FDA Provides Status Report on Recall Rapid-Response Team Activities

  • In April 2016, the Food and Drug Administration established a team of Agency leaders to oversee challenging recalls and to help overcome obstacles and streamline the recall process. Shortly after the team—called SCORE (Strategic Coordinated Oversight of Recall Execution)—was created, we reported on this blog that the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued an “early alert” to indicate that its ongoing audit of FDA’s food recall program found that “FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply.”
  • Six-months after the creation of the rapid-response team, FDA posted on its blog, FDA Voice, an article about the SCORE team’s activities since its inception, and an interview with the co-chairs of SCORE: William Correll, Director of the Office of Compliance in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Douglas Stearn, Director of the Office of Enforcement and Import Operations in FDA’s Office of Regulatory Affairs (ORA). In the interview, the co-chairs discussed several of the cases that SCORE has been involved with, namely:
    • Suspension of a facility registration because the food there may have been contaminated with Listeria monocytogenes
    • Advising companies that made finished food items with flour containing a peanut protein that the agency would publicize the potential contamination if the company supplying the flour did not implement a voluntary recall within 24 hours
    • Advising a company that made sandwiches distributed in the U.S. Department of Agriculture’s Food Nutrition Service’s school lunch program and where Listeria monocytogenes were found on surfaces where the food was made that the agency would notify the press if a voluntary recall was not initiated within 24 hours
    • Threatened enforcement actions if a company that manufactured infant formula without testing for Cronobacter did not initiate a voluntary recall within 24 hours
  • Under the Food Safety Modernization Act (FSMA), FDA was given mandatory recall authority over conventional foods. Keller and Heckman attorneys can advise companies on FDA’s expanded recall and detention authority under FSMA, counsel companies on how to effectively remove products from the market if a recall is necessary, and help develop strategies to address publicity surrounding a potential recall.

FTC Complaint Targets Egg Supplier Ads

The Humane Society of the United States (HSUS) has filed a complaint with the FTC against a national egg marketer alleging false animal welfare advertising.

  • Animal raising claims, such as “pasture raised” have come under increased scrutiny in recent years.  For example, as previously discussed on this blog, the term “pasture raised” was the subject of a recent complaint filed against an egg retailer alleging that its “pasture raised” eggs are actually being sourced from supplier farms that provide limited indoor space or outdoor access for its birds, thereby falling short of consumer expectations.
  • On October 14, 2016, the Humane Society of the United States (HSUS) filed a complaint with the Federal Trade Commission alleging that National Pasteurized Eggs, marketed in grocery stores nationwide, is misrepresenting how its eggs are produced.  The complaint alleges that the egg cartons prominently depict lush open pastures, a red barn and free-roaming hens despite eggs in those cartons being sourced from hens living in battery cages such that the birds cannot “spread their wings, venture outside, breathe “fresh” air, or see natural sunlight”.
  • This latest case represents yet another example of the ongoing regulatory and litigation risk faced by food companies responding to increasing consumer demand for “clean label” foods, particularly in cases where a marketing claim is not federally defined.

GMO Labeling Law Update: USDA Appears to Drop Consumer Use Study

Responding to industry complaints, USDA appears to have dropped GMO consumer use study.

  • As previously discussed on this blog, on July 29, President Obama signed S. 764 into law, establishing a federal framework for the labeling of genetically modified (GM) foods and food ingredients. This law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bioengineered foods by July 2018.  As also covered on this blog, last month, the Agency issued a request for information (RFI) to inform the design of two studies intended to assist the Agency with developing mandatory disclosure requirements for bioengineered foods.  One study would identify potential nationwide technological challenges that may impact whether consumers would be able to rely on electronic or digital links on food packages, and the other would evaluate the likelihood consumers will use electronic or digital disclosures.
  • In an October 19, 2016 press release announcing the solicitation for vendors to submit proposals to conduct a Study on the Electronic or Digital Link Disclosure, the Agency appears to have dropped the consumer use study.  The press release notes that, based on comments received during the RFI, the Agency has revised its requirements for what the study will entail, “including modifying the study design to align more closely with the factors identified in the statute.”  The proposals for the study on technological challenges are due on November 22, 2016.
  • USDA’s decision to drop the consumer use study follows industry complaints that the consumer study was unnecessary and outside the scope of the law’s requirements.  We will continue to keep you apprised of the latest developments regarding USDA’s implementation efforts of this new federal GMO labeling law.

Global Poultry Industry Body Pledges to Address Antibiotic Resistance

The International Poultry Council has pledged to tackle antibiotic resistance in food producing animals. (subscription to meatingplace.com required)

  • As previously covered on this blog, for years, FDA, USDA, and various stakeholders have grappled with how to address concerns about the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  This issue has now become a hot topic on the global stage.  For example, on September 21, 2016, the United Nations held a ministerial meeting on antimicrobial resistance.
  • Most recently, during a conference last week in Estoril, Portugal, the International Poultry Council, which represents about 80 percent of the world’s poultry production, and about 95 percent of global trade in poultry meat, pledged to tackle antibiotic resistance in food producing animals.  IPC President Jim Sumner (also president of the USA Poultry & Egg Export Council), noted that the “IPC recognizes the need for collaborative efforts among governmental organizations, non-governmental organizations and the poultry sector to minimize the development and transfer of antibiotic resistance.”
  • It remains to be seen whether and how the IPC’s position will affect producers’ efforts to work with their respective governments to reduce the use of medically important antimicrobials in food animals.

Organic Industry Calls for Federal Policies to Strengthen Integrity of the Organic Seal

The organic industry, led by the Organic Trade Association, has called for federal policies to ensure “organic” always means “organic”.

  • Organic production in the U.S. is regulated by the U.S. Department of Agriculture’s National Organic Program (NOP) under the Organic Foods Production Act of 1990 (OFPA) (Public Law 101-624, Nov. 28, 1990).  The national standards developed by the NOP for organically-produced agricultural products are designed to assure consumers that products with the USDA organic seal meet consistent, uniform standards.
  • Yesterday, the Organic Trade Association (OTA) issued a press release calling for federal policies to strengthen the integrity of the organic seal for all products branded as organic.  The OTA specifically noted that while consumer trust in organic foods is high, the same is not true for non-food products such as household cleaners or personal care products.  This press release came in advance of a joint Federal Trade Commission (FTC)/USDA roundtable being held today regarding consumer perception of organic claims for non-food products.  A main goal of today’s roundtable is to discuss whether the FTC needs to issue further guidance to makers of non-food products that use the organic claim or term without reference to the USDA Organic seal, whether they refer to another organic certification program or no certification at all.
  • It remains to be seen whether and to what extent industry’s efforts to strengthen consumer trust of “organic” will result in the FTC exercising its consumer protection authority regarding organic claims on products that fall outside of USDA’s purview.

Another “Natural” Lawsuit

A leading meat producer has been sued over “natural” claims on deli meats. (subscription to Law360 required)

  • Challenges to “natural” claims continue, with many cases targeting “natural” claims for products containing synthetic ingredients or preservatives.  As previously covered on this blog, FDA is considering whether to regulate the term “natural”.  USDA, which regulates meat and poultry, currently has in place an informal policy on “natural” which permits USDA-regulated products to be labeled “natural” when the product does not contain any artificial flavor or flavoring, coloring ingredient, chemical preservative (as defined in 21 C.F.R. 101.22), or any other artificial or synthetic ingredient; the policy also provides that the product and its ingredients cannot be more than minimally processed.
  • On October 11, 2016, a class action lawsuit was filed against Hormel Foods Corp. alleging that it includes synthetic ingredients and preservatives in deli meat labeled as “100% Natural” or “No Preservatives”. This lawsuit comes on the heels of another “natural” lawsuit filed against Hormel by the Animal Legal Defense Fund, Public Justice, and the Richman Law Group filed in the District of Columbia Superior Court on June 30, 2016.  That lawsuit alleges that certain of the company’s natural products are derived from food animals treated with additives, hormones and antibiotics.  Hormel contends that its “natural” branded products are produced, labeled, and marketed in conformance with all applicable laws and regulation.
  • Assuming the products at issue do not run afoul of current USDA policy on “natural”, the lawsuit may face an uphill battle if the claims and labels themselves were specifically approved by USDA.

EU Food Name System Could Cost U.S. Dairy Industry Billions

  • Geographic indications (GIs) identify specific geographic areas and are allowed for certain specialty food products. Only products that originate in the designated area may be labeled with the GIs. Examples in the U.S. are: Washington State Apples and Idaho Potatoes. The European Union (EU) has suggested extending GI protections to cheeses, such as parmesan, gorgonzola, asiago and feta. GIs are part of the Transatlantic Trade and investment Partnership (TTIP) negotiations.
  • The Consortium for Common Food Names (CFN) commissioned a study to evaluate the impact on the U.S. dairy sector if GI protections are allowed for the dairy products sought by the EU. The study found that extending the recommended GI protections could have the following impact:
    • Reduce U.S. cheese consumption by 21%, or 2.3 billion pounds
    • Reduce the size of U.S. dairy herds by 9% overall
    • Cost U.S. dairy framers a cumulative $59 billion in revenues
    • Force consumers to pay more for cheese varieties to pay more for cheese varieties with familiar names
    • Result in the loss of up to 175,000 rural jobs
  • The CFN recommends that the “use of common names by the U.S. dairy industry – and indeed all other sectors relying on typical food terms – should be aggressively preserved, both for domestic and international use.” Of course, although this will require watching, it is difficult to believe that FDA will amend standards of identity for cheeses, such as “parmesan” to ultimately satisfy the EU.

Furfuryl Alcohol Added to Prop 65

Furfuryl alcohol was recently added to California’s Proposition 65 list of carcinogens, effective September 30, 2016.

  • Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, prohibits knowingly exposing any individual to a listed chemical without first providing a “clear and reasonable warning” to such individual.
  • Effective September 30, 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) added furfuryl alcohol (CAS No. 98-00-0) to the list of chemicals known to the State to cause cancer under Proposition 65.  Furfuryl alcohol was listed under the authoritative bodies listing mechanism based on the U.S. Environmental Protection Agency (EPA) 2014 report, “Cancer Assessment Document, Evaluation of the Carcinogenic Potential for Furfural and Furfuryl Alcohol.” According to the CDC, furfuryl alcohol is found in processed natural foods, including the oils of chicory and roasted coffee, in yellow leaf tobacco, and in heated skim milk, usually as result of processing.
  • Affected stakeholders should ensure compliance with applicable clear and reasonable warnings required under Proposition 65. Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions related to California’s Prop 65. Should you have any questions, please feel free to email us at prop65@khlaw.com.

FSMA Compliance – What to Expect in the Next Few Months

FDA has released a Q&A document regarding the Agency’s expectations going forward for FSMA compliance now that the first set of major FSMA compliance dates have arrived. 

  • The first major FSMA compliance dates arrived on September 19, 2016 for the preventive controls rules for human and animal food under the FDA Food Safety Modernization Act (FSMA). In short, larger businesses are now subject to certain new standards.  In particular, human food facilities must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs), and animal food facilities must meet CGMPs.
  • Yesterday, Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, addressed questions that have been raised about what the next few months will look like. Highlights of the Q&A document include:
    • reiterating that the first year of compliance will affect the larger businesses, generally those with 500 or more employees;
    • underscoring the importance of documenting all steps taken to proactively prevent against food contamination events; and
    • indicating that the Agency will initially be focused on education, i.e., working with the food industry “to create a culture of food safety, a culture of compliance with procedures, processes, and practices that we know will minimize the risk of serious illness or death.” That being said, the Agency indicates that it would certainly take swift action, when necessary, to protect public health.
  • Stakeholders subject to FSMA should make every effort to be well-versed in the various regulatory obligations imposed by FSMA.

Extension to Vinpocetine Comment Period Requested

 The Natural Products Association has asked FDA to extend the comment period deadline concerning the regulatory status of vinpocetine until September 6, 2017.

  • Vinpocetine is a semisynthetic derivative of the vinca alkaloid vincamine, an extract from the lesser periwinkle plant.  Dietary supplements containing vinpocetine as a dietary ingredient have been on the market for roughly 20 years.  From a regulatory standpoint, the Agency had previously accepted five 75-day New Dietary Ingredient Notifications (NDINs) for vinpocetine and did not raise any concerns about the ingredient’s status when evaluating those submissions.  In recent years, however, vinpocetine has been the subject of some controversy.  FDA took note and, as previously covered on this blog, on September 7, 2016, FDA requested public comment (by November 7, 2016) on the regulatory status of vinpocetine.  In requesting public comment, the Agency stated that it has “tentatively concluded” that vinpocetine is not eligible to be marketed as a dietary ingredient.
  • Earlier this month, the Natural Products Association requested that FDA extend the comment period deadline to September 6, 2017, noting that industry will need this “time to conduct additional research, as well as identify the extent to which these changes might impact manufacturers, distributors and consumers” of these products.
  • Given the somewhat unusual, but not unprecedented move by the Agency in revisiting the regulatory status of vinpocetine, coupled with its widespread use (in as much as 350 brands according to the Natural Medicines Comprehensive Database), it would not be surprising if FDA extended the comment period.  However, it remains to be seen whether the Agency will agree to grant the substantial amount of additional time NPA requested.