• An Illinois consumer has filed a class action lawsuit against Kellogg in federal court, claiming that Frosted Strawberry Pop-Tarts’ packaging is misleading because the product contains less strawberry than implied by the packaging.  The complaint highlights that the ingredient declaration indicates that the product “contains 2% or less” of dried strawberries, pears, and apples and speculates that apple and pear could be more prominent than the strawberry component. In addition, the complaint notes that the product contains Red 40 as an ingredient, which allegedly misleads the consumer into thinking there is more strawberry in the product.
  • The plaintiffs in this case raised that the Pop Tarts are not described as being strawberry flavored.  The complaint compared the label of the Frosted Strawberry Pop-Tarts to other brands’ strawberry toaster pastries, like Great Value and Clover Valley, which describe the products on the front of the package as being “artificially and naturally flavored.” The Pop Tarts are described as being “Frosted Strawberry” without reference to being flavored.
  • The newly filed complaint is similar to our previous post on a similar complaint concerning Kashi Strawberry Bars.  Kellogg has yet to respond but will be able to draw from the motion to dismiss it filed earlier this year in response to an analogous Sheehan & Associates complaint concerning Strawberry Pop Tarts filed in New York District Court in the fall of 2020.
  • FDA recently published the guidance document “FDA Export Certification: Guidance for Industry,” which is intended to provide a general description of the FDA’s export certification to industry and foreign governments. Companies exporting products from the US are often asked by foreign customers or governments to supply a certification relating to products subject to the Federal Food, Drug, and Cosmetic Act and other statutes administered by the Agency.
  • FDA export certification provides information concerning a product and/or establishment’s regulatory or marketing status, based on available information at the time FDA issues the certification (including attestations provided by the person seeking the export certification). For some Agency Centers, if a product has received approval or clearance from FDA, it is indicated on the export certification and/or a copy of approved labeling is appended, as appropriate. FDA issues several types of export certificates, including “Certificate of Free Sale” for human food, animal food/drugs, and cosmetics, “Health Certificate,” “Certificate of a Pharmaceutical Product,” “Non-Clinical Research Use Only Certificate,” “Certificate to Foreign Government,” and “Certificate of Exportability.”
  • This guidance supersedes previous versions that were issued in July 2004, April 2005, and February 2019. The FDA is accepting comments on the guidance document electronically via docket ID: FDA-2013-S-0610. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • As we have previously reported, in September 2020, Mexico and Canada signed a Statement of Intent (SOI), which expanded the countries’ partnership in dealing with food safety issues. Among other things, the 2020 SOI expanded the partnership to include all foods traded between the countries and encouraged the development and use of new technologies to improve food safety.
  • On August 20, 2021, FDA and its regulatory counterparts in Mexico (Cofepris and SENASICA) held the first Food Partnership Annual meeting in which they discussed the accomplishments and goals of the partnership. The discussion was summarized in a recent press release by Frank Yiannis, FDA Deputy Commissioner for Food Policy and Response. (See also Constituent Update)
  • Specifically, Mr. Yiannis stated that the agencies were continuing to work on four strategic priorities: (1) foodborne illness prevention, (2) enhanced coordination for outbreak response, (3) regulatory laboratory coordination, and (4) food safety training opportunities for industry. The agencies’ efforts included sharing analytical methods and laboratory protocols to improve detection and reduce exposure to food illness pathogens, sharing outbreak data to improve outbreak response communications, and working to revise a coordinated outbreak response protocol. Mr. Yiannis also announced progress in training industry on best agricultural practices, including the training of 90% of the Mexican papaya industry on papaya growing best practices.
  • Keller and Heckman will continue to monitor and report on developments in the regulation of food safety.
  •  On July 25, 1996, USDA’s Food Safety and Inspection Service (FSIS) issued a final rule to address the problem of harmful bacteria on raw meat and poultry products.  Such bacteria include Listeria, Salmonella and Escherichia coli O157:H7, which killed 4 children and sickened 732 others in an infamous 1993 outbreak linked to undercooked beef patties at Jack in the Box restaurants in four western states.
  • In an August 19, 2021 press release FSIS reflects on the 25 year old Pathogen Reduction (PR)/Hazard Analysis and Critical Control Point (HACCP) final rule that upended “command-and-control” inspections of meat and poultry facilities under which FSIS had the responsibility of approving production decisions.  As part of a broad overhaul of the FSIS regulatory program, the PR/HACCP rules made inspected facilities responsible for developing and implementing site- and product appropriate process control measures to achieve FSIS-established performance standards for pathogen reduction and control.  FSIS attributes a reduction in pathogen contamination of meat and poultry, such as a 56% decrease in Salmonella contamination of broiler chicken carcasses, as cited in the press release, to changes brought about by HACCP including:
    • A large scale-microbial testing program by FSIS that was developed to address the need for verification of companies’ HACCP plans; and
    • Ongoing industry innovations to address the continuing need for food safety improvements.
  • In September, FSIS is expected to further mark the 25th anniversary of the PR/HACCP final rule by taking a closer look at how the rules and regulations for HACCP were developed and the expanded role of the microbial testing laboratories.
  • FDA issued a corporate-wide warning letter to Midwestern Pet Foods, Inc. (Midwestern) on August 9, 2021. The letter states that inspections of the company’s pet food manufacturing plants revealed violations across multiple plants that were connected to illness or death of hundreds of animals that ate Midwestern’s dry dog food. The warning letter states that Midwestern’s manufacturing facilities presented serious violations of FDA’s Hazard Analysis and Risk-Based Preventative Controls (HARPC) requirements and that the company has not taken sufficient action to respond to FDA’s concerns about preventative measures for the presence of mycotoxins and Salmonella.
  • In January 2021, Midwestern recalled over one thousand lots of its SPORTMiX-brand cat and dog food products manufactured in the company’s Oklahoma plant because of the presence of aflatoxin. This was followed by a March recall of other Midwestern brands manufactured at the company’s Illinois plant where samples tested positive for Salmonella.
  • Some Midwestern product samples were found to contain levels of aflatoxin as high as 558 ppb; FDA considers pet food to be adulterated if it contains more than 20 ppb of aflatoxin. The adulterated products were linked to 130 pet deaths and more than 220 pet illnesses. Groups of consumers with pets that died or became ill after consuming the recalled products filed two proposed class action lawsuits in January and February 2021. We will continue to monitor and report on developments regarding these cases and FDA enforcement in pet food manufacturing.
  • On July 12, the Southern District of New York dismissed a putative class action lawsuit against Coca-Cola and their Gold Peak iced tea. The plaintiff had alleged violations of various federal and New York state laws, as well as claims of fraud and unjust enrichment based on the argument that the claim “slightly sweet” led consumers to believe that the product was low in sugar, despite containing 24 grams of sugar per serving (equivalent to 48% of the daily reference value).
  • Coca-Cola argued that the claim “slightly sweet” was a subjective statement describing the product’s taste. They further argued that the principal display panel (PDP) and nutrition information clearly indicated the calorie and sugar content of the product. In the dismissal, the court found that there were no plausible allegations to support that a reasonable consumer would assume the beverage was “low sugar” and thus “low calories” based on the “slightly sweet” label. In finding that the label was not deceptive, the court agreed with Coca-Cola’s argument that the nutrition information accurately displayed the sugar content and that the “90 Calories” claim on the PDP was accurate.
  •  “Low sugar” and similar type claims have recently been the focus of several lawsuits and related actions.  In addition, as we have previously blogged, the Center for Science in the Public Interest (CSPI) recently urged the Agency to take enforcement action against such claims like “lightly sweetened” and “slightly sweet,” arguing that they are equivalent to a “low sugar” claim, which is an undefined and therefore impermissible nutrient content claim.
  • On August 13, the U.S. Hemp Roundtable, a hemp industry trade association, filed a formal response to the Cannabis Administration and Opportunity Act (CAOA), just over one month after the bill’s authors introduced a discussion draft (subscription to Law360 required). The CAOA would end the federal prohibition of cannabis, among other issues. If implemented, regulatory responsibility of cannabis would be transferred from the Drug Enforcement Agency (DEA) to the Alcohol and Tobacco Tax and Trade Bureau (TTB) and the FDA.
  • The U.S. Hemp Roundtable urged the CAOA sponsors, Senators Chuck Schumer, Cory Booker, and Ron Wyden, to clear regulatory pathways for non-intoxicating cannabis products to be marketed and sold legally in food and beverages. While the comments largely focused on CBD, the group encouraged the inclusion of other non-intoxicating cannabis substances, like CBG and CBN.
  • The group’s comments primarily focused on the bill’s lack of protection for CBD products and encouraged lawmakers to further clarify the legal difference between marijuana and hemp. “Hemp-derived CBD, as well as other hemp derivatives, have been sold in the consumer marketplace for years […] By subjecting hemp-derived ingredients to a uniquely onerous regulatory regime, or continuing to treat them as illegal substances, the draft CAOA not only unfairly burdens hemp farmers, manufacturers and consumers, but it may also encourage black market sales of these products.”
  • The group also encouraged the CAOA authors to amend the statutory definition of “hemp.” The 2018 Farm Bill defined hemp as containing no more than 0.3% Delta-9 THC on a dry weight basis. The U.S. Hemp Roundtable proposed that the limit on finished consumer products be capped at 0.3% total THC, including Delta-8, but that the legal limit on the crop and intermediate stages of the products be raised to 1.0%.
  • Comments on the draft CAOA will be accepted until September 1. Keller and Heckman will continue to monitor any developments.
  • On August 5, 2021, Senate Republicans introduced the Exposing Agricultural Trade Suppression (EATS) Act, which aims to “prevent States and local jurisdictions from interfering with the production and distribution of agricultural products in interstate commerce.” The EATS Act would grant a private right of action allowing affected persons to seek an injunction against any state or local regulation that imposes a production or manufacturing standard on agricultural products that is more restrictive than a standard at the federal level.
  • The EATS Act is intended to invalidate California’s Proposition 12. As we have previously blogged, Proposition 12 establishes minimum confinement standards for certain farm animals and bans the sale of food products from animals that are not raised in compliance with the standards, which subjects out-of-state food manufacturers selling products into California to Proposition 12.
  • Introduction of the EATS Act comes in the wake of unsuccessful legal challenges to the constitutionality of Proposition 12.  In July 2021, the 9th Circuit Court of Appeals affirmed the dismissal of a lawsuit filed by the National Pork Producers and American Farm Bureau Federation, which alleged that Proposition 12 violated the Commerce Clause of the Constitution by placing an undue burden on interstate commerce.  A similar challenge to Proposition 12 filed by the North American Meat Institute also ended unsuccessfully earlier this summer.
  • Despite implementing regulations not having been introduced until mid-2021, several Proposition 12 requirements are already in effect as of January 1, 2020, while others (e.g., standards for breeding pigs), will not go into effect until January 1, 2022. Keller and Heckman will monitor and report on any updates to the EATS Act and Proposition 12.

 

  •  Previous New Dietary Ingredient Notifications (NDINs) for cannabidiol (CBD) products, i.e., NDINs #984, #1116, #1117, #1128, and #1135, were not filed based solely on FDA’s determination (discussed here) that with limited exceptions, a substance such as CBD, which is an active ingredient in an approved drug (i.e., Epidiolex) or has been the subject of substantial, publicly known clinical investigations, is excluded from the legal definition of “dietary supplement.”  Although FDA has also consistently maintained there are substantial safety gaps that need to be addressed, these previously submitted NDINs were refused without a safety evaluation.
  • In a departure from previous responses that refused NDINs solely on the basis that CBD products are excluded from the dietary supplement definition, FDA’s letters dated July 23, 2021 and posted on August 11, 2021, responding to NDIN #1199 for Irwin Naturals – “Full Spectrum Hemp Extract” and NDIN #1202 for Charlotte’s Web – “Full Spectrum Hemp Extract,” indicate that FDA went on to review the safety data and found it did not reach the “will reasonably be expected to be safe” standard.  Safety data gaps noted in FDA’s letters include:
    • Evidence on a general history of use was vague and did not provide an adequate description of the cannabis preparations (e.g., composition), serving levels, or frequency and durations of use for comparison to the currently proposed ingredient use.
    • Preclinical and clinical studies on different phytocannabinoid mixtures were, in some cases, not completely characterized and could not be compared to the current ingredient.
    • Most importantly, certain reported toxicity endpoints of CBD such as hepatotoxicity and reproductive toxicity, were not adequately addressed.
  • FDA’s taking the additional step of commenting on safety, after concluding that CBD is not an eligible dietary ingredient, reinforces that unresolved safety concerns could prevent the legal marketing of dietary supplements (as well as food) containing CBD, even if legislative action were to otherwise clear a regulatory pathway.  Keller and Heckman will continue to monitor and report on developments that impact the use of CBD in FDA regulated products.
  • The European Commission has again taken aim to reduce the presence of heavy metals in food by setting new limits for lead and cadmium in certain food products. Lead and cadmium, along with other heavy metals like arsenic and mercury, are naturally occurring and can be present in foods, cosmetics, and dietary supplements. Studies have suggested they may pose a health risk, particularly to neurological development in children.
  • In revising its standards for lead, the Commission considered the European Food Safety Authority’s (EFSA) 2010 opinion on lead in food and recent data from the Codex Alimentarius Commission to determine that limits for infant food, salt, and wild fungi merited revision. For cadmium, the Commission considered a 2009 EFSA opinion about health risks of cadmium in food and other new data showing that cadmium levels can be further reduced. The new limits cover a variety of products, including garlic, berries, nuts, fish, and salt. The new measures for lead will take effect on August 30, 2021, and the limits for cadmium will take effect the following day.  Foodstuffs that were lawfully placed on the market before the new limits go into effect may remain on the market until February 28, 2022.
  • Officials in the U.S. have also increased scrutiny on heavy metals in food, particularly in baby foods. In particular, FDA’s Toxic Elements Working Group seeks to identify vulnerable populations, prioritize toxicity concerns, and improve testing for heavy metals in foods. We will continue to monitor and report on updates in this area.