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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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?

3DPrinterWe agree – the Jetsons era has indeed arrived. Beyond the days of “smart” everything, now 3D printing has taken center stage in the tech world. While it is not so farfetched to imagine 3D-printed machine parts, prototype models, or even toys, it is might be harder to watch it printing foods, implantable medical devices, cosmetics, drugs and even human tissue. All too futuristic? Not really. The technology of 3D-print 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 U.S. Food and Drug Administration’s (“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.

Through this multi-part blog series, we will explore these questions, considerations and challenges for 3D printing that are likely to be regulated by FDA, with particular focus on foods (consumed on earth and in space), cosmetics and medical devices. While, at this stage, FDA issues may raise more questions than clear answers, this blog series will explore and discuss the topics that are at the forefront of FDA’s agenda regarding 3D printing and, therefore, require careful consideration by any company that contemplates involvement in the 3D-printed foods, cosmetics or devices industries. 
Continue Reading 3D Printing Series: Before You Click “Print” On Your Pizza, Palette or Prosthetic: FDA and IP Considerations With 3D-Printed Foods, Cosmetics And Medical Devices

On April 2, 2013, USDA released Draft Guidance here, here, and here addressing an issue that has plagued the National Organic Standards Board (NOSB”) for years: how to determine whether a substance is agricultural or non-agricultural and synthetic or non-synthetic. These determinations are paramount when considering whether a substance may be used in…