Despite a stiff litigation challenge from the food industry, Vermont’s GMO-labeling campaign marches on. This week saw major developments in the suit brought by the Grocery Manufacturers’ Association and other food industry groups challenging the constitutionality of Vermont’s GMO-labeling law, Act 120. Each side won an important victory in motions decided by the court, leveling the playing field and setting the stage for trial.
On Monday, the federal district court judge in Grocery Manufacturers Association v. Sorrell issued a decision denying the industry groups’ request for a preliminary injunction, which would have stopped Vermont’s labeling law from going into effect in July 2016 while the lawsuit remains ongoing. The court ruled that the industry groups had not shown they faced a risk of “irreparable harm”–that is, that the implementation of the law would impose severe costs on their members that could not later be remedied with a damages award. And specifically, the court found that the industry groups had not done enough to show that the law’s labeling restrictions would force their members to “make material changes in the way they conduct business” to justify freezing its implementation.
But every cloud has a silver lining, and the food industry won a significant battle in its own right. In the same opinion, the judge also denied the Vermont Attorney General’s motion to dismiss many of the claims in the lawsuit. The court held that several of the industry groups’ claims were reasonably “likely to succeed” and could proceed to trial, including their claims that:
For the first time in recent memory, the Department of Justice (DOJ) and Consumer Product Safety Commission (CPSC) jointly announced the filing of a lawsuit in federal court for the imposition of a civil penalty and injunctive relief for violation of the Consumer Product Safety Act (CPSA). The lawsuit is against arts and crafts retailer Michaels Stores and its subsidiary Michaels Stores Procurement Co. Inc. (collectively, “Michaels” or “the Company”) for failing to timely report a potential product safety hazard to the CPSC. Unlike other CPSC civil penalty actions involving DOJ, this penalty does not already have a negotiated consent decree in place and it appears that the case could be fully litigated.
The complaint alleges that Michaels knowingly violated the CPSA by failing to timely report to the CPSC that the glass walls of certain vases were too thin to withstand normal handling, thereby posing a laceration hazard to consumers. According to the complaint, multiple consumers suffered injuries, including nerve damage and hand surgeries, from 2007 to late 2009.
Michaels allegedly did not report the potential defect to the Commission until February 2010. Of course, we only know one side of the allegations, and Michaels will respond to those allegations in the coming weeks. The Company did state that “it believes the facts will show it acted promptly and appropriately.” Continue Reading
The USDA is facing a lawsuit in federal court stemming from its decision to unilaterally alter the process for exempting synthetic and non-organic substances used in producing organic food. Until September 2013, substances on the National List of Allowed and Prohibited Substances–which identifies approved non-organic and synthetic substances that can be used in organic agriculture because organic counterparts are not available–would “sunset” or be removed from the list after five years, unless two-thirds of the National Organic Standards Board (NOSB) voted to keep the substances on the list. Under the USDA’s new policy, an exempt substance would be permitted to remain on the National List indefinitely, unless a two-thirds majority of the NOSB votes to remove the substance from the list.
On April 7, 2015, several organic food producers and consumer groups filed a suit in the Northern District of California alleging that the USDA’s unilateral policy change, enacted without public comment or oversight, violated the Administrative Procedures Act and Organic Foods Products Act. The coalition of 15 organic food producers and farmer, consumer, environmental, and certification groups asked the court to require USDA to reconsider its decision on the rule change and reinstitute the agency’s customary public hearing and comment process. According to the plaintiffs, USDA’s revisions to the sunset provision threaten the integrity of the National Organic Program and lower the quality of organically labelled food.
Whether the court decides it has the jurisdiction in the first place and whether, assuming jurisdiction exists, the court would grant an injunction vacating USDA’s rulemaking and mandating submission of the sunset provision to public comment remains to be seen…
This week we welcomed Joanne S. Hawana to our FDA and Health Law practices. Joanne represents clients in the food, drug, medical device, and biotechnology industries on issues ranging from prescription drug advertising to state licensing requirements for wholesale distribution. She is well-positioned to work with clients on issues that may arise as a result of matters currently being considered by the FDA, Congress, and the President. For more information about Joanne and her practice, please see our recent press release on her arrival or her Mintz Levin profile.
In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food, Drug, and Cosmetic Act (the Act) and may run afoul of the U.S. Food and Drug Administration (FDA or the agency) if marketing or label claims for the products cross the line into the world of “drug claims.”
Over the past few months, FDA has issued several Warning Letters to personal care companies for making product claims that the agency has interpreted as drug claims. This recent uptick in Warning Letters from the agency objecting to “drug-like” claims for cosmetic products is significant because it may indicate that FDA is increasing its scrutiny of aggressive marketing claims for these types of products. There had been very few such letters since the agency made a high-profile enforcement sweep of the industry in late 2012.
Some of the statements in the marketing materials for certain personal care products that recently elicited FDA’s written warnings (and a public release of those warnings) made performance-related claims or claims that a product or ingredient was effective against a specific skin condition. Examples of claims that the agency found to be objectionable include the following (among others): Continue Reading
On April 7, Renee Dudley of Bloomberg News authored an article entitled “The Cheap Toys You Buy Your Kid Are Rarely Inspected.” The article has been republished by major news publications and gained some nationwide attention. Ms. Dudley’s article uses the tragic death of a toddler to argue that the American consumer product safety system is flawed because not every product is inspected by the United States government. This is an incorrect conclusion based on a failure to garner and evaluate relevant facts about the overall state of consumer product safety in the United States.
Naturally, this story is being disseminated broadly and creates an unfounded fear, particularly in the minds of parents, that their children are in constant and imminent peril from common consumer products, particularly children’s toys. This is, in fact, not the case. The consumer products “economy” is safer and more protective than ever. The CPSC itself recently reported: Continue Reading
Over the past year, we have blogged about the CPSC’s rulemaking process to regulate high-powered magnet sets via a safety standard as well as the administrative complaints brought by the agency to force multiple companies (e.g., Buckyballs and Zen Magnets) to recall certain magnetic products deemed to be defective by CPSC staff. In a major development that could potentially affect both, last Wednesday (April 1), the U.S. Court of Appeals for Tenth Circuit (“Tenth Circuit”) issued an order temporarily staying the “enforcement and effect of the Safety Standard for Magnet Sets…until further order of the court.” Given the infrequency of such stays, and publicity surrounding both the regulation of these magnets and administrative litigation over whether the magnets should be recalled, this recent news is very noteworthy.
Zen Magnets (“Zen” or “the Company”), who has refused to voluntarily recall its spherical rare-earth magnet sets (“SREMs”) at the request of the CPSC, filed with the Tenth Circuit last December a petition for the court to review the final magnets rule. The CPSC’s final rule establishes safety requirements for these rare earth magnets. However, the practical effect of the rule is a ban on the sale and/or distribution of these products. Last week, on April 1, the date the rule went into effect, the Company filed a Motion to Stay (“Motion”) the enactment and enforcement of the agency’s rule. Three hours later, the court granted the Motion.
The Tenth Circuit’s stay of enforcement of the rule pending review is significant. Courts typically do not grant motions to stay the enforcement of a final agency rule while reviewing challenges to the rule itself. In fact, litigants seeking a stay of a final agency rule must convince the court that the following factors considered weigh in their favor: Continue Reading
Recent attempts to modify California’s Safe Drinking Water and Toxic Enforcement Act of 1986, Proposition 65, have been the work of the California Legislature. (See A Sane Tweak To Proposition 65 and California Reenters the GMO Food Labeling Arena – This Time Through The Legislature). This past week, however, the California Appellate Court for the First District in Environmental Law Foundation (ELF) v. Beech-Nut Nutrition Corp., 2015 B.L. 72035, (Cal. Ct. Ap., No. A139821, 3/17/15) upheld a trial judge who determined, after entertaining extensive expert testimony, that low levels of lead in products including baby food, fruit juice and packaged food do not produce exposures that trigger a requirement for warnings under Proposition 65.
The Beech-Nut case is one of the few situations where a Proposition 65 plaintiffs’ group has had to litigate what triggers a requirement for warnings under the law. In this case, the court held that the manufacturers met their burden of proof.
This space has addressed on several occasions, [HERE, HERE, HERE, and HERE], recent attempts to modify California’s Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65. Many of the comments on proposed changes to Proposition 65 have panned the proposed changes because they either do too little or make businesses’ lives more difficult.
Legislation introduced last week (AB543) by Rep. Bill Quirk (D-Hayward) proposes some sane changes to Proposition 65. Representative Quirk holds a PhD in Astrophysics and was a scientist at Lawrence Livermore National Laboratory before election to public office. It appears that Dr. Quirk understands both the issues of Proposition 65 and politics. Rather than taking a meat axe to the proposition (which more than likely will have no chance in the California Legislature), the legislation focuses on the scientific evidence needed before an exposure warning is mandated under Proposition 65.
Proposition 65 prohibits any business from knowingly and intentionally exposing any individual to a chemical known to California to cause Cancer or reproductive toxicity without giving a specified warning.
The proposed bill would provide that a business does not knowingly and intentionally expose an individual to a chemical known to California to cause Cancer or reproductive toxicity if there exists an exposure assessment that meets three specified requirements:
Another potentially meaningful development in legislation affecting consumer products companies: on February 25, a California legislator introduced a bill, AB 708, that would require manufacturers, distributors and retailers to disclose all “chemical” ingredients for designated consumer products “manufactured from chemicals or chemical compounds.” The bill designates a broad swath of consumer goods for disclosure, from cleaning products and floor polishes to air fresheners and car wax. Covered products include: