Search closer to zero

  •  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 21, the Attorney General of Washington, DC, Karl A. Racine, filed a lawsuit against Beech-Nut Nutrition Company, one of the largest baby food manufacturers for “misleading parent-consumers about the health and safety of its products.” As stated in a press release, the DC Office of the Attorney General (OAG) alleged that Beech-Nut’s advertising violated the District’s consumer protection laws and misled parents that its baby food underwent the most stringent testing and was safe for babies when the food contained high levels of heavy metals. The OAG’s lawsuit seeks to stop Beech-Nut from engaging in these and similar violations, to obtain restitution damages for parent-consumers and their children, and to obtain civil penalties.
  • The OAG alleged that Beech-Nut violated DC’s Consumer Protection Procedures Act and harmed DC consumers by:
    • Misleading parents about the safety of its baby food;
    • Misrepresenting its testing practices; and
    • Falsely claiming to have high internal safety standards
  • As our readers know, the OAG’s lawsuit comes as a result of the congressional investigative report that found high levels of heavy metals in several brands of popular baby foods. Additionally, several baby food manufacturers have been hit with class action lawsuits that alleged consumer deception claims relating to the presence of heavy metals in baby foods. The FDA has responded with a plan, called Closer to Zero, to reduce exposure to toxic elements in baby foods.
  • Keller and Heckman will continue to monitor and report on any developments with the DC OAG lawsuit and other baby food-related lawsuits.
  • 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.

Parties settle “Made in USA” lawsuit in California. (subscription to Law360 required)

  • As previously covered on this blog, a product may bear a “Made in USA”-type (MIU) claim in accordance with federal guidelines where “all or virtually all” of the product is made in the U.S.  Until a recent statutory change, California’s MIU claim standard had been much stricter, prohibiting such claims if any unit or part of the product has been entirely or substantially made outside of the U.S.  Major lawsuits have been filed based on allegations that components or ingredients of manufactured products bearing MIU claims came from foreign sources, in violation of the “zero-tolerance” policy.  One high-profile lawsuit — David Paz et al. v. AG Adriano Goldschmied Inc. et al. (S.D. Cal.) — now has settled, with the defendants — Nordstrom and a denim manufacturer — agreeing to pay $4 million to the plaintiff class.  The case was based on allegations that jeans sold at retail bore MIU claims although the fabric, thread, buttons, rivets, and components of the zipper assembly were produced outside of the U.S.  Although this settlement concludes the instant case — and possibly may serve as precedent for settlements in other pending cases involving similar allegations — a judicial disposition might have produced a more nuanced analysis or a closer examination of the limits (if any) of California’s prior zero-tolerance standard.

New York City’s sodium warning requirement takes effect.

  • As previously covered on this blog, New York City (NYC) health officials adopted the nation’s first sodium warning requirement.  The rule requires restaurants that are part of chains with more than 15 locations nationwide to display a salt shaker icon on menus and menu boards next to any food item with a high sodium content (>2,300 mg of sodium) or on tags next to any food on display that is a food item with a high sodium content.  Restaurants also must post the following statement conspicuously at the point of purchase:  “Warning: [salt shaker icon] indicates that the sodium (salt) content of this item is higher than the total daily recommended limit (2300 mg).  High sodium intake can increase blood pressure and risk of heart disease and stroke.”  The rule took effect on December 1, 2015.  Although the rule is now effective, the National Restaurant Association has indicated that it plans to sue the NYC health department over the requirements.  It remains to be seen whether opponents will challenge the rule, and if so, whether such a challenge will succeed.