Much of the recent discussion regarding Prop 65 has been focused on the regulatory changes going into effect in August of 2018. And that makes sense since there will be significant changes to the warnings, responsibility, and labeling obligations on product websites. There is, however, other activity that may result in a more profound change as to which chemicals require Prop 65 warnings. As we have discussed in the past (see prior post here), there has been litigation in California state court addressing the appropriateness of adding the pesticide ingredient Glyphosate to the Prop 65 list. Continue Reading A Federal Court Gets Opportunity to Weigh In on Prop 65 With a Little Help from Some Friends
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.
Similar disputes related to identity standards that don’t accommodate plant-based versions of foods, or that just don’t allow for new or innovative uses of traditional ingredients, seem to have increased in frequency and visibility over the past year. As a result, we expect that FDA is feeling pressure from diverse stakeholder groups to revisit some of its regulations and policies related to enforcing food standards of identity (SOI). This post highlights some of these emerging disputes and the trend of interested parties raising more challenges to long-standing (but potentially obsolete) food identity standards. Continue Reading Food Identity Disputes Continue to Impose High-Profile Pressure on FDA
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). Continue Reading Reading the Tea Leaves: Sales of Macadamia Nuts Could Be Going Up!
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
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
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!
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, such as a serious illness or allergic reactions, or other complaints like packaging problems, that are received through FDA’s voluntary adverse event reporting systems for these classes of regulated products (except for in the case of dietary supplement manufacturers, who have mandatory reporting obligations).
The CFSAN Adverse Event Reporting System, called “CAERS,” includes data from reports submitted by consumers, medical professionals, and industry. The initial data file made public by the Agency contains CAERS data from January 2004 through September 2016. Continue Reading FDA Increases Transparency of Adverse Event Data for Cosmetics and Foods
On November 8, 2016, California voters approved Proposition 67, the statewide ban on carry-out plastic bags, by 52 percent. At the same time, California voters rejected Proposition 65 by 55 percent–a measure that would have sent the proceeds from sales of paper bags and reusable bags to environmental causes.
Main Provisions of Proposition 67
- Prohibits most grocery stores, convenience stores, large pharmacies, and liquor stores from providing single-use plastic carry-out bags. The provision excludes plastic bags used for certain purposes, such as those used for unwrapped produce.
- Creates new standards for the material content and durability of reusable plastic carryout bags. The California Department of Resources Recovery and Recycling (CalRecycle) would be responsible for ensuring that bag manufacturers meet these requirements. The measure also defines standards for other types of carryout bags.
- Requires a store to charge at least 10 cents for any carryout bag that it provides to consumers at checkout. Certain low-income would not have to pay the charge.
Main Provisions of Proposition 65
- Redirects carryout bag revenue to a new state environmental fund called the Environmental Protection and Enhancement Fund.
- Allows funds to be used for grants to support programs and projects related to (1) drought mitigation; (2) recycling; (3) clean drinking water supplies; (4) state, regional, and local parks; (5) beach cleanup; (6) litter removal; and (7) wildlife habitat restoration.
- Takes effect only if both propositions pass and Proposition 65 gets more “yes” votes than Proposition 67.
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 (meaning it will not take action against) foods labeled with the term “healthy” as long as they meet the conditions in the regulatory definition at 21 CFR 101.65(d) and other criteria laid out in a newly issued guidance document.
FDA explained in announcing this initiative late last month that: Continue Reading Moving on From “Natural,” FDA Seeks Comments on What It Means to Be a “Healthy” Food
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 it also completed work on a National Strategy for Modernizing the Regulatory System for Biotechnology Products. Together, these documents clarify the authority that Federal administrative agencies have to regulate certain products of biotechnology and they establish goals to ensure the proper use of those authorities in the future.
First, the Working Group’s proposed Update to the Coordinated Framework outlines the specific roles that FDA, USDA, and EPA serve to regulate biotechnology-derived products and the ways in which the agencies work together when those roles overlap. The Coordinated Framework, as noted in the Administration’s corresponding blog post, presents this information in three forms:
- “graphics that illustrate agency-specific overviews of regulatory roles;
- case studies that demonstrate how a product developer might navigate the regulatory framework; and
- a comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.”
The Administration is soliciting public comment on its proposed Update. The deadline for submitting comments will be forty days after the Update is published in the Federal Register.
Second, the Working Group’s National Strategy dovetails with the Coordinated Framework, by listing a number of objectives related to the agencies’ use of their regulatory authorities. It groups these objectives under three overarching goals: “increasing transparency, increasing predictability and efficiency, and supporting the science that underpins the regulatory system.”
EPA, FDA, and USDA have agreed to report annually to the White House on their progress in meeting these three goals for at least the next five years. In addition, sometime soon, the Working Group plans to release a study on the future of biotechnology, the one item remaining on the group’s to-do list announced at its inception last year.
Consumer Product Matters will continue to follow the waning days of the Obama Administration and the transition to the next Administration – when the updated Coordinated Framework and the National Strategy ultimately will be put to the test.