Claudia A. Lewis

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Claudia Lewis, co-chair of Venable’s FDA Group, counsels clients on matters involving Food and Drug Administration (FDA) regulation, labeling, and marketing of foods, over-the-counter (OTC) drugs, medical devices, and other products. With deep knowledge of dietary supplement labeling regulations, Claudia represents scientists, physicians, nutritionists, healthcare associations, and citizen groups. She has also aided international clients in establishing a U.S. market for their products. She has prepared and presented constitutional and administrative law cases before the FDA, Federal Trade Commission (FTC), Department of Justice (DOJ), Bureau of Land Management (BLM), and Environmental Protection Agency (EPA).

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The Federal Trade Commission (FTC) issued warning letters to ten companies for alleged deceptive review practices, indicating its intent to step up enforcement of its relatively new Consumer Review Rule (16 C.F.R. Part 465) (“the Rule”).

The warning letters have implications for all direct-to-consumer sellers. For industries that rely heavily on consumer reviews, including dietary supplement, health and wellness, and beauty/personal care companies, the FTC’s action is particularly significant. These industries often market using consumer reviews, influencer endorsements, testimonials, and before-and-after content—practices that now carry increased regulatory risk. While the warning letters do not constitute formal findings of liability, they underscore the FTC’s readiness to pursue civil penalties of up to $53,088 per violation against the recipients (an amount that will likely increase in 2026 with inflation-adjusted civil penalties).Continue Reading FTC Signals Heightened Enforcement of New Consumer Review Rule

Last month, a putative class action was filed against Procter & Gamble challenging various green advertising claims for its Charmin toilet paper. The complaint brought a variety of state law claims targeting P&G’s sustainability claims, including “Keep Forests as Forests,” and alleged that the claims were explicitly false and misleading.

According to the complaint, P&G’s “Keep Forests as Forests” campaign made three promises to consumers by leveraging the “Protect-Grow-Restore” logo:Continue Reading Lawsuit Alleging Greenwashing Filed against Procter & Gamble for Charmin Toilet Paper

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

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

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

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

By Mokkie (Own work) [CC BY-SA 3.0], via Wikimedia Commons
Countless Cosmetic and Dietary Supplement Products Implicated

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, 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

Image via Inhabitat.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