California’s Safe Drinking Water & Toxic Enforcement Act of 1986 (affectionately known as “Proposition 65”) has long been the subject of discussion, both pro and con. Much of the conversation is on various issues surrounding the enforcement of Proposition 65 (for example, see a prior post here). In March 2017, a California trial court in Monsanto Co. v. Office of Environmental Health Hazard Assessment (“OEHHA”), No. 16-CE CG 00183, addressed a much more basic issue: should a chemical – here Glyphosate, a key ingredient in Monsanto’s Round-Up® product – even be on Prop 65’s list of cancer-causing chemicals? Continue Reading California’s Prop 65: More Form Over Substance
Today, President Donald Trump officially announced his intent to nominate Acting Chairman Ann Marie Buerkle to be the permanent Chairman of the U.S. Consumer Product Safety Commission. Her new seven year term will begin on October 27, 2018 when her first term is set to expire. If confirmed, she will become the permanent Chairman immediately and her new term will end in October 2025.
The official announcement is copied below and was released by the White House Office of the Press Secretary just a few hours ago. Continue Reading President Trump Nominates Acting Chairman Ann Marie Buerkle as Permanent Chairman of the CPSC
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 administration would crack down on “predatory online sales of foreign goods” that are hurting U.S. retailers. According to a senior official, the United States loses about $300 billion a year to theft of intellectual property ranging from semiconductors to jeans. In March of this year, the President signed an executive order that gave customs officials more authority to stop pirated and counterfeit items.
This space has addressed the issues, both regulatory and litigation, relating to “Made in America” claims (see here, here, and here). Based on the Administration’s comments, the White House plans to work with the private sector on the new certification and verification system rather than create new regulations or spend taxpayer money. Continue Reading The Turn of the “Made in America” Claim Enforcement
On July 25, 2017 at 9:00 AM, the Consumer Product Safety Commission will be hosting a public workshop on Recall Effectiveness. The workshop, to be held in the Hearing Room at CPSC Headquarters in Bethesda, Maryland, is intended to allow consumer safety professionals and the CPSC staff to discuss ways to improve the effectiveness of recalls. Mintz Levin’s product safety team will be in attendance.
The agenda for the workshop includes: Continue Reading CPSC to Host Recall Effectiveness Workshop; Commissioner Kaye Issues Recall Effectiveness Statement
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 on what constitutes a “healthy” food and proper labeling of such foods, and the Agency simultaneously requested public input on a significant number of questions related to use of this particular claim.
Last week, FDA announced two actions that are intended to further advance this public consultation process for “healthy” label claims. First, it has extended the comment period that was initiated in October with the release of the draft guidance document until April 26, 2017. And it is convening a public meeting to discuss the use of the term “healthy” in the labeling of human food products, in part to further the feedback that may be received during this ongoing comment period. Continue Reading Reexamination of “Healthy” Continues with an FDA Public Meeting in March 2017
This morning it was announced internally at the CPSC that Commissioner Ann Marie Buerkle has become the Acting Chairman of the agency. The CPSC has not yet released a statement concerning the transition of the chairmanship from Elliot Kaye to Ann Marie Buerkle, but we have confirmed the change in leadership with multiple sources inside the agency. In a move largely seen as a precursor to this change in leadership, the Commission recently voted to install Buerkle as the Vice Chairman of the agency — ensuring that she would become the Acting Chairman of the agency once Kaye vacated the Chairman’s office.
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 Modernization Amendments of 2015 (H.R.4075).
Overall, the proposed legislation would amend the Federal Food, Drug, and Cosmetic Act with respect to FDA’s regulation of cosmetics by creating new requirements such as the registration of manufacturing establishments and the submission of a cosmetic and ingredient statement for each marketed cosmetic. It also would require cosmetic manufacturers, packers, and distributors to report to FDA any serious and unexpected adverse events caused by a cosmetic product. Likewise, cosmetic labels would be required to include contact information for consumers to report such events to the manufacturer or distributor.
Below, we break down in detail pertinent sections of the Sessions bill, as it was introduced in the previous Congress (although reports indicate that the reintroduced version has not been altered significantly). Continue Reading Cosmetics Reform Activity Begins in the 115th Congress
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, defenses based on faulty damages models. Beyond proving the factual truth of the allegedly misleading labeling claims, the authors tell us, food and other consumer product companies can combat meritless suits by showing that the plaintiff’s damages-calculation model does not meet the requirements established under Rule 23 of the Federal Rules of Civil Procedure.
When reviewing a purported class action lawsuit, Federal Rule 23(b) requires the court to determine that “questions of law or fact common to class members predominate over any questions affecting only individual members.” Generally, a consumer’s damages in a false advertising case are equal to the amount of money needed to make the consumer “whole” — that is, to compensate the consumer for the harm caused by the false claim. But measuring the actual value received by a consumer and the but-for value that consumer would have received absent the false labeling by the product’s manufacturer requires a fact-intensive economic inquiry (for example, questions related to individual consumers’ behavior and preferences, the actual amount consumers paid for the product, time frame of the purchase, etc.). As a result, according to our expert litigators, defendants in product labeling lawsuits can oppose class certification or even file an early motion to decertify by showing that the plaintiffs’ damage model cannot be calculated with proof that is “common” to the class.
Joshua, Crystal, and Grace’s full article can be viewed here. Any manufacturer or retailer of consumer products that is facing a false labeling suit should give it a quick read!
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 a final rule to exclude products derived from tobacco from Federal regulation as “tobacco products,” if or when such products are intended for use as a drug, device, or combination product (the “Final Rule”). In other words, the Agency has formally clarified that even a product made or derived from tobacco may be regulated as a medical product if it is intended for use in a way that meets the legal definition of “drug” or “device.”
However, FDA’s attempt to apply further requirements and restrictions on tobacco-derived products comes amid intense government wrangling over how to regulate products like ENDS more generally. It also comes at the eleventh hour of the Obama Administration and in the face of a Republican-controlled Congress that has expressed an interest in repealing, or at least reviewing, a large proportion of Federal agency rulemakings completed in the past several months. So it is worth noting that although this Final Rule could have a profound effect on marketing schemes for tobacco products, drugs, and medical devices alike, Congress’s recent passage of the Midnight Rules Relief Act could eliminate the rule before it ever takes effect (set for February 8, 2017). Continue Reading FDA Finalizes Tobacco Product Intended Use Rules, Under a Risk of Rescission by Congress
First off, I will admit that I am somewhat of a sucker for fresh pineapple (in fact, it was my “gorging” food of choice during my pregnancies, when I could literally eat a whole pineapple in one sitting – which is embarrassing but, in my opinion, better than cravings for weird combinations like ice cream and pickles!). So the recent news that FDA cleared a new genetically engineered variety of pineapple for sale in the U.S. certainly caught my eye.
The Agency announced on December 14th that it had evaluated a variety of pineapple genetically engineered by Del Monte Fresh Produce (DMFP) to have pink fruit. According to this announcement, “DMFP’s new pineapple has been genetically engineered to produce lower levels of the enzymes already in conventional pineapple that convert the pink pigment lycopene to the yellow pigment beta carotene.” So the nutritional profile of the pineapple and other plant characteristics, when compared to the non-engineered version, were not affected by the underlying genetic change. Continue Reading “Extra Sweet Pink Flesh Pineapple” – Oh My!