• Yesterday FDA issued a guidance document to clarify and improve the Temporary Marketing Permit (TMP) application process.
  • By way of background, Section 403(g) of the Federal Food Drug and Cosmetic Act (codified at 21 U.S.C. § 343) prohibits the sale of any food for which a standard of identity (SOI) is prescribed if the food does not conform to the SOI or if it is not named accordingly. However, FDA may issue TMPs allowing the sale of a food which does not conform with the applicable to SOI if it determines that the sole purpose of the TMP is to generate market data to support a petition amending a SOI, the data sought by the TMP is necessary for the intended purpose, and consumers are adequately safeguarded. See 21 C.F.R. § 130.17.
  • FDA is in the process of modernizing its SOIs to promote innovation and allow for greater flexibility. As part of this effort, and in response to industry feedback, the TMP guidance document provides the following clarifications and changes to the TMP application process:
    • Multiple standardized foods may be included on a single TMP.
    • Multiple companies may submit a single TMP if the requested deviation is the same, but the TMP will be issued to each company individually.
    • The default test period authorized by a TMP is 15 months, but longer periods may be granted upon a showing of good cause. Extensions may also be requested.
    • A single representative label for each market-tested food is all that is required.
  • By issuing this guidance, FDA is reminding, and perhaps encouraging, the food industry to use the TMP approach with regard to the use of standardized food names on alternative products.

 Coke’s Piña Colada Fanta Not The Real Thing, Suit Says (Law360 Subscription Required)

  • On October 28, 2021, a class action lawsuit was filed against the Coca-Cola Company (Coke), alleging that Coke’s piña colada-flavored Fanta soda is deceptively labeled with a claim of “100% Natural Flavors” where laboratory testing detected the presence of DL-malic acid.  In contrast to L-malic acid, which occurs naturally in many fruits, DL-malic acid is commercially manufactured and is considered by some to be artificial.
  • According to the pleading in the case, Hawkins v. The Coca-Cola Company, filed in the New York Southern District, the DL-malic acid is used to impart a ripe pineapple flavor in the Fanta soda, which makes the label claim of “100% Natural Flavors” false because DL-malic acid is synthetically produced from petroleum products.  The complaint also alleges that a cloudy appearance, similar to pineapple juice, and pictures of a pineapple wedge and coconut on the label further lead consumers to believe that the piña colada-flavored Fanta soda contains only natural flavors.  The ingredient statement on the soda includes “natural flavors” and “malic acid.”  Malic acid may be used as a food ingredient in a variety of ways, including as a flavor enhancer, flavoring agent and adjuvant, and as a pH control agent.  See 21 CFR 184.1069 (“Malic acid”).  Coke has not commented on the proposed class action or otherwise indicated what function malic acid performs as an ingredient in the piña colada-flavored soda.
  • We have previously discussed the difficulty of making natural flavor claims for products containing DL-malic acid and/or other ingredients that may serve multiple functions.  These cases are not amenable to early dismissal because courts generally consider the function of malic acid, including distinctions between “flavor” versus “flavor enhancer,” to be a question of fact.  Keller & Heckman will continue to monitor and provide updates regarding class-action litigation in the food industry.

 

 

  • On October 25, 2021, FDA issued its final results from a year-long sampling assignment to test talc-containing cosmetic products for the presence of asbestos. All 50 samples tested negative for detectable asbestos.
  • Talc, a naturally occurring mineral, is used in many cosmetic products, and there are concerns regarding the potential for contamination of talc with asbestos, a known carcinogen. Thus, in 2018 FDA formed the Interagency Working Group on Asbestos in Consumer Products to develop recommendations and standardized testing methods for asbestos and other mineral particles of concern in talc.
  • The first sampling assignment was completed in 2019.  The results of the 2019 sampling assignment showed that 43 samples were negative and 9 were positive for the presence of asbestos. These findings resulted in recalls and FDA advisories, warning consumers not to use the cosmetics  that had tested positive for asbestos.
  • FDA will conduct another talc sampling assignment in 2022, with 50 additional talc-containing cosmetic product samples. The final results are expected to be released next year.
  • A proposed federal class action filed on October 24 alleges that Fermented Sciences Inc., which sells Flying Embers brand beverages, misled consumers into thinking its alcoholic kombucha and seltzer drinks are healthier than they are (subscription to Law360 required). According to the complaint, the beverages are promoted as containing “Antioxidant Vit[amin] C,” “Antioxidants,” “Real Botanicals,” and “Crafted with Live Probiotics,” among other claims like “Brewed with Benefits.” However, the plaintiff argues that the beverages are unlawfully fortified, the consumption of alcohol is contrary to dietary guidelines, and the addition of antioxidants, probiotics, and adaptogens to alcohol is misleading.
  • Additionally, the complaint alleges the label claims mislead consumers into believing that the positive effects of the drinks’ ingredients would outweigh the negative effects of alcohol. The ingredients in the alcoholic beverages are alleged to provide little to no health benefits. Fermented Sciences Inc. is alleged to have used false health benefit claims in order to stand out in a saturated market and increase product prices.
  • The plaintiff argues that the claims constitute false advertising in violation of the Illinois Consumer Fraud and Deceptive Business Practices Act, breaches express and implied warranties, and are fraudulent. The court has been asked to certify two classes: one of Illinois residents who purchased Flying Embers products, and one of consumers who bought the products in North Dakota, Kansas, West Virginia, Wyoming, and Delaware. The suit alleges that Flying Embers violated consumer fraud laws in those states.
  • Keller and Heckman will continue to monitor and report on this and similar litigation outcomes.
  • FDA is withdrawing a trio of temporary policies implemented in the beginning of the COVID pandemic which allowed certain businesses that are not regulated as drug manufacturers, including pharmacies and alcohol producers, to produce alcohol-based hand sanitizers. See Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products, Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products, and Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products.
  • The policies were intended to provide temporary regulatory flexibility and encourage increased production of alcohol-based hand sanitizer to keep pace with the demand for these products experienced during the pandemic. FDA is withdrawing the policies because it has determined there is no longer a shortage of hand-sanitizer.
  • After December 31, 2021, manufacturers of these products will no longer be able to rely on the temporary policies and instead must meet all regulatory requirements, including the tentative final monograph for over-the-counter (OTC) topical antiseptics and cGMP requirements. Furthermore, manufactures may not distribute alcohol-based hand sanitizers produced under the temporary after March 31, 2022. However, there is no cut-off date for retailers who may continue to sell their stock of hand sanitizer produced under the temporary guidance even after March 31, 2022. See Q&A.
  • Manufacturers who will no longer produce hand sanitizers must deregister their facilities and delist their products in FDA’s Drug Registration and Listing System by following the instructions on FDA’s webpage.
  •  In the spring of 2021, China published the Chinese General Administration of Customs (GAC) Decree 248 – Regulations on Registration and Administration of Overseas Manufacturers of Imported Food, to impose new registration requirements on all foreign food companies.
  • In October 2021, some foreign governments (e.g., Singapore and Malaysia) provided instructions to their local food companies on how to satisfy the overseas food facility registration requirements in China.  On October 5, 2021, the Singapore Food Agency (SFA) published a notice, which states that if the producers of certain designated food categories (e.g., edible fats and oils, functional foods, egg products, condiments) have exported the products to China since January 1, 2017, they could be entitled to GAC’s fast-track registration if they can submit their declaration to SFA by October 31, 2021.  The Malaysian food authority also posted detailed guidance to facilitate the registration in China.
  • Although the enforcement date of January 1, 2022 is approaching, no official guidelines have yet been released by GAC to detail the implementation.  An overseas food company may want to reach out to the local responsible food authority to understand whether any conversation has taken place between China and its home country as to how to comply with the Chinese food facility registration requirement.
  • Note also that GAC Decree 249 – Administrative Measures on Import and Export Food Safety, under which new requirements governing the inspection and evaluation of imported foods are imposed, will also take effect on January 1, 2022.
  • Keller and Heckman will continue to monitor and keep you alerted to developments with the new overseas food facility registration and inspection/evaluation requirements in China.
  • On October 18, 2021 a New Jersey federal judge dismissed plaintiff Regan Iglesia’s proposed class action lawsuit against Tootsie Roll Industries (“Tootsie Roll”). The case was dismissed for lack of standing, due to a failure to show actual harm. Plaintiff Iglesia alleged that Tootsie Roll dramatically underfilled its boxes of Junior Mints and Sugar Babies. He alleged that the company “packages, markets, and advertises Junior Mints and Sugar Babies in a misleading manner by representing them as adequately filled, when in fact they contain ‘an unlawful amount of empty space, or slack-fill.’” However, judge Anne E. Thompson concluded that plaintiff Iglesia could not prove that the candy he received was “worth less than [he] paid.” The case was dismissed without prejudice, so the plaintiff may file an amended claim.
  • This is not the first time that Tootsie Roll has been faced with a class action challenge.  In  a 2019 case, the Company faced a slack-fill challenge regarding its Junior Mint candy, but that case was also dismissed due to the plaintiff’s inability to show actual harm. The judge concluded that the plaintiff failed to show that the candy she received was worth less than what she paid. Many companies have faced slack-fill challenges in recent years, including manufacturers of chips, pasta, and other candy products.
  • As we have previously blogged, these challenges involve alleged differences between the actual capacity of a container and the volume of product it contains. Federal law permits slack-fill in certain circumstances, such as packaging equipment limitations and protection of the integrity of the product, but prohibits nonfunctional slack-fill.  There are also state specific unfair business practice laws that are applicable to claims of slack-fill.
  • Keller and Heckman will continue to monitor and report on this and similar litigation outcomes.
  • As previously reported, after disagreement with the National Organic Standards Board regarding the ability of hydroponic systems to bear the organic label, the U.S. Department of Agriculture (USDA) issued a statement in 2018 reaffirming its policy that hydroponic operations can make organic claims if they demonstrate compliance with federal organic rules. This decision prompted the Center for Food Safety (CFS) and others to file a petition calling for the Agency to reverse course, arguing that hydroponic operations cannot be certified as organic because they do not foster soil fertility and improve the organic matter content of the soil as required under the Organic Foods Production Act (OFPA).
  • USDA denied the petition in 2019, arguing that the soil fertility requirements cited by the petitioners only apply to production systems that use soil.  In response, CFS and stakeholders filed a lawsuit challenging the Agency’s petition denial. On March 18, 2021, the U.S. District Court for the Northern District of California granted USDA’s motion for summary judgement and found that USDA did not err in deciding that the OFPA does not prohibit hydroponic systems from qualifying for the National Organic Program.
  • On October 4, 2021, CFS and stakeholders filed a brief with the Ninth Circuit Court of Appeals, seeking reversal of the district court’s ruling. In its conclusion, the brief argues that, “The district court rubberstamped an unlawful loophole in organic crop production deeply undermining its integrity. Left standing, the decision creates not only a slippery slope towards inconsistent organic standards, but a dangerous administrative law precedent.”  The brief highlights the environmental benefits of farming with soil, as opposed to hydroponic systems that “simply cannot ‘foster soil fertility.’” We will continue to monitor any developments.
  • On October 19, the USDA’s FSIS announced a new effort to reduce Salmonella illnesses associated with poultry products. FSIS initiated this effort to gather data and information necessary to support future action and move closer to the national target of a 25% reduction in Salmonella illnesses. Despite consistent reductions, over 23% of the more than 1 million illnesses caused by Salmonella annually are linked to the consumption of chicken or turkey.
  • According to USDA Deputy Under Secretary Sandra Eskin, who is leading the effort, “[r]educing Salmonella infections attributable to poultry is one of the Department’s top priorities. […] Time has shown that our current policies are not moving us closer to our public health goal. It’s time to rethink our approach.”
  • FSIS will seek stakeholder feedback on specific Salmonella controls and measurement strategies in poultry slaughter and processing establishments. A key component of this approach is encouraging preharvest controls to reduce Salmonella contamination coming into the slaughterhouse. The data generated from these pilots will be used to determine if a different approach could result in a reduction of Salmonella illness in consumers.
  • The initiative will require collaboration and ongoing dialogue with stakeholders — industry, consumer groups, and researchers. FSIS will strengthen its partnership with the Research, Education, and Economics (REE) mission area to address data gaps and develop new lab methods to guide future policy. Additionally, the National Advisory Committee for Microbiological Criteria in Foods will advise on how FSIS can use the latest science to improve policy.

Godiva Inks $20M Deal To Settle ‘Belgium 1926’ Label Suit (Law360 Subscription Required)

  • Plaintiffs Steve Hesse and Adam Buxbaum are seeking preliminary approval for the settlement of a class action lawsuit filed in US District Court for the Southern District of New York in March of 2019 against Godiva Chocolatier, Inc. (“Godiva”).  The plaintiffs alleged that the company falsely represented that its chocolate products were made in Belgium and imported into the United States. The proposed settlement includes a $20M payout to an estimated 18 million class members who purchased the Godiva chocolate products.
  • These and similar lawsuits challenge allegedly misleading geographic origin labeling and promotional claims on various food products. The lawsuits particularly focus on companies that use geographical phrases on product packaging, social media, and marketing campaigns that lead consumers to believe that the product was produced in a specific geographic location. The lawsuits allege that consumers rely on these labeling and promotional claims in making purchasing decisions. In particular, plaintiff consumers allege that they paid premium for products that are believed to be sourced from a specific country or region.
  • Class action lawsuits focused on products that utilize geographic origin claims about food products have been on the rise. Take for example this October 2021 Himalayan Salt case, where the plaintiff alleged that the Kirkland brand of Ground Himalayan Pink Salt misrepresented its source as from “the heart of the Himalayan Mountains.” These types of geographical claims are likely to continue to be a source of litigation because they are relatively easy to dispute.
  • Keller and Heckman will continue to monitor and report on this and similar litigation outcomes.