • Of course, it remains to be seen which rules actually will be published in accordance with the time frames specified in the agendas.  Nevertheless, the Regulatory Plan is a good resource to indicate the regulatory (and deregulatory) priorities of various agencies of relevance to the food and agricultural sectors.

House Agricultural Committee votes to repeal COOL requirements.

  • As covered on this blog earlier this week, the World Trade Organization (WTO) rejected the U.S. appeal of a ruling regarding the propriety of its country of origin labeling (COOL) requirements for meat products.  The WTO’s latest action means that its earlier ruling against the COOL requirements will stand, exposing the U.S. to trade sanctions from Canada and Mexico if the government does not act to repeal or amend the requirements.
  • In response to the ruling, the House Agriculture Committee has voted to repeal the COOL requirements.  The bill, H.R. 2393, would amend the Agricultural Marketing Act of 1946 such that labels for beef, pork, and chicken products would not need to declare where animals were born, raised, and slaughtered.
  • Because the controversial COOL requirements were imposed by statute, a legislative fix was the only viable way for the U.S. to act in a manner consistent with the WTO ruling.  It is hoped that Congress will act quickly to enact this legislation to avoid significant retaliatory tariffs from neighbors in trade.

FDA releases additional Blue Bell inspection reports.

  • As covered on this blog yesterday, Blue Bell Creameries continues to face the ramifications of a multi-state listeriosis outbreak linked to consumption of its ice cream products.  FDA has published inspectional observations for Blue Bell production facilities, indicating the company’s awareness of positive tests for Listeria monocytogenes in one plant as far back as 2013.  At least one private lawsuit has been filed in the matter, with others likely to follow.
  • Responding to a request from a Dallas newspaper, FDA now has released four additional inspection reports from Blue Bell facilities dating back to 2007.  Although the earlier reports do not indicate Listeria contamination, they cite numerous violations of food safety protocols.
  • The additional negative publicity is likely to provide additional fodder for the upcoming complaints that we expect to be filed in this matter.  FDA’s willingness to issue public updates and to share the results of specific inspections indicates the Agency’s continued use of the media as a quasi-enforcement tool.

ConAgra to pay $11.2 million in connection with Salmonella outbreak.

  • In 2006-2007, Peter Pan peanut butter produced by ConAgra Foods, Inc. was recalled in connection with a nationwide Salmonella Tennessee outbreak.  The outbreak resulted in hundreds of infections and hospitalizations across 44 states.  The contamination ultimately was traced to plant and equipment conditions in a Georgia facility.  In 2011, the federal government launched a criminal investigation into the matter.
  • To resolve the investigation, ConAgra has agreed to plead guilty to a single misdemeanor violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Under the plea agreement, the company would pay a fine and forfeiture in the amount of $11.2 million.  The plea agreement must be approved by the U.S. District Court in Albany, Georgia.
  •  The ConAgra situation serves as a reminder to industry that the FD&C Act is a criminal statute with potentially severe financial and other penalties for violations.  Although many FDA enforcement actions ultimately are resolved before turning into criminal proceedings, plea agreements of this nature show that FDA (working through federal prosecutors) can impose significant consequences for companies when problems in a facility are linked to outbreaks of foodborne illness.

First lawsuit filed in wake of Blue Bell listeriosis outbreak.

  • In recent months, Texas-based Blue Bell Creameries has recalled all of its products after the company’s ice cream was linked to listeriosis outbreaks in multiple states, resulting in hospitalizations and deaths.  FDA published an update alerting consumers to the issue and released a series of inspectional observations from Blue Bell production facilities, indicating the company’s awareness of positive tests for Listeria monocytogenes in one plant as far back as 2013.  We speculated that class action lawsuits were likely to follow.
  • As anticipated, the first lawsuit has now been filed.  The affected consumer states that he contracted a severe listeriosis infection after consuming Blue Bell products in 2013 and alleges that Blue Bell acted with gross negligence for failure to use adequate sanitation in its plant to prevent product contamination.  The complaint includes specific references to the inspectional observations that FDA recently made public in connection with Blue Bell’s product recall.
  • The lawsuit filed in this case is unlikely to be the last that Blue Bell faces in connection with the listeriosis outbreak.  Again, it serves as a reminder to industry that FDA regulatory violations can trigger significant product liability and litigation implications where human health consequences result.

FDA proposes to expand collection of data on animal drug usage to include major food-producing species.

  • For years, FDA and the animal feed industry have grappled with how to address concerns about the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  In 2013, FDA asked animal pharmaceutical companies to voluntarily revise the FDA-approved conditions of use on antibiotic labels to remove production indications.  Earlier this year, Dianne Feinstein (D-CA) and Susan Collins (R-ME) reintroduced a bill that would require FDA to withdraw its approval of medically important antibiotics that are at a high risk of abuse in food-producing animals.
  • On May 19, 2015, FDA proposed a rule to require animal drug sponsors of all antimicrobials sold or distributed for use in food-producing animals to obtain and provide estimates of sales by major food-producing species (cattle, swine, chickens, and turkeys).  FDA hopes that collecting these additional data will improve general understanding of the use of this product class among major food-producing animals and help the Agency target its efforts to ensure judicious use of medically important antibiotics.
  • Reacting to FDA’s proposal, Rep. Louise Slaughter (D-NY) reintroduced a bill that also would require reporting of the reason for animal antimicrobial use.  Many question the relative strengths of different approaches to reducing the use of medically important antibiotics in food production.  It remains to be seen whether the most effective strategies will come from voluntary industry initiatives, FDA efforts, legislative action, or a combination of these tools.

WTO rejects U.S. appeal of COOL ruling.

  • In 2013, the U.S. Department of Agriculture (USDA) implemented country of origin labeling (COOL) rules, requiring meat labels to indicate where animals were born, raised, and slaughtered.  Meatpacking and livestock commodity groups in the U.S., Canada, and Mexico challenged the COOL requirements via appeal to the World Trade Organization (WTO) and a lawsuit filed in the U.S. (alleging that the requirements infringe First Amendment rights).  In October 2014, the WTO ruled that the COOL requirements violate U.S. trade obligations to Canada and Mexico, but U.S. federal courts consistently have upheld the requirements.  The U.S. meat industry plaintiffs ultimately dropped their lawsuit, but the U.S. appealed the WTO ruling.
  • The WTO has now rejected the U.S. appeal of its decision that existing COOL requirements create an uneven playing field in the meat trade by discriminating against imports while providing an advantage to domestic producers.  Now that this final ruling has been issued, the U.S. must either repeal or amend the COOL requirements to avoid trade sanctions from Canada and Mexico.
  • Because USDA’s COOL requirements implement statutory provisions, it seems that only a legislative fix will address the trade implications here.  It now remains to be seen whether Congress will act swiftly enough to avoid retaliatory tariffs by Canada and Mexico.

Organic & Natural Health Association files Citizen Petition to request application of dietary supplement GMPs to ingredient suppliers.

  • As previously covered on this blog, the Organic & Natural Health Association (ONHA) has indicated its interest in seeing FDA extend the application of current Good Manufacturing Practice (GMP) regulations in 21 CFR Part 111 (which apply to finished dietary supplements) to dietary ingredients themselves.
  • ONHA has now filed a Citizen Petition with FDA, requesting that the Agency expand the scope of 21 CFR Part 111 accordingly.  Specifically, the Citizen Petition asks FDA to amend Part 111 to (1) include dietary ingredient suppliers within the scope of the requirements; and (2) clarify the regulatory obligations imposed on private label distributors of finished dietary supplements.
  • ONHA has acknowledged that the dietary supplement industry’s response to its request will be “mixed,” which is understandable in light of the additional regulatory burdens on ingredient suppliers that ONHA proposes.  FDA typically takes a very long time to respond to Citizen Petitions, so we do not expect Agency action on this matter anytime soon.  Still, the filing of the Citizen Petition itself marks a bold public step for ONHA.  Particularly in light of recent supplement controversies, one wonders whether de facto “ingredient supplier” GMPs could become a voluntary industry standard, even in the absence of formal Agency action.

 

USDA creates new voluntary “non-GMO” certification option for industry.

  • As the food industry is well aware, companies continue to confront the challenge of developing appropriate marketing claims to advertise the absence of genetically modified (GM) content in food products.  FDA has issued draft guidance on this topic dating back to 2001, but such guidance has not been revisited or finalized and there is little FDA enforcement in this claim arena.  There also is a third-party organization, the “Non-GMO Project,” that offers independent verification (based on process verification and the testing of high-risk ingredients) of the “non-GMO” status of food products.
  • On May 1, Secretary Tom Vilsack of the U.S. Department of Agriculture (USDA) issued a letter to Agency employees announcing the development of the “first Process Verified Program claim for non-GMO/GE food products.”  Regarding the program itself, the letter states as follows:

Recently, a leading global company asked AMS [USDA’s Agricultural Marketing Service] to help verify that the corn and soybeans it uses in its products are not genetically engineered so that the company could label the products as such. AMS worked with the company to develop testing and verification processes to verify the non-GE [genetically engineered] claim.  While the Process Verified Program itself is not a new program, this is the first non-GMO/GE claim verified through USDA. It will be announced soon, and other companies are already lining up to take advantage of this service.

  • USDA has declined to issue further comments on the certification program at this time.  Media reports are hailing the program as a government-issued certification to support GM-“FREE” claims, although it is not clear that USDA would support this particular claim wording.  Many question whether any foods truly can be certified as GM “free” due to the potential for cross-contamination by GM ingredients.  Although details regarding the scope, cost, and claims that will be supported under USDA’s program remain to be seen, the program represents a significant development in the “non-GM” claim space as it will be the first government-sponsored effort to provide verification in support of such claims.

USDA issues final rule implementing new labeling requirements for mechanically tenderized beef.

  • The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) regulates the quality, safety, and labeling of meat and poultry products marketed in the United States.
  • On May 13, 2015, FSIS announced new labeling requirements for raw or partially cooked beef products that have been mechanically tenderized.  The new requirements will take effect in May 2016, one year after publication of the rule in the Federal Register.  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.
  • This regulatory development fits into the continuing conversation about the sufficiency of FSIS’ authority to assure the safety of the U.S. meat supply.  With this year’s reintroduction of a bill in Congress to grant FSIS mandatory recall authority over contaminated meat and poultry, it remains to be see what legislative or regulatory developments will be next in this space.

Recent decision in challenge to Vermont GM labeling law being appealed.

  • As previously covered in this blog, the food industry has been paying close attention to developments in the lawsuit brought by the Grocery Manufacturers Association (GMA) and other trade associations to challenge Vermont’s labeling mandate for Genetically Modified (GM) food products.  On April 27, 2015, the Vermont district court denied the plaintiffs’ motion for a preliminary injunction, dismissed specific counts in the challenge, and permitted the law to stand for the time being.
  • On May 6, 2015, GMA filed a notice of appeal and announced its intent to file the actual appeal documents in the coming weeks.
  • The filing of this appeal will renew the industry’s hopes that the judiciary could stay (whether temporarily or permanently) the implementation of the Vermont law, which currently is set to take effect on July 1, 2016.