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  • Last year, we reported that USDA’s Food Safety & Inspection Service intends to move forward with plans to modernize swine slaughter inspections by way of a “Modernization of Pork Slaughter” rule. The new rule – which has garnered significant industry support – aims to increase the efficiency and effectiveness of the federal inspection process for pork and to allow for the rapid adoption of new food safety technologies in pork slaughter.  The rule could potentially lead to an increase in U.S. hog slaughter capacity.  The rule also calls for certain food safety responsibilities to be shifted from federal inspectors to packing plant workers and could thus lead to faster pork production lines.
  • This week, the White House Office of Management of Budget (OMB) cleared the rule.  OMB’s approval is the last step in the rule-making process before the Modernization of Swine Slaughter Inspection Rule is finalized for publication in the Federal Register.
  • Although some pushback is expected from food and worker safety advocates, the “Modernization of Pork Slaughter” rule – which bears many similarities to the “Modernization of Poultry Slaughter Inspection” rule – is anticipated to ultimately become law.  (As our readership will recall, food and worker safety advocates met with OMB officials in 2012 seeking to upend USDA’s efforts to implement the poultry rule which has since become law).  We will, of course, continue to keep an eye on any developments related to the “Modernization of Pork Slaughter”  rule as they unfold and report them to you here.

A leading poultry producer has been sued over “natural” claims on its chicken products.  (subscription to Law360 required)

  • Americans’ increasing appetite for clean label, ethically-raised foods has resulted in the continued proliferation of consumer advocacy litigation targeting “natural” claims for products containing synthetic ingredients or preservatives.  Adding fuel to the continued uptick in “natural” litigation is the fact that neither the U.S. Food and Drug Administration (FDA)  nor the U.S. Department of Agriculture (USDA) formally define the term “natural.” As previously covered on this blog, the FDA is considering whether to regulate the term “natural”.  USDA’s Food Safety & Inspection Service (FSIS), on the other hand – which regulates meat and poultry products – 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.  USDA-regulated products bearing “natural” claims must be specifically approved by FSIS before entering commerce.
  • Against this regulatory backdrop, on June 22, 2017, three consumer advocacy groups – the Organic Consumers Association, Friends of the Earth and Center for Food Safety – filed a complaint against Sanderson Farms Inc., the third largest poultry producer in the United States, accusing the company of falsely advertising its chicken as “100 percent natural” and misleading consumers about how the birds are raised by concealing the presence of antibiotics and other drugs in its chickens.  In particular, the complaint – filed in the U.S. District Court for the Northern District of California – alleges that FSIS National Residue Program testing in 2015 and 2016 identified 49 instances in which samples of Sanderson Farms chicken products tested positive for residues of synthetic drugs, including antibiotics used in both humans and animals and other drugs including the anesthetic ketamine.  The complaint also alleges that FSIS testing revealed an additional 82 instances of unconfirmed residues including pesticides.
  • In a statement released on June 23, 2017, Sanderson Farms denied the allegations, stating that it “does not administer the antibiotics, other chemicals and pesticides, or ‘other pharmaceuticals’ listed in the complaint to its flocks”.  The Company added, however, that its “veterinarians do, on rare occasions, prescribe penicillin to treat sick poultry flocks when in their professional judgement they consider it necessary for animal welfare” in line with FDA guidance.
  • This latest lawsuit represents a recent trend in “natural” litigation targeting USDA-regulated products.  As our readership will recall, just last Fall, a class action lawsuit was filed against Hormel Foods Corp. alleging that Hormel includes synthetic ingredients and preservatives in deli meat labeled as “100% Natural” or “No Preservatives”.  Key defenses there included federal preemption and primary jurisdiction.  Assuming the Sanderson Farms products at issue do not run afoul of the current USDA policy on “natural” and the labels themselves were specifically approved by USDA, we would expect Sanderson Farms to avail itself of similar defenses. In addition, because USDA is working to update the definition of “natural”, Sanderson Farms could potentially request a stay on the proceedings pending the issuance of the forthcoming definition as has been successfully done in a number of recent “natural” cases concerning FDA-regulated products, see e.g., here and here (although the difference in this case is that USDA has not yet formally published a document for public comment).
  • Given increasing consumer demand for “natural” products, and the corresponding increasing market share for such products, the ultimate disposition of the ongoing litigation will be of great interest to industry and consumers alike. We will be sure to keep a close eye on developments in this case and report them to you here.
  • Earlier this Spring, we reported that USDA’s Food Safety & Inspection Service intends to move forward with plans to modernize swine slaughter inspections by way of a “Modernization of Pork Slaughter” rule. The new rule – which has garnered significant industry support – aims to increase the efficiency and effectiveness of the federal inspection process and to allow for the rapid adoption of new food safety technologies in pork slaughter.  The rule could potentially lead to an increase in U.S. hog slaughter capacity.  The rule also calls for certain food safety responsibilities to be shifted from federal inspectors to packing plant workers and could thus lead to faster pork production lines.
  • On June 10, 2017, FSIS submitted a copy of the rule to the Office of Management and Budget (OMB) for final review.
  • Although some pushback is expected from food and worker safety advocates, the “Modernization of Pork Slaughter” rule – which bears many similarities to the “Modernization of Poultry Slaughter Inspection” rule – is anticipated to ultimately become law.  (As our readership will recall, food and worker safety advocates met with OMB officials in 2012 seeking to upend USDA’s efforts to implement the poultry rule which has since become law).  We will, of course, continue to keep an eye on any developments related to this rule as they unfold and report them to you here.
  • As previously reported on this blog, in August 2013, the U.S. Food and Drug Administration (FDA) issued a final rule on “gluten-free” food labeling. After the final compliance date of August 5, 2014, FDA measured the gluten level of more than 250 different products labeled “gluten-free.”
  • More than 99.5% of the food products labeled “gluten-free” that FDA tested were in compliance with the requirement that such foods have less than 20 ppm (parts per million) of gluten. In total, FDA collected and analyzed 702 samples from more than 250 products labeled “gluten free.” The products were collected between July 2015 to August 2016.
  • Only five samples from one of the products labeled “gluten-free” did not comply with the less than 20 ppm requirement. That product was recalled and subsequent sampling by FDA did not find levels of gluten that violated the regulation.
  • Products tested were from three commodity groups: cereals, grain bars and flours. Results of the surveillance sampling can be accessed from FDA’s website.
  • As our readership is well aware, under current law, establishments regulated by USDA’s Food Safety and Inspection Service (FSIS) are required to declare all ingredients, including allergens, on their products’ labels.  If FSIS determines that a product under its jurisdiction contains undeclared allergens, the Agency requests the establishment to recall the product.  FSIS recently reported that since 2008, the Agency has seen “a notable increase” in the number of recalls due to undeclared allergens in regulated products.
  • To address the continued occurrence of product recalls due to undeclared allergens and best practices for preventing the presence of undeclared allergens in FSIS-regulated products, FSIS has announced a public meeting to be held on March 16, 2017.  The meeting will include participation from the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), international partners, and academic institutions.  In addition to holding this public meeting, FSIS has published a compliance guideline to assist regulated establishments in addressing the hazards posed by allergens in their products.
  • The upcoming March 16, 2017 meeting is scheduled to be held at USDA’s Jefferson Auditorium in the South Building at 14th & Independence Ave. SW in Washington D.C., from 8 a.m. to 5:30 p.m.  For additional information on this meeting, please see the Federal Register Notice here.
  • As our readership is well aware, Listeria monocytogenesis is a pathogen that causes the infection listeriosis and is the source of numerous food recalls.  See examples of recent recalls caused by Listeria monocytogenes contamination here and here.  Listeria monocytogenes can grow in various settings, including cold, refrigerated environments, and is particularly harmful to the elderly, pregnant women and/or their pregnancy, and those who are immunocompromised.
  • Today, the FDA released an updated draft guidance, “Control of Listeria monocytogenes in Ready-To-Eat Foods,” which supports ongoing efforts by industry and government agencies to reduce the risk of Listeria monocytogenesin in ready-to-eat (RTE) foods. The updated draft guidance has an emphasis on prevention, consistent with the FDA Food Safety Modernization Act (FSMA) and reflects the Agency’s current good manufacturing practice (CGMP) requirements, as well as new requirements for hazard analysis and risk-based preventive controls, including verification of preventive controls.  The guidance includes recommendations for controls involving personnel, cleaning and maintenance of equipment, and sanitation, as well as for treatments that kill Listeria monocytogenes and formulations to prevent it from growing during storage of the food between production and consumption.
  • Of note, FDA has incorporated industry best practices and the “seek and destroy” approach used by USDA’s Food Safety and Inspection Service (FSIS) into its draft guidance. RTE facilities that produce foods that are regulated by both USDA/FSIS and FDA should benefit from a uniform federal approach to reducing the risk of environmental contamination with Listeria monocytogenesis.
  • FDA will be accepting public comments beginning on January 17, 2017.

FDA issues 5th annual Reportable Food Registry report.

  • Since 2009, FDA has operated the Reportable Food Registry (RFR), an electronic portal to which instances of “reportable food” must be submitted.  A “reportable food” is a food (other than dietary supplements and infant formula) that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. The definition of “reportable food” is essentially identical to the criteria established for a Class I recall.
  • FDA recently released its 5th annual RFR report, which summarizes data from the Registry’s first five years of operation.  FDA received 909 reportable food entries in year 5 with 201 of these being primary reports (initial reports about a food-related safety concern), 464 being subsequent reports from suppliers or recipients of a product for which a primary report had been submitted, and 244 being amended reports (to correct or add information to previously submitted reports).  Undeclared allergens triggered almost half (47%) of the RFR reports submitted in year 5, with most of these reports associated with bakery products.
  • FDA noted that although the total number of RFR submissions in year 5 represented a decrease as compared to the previous two years, amended report submissions are on the rise, which may indicate industry cooperation and familiarity with the reporting process.  Under the FDA Food Safety Modernization Act (FSMA), FDA has been tasked with modifying the RFR system to make it more “consumer-oriented.”  Although there has not been much activity since FDA published an advance notice of proposed rulemaking (ANPRM) in 2014, the industry should stay tuned for potential developments on this front.

FDA investigating low levels of peanut residue found in flour.

  • Peanuts are among the “Big 8” allergens covered by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).  Food companies must declare the presence of major allergens on the labels of food products.  Additionally, as part of good manufacturing practices (GMPs), facilities must take steps to protect food against unintentional cross-contact with allergens.
  • FDA recently issued a safety advisory to consumers, advising them to avoid specific products because of peanut residue that may have been present in the flour used to make these foods.  The flour supplier notified FDA that sampling by a customer found peanut residue in cookies and that subsequent investigation identified soft red winter wheat flour as the source.  Both the supplier and FDA have reported additional samples testing positive for peanut residue since that time.  The supplier ceased manufacturing and distribution of the flour product and conducted a recall, which implicates food processors (since the supplier does not sell directly to consumers).  FDA is actively working with food processors to determine whether their products pose a safety hazard that would trigger a recall.  Of some comfort to the food industry, FDA does not publicize the names of each potentially affected recipient, noting that “it is prohibited by law from releasing publicly certain information about supply chains, such as the names of customers, if it constitutes confidential commercial information.”
  • It is somewhat unusual, although not unprecedented, for FDA to issue consumer safety advisories in this type of situation.  This case illustrates the way in which a safety problem at a single supplier’s facility can affect multiple processors and finished foods.

New Jersey amends law to facilitate distribution of dietary supplements by physicians.

  • In recent years, the dietary supplement industry has grappled with concerns about regulation and enforcement action at the state level.  In terms of state-specific regulation, New Jersey law prohibited physicians from distributing more than a 7-day supply of any drug and imposed pricing restrictions on drug sale.  The law did not distinguish between pharmaceuticals and dietary supplements, even though a 7-day supply restriction is a non-starter in the supplement area.
  • New Jersey has now amended its law to exempt from the restrictions any “licensed physician, podiatric physician, or chiropractic physician who dispenses food concentrates, food extracts, vitamins, minerals, herbs, enzymes, amino acids, tissue or cell salts, glandular extracts, neutraceuticals [sic], botanicals, homeopathic remedies, and other nutritional supplements.”  The law received early and continued support from a leading trade association, the Council for Responsible Nutrition (CRN).
  • The lifting of New Jersey’s prior restrictions is being welcomed as a positive development in the supplement industry and one that will allow doctors to integrate supplements into patient health care regimens.  Still, the industry must remain attuned to regulatory and enforcement activities at the state level.  Many will recall that the widely-publicized 2015 investigation of the dietary supplement industry — targeting major retailers for marketing allegedly misbranded products — was kickstarted by the New York Attorney General before expanding to other states.  The significance of state-level activity in the supplement area should not be discounted.

FDA announces seizure of dietary supplements containing kratom.

  • FDA has many tools in its arsenal to protect the public from adulterated, misbranded, and/or dangerous food and dietary supplement products; these include the Agency’s inspection power and various enforcement authorities (e.g., Warning Letters, mandatory recall orders in class I situations, administrative detention, seizure, suspension of facility registration).  Under its administrative detention authority, FDA can detain a food or dietary supplement product if the Agency has reason to believe the product is adulterated or misbranded.  The Agency can keep detained products out of the marketplace for a maximum of 30 days while it determines whether to take further enforcement action, such as seizure.
  • Earlier this month, FDA administratively detained dietary supplement products containing “kratom” — a botanical substance from Southeast Asia that may pose a risk to public health and that has the potential for abuse when consumed.  On January 6, U.S. Marshals initiated a seizure of approximately 90,000 bottles of kratom-containing supplements.  The U.S. Department of Justice filed a complaint in federal court on FDA’s behalf, alleging — among other things — that supplements containing kratom are adulterated because there is insufficient information to provide reasonable assurance that these products do not present a significant or unreasonable risk of illness or injury.
  • FDA’s use of its administrative detention authority, followed quickly thereafter by product seizure, indicates the Agency’s willingness to take swift and highly-publicized enforcement action against supplements that may pose safety risks.