Federal Judge Dismisses Amended Complaint Over Dog Food Labeled as “Natural” Containing Trace Levels of Glyphosate Weed Killer

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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 Reopens Comment Period on General Principles for Food Standards Modernization

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  • As previously discussed on this blog, the U.S. Food and Drug Administration (FDA) held a public meeting on September 27, 2019, to give interested parties an opportunity to discuss FDA’s effort to modernize food standards of identity (SOI).  On February 20, 2020, FDA announced it plans to reopen the comment period on a 2005 proposed rule (which had initially been jointly published with the U.S. Department of Agriculture (USDA)) to establish a set of general principles for FDA to use when considering whether to establish, revise, or eliminate a food SOI. 
  • FDA is reopening the comment period to receive new data, information, and further comments only on FDA-specific aspects of the 2005 proposed rule (including 13 general principles for food standards modernization); however, FDA has indicated it will continue to engage with USDA before finalizing the proposed rule.
  • Food SOIs are regulatory requirements related to the content and production of certain food products such as milk (as previously discussed on this blog, FDA is particularly evaluating the use of the term, “milk,” in labeling plant-based products), bread, jam, and chocolate.  As previously discussed on this blog, with the development of new types of food products and updated nutritional science, FDA is reconsidering SOIs as part of its Nutrition Innovation Strategy (NIS).
  • Written/electronic comments will be accepted for 60 days following the date of publication in the Federal Register.

 

Several U.S. and State Legislatures Propose Changes to State Bottle Bills and Advocate for a National Bottle Bill

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  • On February 11, 2020, Repres­entative Alan Lowenthal of California and  Senator Tom Udall of New Mexico introduced the “Break Free from Plastic Pollution Act of 2020.” The bill would enact nationwide extended producer responsibility for all packaging materials, minimum-recycled-content mandates for certain products, a national container deposit, single-use plastic product bans, a three-year pause on new virgin plastics production facilities, and more.  The proposed legislation includes a national bottle bill, which would add a 10-cent deposit on all beverage containers, regardless of material type.  Udall and Lowenthal stated that this bill serves as a model for states and local governments to use in crafting their own legislation regardless of whether the proposal is successful in Congress.  Currently, only ten states have a container deposit law or “bottle bill.”  Some of these states are also considering proposed legislation, which would change their existing bottle bills.
  • In California, a senate committee will soon hold hearings on Sen. Bob Wieckowski’s Senate Bill 372 that would pressure beverage manufacturers to help consumers recycle.  Senate Bill 372 would also extend the Bottle Bill provisions to wine and liquor makers.
  • In Michigan, a bipartisan group of lawmakers introduced H.B. 5422–5425, which would update Michigan’s current bottle bill.  This would be the first update to Michigan’s bottle bill since 1976.  The proposed bill seeks to increase recycling rates and reduce fraud and abuse.  According to the Executive Director of Michigan Recycling Coalition, the legislation would allocate funding to the counties, which could then use it to boost existing or create new municipal recycling programs.  Moreover, H.B. 5424, would create enhanced criminal penalties for a distributor that violated the bottle deposit law with the intent to defraud and cheat.
  • In Massachusetts, H2881 and S452 seeks to include miniature containers that can hold 100 milliliters (specifically miniature liquor bottles) under the state’s existing “bottle bill” law, charging the same 5-cent deposit on their sale as other bottles.  We will continue to monitor any developments.

FDA Releases Third and Final Installment of Intentional Adulteration Draft Guidance

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  • On February 13, the FDA released a supplemental draft guidance to support compliance with the Intentional Adulteration (IA) rule under the Food Safety Modernization Act (FSMA). This draft is the third and last installment of the IA draft guidance.
  • FSMA’s final IA rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to the public health. Unlike other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration. In the 2016 IA final rule, FDA identified four key activities that are most vulnerable to intentional adulteration: (1) bulk liquid receiving and loading, (2) liquid storage and handling, (3) secondary ingredient handling, and (4) mixing and similar activities.
  • The supplemental draft guidance adds to the draft guidance published in March 2019 with chapters covering topics focusing on food defense corrective actions, food defense verification, reanalysis, and recordkeeping. For example, the draft guidance explains the differences between food defense corrective actions and food safety corrective actions as well as the verification of mitigation strategies and the verification of preventive controls. It also includes appendices on FDA’s mitigation strategies database and how businesses can determine Small and Very Small Business status under the IA rule.
  • Stakeholders may submit comments on this IA draft guidance until June 15, 2020. Keller and Heckman attorneys are well-versed in FSMA provisions and are available assist interested parties in preparing comments for submission to FDA. For assistance, please email: fooddrug@khlaw.com.

FDA Releases Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices

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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.

Proposed Class Action Lawsuit Claims Arizona Beverage’s Gummies are Not “All Natural” Because They Contain Synthetic Ingredients (Law360 Subscription Required)

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  • On February 11, 2020, Christopher Silva, a New York resident, filed a proposed class action lawsuit against Hornell Brewing Co. Inc., Arizona Beverages USA LLC, Beverage Marketing USA, Inc., and Arizona Beverage Co. (“Defendants”) over defendants’ “all natural” gummy snacks.
  • The plaintiff claims that defendants’ advertising and marketing campaign is false, deceptive, and misleading because the gummies contain several synthetic ingredients, such as ascorbic acid, citric acid, gelatin, dextrose, glucose syrup, and modified food starch.  Silva seeks to represent a New York class and individual classes for all 49 other states.
  • In the complaint, Silva cited to the United States Department of Agriculture’s Draft Guidance Decision Tree for Classification of Materials as Synthetic or Nonsynthetic (natural).  Per that guidance, a substance is natural – as opposed to synthetic – if (a) it is manufactured, produced, or extracted from a natural source (i.e. naturally occurring mineral or biological matter); (b) it has not undergone a chemical change (i.e. a process whereby a substance is transformed into one or more other distinct substances) so that it is chemically or structurally different than how it naturally occurs in the source material; or (c) the chemical change was created by a naturally occurring biological process such as composting, fermentation, or enzymatic digestion or by heating or burning biological matter.
  • Silva noted that while the synthetic ingredients are all listed on the back of the package, reasonable consumers are not expected or required to review the ingredients list on the back in order to confirm or debunk defendants’ prominent front-of-the-product claims.  The package in question includes the phrase “All Natural” on the packaging behind the words, “Arizona” and “fruit snacks.” We will continue to monitor any developments.

Trump Administration Proposes to Remove FDA’s Authority to Regulate Tobacco Products

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  • As our readers may recall, under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, FDA has the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency deems to be subject to the law.
  • However, on February 10, the Trump administration proposed creating a new federal agency to regulate tobacco products and to remove that authority from the FDA. The administration’s plan is included in their 2021 budget proposal, but to take effect, the budget proposal must be passed by Congress, which appears unlikely given the current political landscape.
  • In sum, the budget proposes to move the Center for Tobacco Products out of the FDA and to create a new agency within HHS to focus solely on tobacco regulation. The new agency would be led by a Senate-confirmed Director. According to the proposal, a “new agency with the singular mission on tobacco and its impact on public health would have greater capacity to respond strategically to the growing complexity for new tobacco products. In addition, this reorganization would allow the FDA Commissioner to focus on its traditional mission of ensuring the safety of the Nation’s food and medical products supply.”
  • The proposal comes after the head of the White House Domestic Policy Council, Joe Grogan, told reporters last year that tobacco regulation was a “huge waste of time” for the FDA.  Grogan further stated that “tobacco has no redeeming qualities and it should not be regulated by a health agency like this.”  However, public health and policy experts have already criticized the proposal. For example, Matthew Myers, present of the Campaign for Tobacco-Free Kids state that “[i]t has taken a long time for the FDA Center for Tobacco Products to build up the staff, legal expertise and structure to do the job.” Myers elaborated further lamenting that the proposal is “yet another giveaway to the tobacco and e-cigarette industry.”

Supplemental New Drug Application Submitted for FDA-Approved CBD Drug Epidiolex

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  • As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marijuana.” As a result, while marijuana remains a Schedule I drug, hemp is no longer a controlled substance under Federal law. However, since CBD has been approved for use in the drug Epidiolex, the Federal Food, Drug, and Cosmetic Act (FD&C Act) has prohibited adding it to a food or a dietary supplement.  Epidiolex is a liquid formulation of pure plant-derived CBD.
  • GW Pharmaceuticals PLC, the manufacturer of Epidiolex, recently submitted a supplemental New Drug Application (sNDA) to expand the label of its Epidiolex cannabidiol oral solution, CV, to include the treatment of seizures associated with Tuberous Sclerosis Complex (TSC). Epidiolex is currently approved in the U.S. for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome. The submission is supported by data from a favorable Phase 3 safety and efficacy study conducted in 2019, which showed that Epidiolex reduced TSC-associated seizures by roughly 48% from baseline. The Phase 3 study also demonstrated that the observed safety profile was consistent with data from prior studies.
  • TSC is a rare genetic disorder that causes predominantly benign tumors to grow in various vital body organs such as the brain, heart, kidneys, and lungs. Affecting more than 40,000 people in the U.S. and nearly one million people around the world, TSC is a leading cause of genetic epilepsy today. More than 60% of individuals with TSC are not able to achieve seizure control via standard methods and treatments. The disorder typically manifests in the first year of life and is linked to an increased risk of autism and intellectual disability in children.
  • Epidiolex has been granted Orphan Drug Designation from FDA for the treatment of TSC. According to GW Pharmaceuticals, FDA approval of the sNDA is expected later this year. Epidiolex is GW’s lead cannabinoid product candidate and the first FDA-approved drug that contains a purified drug substance derived from marijuana.

Proposed Amendments to California’s Proposition 65 Warning Regulations

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  • 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 prop65@khlaw.com.

FDA Sampling Survey Interim Data: Frozen Berries

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  • The U.S. Food and Drug Administration (FDA) and industry are continually seeking innovative ways to curb foodborne illness outbreaks. As covered previously on this blog, FDA has undertaken a robust surveillance sampling program intended to promote food safety. In 2014, the Agency launched a proactive sampling program for a variety of commodities to learn more about the prevalence of disease-causing bacteria, including identification of patterns that may help predict and prevent future contamination events. The Agency’s sampling approach involves the collection of a statistically determined number of samples of targeted foods over a 12- to 18-month period, and the testing of samples for microbial contaminants.
  • On January 22, 2020, FDA released interim data from its sampling program of frozen berries. As of September 30, 2019, the Agency indicates it has tested 339 domestic samples and 473 import samples of frozen berries. Of the frozen berries sampled, FDA found genetic material from hepatitis A virus in five samples and genetic material from norovirus in eight samples, using multiple-laboratory validated RT-qPCR methods for the detection of those viral sequences in soft fruit. These 13 samples were then further tested by the “Sanger sequencing” method to see if the viral material could be further characterized by examining a separate, distinct section of the viral genomes. Nine of the 13 samples could be further characterized using this technique. Upon detection of genetic material from hepatitis A virus or norovirus in a sample, the Agency notified the firm of the findings and worked with them to take appropriate action to protect the public health.
  • The information released is interim data, and FDA indicates that testing remains ongoing and no conclusions can be drawn at this time.
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