• Public health officials in Mendham, New Jersey are dealing with a relatively rare instance of a foodborne hepatitis A outbreak due to an ill food handler.  The employee has been linked to illnesses in 27 people, with 1 death reported.
  • According to the Centers for Disease Control and Prevention, foodborne outbreaks of hepatitis A are not common in the U.S.  CDC does not recommend that all food service workers receive routine vaccination against hepatitis A—except in areas with an active community-wide outbreak and where state and local health authorities (or private employers) indicate that vaccination would be cost-effective.
  • There are hepatitis A outbreaks in Alabama and Nevada where infected food handlers have been identified but where illnesses have not been traced to such workers.  Twenty-five counties in Alabama are reporting cases of hepatitis A in an outbreak that has been ongoing since September 2018, including among food workers; officials are urging food handlers in that area to get vaccinated.  Officials in Las Vegas, which also has an ongoing outbreak with 86 cases and one death, have warned customers who purchased non-prepackaged foods at a 7-Eleven store where a worked tested positive for hepatitis A to be on the lookout for symptoms.
  • CDC’s hepatitis A surveillance is updated through 2016.  Thus, it is not yet clear whether the 2019 cases reflect a marked increase in the incidence of hepatitis A in the U.S.
  • On August 26, the FDA issued a letter to all sectors of the papaya industry to take action to prevent future foodborne illness outbreaks. As noted in the letter, since 2011, consumers have been exposed to eight outbreaks caused by Salmonella serotypes linked to imported, fresh papaya. In June of this year, FDA started an investigation into an outbreak of Salmonella Uganda illnesses tied to the consumption of whole, fresh papaya imported from Mexico. While the 2019 outbreak is ongoing, the first seven outbreaks accounted for almost 500 reported cases of illness, more than 100 hospitalizations, and two deaths.
  • In the letter, the FDA stated that it intends to use all the tools and enforcement powers available to the Agency to further strengthen safeguards and prevent contaminated papayas from being imported into the U.S. Such tools include education, outreach, training, enforcement, and research activities.  However, the FDA noted that more must be done within the industry to protect customers and meet legal obligations, such as the requirements set forth under the Produce Safety Rule and the Foreign Supplier Verification Program. Thus, the Agency set forth a number of action items for the papaya industry to implement:
    • Assess the factors that make crops vulnerable to contamination. If a foodborne pathogen is identified in the crop or growing environment, a root cause analysis should be performed to determine the likely source of contamination. Procedures and practices that minimize that risk must be implemented.
    • Examine the use and monitoring of water used to grow, spray (pesticides, fungicides), move, rinse or wax crops to identify and minimize risks from potential hazards.
    • Adopt tools and practices needed to enhance traceability. Papayas are a perishable commodity, and traceability information should facilitate the rapid tracking of involved product to expedite its removal from commerce, prevent additional consumer exposures, and properly focus any recall actions.
    • Fund and actively engage in food safety research to identify the potential sources and routes of microbial pathogens and develop data-driven and risk-based preventive controls.
  • FDA noted that the pattern of recurrent outbreaks observed since 2011, including the 2019 illnesses, have involved papaya grown in Mexico. As mentioned in both the industry letter and an agency press release, the FDA has increased sampling and screening of papayas at the U.S.-Mexico border, and is actively collaborating with counterparts in the Mexican government to further prevention efforts. Additionally, FDA has issued a warning letter to the papaya importer, Agroson’s LLC, due to significant violations of the Federal Food, drug, and Cosmetic Act found at the facility in conjunction with the latest Salmonella outbreak.
  • As our readers are aware, a number of states have enacted laws to prohibit marketing a product as “meat” if it is not derived from livestock or poultry and that several of these laws—including ones in Mississippi, Missouri, and Arkansas—have been challenged in court. (Other states that have enacted similar laws include Louisiana, North Dakota, South Dakota, Oklahoma, and Wyoming.)
  • The Arkansas Truth in Labeling Law (Act 501) includes the following definitions:
    • Beef: the flesh of a domesticated bovine, such as a steer or cow, that is edible by humans
    • Pork: the flesh of a domesticated swine that is edible by humans
    • Poultry: domestic birds that are edible by humans

Under this law, misbranding or misrepresenting an agricultural product can result in a fine of up to $1,000. As we previously reported on this blog, two days before the Arkansas law was scheduled to become effective, on July 22, 2019,  the American Civil Liberties Union (ACLU), The Good Food Institute, the Animal Legal Defense Fund, and Tofurky filed a lawsuit in the U.S. District Court for the Eastern District of Arkansas claiming that Act 501 violated the First and Fourteenth amendments.

  • Earlier this month, the Plaintiffs asked the court to issue a preliminary injunction to stop enforcement of the law while the case is being decided (see Turtle Island Foods, SPC doing business as The Tofurky Company v. Nikhil Soman, in his official capacity as Director of the Arkansas Bureau of Standards, Case No. 4:19-cv-514-KGB). In response to Tofurky’s request, the Arkansas Attorney General’s office explained that since the lawsuit challenging the constitutionality of the labeling law was filed before the law was scheduled to take effect, the Arkansas Bureau of Standards decided not to enforce it yet and, therefore, there is no threat of irreparable harm to support an injunction (Vox Media).
  • U.S. sales of plant-based meat grew 37.1% between April 2017 and April 2019 to reach $801 million in the year ending in April 2019, reports the Good Food Institute. We will continue to monitor and report on legal and regulatory activity in this area.
  • On July 24, 2019, the U.S. Department of Agriculture’s (USDA) Food and Nutrition Service (FSN) published a proposed rule, “Revision of Categorial Eligibility in the Supplemental Nutrition Assistance Program (SNAP)” aiming to close what it calls an automatic eligibility “loophole” in the program. As background, the law authorizing SNAP includes specific income and asset standards to qualify for SNAP benefits, but the law also allows states to confer “categorical eligibility” on those who have already been certified for similar means-tested programs (i.e., programs that check income, assets, etc. to ensure applicants are eligible, such as the Temporary Assistance for Needy Families (TANF)).
  • Some states have expanded the use of categorical eligibility so that households who receive TANF benefits are automatically eligible to participate in the SNAP, without having to qualify for the federal income or assets limits for SNAP. The administration is calling this expansion a “loophole” as some households may qualify under SNAP when they would otherwise not under regular program rules, with USDA Secretary Sonny Perdue stating that “For too long, this loophole has been used to effectively bypass important eligibility guidelines. Too often, states have misused this flexibility without restraint.”
  • Under the new rule, an estimated 3.1 million people would lose their food assistance under SNAP. On August 21, 2019, in a letter to an administrator for SNAP, 70 U.S. mayors rejected the proposal. “This proposal will put children’s health and development at risk by removing their access to healthy school meals; and harm our economy by reducing the amount of SNAP dollars available to spur regional and local economic activity.” Written comments on the proposed rule must be received on or before September 23, 2019.
  • As previously reported on this blog, state regulators want a role in the regulation of CBD-infused food, beverages, and supplements. And while industry has been pressuring FDA to create a pathway for the lawful use of CBD in food and dietary supplements, currently, under the Federal Food, Drug and Cosmetic Act (FD&C Act), CBD (or cannabidiol) cannot lawfully be added to a food or marketed as a dietary supplement.
  • Washington State Department of Agriculture (WSDA) updated its website this month to clarify that hemp-derived CBD is not permitted as a food ingredient or additive. WSDA points out that while food processors licensed in the state of Washington may currently use certain hemp products in foods—such as hulled hemp seeds, hemp seed protein power, and hemp seed oil—”[o]ther parts of the hemp plant, including CBD, cannot be used as a food ingredient under a Washington State Food Processor License.” The department further states, “Recognizing that these recent changes in law may have caused some confusion in the manufactured-food industry, WSDA has been reaching out to the industry so they can take appropriate actions, such as removing CBD ingredients from their products or discontinuing distribution of CBD-containing food products in the state.”
  • As recently as last week, Cara Welch, FDA’s Acting Special Assistant to the Deputy Commissioner for Policy Legislation & International Affairs, reminded attendees at the American Herbal Products Association Hemp-CBD Supplement Congress that it is prohibited to add CBD to food. Noting that, “There is still a significant amount of missing data to better understand the effects on human exposure and the long-term effects of regular consumption,” Welch pointed out that some studies show some toxic effects on the liver in high doses, and there is inadequate research about the use of CBD by pregnant or nursing mothers or people with low immunity (see U.S. News). She added, “We’re trying to be as transparent and informative as possible on these issues, and to resolve open questions quickly, efficiently, but also thoughtfully.”
  • Preliminary data on the growth of hemp-derived CBD was presented during the AHPA Congress. AHPA reports in a press release on the Hemp-CBD Congress that, hemp-derived CBD sales ballooned to $238 million, an increase of 57% in 2018 over the previous year, according to Nutrition Business Journal. Additionally, hemp acreage under license across the U.S. increased nearly five-fold in the past year from 112,000 acres in 2018 to 480,000 acres in 2019, according to data gathered by advocacy group votehemp.com. We will continue to report on developments in the regulation of CBD-infused food, beverages, and supplements.
  • FDA has issued Guidance for Industry (“Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels”) on how to declare certain vitamins and minerals whose recommended daily intakes (RDIs) changed when FDA issued its revisions to 21 CFR 101.9 in 2016.
  • While some changes to RDIs involved changes only to the quantitative amounts of nutrients (e.g., the RDI for Vitamin C increased from 60 mg to 90 mg under the 2016 final rule), other RDI changes were less straightforward.  For example, under the old Nutrition Facts regulation, the RDI for Vitamin A was 5,000 International Units, and under the 2016 final rule, the RDI changed to 900 micrograms “RAE.”  (RAE stands for “Retinol Activity Equivalents” in which 1 microgram RAE is equivalent to 1 microgram retinol, 2 micrograms supplemental β-carotene, 12 micrograms dietary β-carotene, or 24 micrograms of either dietary α-carotene or dietary β-cryptoxanthin.)  In other words, the new 2016 RDIs changed the way certain micronutrient values are quantified and expressed.
  • FDA’s guidance provides industry with conversion factors and examples of conversion calculations for folate, niacin, Vitamin A, Vitamin D, and Vitamin E in both conventional foods and dietary supplements.  The guidance will be useful in ensuring compliance with the new Nutrition Facts regulations that become mandatory for most businesses on January 1, 2020.
  • On August 19, two consumer groups, Center for Food Safety (CFS) and Center for Environmental Health (CEH), filed suit against the FDA in California federal court for its failure to promulgate final regulations and complete actions by mandatory deadlines set by Congress in the Food Safety Modernization Act of 2011 (FSMA). At issue in the lawsuit is Section 422 of the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by FSMA.  Section 422 (21 U.S.C. 350k) required that by January 4, 2013, FDA establish a program to detect and address foodborne illness outbreaks with more accredited laboratories and provide a database of accredited labs.  Among other requirements, FDA was to establish a program for the testing of food by accredited laboratories; establish a publicly available registry of accreditation; and develop model standards that a laboratory must meet in order to be accredited by a recognized accreditation body. 21 U.S.C. §350k(a).
  • In the complaint, CFS and CEH allege that missing the 2013 deadline and failing to propose final regulations by six years violated FSMA and the Administrative Procedures Act (APA), and “is putting millions of lives at continued risk from contracting foodborne illness, contrary to Congress’s commands.” According to CFS staff attorney, Ryan Talbott, “[a]ccurate laboratory testing is essential to reduce the foodborne illness threat. […] FDA was required to establish a comprehensive food testing program years ago, but has yet to do so. We will hold FDA accountable and protect the public health, as we always have.”
  • The lawsuit comes after 2018 saw several foodborne illness outbreaks, most notably the multistate outbreak of E. coli linked to romaine lettuce. In 2018, the Centers for Disease Control and Prevention (CDC) investigated 24 foodborne illness outbreaks as compared to 7 outbreaks in 2017.  This year, the CDC has already investigated 12 outbreaks.
  • CFS and CEH have sued FDA over missed FSMA deadlines twice before. Our readers may recall the 2012 suit against FDA after the agency missed seven statutory Congressional deadlines for promulgating FSMA’s food safety regulations. See Str. For Food Safety v. Hamburg, 954 F.Supp.2d 965 (N.D. Cal. 2013). The 2012 Court held that “FDA’s failure to promulgate the mandated regulations by their statutory deadlines constituted a failure to act under the Administrative Procedure Act (APA) and unlawful withholding of the regulations in violation of FSMA and the APA.” The Court granted injunctive relief and established a timeline for FDA to promulgate the final regulations. In October of 2018, CFS and CEH sued the agency for failure to classify and designate certain foods as “high-risk” for foodborne illness purposes, and to create additional recordkeeping requirements for facilities handling such foods by the statutory deadlines. On June 7, 2019, via Consent Decree, FDA agreed to a schedule of deadlines to establish reporting requirements for “high-risk” foods.
  • FDA has yet to respond to the current CFS and CEH complaint. Keller and Heckman will continue to monitor the developments of this case.
  • On August 14, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) finalized amendments to the rules (9 CFR 318.12 and 9 CFR 381.152) relating to the preparation and handling of “uninspected, inedible products, such as pet food” in USDA registered facilities.  As described in the proposed rule from July 31, 2018, the existing rules “set forth prescriptive requirements intended to prevent the creation of insanitary conditions in official establishments, the commingling of inedible and edible meat and poultry products, and the movement of inedible meat and poultry products into commerce as human food” and that manufacture occurs “only when an FSIS inspector is on the premises” (emphasis in original).
  • However, these rules predate the Hazard Analysis and Critical Control Point (HACCP) regulations at 9 CFR Part 417 and related sanitation rules at 9 CFR Part 416 and, according to USDA, they are incompatible with the flexible approach available under the HACCP regulations.  Under the HACCP regulations it is the responsibility of the facility to develop and implement plans with necessary and appropriate controls for safe, unadulterated product.  Specifically, HACCP requires the determination of hazards reasonably likely to occur in the production process, the institution of controls to prevent the hazards or keep them within acceptable limits, monitoring and verification that the HACCP system is working as intended, and records maintenance.  Though there are required objectives and some firm requirements (like recordkeeping), the HACCP regulations provide considerable flexibility in how a firm will achieve compliance.  Similarly, the sanitation rule sets forth sanitation objectives for facilities but it permits great flexibility in achieving compliance.
  • Under the revised rules, facilities may produce uninspected, inedible products at any time and with the only limitations that manufacture of these products will not:
    • Adulterate edible products;
    • Create insanitary conditions such that edible products might become adulterated; or
    • Prevent or interfere with inspection or other FSIS efforts to regulate the establishment.

   Further, the handling of the products must be such that they will not accidentally be distributed as human food.

  • As noted in USDA’s response to the comments, manufacture of pet food is also subject to FDA regulation, including compliance with the Hazard Analysis and Risk-Based Preventive Controls and Good Manufacturing Practices (HARPC and GMP; 21 CFR Part 507).

Keller and Heckman attorneys are available to assist interested parties in navigating compliance with USDA HACCP and FDA HARPC and GMP.  For assistance, please email: fooddrug@khlaw.com.

 Danone Dodges Deceptive Ad Suit Over Coconut Milk (Subscription to Law360 required)

  • The U.S. District Court for the Southern District of California on August 14, 2019 dismissed a proposed class action alleging the term “healthy” is deceptive when used to market coconut milk containing high levels of saturated fat.  At issue in Andrade-Heymsfield v. Danone US, Inc. were marketing claims that So Delicious coconut milk contains “good fats” and can help promote bone strength through calcium and vitamin D.  U.S. District Judge Cathy Ann Bencivengo found the advertised benefits are permitted under the Food and Drug Administration (FDA) guidelines, that the labeling made accurate admissions about the saturated fat content, and “plaintiffs cannot claim deception on label statements modelled on FDA guidance.”  The judge also rejected the plaintiffs breach of an express or implied warranty claim about treating osteoporosis, finding statements about the coconut milk’s nutrients and their effects are structure and function claims permitted by FDA.
  • Under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(r)(1)(A)), a food is misbranded if it bears claims that characterize the level of a nutrient which is of a type required to be declared in nutrition labeling unless the claim is made in accordance with a regulatory definition established by FDA.  FDA’s regulation at 21 CFR 101.65(d) provides such regulatory definition for use of the term “healthy” as an implied nutrient content claim on the label or in labeling of a food that meets certain nutrient conditions, including specific criteria for nutrients to limit in the diet, such as saturated fat.
  • As previously reported on this blog, FDA is considering updating its nutrient content claim regulations to be consistent with current federal dietary guidance.  In the interim, food manufacturers may continue to use the term “healthy” on foods that meet the current regulatory definition (21 CFR 101.65(d)).  FDA has also issued a guidance document, stating that FDA does not intend to enforce the regulatory requirements for foods that use the implied nutrient content claim “healthy” on their labels which: (1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or (2) contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.  It is the second provision of FDA’s enforcement policy that the U.S. District Court found applicable to the “healthy” claim on Danone’s coconut milk.
  • The Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by Section 201 of the Family Smoking Prevention and Tobacco Control Act (TCA; signed into law on June 22, 2009) directs the U.S. Food and Drug Administration (FDA) to develop graphic warnings for cigarette packages and promulgate regulations requiring the warnings within 24 months of enactment of the TCA.  Accordingly, FDA issued a final rule requiring graphic warnings on June 22, 2011. However, the original graphic warning images did not survive a First Amendment challenge by the tobacco industry (see R.J. Reynolds Tobacco Co. v. FDA), and FDA withdrew the rule.
  • In response to a lawsuit filed against FDA by a coalition of public health groups lead by The Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, the American Heart Association and others, the U.S. District Court for the District of Massachusetts ruled that FDA “unlawfully withheld” or “unreasonably delayed” a revised graphic warning rule because nearly a decade had passed since the TCA was enacted. In March 2019, the Court ordered FDA to publish the new proposed rule by August 2019 and issue a final rule in March 2020.  FDA promulgated a notice of proposed rulemaking on the new cigarette health warnings on August 15, 2019 (available here).
  • The proposed rule would require advertising and packages of cigarettes sold in the United States to include one of thirteen warnings:
    • WARNING: Tobacco smoke can harm your children.
    • WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
    • WARNING: Smoking causes head and neck cancer.
    • WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
    • WARNING: Smoking during pregnancy stunts fetal growth.
    • WARNING: Smoking can cause heart disease and strokes by clogging arteries.
    • WARNING: Smoking causes COPD, a lung disease that can be fatal. (This statement is paired with two different images.)
    • WARNING: Smoking reduces blood flow, which can cause erectile dysfunction.
    • WARNING: Smoking reduces blood flow to the limbs, which can require amputation.
    • WARNING: Smoking causes type 2 diabetes, which raises blood sugar.
    • WARNING: Smoking causes age-related macular degeneration, which can lead to blindness.
    • WARNING: Smoking causes cataracts, which can lead to blindness.
  • Under the proposal, each statement is paired with a graphic image, except the COPD statement which is paired with two different images.  The proposed labels, with the accompanying graphic images, can be found here.  Among other requirements, the top fifty percent (50%) of the front and rear panels of the package and 20% of the top of the advertisement would need to provide a graphic warning.
  • For more information, see FDA’s press release, landing page for Cigarette Health Warnings, and Web Feature.  Keller and Heckman attorneys in the Tobacco and E-Vapor Practice would be happy to assist those wishing to submit comments before the October 15 deadline for comments or with questions regarding the regulation of tobacco or e-vapor products.