#3dprintconfsc

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
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
Where Do the Regulators
Come into Play?
© 2014 Venable LLP

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
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
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
© 2014 Venable LLP
Questions?
Contact Information
YOUR VENABLE TEAM
Heili Kim, Esq.
hkim@Venable.com
t 202.344.4677
f 202.344.8300
Kristen Klesh, Esq.
krklesh@Venable.com
t 202.344.4830
f 202.344.8300
Claudia Lewis, Esq.
calewis@Venable.com
t 212.344.4359
f 212.344.8300
www.Venable.com