Welcome to our selected regulatory and litigation highlights impacting the food and beverage industry in March 2021.  The food court saw its own brand of March Madness with disputes over food delivery fees kicking off this month’s update.

Litigation Developments

Hidden Delivery Fees

A number of suits were filed in March regarding undisclosed delivery fees. 

Earlier this week, Judge Cynthia Bashant of the Southern District of California granted a plaintiff’s second bite at the apple (or rather biscuit) to certify a class of purchasers of belVita breakfast biscuits in McMorrow v. Mondelez International, Inc.  The plaintiff alleged that Mondelez falsely labeled its belVita biscuits as providing “NUTRITIOUS SUSTAINED ENERGY;”  “NUTRITIOUS

Welcome to our monthly digest of litigation and regulatory highlights impacting the food and beverage industry.  February saw another win for industry on the vanilla front, a preemption win in California state court, and FDA continuing with COVID-19-related warning letters and foreign supplier verification enforcement.  Let’s take a look….

Litigation

Industry scored another win on

Welcome to our monthly roundup of regulatory and litigation highlights impacting the dietary supplement and personal care products industries.  Sit back, relax, and enjoy the read.  February was a short month, with a lot going on.

NAD

Health claim substantiation was front and center before NAD in a monitoring case involving Pendulum Therapeutics and a “medical probiotic” product featuring claims such as “The only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D*” (*Consult your physician as part of your total diabetes management plan.  Results may vary from person to person.”)

The advertiser submitted a 12-week multi-center, randomized, double-blind, placebo-controlled study (the “Perraudeau Study”) to assess Pendulum Glucose Control’s safety and effectiveness in improving glycemic control in Type 2 diabetics and, ultimately, their dietary management of the disease – specifically, the role of certain probiotic strains found in prior research to be associated with the promotion of a healthy gut microbiome through the production of short-chain fatty acids (SCFAs).

The advertiser also provided clinical studies and research articles demonstrating the roles of A1C, fasting glucose and postprandial glucose levels in managing Type 2 diabetes. The advertiser also referred to the FDA’s Guidance document (Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention) to demonstrate what level of reduction in HbA1c was clinically meaningful.

While NAD expressed some concerns about the evidence, ultimately, NAD determined that the Perraudeau Study was a good fit for the challenged claim “The only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D*” (*Consult your physician as part of your total diabetes management plan. Results may vary from person to person.”) but recommended the following modifications: (1) limiting the claim to individuals who are taking metformin; (2) modifying the claim to clarify that the product can be used as part of the dietary management of type 2 diabetes; and (3) removing the references to percent reductions in blood glucose spikes in the absence of evidence in the record demonstrating that the reductions were clinically relevant.

This decision is a helpful discussion of the competent and reliable scientific evidence standard.  Anyone seeking to understand health claims substantiation better should check it out.
Continue Reading Dietary Supplement and Personal Care Products Regulatory Highlights – February 2021

Welcome to our monthly digest of litigation and regulatory highlights impacting the food and beverage industry.  As it has been for many months, the story was mostly about what’s going on in the food court.  Let’s take a look….

Litigation

Vanilla, vanilla, and more vanilla….The plaintiff’s bar remains skeptical of any product labeled as vanilla. 

The United States Court of Appeals for the Fourth Circuit recently affirmed a West Virginia federal district court’s holding that a plaintiff’s common law tort claim was preempted by the 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”). Under the MDA, certain medical devices, known as Class III devices, are required to receive premarket approval from the Food and Drug Administration (“FDA”).  The MDA also allows the FDA to condition a grant of premarket approval on a requirement that a device meet certain performance standards. The establishment of a performance standard is a formal process that requires publication in the Federal Register and providing interested parties with an opportunity to comment.  The MDA expressly preempts state medical device regulations that are “different from, or in addition to, any [federal] requirement.”


Continue Reading Fourth Circuit Clarifies Scope of Federal Preemption for Requirements Governing Medical Devices

In a unanimous opinion published on January 23, 2012, the Supreme Court reversed the Ninth Circuit Court of Appeals and held that a California law prohibiting the sale, processing or holding of a nonambulatory animal was expressly preempted by the Federal Meat Inspection Act (FMIA).

The case, National Meat Association v. Harris, dealt with Section 599f of the California Penal Code, which was enacted in 2008 in response to an undercover video released by the Humane Society showing workers in California kicking and electroshocking sick and disabled cows in an attempt to move the cows. The law makes it a crime for any slaughterhouse to “buy, sell or receive a nonambulatory animal,” or to “process, butcher or sell meat or products of nonambulatory animals for human consumption,” or “hold a nonambulatory animal without taking immediate action to humanely euthanize the animal.”

The National Meat Association (NMA) sued to enjoin enforcement of the law as applied to swine slaughterhouses and argued that the FMIA’s broad express preemption provision prohibited California from enacting distinct requirements for the handling of nonambulatory pigs. The FMIA and implementing regulations enacted by the Department of Agriculture’s Food Safety and Inspection Service (FSIS) broadly regulate slaughterhouses to promote meat safety and humane treatment. With respect to the treatment of nonambulatory pigs, FSIS regulations permit slaughterhouses to hold and eventually sell nonambulatory animals, subject to a “post-mortem” examination.


Continue Reading Supreme Court Unanimously Holds California Law Prohibiting Sale, Processing or Holding of Nonambulatory Pigs Expressly Preempted under the Federal Meat Inspection Act

On June 23, 2011, the Supreme Court rendered its decision in Pliva, Inc. v. Mensing holding that FDA regulations governing generic drug products directly conflict with and preempt state laws that would require generic drug manufacturers to modify the FDA-authorized labeling for their products to provide "adequate warnings" as defined by state law. The Court

Last week, the Center for Environmental Health, a non-profit organization, filed a complaint in California Superior Court alleging that 34 cosmetics companies violated the California Organic Products Act of 2003 (“COPA”) by selling, labeling, or marketing cosmetic products containing less than 70% organic ingredients as “organic.” The Center seeks an order enjoining the defendants from

Late last month, the U.S. Supreme Court ruled on a significant federal preemption case concerning an individual’s right to sue a vaccine manufacturer for injury that is alleged to have resulted from a defect in a vaccine’s design. The 6-2 decision (Justice Kagan recused herself) in Bruesewitz v. Wyeth held that a provision within the National Childhood Vaccine Injury Act of 1986 (NCVIA) preempts all design-defect tort claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by vaccine side effects. The NCVIA was originally enacted to establish a no-fault compensation program that serves as an alternative to the traditional tort system for resolving vaccine injury claims.

In 1995, the parents of Hannah Bruesewitz claimed that their daughter became disabled after receiving a vaccine manufactured by Lederle Laboratories (now owned by Wyeth). In response, they filed a vaccine-injury petition in the U.S. Court of Federal Claims, which the NCVIA designated to decide which vaccine injury claims should be compensated. After the Bruesewitz’s claim was denied, the parents sued Lederle in Pennsylvania state court alleging that Lederle was subject to strict liability and liability for negligent product design under Pennsylvania common law. The case was removed to the U.S. Third Circuit Court of Appeals, which sided with Wyeth on its summary judgment motion and held that the state law claim was preempted by the NCVIA.

The Supreme Court affirmed the Third Circuit decision based on a textual analysis of the NCVIA preemption provision, which reads:


Continue Reading U.S. Supreme Court Upholds Federal Preemption In Childhood Vaccine Liability Case