• Greenbrier International, Inc., the parent company of Dollar Tree, has been sued over alleged lead contamination in ground cinnamon (Law360 subscription required). The lawsuit follows recalls of lead-tainted ground cinnamon and cinnamon apple sauce products.
  • According to the plaintiff, Dollar Tree’s Supreme Tradition Ground Cinnamon, which was purchased for normal household use, contained hundreds of times more lead than the FDA’s proposed action levels for lead contamination suggest are safe. The plaintiff claims that the company violated New York State’s false advertising laws by labeling the product in a “way to impact consumer choices and gain market dominance” even though the company knew consumers “would be unwilling or less likely to buy the product if [they] knew the product contained lead.”
  • The plaintiff stated that Dollar Tree is responsible for ensuring its products are safe and not contaminated with dangerous substances and that the company and its cinnamon manufacturer should have measures in place to ensure the products are safe.
  • We have blogged previously about the lead-contaminated cinnamon and cinnamon products, as well as the related recalls. Keller and Heckman will continue to monitor this issue.
  • On March 6, 2024, the U.S. Food and Drug Administration (FDA) sent a letter to all cinnamon manufacturers, processors, distributors, and facility operators in the US, reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including ground cinnamon products.  The Agency also recommended the voluntary recall of certain ground cinnamon products sold by a number of brands at six different retail chains that were found to contain levels of lead.
  • This letter follows the recent incidents associated with certain cinnamon apple sauce pouches that resulted in lead poisoning in young children.  As we have previously blogged, FDA’s investigation into the contaminated apple sauce pouches traced the contamination back to a manufacturer and cinnamon supplier in Ecuador.
  • FDA notified the distributors and manufacturers of products found to contain elevated levels of lead and recommended that the manufacturers voluntarily recall these products because prolonged exposure to them may be unsafe.  The products were identified during an FDA-initiated sampling and testing effort to assess cinnamon sold across numerous retail stores.  No illnesses or adverse events have been reported to date related to the ground cinnamon products listed in this news release, but the FDA is concerned that, because of the elevated lead levels in these products, continued and prolonged use of the products may be unsafe.
  • Since the issuance of the letter, recipient companies El Chilar and Raja Foods, as well as Stonewall Kitchen and Colonna, have issued voluntary recalls for some of their cinnamon products.
  • FDA continues to work with the Center for Disease Control and Prevention (CDC), as well as state and local partners, to investigate elevated lead and chromium levels in individuals with reported exposure to apple cinnamon fruit puree pouches.  Keller and Heckman will continue to monitor and relay any developments in this area.
  • The attorneys general from 20 states sent a letter to FDA urging the agency to take official notice of three documents relating to lead in baby food in support of a 2022 petition for reconsideration requesting actions on heavy metals in food for babies and young children. The group of attorneys general filed a citizen petition on October 21, 2021, which FDA denied. The group then filed a reconsideration petition on June 1, 2022. That petition is still pending.
  • The 2021 petition urged FDA to drive down the levels of lead, inorganic arsenic, cadmium, and mercury in food intended for babies and young children, including by issuing guidance on finished product testing. According to the petition, this testing would amount to a “preventive control” that should be performed by food manufacturers. Now, the attorneys general say that a January 2023 guidance document on lead action levels, FDA’s public notices relating to the investigation into elevated lead levels in applesauce, and a December 2023 report on the inspection of the applesauce manufacturer provide additional support for the reconsideration petition.
  • According to the attorneys general, these documents “make it evident that some manufacturers and distributors of baby foods in the U.S. currently lack a clear understanding of the proper way to apply preventive controls to avoid adulteration of finished baby food products.” In the documents, FDA reported that the baby food products contained more than 200 times the maximum acceptable concentration of lead under the proposed action levels, yet there was no finished product testing prior to the recall. The harm to children demonstrated in the documents reinforces the need for required toxic element testing in finished products for babies and young children.
  • The letter requests FDA take official notice of the documents without reopening the administrative record since the documents are official and reliable FDA publications.
  • As our readers are likely aware, in November of last year, WanaBana voluntarily recalled apple cinnamon fruit pouches which were linked to acute lead toxicity in children. The products were sold under the WanaBana, Schnucks, and Weis brand names. The subsequent investigation traced the contamination to cinnamon from Austrofoods, an Ecuadorian food distributor. Cinnamon at the Austrofoods’s facility was also found to contain elevated levels of chromium, although it was not clear from the testing whether it contained chromium III, or the more toxic chromium VI. Considering the very high levels of lead and chromium, FDA raised the possibility of intentional economic adulteration.
  • The contaminated (ground) cinnamon was supplied to Austrofoods by Negasmart (also known as Negocios Asocidos Mayoristas S.A.), which sourced the cinnamon sticks from Sri Lanka but had the sticks processed by Carlos Aguilera. Both Negasmart and Carlos Aguilera are also Ecuadorian companies.
  • In the most recent update, released yesterday (February 6th), FDA announced that Ecuadorian officials have reported that the cinnamon sticks from Sri Lanka were found to be uncontaminated and that the cinnamon processor, Carlos Aguilera, is the most likely source of contamination. Per the report, Carlos Aguilera is “not in operation at this time.”
  • The recall highlights the complexity of modern supply chains and the difficulty in orchestrating a response when the issue crosses borders. FDA cannot take direct action against companies that do not export products to the United States including, in this case, Negasmart and Carlos Aguilera.
  • Following a previous recall of its Chewy granola products in December, Quaker Oats has broadened its recall to its granola bars, snacks, and some varieties of its popular Cap’n Crunch cereal products sold nationwide due to possible Salmonella contamination.
  • The U.S. Food and Drug Administration (FDA) has provided a list of the affected products, which now include the following:  Quaker Chewy Granola Bars (Fruity Fun) Amazing Apple, Quaker Chewy Granola Bars (Fruity Fun) Amazing Apple and Splendid Strawberry Variety Pack, Quaker Chewy Granola Bars Yogurt Strawberry Flavor, Cap’n Crunch Treats Crunch Berries Cereal Bar, Quaker Chewy Granola Breakfast Cereal Strawberry, Cap’n Crunch Cinnamon Crunch Cereal, and Cap’n Crunch OOPS! All Berries Instant Oatmeal.
  • Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.
  • The listed products were sold throughout the US, Puerto Rico, Guam, and Saipan.  Consumers can scan the SmartLabel QR code on the product package to determine whether it has been recalled.
  • Keller and Heckman will continue to monitor and relay any updates regarding food safety.
  • The U.S. Food and Drug Administration (FDA) has provided an update regarding the cinnamon applesauce pouches that have been recalled.  FDA’s investigation began on November 9, 2023, when WanaBana USA voluntarily recalled all lots of WanaBana Apple Cinnamon Fruit Puree pouches, Schnucks-brand cinnamon flavored applesauce pouches, and Weis-brand cinnamon applesauce pouches due to reports of elevated levels of lead.
  •  As of January 8, 2024, FDA has received 87 confirmed complaints/reports of adverse events potentially linked to the recalled product.
  • CDC’s National Center for Environmental Health is currently conducting case finding efforts in collaboration with state and local health departments.  As of January 5, 2023, CDC has received reports of 86 confirmed cases, 209 probable cases, and 26 suspected cases, totaling 321 cases from 38 different states through their reporting structure.
  • FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses.  Because of the products’ long shelf life, cases are still being reported.
  • Keller and Heckman will continue to monitor and relay any developments in the investigation.
  • FDA is continuing to investigate the elevated lead levels in cinnamon used in applesauce pouches that were recalled beginning October 31, 2023. Most recently, inspectors collected samples that the cinnamon supplier sold to the applesauce manufacturer, finding extremely high levels of lead contamination at 5,110 parts per million (ppm) and 2,270 ppm. For context, the Codex Alimentarius Commission is considering adopting 2.5 ppm as the maximum level for lead in cinnamon, among other similar spices.
  • To date, there have been approximately 65 reported cases of children displaying symptoms of lead toxicity related to the applesauce pouches. FDA has not found evidence that any other products, including pouches from the same brands that do not contain cinnamon, are related to the recall. The pouches implicated in the recall have been traced back to a manufacturer and cinnamon supplier in Ecuador, and FDA is working closely with Ecuadorian officials who are conducting their own investigation.
  • FDA has theorized that lead may have been intentionally added to the cinnamon in a case of economic adulteration. Nevertheless, FDA is continuing its investigation and has provided a timeline that it will continue to update as the investigation progresses.
  • Keller and Heckman will continue to monitor and provide updates on this investigation.
  • The U.S. Food and Drug Administration recently issued a warning letter to Smart Toothpicks LLC, of Tempe, Arizona, for several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. Smart Toothpicks sells nicotine-infused birch toothpick products in different flavors, including “Peppermint Ice,” “Wintergreen,” and “Cinnamon” Nicotine Toothpicks.  FDA’s warning letter focused on the following, specific violations: (1) selling a tobacco product to a minor through the company’s website;  (2) selling unauthorized modified risk tobacco products; and (3) failing to include required nicotine addiction warning statements on both packaging and advertising. In making the illegal sales finding, FDA cited the fact that a person younger than 18 years of age was able to purchase Peppermint Ice Nicotine Toothpicks from the company’s website. The company’s website also contained some advertising claims that came under scrutiny as modified risk claims because they represented that the product presents a lower risk of tobacco-related disease or is less harmful than other commercially marketed tobacco products (such as its website claims, “Nicotine Satisfaction without smoke damage to your lungs” and “Smart Toothpicks – A catalyst to promote a healthier way of life… in a flavorful way!”). The products were also found to be misbranded because both the website and the product packaging were missing the required nicotine addiction warning statement.
  • This action provides an illustration of the Agency’s interpretation of “tobacco product,” which FDA defines broadly as any product made or derived from tobacco that is intended for human consumption. The Agency takes the position that this definition includes novel, non-tobacco products that contain nicotine derived from tobacco, such as nicotine-infused toothpicks. Referring to the nicotine-infused toothpicks as “dissolvable tobacco products,” the Agency concluded that the products are “covered tobacco products” under 21 C.F.R. § 1140.3, and thus subject to the same FDA requirements as other deemed products, including sales restrictions to minors and marketing authorization requirements.
  • This action also signifies the extensive reach of FDA’s regulatory authority, and highlights to others in the growing novel nicotine products industry that FDA remains focused on holding retailers and manufacturers accountable for marketing and sales practices that can lead to increased youth appeal of tobacco products.  In fact, FDA has gone on record to state that it is increasingly focused on “novel nicotine-containing products” as one such way to facilitate youth access and nicotine addiction. Accordingly, others in the industry would be prudent to heed this warning and ensure full compliance with FDA regulations, including heightened age verification for online sales and reviewing product advertising and any use of non-tobacco flavors appealing to minors.

Be sure to register for Keller and Heckman’s E-Vapor and Tobacco Law Symposium on February 11-12, 2020 in Irvine, California.  Details and Registration information can be found here.

  • On January 9, the Center for Science in the Public Interest (CSPI) sent a letter to Dr. Susan T. Mayne, Director of the Center for Food Safety and Applied Nutrition (CFSAN) at FDA, urging the Agency to “take immediate enforcement action to prevent unauthorized implied ‘low sugar’ and ‘reduced sugar’ claims, such as ‘lightly sweetened’ and ‘less sweet’ on beverage products that are high in sugar.”  CSPI argues that these claims mislead consumers and are in violation of the federal Food, Drug, and Cosmetic Act (FDCA).
  • In the letter, CSPI identified 19 products from 5 brands that they allege make unauthorized implied “low sugar” or “reduced sugar” claims. “Low sugar” and “reduced sugar” claims are nutrient content claims (NCCs), which are claims that expressly or implicitly characterize the level of a nutrient of the type required to be in nutrition labeling.  NCCs may not be made on labels or in labeling unless the claim is made in accordance with the regulations authorizing the use of that claim. CSPI argues that claims such as “lightly sweetened,” “sorta sweet,” “slightly sweet,” and “just a tab sweet” are synonyms for “low sugar” and are therefore prohibited under federal law because “low sugar” is not a defined or permitted NCC. Similarly, CSPI alleges that some products make “less sweet” claims but do not meet the requirements to make a “reduced sugar” NCC.
  • In addition to urging the FDA to take enforcement action against the manufacturers identified in the letter for making implied “low sugar” and “reduced sugar” claims, CSPI encourages the Agency to issue regulations authorizing a “low added sugar” NCC to allow the claim to be made on products that are low in added sugars. CSPI recommends the NCC be based on a per-reference amount customarily consumed (RACC) threshold, similar to the requirements for other “low” NCCs.
  • Notably, Kellogg recently settled a class action lawsuit over use of the label claims “lightly sweetened,” “healthy,” “nutritious,” and “wholesome,” on select cereals, including Krave S’Mores and Cinnamon Roll Frosted Mini Wheats. Plaintiffs argued the claims implied that the cereals were low in sugar when they actually contained 18 – 40% added sugar. In response, Kellogg stated that it had never advertised the cereals as “low sugar” or “reduced sugar,” and that the sugar content was clearly listed on each product’s Nutrition Facts Panel. The class action lawsuit settled for $20 million.

On January 8, 2020 FDA published its new final compliance policy guidance, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (January 2020), which goes into effect in February. Under the final guidance, beginning February 6, 2020, FDA intends to prioritize enforcement of premarket review requirements for the following products:

  1. Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
  2. All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
  3. Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.

Importantly, FDA also intends to prioritize enforcement of any ENDS product (on the market as of August 8, 2016) that is offered for sale after May 12, 2020, and for which the manufacturer has not submitted a premarket application (or after a negative action by FDA on a timely submitted application).  The May 12, 2020 deadline was initially established by a federal district court in Maryland; that decision is now pending appeal in the Fourth Circuit.

While FDA has identified flavored cartridge-based ENDS as a primary concern for underage use, the Agency is also targeting manufacturers that are not adequately preventing minor access, and any products (open or closed system, including e-liquids sold in vape shops) that, in FDA’s view, are targeted to minors or likely to promote ENDS use by minors. FDA’s broad approach could put a significant portion of the vapor industry is at risk of immediate enforcement.

When determining whether a manufacturer is taking or has taken adequate measures to prevent minors’ access to ENDS products, the Agency will consider, for example:

  • Whether adequate programs to monitor retailer compliance with age-verification and sales restrictions have been implemented;
  • Whether retailers face manufacturer-established penalties for failing to comply with age verification and sales restrictions, and whether there is a policy of notifying FDA of retailer violations;
  • If the manufacturer is also a retailer, whether there is an implementation of programs to ensure age-verification and sales restrictions, checking ID at the door, etc.;
  • Whether the manufacturer uses adequate age-verification technology or requires that retailers use such technology to prevent minor access to its website and underage internet sales; and
  • Whether a manufacturer limits or requires retailers to limit the quantity of ENDS products that a customer may purchase in a given period of time.

When determining whether an ENDS product is targeted to minors or is marketed in a manner that is likely to promote ENDS use by minors, the Agency will consider, for example:

  • Whether the labeling and/or advertising of a product resembles kid-friendly foods and drinks or resemble other non-ENDS products that are appealing to youth. Here FDA highlights the numerous warning letters issued to e-liquid manufacturers over the last couple of years.  Those warning letters alleged that the e-liquid products were misbranded because the labeling and/or advertising of the products (i.e., color schemes, label images, brand names, etc.) inappropriately imitated specific food products that are generally marketed toward and/or appealing to children, including cereals (e.g., Cinnamon Toast Crunch, Lucky Charms, Fruit Loops, Franken Berry), candies and snacks (e.g., Life Savers, Sour Patch Kids, Gummy Worms, War Heads, Pocky Sticks, Goobers, Tree Top Apple Juice), and desserts (e.g., Unicorn Cakes, Nilla Wafers, Reddi Wip).
  • Whether marketing materials utilize youth appealing cartoon or animated characters, or use popular children’s characters and titles.
  • Whether paid social media influencers are used; and
  • Whether a product is promoted for being easily concealable (from parents and teachers). In this regard, FDA makes clear in the guidance that the following types of devices and device features present a unique concern for youth, even if adults may prefer these as well:
    1. Small size that allows for easy concealability and features that facilitate the ease of use (draw activation, prefilled cartridges or pods, and USB rechargeability);
    2. Small size that allow for use in school, quick concealment, product use in a social setting without others’ awareness, and products’ ability to be concealed with other equipment;
    3. Products with no settings to change and very little assembly required; and
    4. Products with features such as pre-filled cartridges, draw activated batteries, and that can be recharged via a USB ports, charging adapters or cell phone.

In short, while FDA’s focus is on the flavored cartridge and pod-systems, ENDS companies should be aware that FDA’s guidance is broad enough to capture a wide variety of open and closed-system products that may be viewed by FDA as accessible to kids, marketed to kids or easily used and/or concealed by kids.

Be sure to register for Keller and Heckman’s E-Vapor and Tobacco Law Symposium on February 11-12, 2020 in Irvine, California.  Details and Registration information can be found here.