Federal Regulations

Happy New Year! And now on to your regular Consumer Product Matters programming…

As we predicted earlier this year, Congress is making moves toward enacting cosmetics reform legislation in the near future. In late October 2017, Senator Orrin Hatch (R-UT) introduced S. 2003, the “FDA Cosmetic Safety and Modernization Act,” which we will refer to as the “Hatch bill” for purposes…

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter (OTC, also known as nonprescription) drug products. In June of 2016, the Agency held…

As we reported on previously (see here and here), FDA recently tussled with the manufacturer of an innovative vegan condiment called “Just Mayo” based on the existence of a Federal standard of identity for mayonnaise that requires the food product to incorporate eggs.

On July 24, 2017, the Food and Drug Administration announced that it had responded to a November 2015 petition from Royal Hawaiian Macadamia Nut, Inc. for a new qualified health claim characterizing the relationship between macadamia nut consumption and a reduced risk of coronary heart disease (CHD).

It has recently been reported that President Donald Trump is looking for ways to defend American-made products by certifying legitimate U.S. goods and aggressively going after imported products unfairly sporting the “Made in America” label, the White House said on July 18, 2017. President Trump announced that his…

As we’ve previously reported, FDA has signaled its interest in reviewing the scope and meaning of the nutrient content claim “healthy,” in part as result of a dispute with KIND LLC about label claims for its KIND Bar products. Then last fall FDA released a new guidance document…

As we have discussed in previous posts, Congress may be moving towards finally enacting some long-awaited cosmetics reform legislation this year. On January 13, Representative Pete Sessions (R-TX) reintroduced his cosmetics modernization bill as H.R.575. The package of reforms was first introduced in November 2015 as the Cosmetic…

Some of our colleagues from Mintz Levin’s Class Action Practice, Joshua Briones, Crystal Lopez, and Grace Rosales, recently authored an interesting and timely article in the Bloomberg BNA Product Safety & Liability Reporter. The article examines certain defenses in consumer fraud class actions over product labeling – specifically,…

As we’ve previously written about, 2016 represented a regulatory sea change for manufacturers, distributors, and retailers of e-cigarettes and other electronic nicotine delivery systems (ENDS), who became subject to FDA oversight and requirements under the May 2016 Deeming Rule for tobacco products. In Monday’s Federal Register, FDA issued…

On December 6th, FDA announced that it is publicly releasing data received by the Agency’s Center for Food Safety and Applied Nutrition (CFSAN) about adverse events related to cosmetics and foods, including both conventional foods and dietary supplements. Adverse events can be any negative reaction to a product,…

We do not get many court decisions in the CPSC world, but yesterday we received one. Last evening, a Wisconsin federal district court essentially held in the Government’s case against Spectrum Brands, Inc. (Spectrum) that (1) Spectrum failed to timely report defective coffee pots in violation of Section…

We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that pos t we mentioned that both FDA and the Federal Trade Commission (FTC) held public workshops in 2015 to gather information about…

We have had a huge election result, perhaps the most significant in our lifetime, potentially even exceeding what was called the Reagan Revolution. It is critical, particularly for anybody from Washington DC, to have a great deal of modesty and humility in prognosticating the future under the Trump…

Back in April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act (S.1014). More recently, on September 22, 2016, the Senate Health, Education, Labor, and Pensions Committee received testimony from Senators Feinstein and Collins in support of this bipartisan legislation. The…

“…Clowns to the right of me, jokers to the left, here I am…”

Last week, following up on a more general warning issued on September 30, FDA alerted the public that it had received at least 10 reports of baby deaths associated with the use of homeopathic teething products, as well as over 400 other adverse event reports over the past…

As it signaled it would be doing earlier this year, FDA has initiated a public process to redefine the implied nutrient content claim “healthy” when it is used on food labels and labeling. In addition, while the process is underway, the Agency intends to exercise enforcement discretion for…

After launching with an ambitious agenda fourteen months ago (as we wrote about here), last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks. The Working Group has proposed an Update to the Coordinated Framework for the Regulation of Biotechnology, and…

In the wake of two tragic amusement park ride accidents in Kansas and Tennessee, and the ongoing political debate in America over gun safety issues, we felt it timely to help answer a question that continues to be asked in the media: does the U.S. Consumer Product Safety…

Products like e-cigarettes and other electronic nicotine delivery systems (ENDS) have been under intense scrutiny in recent years from public health officials, legislators at all levels of government, and many other interested parties, including dozens of plaintiffs in lawsuits stemming from battery explosions and other injuries. Newly enacted…

As a parting act before its seven-week recess, the House last Thursday passed by a vote of 306-117 Senator Pat Roberts’s (R-KS) legislation (S.764) requiring the labeling of genetically engineered foods. Already approved by the Senate last week, the bill is now expected to be signed into law…

Four months after the Senate defeated a GE labeling bill (S.2609) introduced by Agriculture Committee Chairman Pat Roberts (R-KS), the upper chamber Thursday night passed, 63-30, a compromise measure (S. 764) that Roberts co-wrote with Senator Debbie Stabenow (D-MI), the Ag Committee’s Ranking Member.

Today the U.S. Consumer Product Safety Commission (“CPSC”) and Health Canada announced a massive joint recall with IKEA involving over 35 million pieces of furniture that can pose a tip over hazard to small children. While we would normally write about the recall itself, a troubling development has…

Continuing a discussion that began in 2014, on June 10, 2016 FDA hosted a public meeting on the potential development of a user fee program for OTC (over-the-counter, or nonprescription) drug products marketed pursuant to the Agency’s monograph system. Agency leader Dr. Janet Woodcock wrote last week in…

Evaporated cane juice, a term usually used to inform about sweeteners derived from the fluid extract of sugar cane, is present on the ingredient lists of many products we see on grocery store shelves. However, newly finalized FDA guidance on use of the term “evaporated cane juice” (“ECJ”)…

On May 17, 2016, the U.S. Department of Agriculture (“USDA”) announced that it is allowing an additional 200,000 short tons of cane sugar imports to meet food manufacturers’ increasing demand for non-genetically modified sugar products. In its news release, the agency explained that

As any company making and selling food products knows, late last year FDA requested information and comments regarding the appropriate use of the term “natural” for food – the Agency asked what types of processing make that claim misleading, or does the food have to be completely unprocessed?…

On July 1, 2016, Vermont’s Act 120 will require food manufacturers to indicate in the labeling of all products regulated by FDA when the food has been produced with the use of genetic engineering (GE). Unless Congress acts with unusual swiftness to pass federal legislation regarding GE or…

On March 25, 2016, Administrative Law Judge Dean Metry found that the U.S. Consumer Product Safety Commission (“CPSC”) case counsel did not prove that high powered, small rare earth magnets (“SREMs”) (1) are defective as sold by Zen Magnets (“Zen”); and (2) constitute a substantial product hazard when…

Last week, FDA finalized new food safety regulations seeking to ensure the sanitary transport of human and animal food, as required under the Food Safety Modernization Act (FSMA). The final Sanitary Transportation of Human and Animal Food Rule will affect shippers, loaders, carriers, and receivers of food transported…

In the wake of the Senate’s defeat of legislation that would have preempted state-mandated GE ingredient labeling on food products, a new trend is emerging, as one food manufacturer after another announces that they will voluntarily label bioengineered ingredients contained in their national food product lines. The chain…

The latest salvo in the legislative food fight over genetically engineered (GE) ingredients came from the Senate, where Agriculture Committee Chairman Pat Roberts (R-KS) has introduced a bill that would instruct the Secretary of Agriculture to create a voluntary food labeling standard for bioengineered foods. Perhaps most importantly,…

Earlier today, the CPSC unanimously agreed to publish in the Federal Register a new enforcement policy proposed by Commissioner Joe Mohorovic regarding the certification of certain adult wearing apparel (click here for policy-related materials and statement prepared by Commissioner Mohorovic). Specifically, the CPSC will not require manufacturers and…

We blog frequently about new regulatory developments coming from CPSC or FDA and about enforcement actions brought by those federal agencies as well as state counterparts and private plaintiffs. But we don’t very often discuss actions involving the Federal Trade Commission (FTC) and its enforcement of the FTC…

President Obama signed Public Law 112-28 (“PL 112-28”) into law on August 12, 2011. PL 112-28 amended numerous provisions of the Consumer Product Safety Improvement Act (“CPSIA”). One such amendment made a notable change to the operation of the CPSC’s Saferproducts.gov database with respect to claims that a…

Reversing course from the end of 2015, FDA recently announced an import ban on genetically engineered (GE) salmon until such a time as comprehensive labeling guidelines are introduced. Despite FDA’s approval of GE salmon in November 2015, the agency appears to have bowed to congressional pressure and placed…

Back in September we blogged about the Warning Letter that FDA issued to Hampton Creek Foods, Inc. for its vegan food dressing and sandwich spread, “Just Mayo” and a similar product, “Just Mayo Sriracha.” In addition to several other interesting labeling violations, FDA noted that “Just Mayo” was…

Last year, we wrote about a growing trend of local jurisdictions regulating children’s products, primarily toys and apparel. One such jurisdiction, Albany County, NY, enacted a far-reaching ordinance, “Local Law J of 2014,” that prohibited the sale of children’s products containing seven chemicals of “high concern” (see previous…

Has your business experienced difficulty identifying on the CPSC’s website which product safety regulations are potentially applicable to your products? In an effort to better guide industry, particularly new product makers and small businesses, through the maze of CPSC regulatory requirements and guidance, the CPSC rolled out earlier…

A courtroom battle concerning a manufacturer’s alleged false marketing of allegedly foreign-produced products as “Made in USA” is potentially nearing a resolution. On November 30, 2015, the lead plaintiff in Paz v. AG Adriano Goldschmied, Inc. et al. asked the court for preliminary approval of a $4 million…

The International Campaign Against Microbeads in Cosmetics is most likely celebrating this week, following the California State Legislature’s passage of a bill that would prohibit the use of plastic microbeads in personal care products after January 1, 2020. The bill, AB 888, now heads to Governor Jerry Brown’s…

California, the beacon of individualism and often marching to its own set of rules, has joined the rest of the country as Gov. Jerry Brown has signed SB 633 which revises California’s take on what constitutes “Made in USA”.

[This article originally appeared on Law360 on August 7, 2015 and updates our prior post on this CPSC corrective action]

Yesterday the CPSC and major furniture company IKEA jointly announced a “repair program” to address the serious and complex hazard of furniture tip over posed by 27 million chests and dressers sold by the company. The repair program offers free wall anchoring repair kits so consumers can secure…

The proposed Federal regulation of GMOs is proceeding. Following the White House’s recent action on GMOs, Representative Pompeo’s “Safe and Accurate Food Labeling Act” (H.R. 1599) was passed by the House Agriculture Committee on July 14.

Last week, the White House waded into the GMO regulatory fray with the Office of Science and Technology Policy’s (OSTP) announcement of a major overhaul of GMO regulation.

Earlier this year, we wrote about a far-reaching product safety ordinance enacted into law in Albany County, NY (the “County”) entitled “The Toxic Free Toys Act.” At the time, we expressed our concern that numerous issues would arise in the local law’s implementation and enforcement, particularly with respect…

Last week, Sen. Barbara Boxer of California, Richard Blumenthal of Connecticut, and Rep. Peter DeFazio (D-Ore)-joined by chef-lebrity Tom Colicchio-announced the reintroduction of The Genetically Engineered Food Right-to-Know Act, a federal bill that would mandate the labeling of foods or beverages containing genetically-modified organisms (GMOs). The bill is…

A vote by European Union (EU) lawmakers in mid-January gave individual governments within the 28-nation bloc the authority to decide whether genetically modified organisms (GMOs) can be grown and cultivated within their borders. The move will give individual member states the ability to prohibit or restrict the cultivation…

This has been a big year for GMO legislation. In 2014 alone, 25 states have proposed 67 pieces of legislation aimed either at the labeling of products containing GMOs or at the ban of GMO-containing crops. While this space has strived to keep you up-to-date with the latest…

As we’ve explored in past posts, Congress is currently considering a bill that aims to harmonize the patchwork of state efforts at regulating GMO labeling by placing such regulation firmly within FDA’s jurisdiction. Dubbed the Safe and Accurate Food Labeling Act (H.R. 4432), this bill would give FDA…

At their April Senate confirmation hearing, both incoming CPSC Chairman Elliot Kaye and Commissioner Joe Mohorovic pledged to Senator John Thune (R-SD) to submit plans for reducing third party testing burdens within 60 days of confirmation. Rather than send separate plans, Kaye and Mohorovic submitted a joint letter…

On October 20, 2014, FDA reached a settlement with the Center for Food Safety (“CFS”) in litigation pending in the U.S. District Court for the District of Columbia. This litigation is related to FDA’s rule for food additives that are “generally recognized as safe” (“GRAS”). In 1997, FDA…

In April 2010, the Council for Education and Research on Toxics (CERT) sued Starbucks Corp. and other coffee sellers alleging they violated California’s Safe Drinking Water and Toxic Enforcement Act, passed by California voters in 1986 as Proposition 65, by failing to warn consumers about carcinogens in their…

On October 14, the Government Accountability Office (GAO) published a report entitled “Consumer Product Safety Commission: Challenges and Options for Responding to New and Emerging Risks.” The report analyzes the timeliness of the Consumer Product Safety Commission’s (CPSC) response to “new and emerging” safety risks from new or…

Earlier this year, we began a series of blog entries to update our readers on legislative efforts on Capitol Hill that affect stakeholders within the product safety arena. Over the summer, we updated you on an amendment to an appropriations bill passed in the House of Representatives that…

We do not typically take positions on product specific issues pending before the U.S. Consumer Product Safety Commission (“CPSC”), but the CPSC’s new safety standard for magnet sets demonstrates both why the agency exists and how it can use its regulatory authority to protect consumers. In enacting the…

This space has thoroughly explored the various forms of civil liability food companies face for the mislabeling and/or deceptive marketing of their products. Last week, a set of landmark convictions in a criminal food-safety prosecution potentially signal increased criminal liability for food companies when matters of public health…

On August 26, 2014, the FDA issued draft guidance to address “controlled correspondence,” which is the correspondence that generic drug manufacturers submit to the FDA to request information and to clarify issues related to generic drug development, and the FDA’s procedure for responding to such correspondence. The FDA…

Although the final rule currently under consideration by the CPSC sets a performance standard for magnet sets, the practical effect of the new safety standard will be a ban on the future sale or distribution of powerful rare earth magnet sets like Buckyballs and Zen Magnets. During the…

Throughout the year, this space has periodically re-visited the topic of regulating the manufacture and labeling of foods with genetically modified ingredients (GMOs) at the state and federal level. This week, a lawsuit out of Kauai, Hawaii shed light on the fate of these regulations at the county…

In the wake of the tragic drowning of Virginia Graeme Baker, the granddaughter of former Secretary of State James Baker, Congress passed and President Bush signed into law the Virginia Graeme Baker Pool and Spa Safety Act. The legislation was sponsored by Congresswoman Debbie Wasserman Schultz (D-FL) and…

Two years ago, the U.S. Consumer Product Safety Commission (CPSC) took the uncommon step of filing administrative complaints against multiple rare-earth magnet companies who refused to voluntarily recall magnetic adult desk toy products deemed to be defective by CPSC staff. Specifically, the agency alleged that these companies sold…

On June 27, 2014, Judge Claude M. Hilton of the Eastern District of Virginia dismissed the complaint filed against the power tool industry by SawStop, LLC. We previously wrote about this lawsuit and the need for companies and trade associations to develop sound legal policies and procedures to…

Yesterday the Supreme Court ruled, 8-0, that Pom Wonderful LLC could pursue mislabeling claims under the federal Lanham Act against the Coca-Cola Company, even though the label at issue complied with FDA labeling regulations. The decision reversed the Ninth Circuit’s 2012 ruling that the FDA’s “comprehensive regulation” of…

(Updated 3/2/14) The CPSC has voted to hold a workshop to discuss potential ways to reduce third party testing costs through additional “determinations” that certain products or materials do not require third party testing. Although the agency refers to these as determinations, they are essentially exemptions from the…

In a somewhat unusual development for a CPSC rulemaking, Pennsylvania Senators Robert Casey and Patrick Toomey submitted a bipartisan comment letter into the official administrative record for CPSC’s proposed voluntary recalls rulemaking that echoed many of the same concerns voiced by at least 45 others who submitted comments…

As the February 4th commenting deadline for CPSC’s voluntary remedial actions rulemaking approaches, many companies and trade associations are pondering not only the wisdom of CPSC’s insertion of compliance programs into voluntary recall negotiations, but also how those compliance programs might evolve and take shape moving forward. To…

We have previously blogged about the sometimes difficult decision that companies face when classifying their products as “children’s” or “general-use” products and the uncertainty of predicting whether the Consumer Product Safety Commission (“CPSC”) will agree with their classification. Although companies who sell personalized products have different business models,…

Since the inception of the U.S. Consumer Product Safety Commission (CPSC), voluntary recall agreements between the agency and companies conducting a recall (commonly referred to as “corrective action plans”) have not been legally binding on the company conducting the recall. At the November 13, 2013 meeting of the…

As readers of this blog are well aware, classifying products as “children’s products,” as opposed to “general use products,” has important ramifications under federal and state consumer product safety laws. For example, under federal law, namely the Consumer Product Safety Improvement Act (“CPSIA”), children’s products must meet strict…

The CPSC is considering whether to issue an interpretative rule (to be included as part of 16 CFR 1115) that would significantly alter the way in which voluntary recalls and corrective action plans (CAPs) are conducted. One major aspect of the proposed rule is turning past agency practice…

Demi Lovato’s hit song “Made in the USA” recounts how her love for her boyfriend is both amazing and patriotic. If they had fallen in love in Paris or Acapulco, however, she may be facing an enforcement action by the FTC or a lawsuit in California under Business…

Proposed legislation has been introduced by 3 members of the House, including Rep. Frank Pallone (D-NJ), senior Democrat on the House Energy & Commerce Health Subcommittee, which would direct the Secretary of Health & Human Services (HHS) to create a single, standard front-of-package labeling system for all food…

The role of the Consumer Product Safety Commission (CPSC) in product liability cases is often a two-sided coin. Evidence of a recall is sometimes allowed to establish notice of a defect though the standard to invoke a recall of a product is not the same as proving a…

When you board a ride at an amusement park, the question of who regulates the ride vs. the toy you just won is probably the last thing on your mind.

When should a court decide a case that has issues involving an area that Congress has already weighed in on? In the case of cosmetics and FDA, when a lawsuit requires a court to decide an issue committed to FDA’s expertise without a clear indication of how FDA…

The U.S. Consumer Product Safety Commission (“CPSC”) recently proposed to substantially alter its 2008 regulation governing the form and contents of certificates of compliance for consumer products. Commonly referred to as “GCCs” within the retail and manufacturing industries, certificates of compliance are used to establish a product’s compliance…