Loren Israelsen NDI GUIDANCE WORKSHOP SESSION 1 NOV 8 2016
UNPA © 2016
UNPA © 2016
NYAG Launches Probe into EpiPen Maker
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UNPA © 2016
1
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Manufacturing Changes In FDA's latest New Dietary Ingredients (NDIs) guidance, released on Aug. 11, 2016, a large range of "manufacturing changes" will trigger an NDI notification. Each notification requires a 75-day waiting period before you can go to market.
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Nanotechnology According to FDA's 2016 New Dietary Ingredients (NDIs) guidance, any dietary supplement, old or new, that uses "nanoscale range" (1 nm to 100 nm [particle size]), requires a separate new dietary ingredient notification.
3
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Solvents According to FDA's 2016 New Dietary Ingredients (NDIs) guidance, solvents—other than water and alcohol (ethanol)—used to extract botanicals will trigger an NDI notification.
4
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Master Files In its 2016 revised NDI guidance, FDA proposes to create an NDI Master File to hold critical and confidential NDI safety and manufacturing data.
5
# The 'ODI List' There is no official Old Dietary Ingredients (ODI) list— a list of those ingredients on the market before October 1994, the date of passage of the Dietary Supplement Health and Education Act. FDA proposes to develop an official list and says it will consider industry-supplied “substantiation.”
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Combination NDIs According to FDA's 2016 New Dietary Ingredients (NDIs) guidance, a combination of two NDI ingredients is itself an NDI that will require a separate, third NDI notification.
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Toxicology & Safety Studies What types of data does FDA recommend to assess dietary supplement safety? • A three-study genetic toxicology battery • A 14-day, range-finding oral study in an appropriate animal • A 90-day chronic oral study in the same animal species • A multi-generation rodent reproductive study (two generations minimum) • A teratology study (rodent or non-rodent).
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History of Food Use Did you know that according to FDA, as it pertains to supplements and "history of food use," fungi mycelium and unripe apples are not considered part of the food supply.
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Supercritical CO2 Extraction According to FDA's 2016 revised draft New Dietary Ingredient (NDI) guidance, the use of supercritical CO2 extraction methods triggers NDI status.
10
# Synthetic Botanicals According to FDA's 2016 draft New Dietary Ingredient (NDI) guidance, synthetic botanicals (synbots) cannot be dietary ingredients because they do not come from a botanical. In fact, on Tuesday, the agency formalized its intention to withdraw “dietary ingredient" status for synthetically produced vinpocetine. Vinpocetine is from the periwinkle plant. Other substances that could be pulled from the marketplace: • Resveratrol • 5-HTP • L-theanine • Astaxanthin
Thanks to our great UNPA staff • Pulling 2:00 A.M.’ers • Canceled vacations • Three cheers and free beer for the staff
UNPA © 2016
Thanks to our Faculty Government and industry sitting down to openly and vigorously discuss important issues
UNPA © 2016
Thanks to our Sponsors
UNPA © 2016
Housekeeping Items • The workshop is being professionally recorded with audio synchronized to each presentation. Attendees will receive this as part of their registration fee. Recording will be available for purchase next week. • So, please wait for a microphone before asking questions. UNPA © 2016
• 3x5 cards are available for written questions. • Join us for the reception at 5:00 p.m. An assortment of ODI solvents will be available, along with super critical CO2 Coca-Cola products.
UNPA © 2016
Thank you! Loren Israelsen President United Natural Products Alliance 1075 E Hollywood Ave Salt Lake City, UT 84105 p: 801.474.2572 e: [email protected] unpa.com
UNPA © 2016
UNPA © 2016
NYAG Launches Probe into EpiPen Maker
UNPA © 2016
UNPA © 2016
1
#
Manufacturing Changes In FDA's latest New Dietary Ingredients (NDIs) guidance, released on Aug. 11, 2016, a large range of "manufacturing changes" will trigger an NDI notification. Each notification requires a 75-day waiting period before you can go to market.
2
#
Nanotechnology According to FDA's 2016 New Dietary Ingredients (NDIs) guidance, any dietary supplement, old or new, that uses "nanoscale range" (1 nm to 100 nm [particle size]), requires a separate new dietary ingredient notification.
3
#
Solvents According to FDA's 2016 New Dietary Ingredients (NDIs) guidance, solvents—other than water and alcohol (ethanol)—used to extract botanicals will trigger an NDI notification.
4
#
Master Files In its 2016 revised NDI guidance, FDA proposes to create an NDI Master File to hold critical and confidential NDI safety and manufacturing data.
5
# The 'ODI List' There is no official Old Dietary Ingredients (ODI) list— a list of those ingredients on the market before October 1994, the date of passage of the Dietary Supplement Health and Education Act. FDA proposes to develop an official list and says it will consider industry-supplied “substantiation.”
6
#
Combination NDIs According to FDA's 2016 New Dietary Ingredients (NDIs) guidance, a combination of two NDI ingredients is itself an NDI that will require a separate, third NDI notification.
7
#
Toxicology & Safety Studies What types of data does FDA recommend to assess dietary supplement safety? • A three-study genetic toxicology battery • A 14-day, range-finding oral study in an appropriate animal • A 90-day chronic oral study in the same animal species • A multi-generation rodent reproductive study (two generations minimum) • A teratology study (rodent or non-rodent).
8
#
History of Food Use Did you know that according to FDA, as it pertains to supplements and "history of food use," fungi mycelium and unripe apples are not considered part of the food supply.
9
#
Supercritical CO2 Extraction According to FDA's 2016 revised draft New Dietary Ingredient (NDI) guidance, the use of supercritical CO2 extraction methods triggers NDI status.
10
# Synthetic Botanicals According to FDA's 2016 draft New Dietary Ingredient (NDI) guidance, synthetic botanicals (synbots) cannot be dietary ingredients because they do not come from a botanical. In fact, on Tuesday, the agency formalized its intention to withdraw “dietary ingredient" status for synthetically produced vinpocetine. Vinpocetine is from the periwinkle plant. Other substances that could be pulled from the marketplace: • Resveratrol • 5-HTP • L-theanine • Astaxanthin
Thanks to our great UNPA staff • Pulling 2:00 A.M.’ers • Canceled vacations • Three cheers and free beer for the staff
UNPA © 2016
Thanks to our Faculty Government and industry sitting down to openly and vigorously discuss important issues
UNPA © 2016
Thanks to our Sponsors
UNPA © 2016
Housekeeping Items • The workshop is being professionally recorded with audio synchronized to each presentation. Attendees will receive this as part of their registration fee. Recording will be available for purchase next week. • So, please wait for a microphone before asking questions. UNPA © 2016
• 3x5 cards are available for written questions. • Join us for the reception at 5:00 p.m. An assortment of ODI solvents will be available, along with super critical CO2 Coca-Cola products.
UNPA © 2016
Thank you! Loren Israelsen President United Natural Products Alliance 1075 E Hollywood Ave Salt Lake City, UT 84105 p: 801.474.2572 e: [email protected] unpa.com
UNPA © 2016
