Rachel Ray Dog Food Once Again Ducks False Ad Suit (Law360 subscription required)
- We reported on a proposed class action lawsuit filed in 2018 against Rachel Ray’s Nutrish dog food brand, alleging that “natural” claims were false and misleading under state consumer protection laws, based on testing that found residues of the herbicide, glyphosate. The New York District Judge in the Nutrish case dismissed the claims in April of last year for failure to indicate the level of glyphosate detected and to say whether it was harmful.
- An amended complaint provided analytical results but did not address harm, continuing to argue instead that any amount of glyphosate in the pet food renders the “natural” claim false and misleading. The judge dismissed the complaint a second time upon finding the total glyphosate alleged to be present in the Nutrish samples is between 0.005% to 0.01% of the Food and Drug Administration’s (FDA) allowed tolerance, and ruled that labeling such pet food as “natural” is not materially misleading to a reasonable consumer.
- There may be less potential for consumer confusion for pet food, as compared to human food, because the pet food term “natural” has an official definition through the Association of American Feed Control Officials (AAFCO). The lawsuit against Nutrish, however, while unsuccessful, pending any possible appeal, shows that natural claims on pet food could nevertheless be a target for litigation.
FDA Releases Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices
- On February 13, 2020, the Food and Drug Administration (FDA) announced the availability of Draft Guidance for Industry #262, “Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices.” When finalized, the guidance document will help industry submit information for efficient consultations with FDA’s Center for Veterinary Medicine regarding both animal feed petitions and GRAS Notices.
- The draft details what information FDA would expect to review when receiving different requests (e.g., a request to review the adequacy of existing data from a completed study versus a request to review a study protocol). The guidance also includes FDA timeline “goals” for reviewing certain types of submissions. For example, FDA’s goal for commenting on a study protocol without method validation or preliminary data is 50 days from the date of submission receipt, whereas the goal for commenting on a study protocol with method validation or preliminary data is 130 days from the date of submission receipt.
- FDA is accepting comments on the draft guidance through April 13, 2020. Comments may be submitted here.
- In response to stakeholder comments, California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed amendments to clarify ambiguities in Article 6 of its Proposition 65 (Prop 65) warning regulations. Prop 65 is a right-to-know law that requires individuals to receive a clear and reasonable warning before being exposed to certain chemicals that California deems to be carcinogens or reproductive toxicants. As summarized here, OEHHA’s final rule amending Article 6 of the regulations implementing Prop 65 became effective in 2018 and imposed requirements on content and methods of transmission, including new Prop 65 warning language.
- Among other clarifications, the amendments proposed by OEHHA on January 31, 2020 would make it explicit that:
- Sales through mobile devices are covered by current Article 6 regulations that require warnings for “internet sales;”
- The option of providing warnings via an electronic device or a process that automatically provides the warning to the purchaser prior to or during the purchase of a product is only for a “physical retail location;”
- Product-specific safe harbor warning provisions apply to all products that are subject to specific safe harbor warnings under Prop 65;
- Product-specific warnings must be provided for online or catalog sales of those products;
- Foreign language translations of product-specific warnings will be required; and
- Product-specific warnings (e.g., for food, furniture, etc.) may be provided under the existing regulation on catalog warnings.
There are also several new proposed amendments that apply specifically to alcoholic beverages. Keller and Heckman has prepared a full analysis, available here, of OEHHA’s proposed amendments to its Article 6 regulations on Prop 65 warnings. OEHHA is accepting comments on the proposed amendments through March 16, 2020.
- Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions related to California’s Prop 65. If you have any questions about the amendments to Article 6 or related matters, or would like assistance preparing comments, please email email@example.com.