Joining the rising tide of local GMO legislation, last week voters in Benton County, Oregon defeated the Benton County Local Food System Ordinance, which would have prohibited the cultivation of GMO crops in the county. The proposed legislation follows on the heels of a Jackson County, Oregon GMO Ban, which passed in 2014 and is currently under legal challenge. It also follows Measure 92, Oregon’s initiative to require labeling on packaging, bins, and shipping containers of GMO foods and foods containing GMO ingredients, which failed by a narrow margin in the November 2014 elections.
The varied success of GMO legislation at the County (Maui County, HI and Humboldt County, CA) and State (Vermont, New York) levels mirrors the GMO debate occurring at the Federal level, where two GMO-labeling bills are competing in Congress:
- The first is Representative Mike Pompeo’s (R-KS) “Safe and Accurate Food Labeling Act” (R. 1599), which would establish a federal labeling standard for foods with genetically modified ingredients, giving sole authority to FDA to require mandatory labeling on such foods if they are ever found to be unsafe or materially different from foods not produced with GM ingredients. The intent is to preempt a patchwork of state regulations and to remove any push toward mandatory labeling of genetically modified foods. The bill also creates a mechanism, via USDA, for those who wish to label their products as non-bioengineered. It remains to be seen how this bill will be affected by USDA’s recent announcement of its Process Verified Program expanding to include a GMO-free certification.
- The second is Senator Barbara Boxer’s (D-CA) “Genetically Engineered Food Right-to-Know Act” ( 511), which would require clear labels for genetically engineered foods intended for human consumption, including whole foods, processed foods, seafood, and animal-based foods to provide consumers with material information about their food and to prevent consumer confusion. Under the bill, if a food has been genetically engineered (GE), it would be identified as a GE food in the ingredients list. Any product that has been genetically engineered would also be prohibited from identifying itself with a “natural” label.
Mintz Levin and its consulting affiliate, ML Strategies, continue to monitor the progress of both State and Federal GMO legislation, and we will post updates as they become available.
Written by: Michelle Gillette and Katherine Fox
Currently, FDA regulates cosmetics to ensure they are not adulterated or misbranded, but does not have the authority to order cosmetic recalls or require adverse event reporting. Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) seek to change that.
On April 20, 2015, they introduced the Personal Care Products Safety Act (S.1014). The Act, if passed, would modify Chapter VI of the Federal Food, Drug, and Cosmetic Act (FDCA) to strengthen FDA’s oversight of, and regulatory authority over, cosmetic products.
Title I of the Act (“Cosmetic Safety”) gives FDA authority to order cosmetic recalls, as well as require manufacturers to: Continue Reading
Written by: Katy E. Ward and Jo Anne Shatkin
In its first step towards regulating nanoscale materials, EPA plans to impose a one-time electronic reporting and recordkeeping requirement under TSCA on manufacturers, importers and processors of particles ranging from 1-100 nanometers and exhibiting unique characteristics due to their size. Until now, nanoscale versions of substances already on the TSCA Inventory have been exempt from reporting requirements.
A manufacturer, importer and processor should first assess whether they are subject to the Proposed Rule. A company handling a nanoscale material is exempt if that material is contained in an “article.” An article is something that has a specific shape and an end-use that is dependent on that shape. Anything that is intended to be removed is not considered part of the article and must be reported (e.g., ink from a pen).
A manufacturer, importer and processor may also be exempt from the Proposed Rule if: Continue Reading
As we wrote about earlier this month, on April 1, 2015, the U.S. Court of Appeals for the Tenth Circuit (“Tenth Circuit”) temporarily stayed the effective date of “the enforcement and effect” of the CPSC’s safety standard for certain high-powered magnet sets. Specifically, the Court stayed the safety rule pending consideration of the CPSC’s response to plaintiff Zen Magnets’ (“Zen” or “the Company”) motion to stay the rule pending judicial review. While the temporary stay ordered by the Tenth Circuit was widely reported in the media, what followed soon thereafter – the lifting of that stay – has received scant attention.
On April 14, CPSC Responded to Zen’s Stay Motion. The Government argued that the rule should not be stayed pending judicial review because Zen could not demonstrate: Continue Reading
We would like to share with our readers that our friend, colleague, and mentor Chuck Samuels, Chair of Mintz Levin’s Consumer Products Safety Practice, received the Chairman’s Partnership Award from the Association of Home Appliance Manufacturers (AHAM) at their annual meeting last week. We thought this honor was worth sharing with others, particularly those in the product safety community.
The AHAM Chairman’s Award recognizes significant contributions to the Association by non-member organizations, companies and individuals. The award is the highest honor AHAM can give to a non-member. Specifically, Chuck was recognized for his work as the organization’s general counsel and his numerous achievements throughout his 30 years of service to the home appliance industry. Continue Reading
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