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  1. 1. Digitally Manufacturing Food to Your Dietary Needs – 1 Are Innovations Advancing Faster than the FDA Regulations are Evolving? Heili Kim, Esq., Claudia Lewis, Esq. © 2012 Venable LLP OCTOBER 22, 2014
  2. 2. 2 Why is the Food Industry Interested in 3D Printing?  Culinary creativity and market appeal – “Personalized” Foods • Identifiable categories of individuals that may require special dietary needs • Elderly, athletes, diabetics, pregnant women  Specialized environments – The Quest for Pizza – Limitations on refrigeration, space, cooking • Conflict areas, NASA program  Alternative ingredients and substitutes – “post-mortem” meat, vegan/vegetarian options © 2014 Venable LLP
  3. 3. 3 Where Do the Regulators Come into Play? © 2014 Venable LLP
  4. 4. 4 FDA Regulation of Foods © 2014 Venable LLP Conventional Foods • Pre-Approval of food additives/processing aides, novel ingredients, food contact substance • Notification/Self-Affirmation of GRAS ingredients • Compliance with cGMP for quality and safety • Food labeling requirements such as Nutrition Facts box, ingredient listing and Nutrient Content and Health Claims Dietary Supplements & New Dietary Ingredients • “Product taken by mouth that contains a dietary ingredient intended to supplement the diet” • NDI is a dietary ingredient not sold in the U.S. in a dietary supplement before October 15, 1994, and requires notification before it may be marketed • Specific dietary supplement labeling and cGMP requirements Medical Foods • “Food which is formulated to be consumed or administered enternally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” • Exempt from certain labeling requirements • Other requirements (ingredient approval/notification, cGMPs) for conventional food generally apply 3D Printed Foods No specific FDA regulations for additive manufacturing vs.
  5. 5. 5 Could a 3D Printer Constitute a Medical Device?  Medical device – “is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body . ..” FDCA Section 201(m) – Monitoring biostatistics = medical device – Accessories to medical device = medical device  3D printer and accessories – What about measuring micronutrients? – Inputting personalized data to detect presence of nutrient deficiency? © 2014 Venable LLP
  6. 6. 6 Food for Thought?  Consumer perception (e.g., GMO/non-GMO, Natural)  Labeling compliance – Standards of Identity – Non-misleading descriptive terms  Marketing & Advertising  Current FDA activity © 2014 Venable LLP
  7. 7. 7 © 2014 Venable LLP Questions? Contact Information YOUR VENABLE TEAM Heili Kim, Esq. t 202.344.4677 f 202.344.8300 Kristen Klesh, Esq. t 202.344.4830 f 202.344.8300 Claudia Lewis, Esq. t 212.344.4359 f 212.344.8300