Consider these six options for challenging your competitors’ advertising and marketing claims—each with its own advantages and disadvantages.
Continue Reading Event in Review: Why Can They Say That, but I Can’t? How to Challenge Your Competitors’ Advertising While Avoiding Being Targeted
New York Proposes Bill Targeting Unhealthy Food Advertising to Children, with Broader Implications
Last month, New York quietly proposed a bill intended to protect children from advertising of unhealthy foods and the “disastrous health outcomes that follow the overconsumption of these products,” suggesting that such marketing is “inherently misleading.” While the law’s stated goal is to protect children from these negative health consequences, the law goes much further and would open the floodgates to litigation.
The law would expand New York’s Agricultural and Markets Law to state “[a]n advertisement concerning a food or food product shall not be false or misleading in any particular” and require courts to give special consideration to advertising directed at a child.
However, it would also amend New York GBL 350, New York’s general false advertising statute, by requiring courts to consider specific additional factors when determining whether any advertising is false or misleading. Specifically, a court would need to consider under GBL 350 such factors as “whether the advertisement targets a consumer who is reasonably unable to protect their interests because of their age, physical infirmity, ignorance, illiteracy, inability to understand the language of an agreement, or similar factor.”Continue Reading New York Proposes Bill Targeting Unhealthy Food Advertising to Children, with Broader Implications
Marketing FDA-Regulated Products: An Excerpt from the Advertising Law Tool Kit
Join us over the next few months as we spotlight select chapters of Venable’s popular Advertising Law Tool Kit, which helps marketing teams navigate their organization’s legal risk. Click here to download the entire Tool Kit, and tune in to the Ad Law Tool Kit Show podcast to hear the authors of this chapter
FDA Puts Homeopathic Industry on Notice – No More Lax Enforcement
Agency Denies Industry Petition and Publishes Revised Draft Guidance
The U.S. Food and Drug Administration (FDA) appears set to ramp up enforcement efforts against companies selling homeopathic products. Since 1988, FDA’s enforcement decisions have been made within the framework of Compliance Policy Guide (CPG) § 400.400. Under this policy, the agency generally limited enforcement actions to products that were either inappropriately labeled or manufactured in violation of good manufacturing practice (GMP) regulations. Publication of the new draft guidance document, which officially withdraws CPG 400.400, is the latest signal that the regulatory landscape is changing – perhaps dramatically.
The agency first revealed a new attitude toward homeopathic drugs with the issuance of a draft guidance in December 2017, which laid out a new “risk-based” model of enforcement that would guide agency decisions on homeopathic products. As we previously reported, this effectively rolled back the permissive framework of the CPG, although the agency noted that the CPG would not be withdrawn until the draft guidance is finalized. Not surprisingly, the homeopathic industry pushed back. One group (Americans for Homeopathy Choice) filed a petition urging the retention of the Compliance Policy Guide and the preservation of FDA’s pre-guidance homeopathy framework.Continue Reading FDA Puts Homeopathic Industry on Notice – No More Lax Enforcement
Have You Evaluated Your Products and Product Packaging for BPA Content? A Prop 65 Warning is Required Beginning in May
Marketers of consumer products, including foods, beverages, dietary supplements, OTC drugs, and cosmetics, should be evaluating their products, including product packaging, for the presence of bisphenol A (BPA) without delay. On May 12, 2016, the one-year grace period permitted by California’s Office of Environmental Health Hazard Assessment (OEHHA) ends, and companies whose products expose California consumers to BPA must provide a Proposition 65 (Prop 65) reproductive toxicity warning to those consumers.
Importantly, California has not yet established a maximum allowable dose level (MADL) (i.e., a safe harbor level) for BPA, so a product that exposes consumers to any amount of BPA will be required to carry a warning for reproductive toxicity in females unless the company marketing the product has established an MADL in compliance with California regulations. As a reminder, Proposition 65 requires “clear and reasonable” warnings prior to exposure.Continue Reading Have You Evaluated Your Products and Product Packaging for BPA Content? A Prop 65 Warning is Required Beginning in May
Aloe Vera (Non-Decolorized Whole Leaf Extract) and Goldenseal Root Powder Now Included on California’s Proposition 65 List
Effective Friday, December 4, the California Office of Environmental Health Hazard Assessment (OEHHA) listed Aloe vera (non-decolorized whole leaf extract) and goldenseal root powder as carcinogens on its list of
3D Printing Series: 3D Printing of Medical Devices
3D printing, also referred to as “additive manufacturing” or “rapid prototyping,” is the process of making three-dimensional objects from digital designs. Two of the most common types of printers are “disposition printers,” which deposit layers of materials until the 3D object is built, and “binding printers,” which build the object by binding, usually with adhesive or laser fusing, the underlying layers, to create a whole object at the end of the process.
Perhaps this seems pretty straightforward, but delving into the 3D printing of medical devices highlights the multiple aspects of this process, and underscores the potential challenges associated with the FDA’s current and future regulatory paradigm.
When it comes to printing medical devices, the first step involves developing a computer-aided design (“CAD”) file, or animation modeling software, which tells the printer what to make and how to make it. After the finished design file is sent to the 3D printer, the user chooses a specific material.
3D-printed medical devices allow for a high degree of customization. Think of 3D-produced dental implants which fit perfectly the first time because they are manufactured for your mouth. Or a map of a highly delicate cardiovascular procedure sized precisely to your needs or, more importantly, those of your newborn.
Continue Reading 3D Printing Series: 3D Printing of Medical Devices
3D Printing Series: Be Right Down — Printing My Makeup
Since we are now fully comfortable with “smart” everything, it should be no surprise that 3D printing has taken center stage in the tech world. It’s easy to imagine 3D-printed machine parts, prototype models, or even toys, but it might be harder to accept 3D-printed foods, implantable medical devices, cosmetics, drugs, and even human tissue. Too futuristic? Not really. The technology to 3D-print, U.S. Food and Drug Administration (“FDA”)-regulated products is, in large part, already here and rapidly progressing.
Yet, as technology continues to develop, questions arise as to whether, and how, the FDA regulatory framework will keep pace to impose the same safety, quality, and efficacy standards to 3D-printed foods, drugs, cosmetics, and medical devices that currently apply to traditionally manufactured goods. How FDA chooses to deal with 3D-printed products will significantly impact not only barriers to market-entry, but also post-marketing enforcement risks. Similarly, even assuming an FDA-regulated 3D-printed product is successfully brought to market in accordance with FDA standards, manufacturers must still assess options and potential challenges associated with protecting their intellectual property.Continue Reading 3D Printing Series: Be Right Down — Printing My Makeup
3D Printing Series: No One Goes into Space for the Food – Yet
As expected, NASA recently successfully completed the first hot-fire tests on an advanced rocket engine thrust chamber assembly using copper alloy materials. This was the first time a series of rigorous tests confirmed that 3D manufactured copper parts could withstand the heat and pressure required of combustion engines used in space launches. In all, 19 hot-fire tests on four injector and thrust chamber assembly configurations were conducted. These successful tests represent a milestone in NASA’s use of 3D printing. However, NASA leaders have set their sights on many other uses of 3D printing, including the on-site preparation of meals.
3D printing, also referred to “additive manufacturing” or “rapid prototyping,” is the process of making three-dimensional objects from digital designs. Two of the most common types of printers are “disposition printers,” which deposit layers of materials until the 3D object is built, and “binding printers,” which build the object by binding, usually with adhesive or laser fusing, the underlying layers, to create a whole object at the end of the process.
Perhaps this seems pretty straightforward, but delving into 3D printing applied to the preparation of food ushers in images of the Jetsons eating on their supersonic armchairs. So it won’t require much of a leap to imagine real astronauts in real space vehicles preparing 3D foods to be consumed in space.Continue Reading 3D Printing Series: No One Goes into Space for the Food – Yet
3D Printing Series: Can You Put my Boyfriend’s Face Inside That Pizza?
We are entering a brave new world of food design and regulation brought to us through the mechanical development and visual artistry of 3D printing. As with any new medium, understanding what we confront and its regulation lag behind the medium’s implementation.
3D printing, also referred to as “additive manufacturing” or “rapid prototyping,” is the process of making three-dimensional objects from digital designs. Two of the most common types of printers are “disposition printers,” which deposit layers of materials until the 3D object is built, and “binding printers” which build the object by binding, usually with adhesive or laser fusing, the underlying layers, to create a whole object at the end of the process.
Continue Reading 3D Printing Series: Can You Put my Boyfriend’s Face Inside That Pizza?