Last week will undoubtedly be marked in the annals of Food and Drug Administration history as an important milestone for the Agency. On November 19, 2015, FDA approved the first genetically engineered (GE) animal intended for use as human food – AquaBounty Technologies’s AquAdvantage Salmon, a transgenic Atlantic salmon that contains a growth hormone gene from Chinook salmon that allows the fish to reach market size more quickly than traditional Atlantic salmon. The Agency’s press release about the decision and related actions is available here.
FDA GE Labeling Guidance
At the same time that it announced the approval decision on AquAdvantage Salmon, FDA finalized its 2001 guidance document called “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants” and also issued a new companion guidance in draft form that is specific to the voluntary labeling of foods derived from GE salmon. The main takeaway message from these documents is that the Agency’s long-standing policy regarding labeling of foods containing genetically engineered ingredients has not changed, even after years of consumer and legislative pressure regarding the public’s right to know whether a food contains one or more GE ingredients. Continue Reading
Although not quite meeting the deadline of October 31 established in a legal settlement last year, FDA has released a set of three more “foundational” Final Rules mandated by the Food Safety Modernization Act (FSMA or the Act). The Final Rules on Foreign Supplier Verification Programs, produce safety, and accredited third-party certification were released by FDA in pre-publication format on November 13, and they will be published in the Federal Register on November 27, 2015.
That official publication date will be key for calculating individual compliance dates for businesses covered by the FSVP and produce safety rules, as those rules stagger compliance depending on business size and other factors, as do the final preventive controls for human and animal food. We blogged about those first two FSMA Final Rules back in mid-September, and the last two rules related to sanitary transportation and intentional contamination of food are expected to be finalized next year, in March and May, respectively.
Readers of this blog may be most interested in the FSVP and third-party certification rules, which are both designed under the Act to enhance the safety of imported food. Continue Reading
Passed in 2010, the California Transparency in Supply Chains Act has a worthy aim: requiring retailers and manufacturers doing big business in California to disclose what measures, if any, they are taking to ensure their suppliers comply with human rights standards. What started as a legislative effort to educate consumers and incentivize good corporate citizenship, however, is quickly becoming a vehicle for private class actions against companies making this information available–even though the Act itself nowhere authorizes private lawsuits seeking damages. For consumer product companies, this is an important trend that could mark the next wave of class action litigation in California.
So what exactly does the Act require? And what litigation risks does this law now pose for companies doing business in California?
On November 12, 2015, FDA is scheduled to publish a notice in the Federal Register announcing a request for public comments on the use of the term “natural” in food labeling. As the Agency points out, it has been under pressure in recent years from many stakeholders to develop a regulatory definition for “natural” in light of the rapidly expanding market for food and other consumer products labeled as natural.
FDA notes that it has received at least four citizen petitions, including one from the Grocery Manufacturers Association, related to this issue, and multiple requests for clarification of the Agency’s view from Federal courts in the context of private litigation (as this blog has pointed out on several occasions, see here and here). As regular readers of this blog know, lawsuits filed under consumer protection and unfair competition statutes stemming from claims that a food, and increasingly a home care or a personal care/cosmetic product, is “natural” have reached dizzying numbers in the past several years.
Although establishment of a docket to receive public submissions is a very early step, and we expect it will be many months if not years before FDA takes any sort of administrative action towards a Federal definition of “natural,” this development signals that the Agency is beginning an active review of its policy on the use of the word. The request for comments lays out a lengthy list of questions for which the Agency is seeking input, including:
Today the Food and Drug Administration (FDA) posted notice of a public meeting to be held on Friday October 30th, in order to clarify the current roles and responsibilities described in the Coordinated Framework for the Regulation of Biotechnology and to develop a long-term strategy for the regulation of the products of biotechnology. The meeting notice follows the White House’s Office of Science and Technology Policy’s (OSTP) July 2015 memorandum announcing a major overhaul of the current biotech regulatory framework.
In its July memorandum, OSTP noted that the current regulatory system for “biotechnology products” (defined for this purpose as products created through genetic engineering of plants, animals, and microbes), as governed by the Coordinated Framework, creates “unnecessary costs and burdens.” It also is difficult for laypeople to understand, which undermines public confidence in the safety of those products. Continue Reading
Earlier this week, the U.S. Department of Justice (“DOJ”)—at the behest of the CPSC—filed suit in California federal court against two companies and three individuals for importing products that violate the Federal Hazardous Substances Act (“FHSA”) and Consumer Product Safety Act (“CPSA”). The respective lawsuits can be accessed here and here.
The individuals and companies—Brightstar Group Inc. (“Brightstar”) and Unik Toyz Trading Inc. (“Unik Toyz”)—are accused of repeatedly importing children’s products and toys that contained high levels of lead, banned phthalates, small parts posing a choking hazard for young children. CPSC and DOJ also alleged that Unik Toyz and Brightstar continued these illegal activities despite receiving twenty-one and nine CPSC “letters of advice” (violation notices), respectively, over multiple years.
The companies and individuals have agreed to settle these charges by binding themselves to consent decrees (which can be accessed here and here). The consent decrees, which will go into force once entered by the court, are significant because they prohibit the companies and individuals from conducting any future business (selling, importing, or distributing) involving children’s products or toys until the CPSC verifies that certain far-reaching conditions are met—all of which relate to future compliance with CPSA and FHSA requirements.
The detailed and extensive conditions are set forth in the consent decrees and include, among other provisions: Continue Reading
The consumer product safety community is a tight knit one and no one is better known or influential in the community than Marc Schoem. Marc has spent much of his 40 years at the CPSC as a key player in the Office of Compliance. Given Marc’s experience, professionalism, and ability to work well with all CPSC stakeholders, it’s an understatement to say his departure is a huge loss for the agency.
A previous post discussing Marc described him as one of the major ambassadors for the agency. In reality, Marc has served as the heart of the CPSC and his tenure of public service at the agency likely will never be matched.
Marc always put the CPSC’s core mission foremost—consumer safety and removing dangerous products from the market—and his reputation and style have been consistent in that regard. Companies and their counsel may not have always agreed with him—or he with them—but Marc always seemed to find a way to reach an effective resolution.
Given his longtime commitment to product safety and institution building, it should come as no surprise that Marc has accepted the position as Executive Director of the preeminent consumer product safety organization, the International Consumer Product Health and Safety Organization (commonly referred to as ICPHSO). As many readers of this blog know, ICPHSO is a non-profit organization “dedicated to providing forums for the exchange of ideas and information on health and safety issues related to consumer products that are manufactured and marketed in the global marketplace.”
Marc has been an active leader within ICPHSO since its founding in 1993 and he has helped build it into what is now a one-of-kind institution for the diverse array of consumer product safety stakeholders from across the world to freely communicate and get to know each other as people. Without his continued support as the CPSC representative to the organization it may not have been as successful as it is today.
In an ICPHSO press release announcing his new role, Marc said: Continue Reading
Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Food for Animals.
The final rule on Preventive Controls for Human Food creates and revises requirements for covered food facilities in three ways. The final rule: Continue Reading
At the very beginning of this year, we wrote that we expected the CPSC to remain active in bringing enforcement actions against companies for violations of the Consumer Product Safety Act (CPSA). About one month later, CPSC Chairman Elliot Kaye remarked at a product safety conference (ICPHSO 2015) that he was directing staff to seek significantly higher civil penalties against companies for such violations as provided for in the Consumer Product Safety Improvement Act. Since the beginning of the year, the CPSC has levied close to $25 million in total civil penalties against multiple companies for alleged reporting violations of product safety hazards—significantly more than any previous year.
Last week, the CPSC announced that phil&teds USA (“phil&teds”) agreed to pay $3.5 million to settle charges that it knowingly failed to report a product defect and unreasonable risk of serious injury to the Commission stemming from its “MeToo high chair.” Notably, in a rare occurrence and as part of the settlement agreement, the Commission agreed to temporarily suspend all but $200,000 of the $3.5 million civil penalty.
In doing so, the Commission relied upon phil&teds’ representations through financial statements that it has insufficient cash or other liquid assets to satisfy a civil penalty payment in excess of $200,000 without ceasing business operations. The company will be obligated to pay the suspended portion of the civil penalty if it fails to pay the non-suspended $200,000 payment or otherwise breaches its duties to implement an internal compliance plan and accurately report information to the Commission. Continue Reading
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 desk for his signature. Although several states already have similar legislation on the books (Maryland, for example), California of course is the largest and most economically significant of those jurisdictions to legislate a ban on microplastics in personal consumer products.
Microbeads, usually made from non-biodegradable polyethylene, are used in personal care products such as body wash and facial scrubs to add exfoliating properties. In recent years, as the potential for adverse environmental, wildlife, and health consequences of microplastics has become more clear (the beads are too small to be filtered out by wastewater treatment plants, so they end up being discharged into lakes, rivers, and oceans), some manufacturers have begun voluntarily removing the ingredient from their personal care products. The impetus for industry action came after Unilever announced in December 2012 that it would phase out plastic in all of its products worldwide by 2015; since that time Colgate-Palmolive and Johnson & Johnson have joined the pledge, along with many smaller companies. The pledge to remove these microplastics also has been taken up by private-label manufacturers and distributors of certain personal care products, including Target and others.
In addition to state policymakers and legislators, the U.S. Congress is taking note of the emerging science and environmental advocacy in this area. The bipartisan Microbead-Free Waters Act of 2015 (H.R. 1321) was introduced this year by Chairman and Ranking Member of the House Energy and Commerce Committee, Reps. Fred Upton (R-Mich.) and Frank Pallone (D-N.J.), respectively, and it is currently listed as having 34 cosponsors. Companion legislation has also been introduced in the Senate by Kirsten Gillibrand (D-N.Y.); that identical bill (S. 1424) is currently listed as having 7 cosponsors. The Microbead-Free Waters Act would effectively ban microplastics from personal care products after January 1, 2018, by deeming any cosmetic that contains them to be adulterated under the Federal Food, Drug, and Cosmetic Act. The Personal Care Products Council, the industry’s primary trade association, noted in May testimony to the House E&C Committee that a uniform federal standard would be preferable to state-by-state action and that non-prescription drugs that contain microbeads should be included along with cosmetics in any such legislation.
We will update our readers of any developments related to federal action to remove plastic microbeads from the marketplace.