• On June 8, 2021, Beech-Nut Nutrition Company issued a voluntary recall for one lot of its Beech-Nut Stage 1, Single Grain Rice Cereal (“Cereal”). The rice flour used for the Cereal was tested and confirmed as being below the FDA guidance level, set at a 100 ppb or 100 µg/kg, for inorganic arsenic. However, a routine sampling program by Alaska found that Cereal samples tested above the guidance level for naturally occurring inorganic arsenic set by the FDA in August 2020.
  • As some of our readers may remember, Beech-Nut was named in a congressional report by the U.S. House of Representatives subcommittee on Economic and Consumer Policy with relation to the levels of heavy metals—including arsenic, lead, cadmium, and mercury—found in baby foods. Since that report, Beech-Nut has been involved in two class-action lawsuits for allegedly misrepresenting Beech-Nut baby foods are “real food for babies” and failing to disclose the presence of dangerous levels of heavy metals. Most recently in April 2021, the DC Attorney General filed a lawsuit against Beech-Nut for “misleading parent-consumers about the health and safety of its products.” The New York Attorney General similarly announced an investigation into arsenic levels in infant rice cereal products and the advertising and promotion of such products.
  • In addition to voluntarily recalling the Cereal, Beech-Nut has decided to exit the market for infant rice cereal products, citing concern over the ability to consistently obtain rice flour well-below the FDA guidance level and Beech-Nut specifications for naturally occurring inorganic arsenic.
    • On May 24, 2021, the consumer protection groups Food & Water Watch and Empire State Consumer Project, Inc. (ESCP) requested (via letter) that the FDA take action to address the allegedly high levels of arsenic and lead found in many vinegar products.
    • ESCP tested 24 samples of major brands of vinegars or vinegar reductions or glazes and found that 11 contained arsenic or lead and 7 contained both. And, of the 11 products, 10 were balsamic products and all were imported from Italy, Greece, or Spain. Arsenic levels in contaminated products ranged from 70 parts per billion (ppb) to more than 1,040 ppb, which means at maximum levels, one tablespoon serving of vinegar would exceed FDA’s maximum allowable level of 0.01 mg arsenic in one liter of drinking water (equivalent to 10 ppb arsenic). Lead levels ranged from 68.6 to 127 ppb, which exceeded the 34 ppb safe harbor level for balsamic vinegars under California’s Proposition 65.
    • Citing to the dangers of arsenic and lead exposure, particularly to developing fetuses, the letter requests FDA to perform product testing and establish limits and warnings addressing lead and arsenic in vinegars and vinegar reductions or glazes.
    • This letter comes in the wake of the fallout from the Congressional report on heavy metals (including arsenic and lead) in baby foods, which has prompted FDA’s Closer to Zero Plan as well as proposed legislation in Congress, both aimed at reducing heavy metals levels in baby foods. Keller and Heckman will continue to monitor any developments in the regulation of heavy metals in food.
  •  We have reported on FDA’s guidance document, “Inorganic Arsenic in Rice Cereals for Infants: Action Level Guidance for Industry,” which was finalized in August 2020 and sets an action level of 100 parts per billion (ppb) as the threshold for considering whether infant rice cereal may be “adulterated” and enforcement action is warranted.  A February 4, 2021 Congressional report on the finding of heavy metals in baby foods in the U.S. raised questions regarding compliance with FDA’s action level and, among other things, recommended the possibility of “phasing out” ingredients such as rice, that are high in toxic heavy metals.  As discussed here, the “Baby Food Safety Act of 2021,” was later introduced, on March 25, 2021, and would impose a lower action level of 15 ppb for inorganic arsenic in infant and toddler cereal.
  • In an April 29, 2021 press release, New York Attorney General Letitia James announced a new investigation into whether infant rice cereal products that are sold in New York contain arsenic at levels exceeding the legal maximum under the law and whether the advertising and promotion of the products complies with New York’s consumer protection laws.  Gerber Products Co., Beech-Nut Nutrition Co., Nurture Inc., and Hain Celestial Group Inc. were identified as targets of the probe.  This action follows Attorney General James’ February 9 2021 request urging FDA to set federal standards for toxic metals in all baby food categories and require all baby food manufacturers to test their finished products for toxic metals rather than testing just individual ingredients.
  • The recently announced NY investigation and U.S. congressional activity, as well as recent litigation (discussed here), involve complicated and multifaceted issues.  As discussed in Closer to Zero, the new FDA action plan released on April 8, 2021 for reducing exposure to toxic elements from foods eaten by babies and young children to as low as possible, FDA is simultaneously focused on avoiding unintended consequences, such as eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one toxic element while increasing another.
  • On April 8, 2021, the U.S. Food and Drug Administration (FDA) unveiled Closer to Zero, a new action plan for reducing exposure to toxic elements from foods eaten by babies and young children to as low as possible.  The plan (announced here) describes FDA’s approach as an iterative process involving four stages: (1) Evaluate the science, (2) Propose action levels, (3) Consult with stakeholders, and (4) Finalize action levels for lead, arsenic, cadmium, and mercury.  A graphic display of the stages shows that FDA’s ongoing research, monitoring, and compliance efforts will continue separately at the center of a cycle of continual improvement.
  • FDA’s Closer to Zero action plan is scheduled to unfold in three phases as follows:
    • Phase 1, which is scheduled for completion by April 2022, will focus on lead and arsenic.  FDA will propose action levels for lead in categories of baby foods (e.g., cereals, infant formula, pureed fruits and vegetables) and other foods commonly eaten by babies and young children, and FDA will consult with stakeholders and federal partners on issues such as feasibility and share best practices for reducing or preventing lead contamination.  With respect to arsenic, FDA will work on the first phase, evaluating the science.
    • In Phase 2, scheduled for April 2022 – April 2024, FDA plans to finalize the action level for lead, propose action levels for arsenic, and begin the evaluation stage for cadmium and mercury.
    • In Phase 3, which is set to begin April 2024 and continue indefinitely, FDA plans to propose action levels for cadmium and mercury, finalize action levels for arsenic, and loop back to the evaluation stage for lead, to assess the feasibility of attaining even lower levels.
  • Closer to Zero follows FDA’s March 5, 2021 announcement of new activities – including a commitment “in the near term” to review current action levels and develop additional action levels for contaminants in key foods – that respond to a February 4, 2021 Congressional report on the finding of heavy metals in baby foods in the U.S.
  • Keller and Heckman will continue to monitor and report on FDA’s regulatory activities, as well as congressional investigation and litigation involving heavy metals in baby food.
  • On March 25, Congressmembers introduced The Baby Food Safety Act of 2021 to amend the Federal Food, Drug, and Cosmetic Act (FDCA) to limit the presence of toxic elements in infant and toddler food. Within a year of the Act coming into effect, manufacturers of infant formula and toddler food for kids up to 36 months would be required to adhere to the following initial maximum levels:
    • Inorganic arsenic: 10 ppb for infant and toddler food (except cereal) and 15 ppb for infant and toddler food that is cereal
    • Cadmium: 5 ppb for infant and toddler food (except cereal) and 10 ppb for infant and toddler food that is cereal
    • Lead: 5 ppb for infant and toddler food (except cereal) and 10 ppb for infant and toddler food that is cereal
    • Mercury: 2 ppb
  • Within 3 years of the date of enactment, the Secretary must set final regulatory limits that are lower than those mentioned above to levels protective of infant and toddler neurological development. Every 5 years afterwards, the established levels must be reviewed, and if needed, lowered by regulation. The Act also permits the Secretary to establish interim action levels and regulatory limits for toxic elements in infant and toddler food.
  • The Act was introduced by Representatives Raja Krishnamoorthi. In an announcement with Representative Tony Cardenas, Senator Amy Klobuchar, and Senator Tammy Duckworth, Rep. Krishnamoorthi stated that the Act was introduced “to dramatically reduce toxic heavy metals in baby food, educate parents about the risks, and invest in cutting edge farming technology to reduce any economic barriers to making baby foods safe for consumption.” As our readers know, the Act follows a February report from the House Oversight and Reform Subcommittee on Economic and Consumer Policy that reported on the levels of heavy metals found in baby foods produced by seven of the largest baby food manufacturers in the U.S.
  • We have previously blogged about the fallout from a Congressional report on the level of heavy metals in baby foods, including class-action lawsuits against Gerber Products Co. and Plum, PBC (see blog post) as well FDA’s response to the report (see blog post).
  • Unsurprisingly, these lawsuits were just the beginning of a trend and in recent weeks a series of new class-actions have been filed, each alleging similar consumer deception claims relating to the presence of heavy metals in baby foods.
    • A class action was filed against Gerber Products Co. and Hain Celestial Group (Hain) in the North District of Illinois for allegedly omitting and concealing the presence of dangerous levels of heavy metal in the baby food products they sell.
    • Another class action was filed in the Northern District of Illinois against Hain for allegedly misleadingly marketing baby foods such as Earth’s Best Organic Banana Raspberry & Brown Rice Fruit & Grain Puree as healthy and free of dangerous substances.
    • Two class-action lawsuits were filed in the North District of New York (see here and here) against Beech-Nut Nutrition Co. for allegedly misrepresenting Beech-Nut baby foods are “real food for babies” and failing to disclose the presence of dangerous levels of heavy metals.
    • A class-action lawsuit was filed against Nurture, Inc. in the Southern District of New York for allegedly misleadingly marketing Happy Baby Superfood Puffs as healthy and nutritious for babies and failing to disclose the presence of heavy metals.
  • Given the recent filings, we have not yet seen briefing or any judicial decisions on the merits of the claims. Keller and Heckman will continue to monitor and report on these class-action lawsuits against baby food manufacturers as well as any other updates regarding the response to the Congressional report.

 

  • On February 10, 2021, the Center for Science in the Public Interest (CSPI) sent a letter to the U.S. Food and Drug Administration urging it to take enforcement action against the marketing of various products labeled as infant formula but marketed for use by children over 12 months.
  • In its letter, CSPI argues that the Federal Food, Drug and Cosmetic Act defines “infant formula” as “a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.”  CSPI notes that because “infant” is defined by regulation as a person no more than 12 months old, infant formulas that are marketed for children over 12 months old are misbranded and should be labeled as “transition formula.”  Further, CSPI argues that any food product marketed for children over 12 months old must bear FDA’s standard Nutrition Facts label, not an infant formula nutrition label.
  • CSPI claims that the infant foods that are marketed for children over 12 months old are primarily composed of powdered milk, vegetable oil, corn syrup solids (or other sources of added sugars), and added nutrients, which are appropriate for infants but not toddlers.  Thus, CSPI claims that these products’ labeling may mislead consumers to believe that infant formula and/or infant formula-like products are necessary for children beyond infancy.  CSPI’s letter to FDA follows recent class action lawsuits against baby food manufacturers for allegedly failing to disclose the presence of unsafe levels of heavy metals in baby foods.  We will continue to monitor any developments.
  • On October 28, 2020, the New York State Department of Health announced the release of the state’s cannabidiol (CBD) proposed regulations to regulate CBD hemp products in New York.  Once finalized and in effect, these new regulations would reverse New York State’s early 2019 ban on the sale of hemp-derived CBD-infused products.
  • By way of background, the U.S. Food and Drug Administration (FDA)’s current position is that CBD does not qualify for use in food or dietary supplements. FDA is investigating whether it can develop a regulatory framework that would permit the use of CBD under the Food Drug and Cosmetic Act, but the Agency has identified numerous safety questions that need to be addressed (discussed previously on this blog here) and little progress has been made to resolve them.  New York indicated that these proposed regulations would fill the regulatory void left by FDA’s refusal to set national standards.
  • The proposed rules reflect legislation enacted in December 2019 that called for the establishment of a Cannabinoid Hemp Program, setting out licensing requirements and quality control standards for both CBD hemp processors and retailers, as well as packaging and labeling requirements that all CBD products must meet.
  • The proposed rules
    • Require all hemp CBD products to be manufactured using good manufacturing practices based on the end product’s intended use.
    • State that individual food or beverage products cannot contain more than 25 milligrams of total CBD per product and supplements would be limited to 3,000 milligrams per product. In addition, products cannot exceed 0.3% total Δ9- Tetrahydrocannabinol (THC) concentration.
    • Clarify that foods and drinks infused with CBD and other hemp derivatives must be packaged by the manufacturer and cannot be added at the retail level or in restaurants.
    • Prohibit the addition of CBD to alcohol products.
    • State that product labels must contain the total amount of CBD in the product, the number of cannabinoids per serving, a nutritional or supplement fact panel, and information on whether it contains THC.
    • Require products to include warnings that state the product has not been evaluated by FDA, is not intended for children, and that it may cause drug test failures.
    • Require labels to caution pregnant or nursing women to consult a healthcare provider before use.
    • Require hemp producers to conduct lab tests for the CBD profile and for heavy metals, microbial impurities, mycotoxins, pesticides, and residual solvents.
    • Require companies to make the testing information retrievable by consumers through a QR code or corresponding link on the product label.
    • Bar claims that suggest CBD will diagnose, cure, mitigate, treat, or prevent disease.
  • New York Department of Health will take comments on the proposed regulations through January 11, 2021.  We will continue to monitor any developments.
  • We have discussed the slow progress toward a regulatory pathway for lawfully marketing FDA-regulated food and dietary supplement products that contain cannabidiol (CBD).  While CBD products remain technically illegal (aside from one FDA-approved drug), FDA is gathering information and has taken action so far only against CBD-containing products that make disease and health-related claims or contain unsafe contaminants such as heavy metals and pesticides.  Product labeling that may be false and misleading with regard to CBD content has meanwhile been the subject of a growing number of private lawsuits, such as the proposed class action discussed here.
  • The most recent Cannabis Law Report covers independent testing sponsored by Leafreport finding that of 22 beverages tested, only 4 (13%) contain the amount of CBD stated.  Three products (13%) were reported to contain a level of CBD that is 20% more (2 products) or less (1 product) than stated.  One product (5%) was reported to contain a level of CBD that is 30% more than stated.  Fourteen products (65%) were reported to have a CBD content that differed by more than 30% from the stated level, with 3 beverages containing more CBD than stated, 9 containing less CBD than stated, and 2 products containing no detectable amount of CBD.
  • The results of independent testing indicating inaccurate labeling for CBD beverages is unsurprising given that FDA’s own market survey data, as discussed in a July 2020 report to Congress, has revealed that of 78 products tested which claim to contain CBD, most contained a level of CBD that differed from the labeling by more for 20%.  Eleven such products contained no detectable CBD and 46 contained some level of tetrahydrocannabinol (THC), a narcotic, including one product with THC levels so high that it was referred to the Drug Enforcement Agency (DEA) for potential action.  Until there is an FDA regulatory framework for foods or dietary supplements containing CBD, however, buyers need to be cautious.
  • On July 8, 2020, the District Court for the Eastern District of Wisconsin granted Defendant Champion Petfoods’ motion for summary judgment and dismissed a proposed class action which alleged that Champion Petfoods had deceptively marketed its pet food products, in part because they contained trace amounts of Bisphenol-A (BPA).
  • The Court, applying its precedent related to trace amounts of heavy metals in animal food products,  held that the failure to disclose trace, non-harmful amounts of BPA did not constitute misleading advertising because BPA is pervasive in the environment and present in many pet foods, and a decision holding Champion Petfoods liable would require virtually all pet food companies to pull their product from the Wisconsin market.
  • While false advertising claims based on the mere presence of BPA (in any amount) are likely to be dismissed, as the Court noted, claims which allege that an “excessive” amount of BPA is present or that BPA is present in a greater amount that other products, may present viable litigation theories. Keller and Heckman will continue to monitor and report on development in the food litigation space.