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.
There are multiple questions, considerations, and challenges which are likely to be considered by the FDA as it reviews 3D printing especially with particular focus on food, cosmetics, and medical devices. While, at this stage, FDA issues may raise more questions than clear answers, we continue to explore the topics that are at the forefront of FDA’s agenda regarding 3D printing, and which require careful consideration by any company that contemplates involvement in the 3D-printed foods and medical devices industries.
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 simplistic enough, but delving into the 3D printing of cosmetics highlights the multiple aspects of this process, and underscores the potential challenges associated with fitting 3D-printed cosmetics into FDA’s current regulatory paradigm.
3D-printed cosmetics are here and now—and will be available for you to print at home. At least one company has developed a 3D printer intended for retail sale that would allow consumers to choose a color pigment, then print that color into a blush, eye shadow, lip gloss, or any other type of make-up. However, there are FDA regulatory considerations that come into play. While many may not realize it, the FDA also has authority over cosmetic products, and cosmetic ingredients. FDA can pursue enforcement action against cosmetics that are deemed “adulterated” (i.e., unsafe or unsanitary), or “misbranded” (i.e., the product’s labeling does not adhere to FDA regulatory requirements).
And while cosmetic products and ingredients do not need FDA approval before going to market, with the exception of color additives, companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products as well as compliance with FDA’s labeling regulations.
If 3D cosmetic printers or printed cosmetics become mainstream and available for home use, FDA and the industry will have to give thought as to how to ensure that (1) the products’ ingredients are safe and (2) the printing process does not cause the printed cosmetic to be contaminated, unsafe, or otherwise deemed “adulterated” by FDA. Further, to the extent that the printed cosmetic is made available for sale, there is a question as to how FDA’s cosmetic labeling requirements will apply to 3D-printed cosmetics.
Printing your own palette of eye shadows and blushes at home is just around the corner and that corner is quickly approaching.
Claudia Lewis, Justin Pierce, and Heili Kim will be presenting at the Inside 3D-Printing conference, April 15th-17th in New York. Click here for more information.