Loren Israelsen NDI GUIDANCE WORKSHOP SESSION 2 NOV 8 2016
UNPA © 2016
Two Perspectives: • FDA • Peter Reinecke, Health Policy Staff Director, Chief of Staff, Senator Tom Harkin
UNPA © 2016
FDA’s NDI Guidance News Release • FDA issued revised guidance to improve dietary supplement companies’ NDI notifications. • FDA estimates there are 55,000 dietary supplements on the market. • 5,560 new dietary supplement products come on the market each year. UNPA © 2016
• FDA has received fewer than 1,000 NDI notifications since DSHEA. • This guidance is an important step to protect public health from potentially dangerous new dietary ingredients. • It is FDA’s only pre-market opportunity to identify unsafe supplements. • In December 2015, the Office of Nutrition, Labeling and Dietary Supplements was elevated to the Office of Dietary Supplement Programs. UNPA © 2016
Peter Reinecke • The framework/lens has to be “what promotes the public health and protects consumer safety.” That must be the lens of responsible industry. • That is the only reason we put NDI notification in DSHEA -- essentially to provide some reasonable assurance of safety of ingredients for which that history didn’t exist. UNPA © 2016
• So, let’s go through this guidance with that lens and see what is necessary to promote the public health and protect consumer safety and what is not. • And then discuss how the guidance can be structured to get that protection in the most cost effective manner possible so as to not reduce consumer access. • That cost is the cost that responsible industry must bear. UNPA © 2016
• But, if it is regulation for regulation sake that adds costs for no advancement of public health and safety, or does so in a cost excessive manner, then it should not be there, or it should be moderated. • This is not different from how we are looking at it today, but more of a starting point and guiding post for discussion. I am concerned if we focus on cost as a test in and of itself, regardless of public safety, we add to our consumer trust / stakeholder trust issues. UNPA © 2016
And yet, if you file your NDIs, we are still left with uncertainty.
UNPA © 2016
“Please note that acceptance of this notification for filing is a procedural matter, and thus, does not constitute a finding by FDA that the new dietary ingredients or supplement that contains the new dietary ingredients are safe or are not adulterated under 21 U.S.C.342. FDA is not precluded from taking action in the future against any dietary supplement containing your new dietary ingredients if they are found to be unsafe, adulterated or misbranded.” -- Dan D. Levy, Ph.D. NDI Review Team Div. of Dietary Supplement Programs UNPA © 2016
Steve McNamara – The Thomas Jefferson of DSHEA
UNPA © 2016
We are now leaving Power Point land. Eyes down. Workbooks open.
UNPA © 2016
NDI Price Tag
UNPA © 2016
FDA Assumptions • You already have safety substantiation as part of your DSHEA compliance. • An NDI is the organization and filing of this existing data. • Estimated assembly time: 20 hrs
UNPA © 2016
• Prior safety research investments are amortized and not new capital costs. • Hence, no need for an economic impact assessment. • No asset value is assigned to the 75-day waiting period.
UNPA © 2016
Industry Assumptions • Many DIs are ODIs with no associated costs. • DS are not NDIs – not relevant to safety assessments. • Manufacturing changes and chemical alteration as defined in the 2016 NDIG are new FDA interpretations. Where does that leave us? UNPA © 2016
• An expectations gap exists. • FDA has an expectation of NDI compliance. • Industry has an expectation that the mission of NDIs is to assess safety of new ingredients as defined by DSHEA and confirmed by DSHEA’s authors. • A growing recognition that a select list of ingredients of interest should be the NDI focus for both sides. • Can both sides be persuaded in this direction? UNPA © 2016
Tox Studies: How Much? Three data points for a tox battery as laid out in the 2016 NDI Guidance: • Data Point 1: $350,000 - 500,000 • Data Point 2: $1-1.5 million • Data Point 3: $950,000 • Average: $790,000 • Consulting fees range from: $20,000 - 100,000 UNPA © 2016
Now back to the workbook to run some numbers together.
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
Two Perspectives: • FDA • Peter Reinecke, Health Policy Staff Director, Chief of Staff, Senator Tom Harkin
UNPA © 2016
FDA’s NDI Guidance News Release • FDA issued revised guidance to improve dietary supplement companies’ NDI notifications. • FDA estimates there are 55,000 dietary supplements on the market. • 5,560 new dietary supplement products come on the market each year. UNPA © 2016
• FDA has received fewer than 1,000 NDI notifications since DSHEA. • This guidance is an important step to protect public health from potentially dangerous new dietary ingredients. • It is FDA’s only pre-market opportunity to identify unsafe supplements. • In December 2015, the Office of Nutrition, Labeling and Dietary Supplements was elevated to the Office of Dietary Supplement Programs. UNPA © 2016
Peter Reinecke • The framework/lens has to be “what promotes the public health and protects consumer safety.” That must be the lens of responsible industry. • That is the only reason we put NDI notification in DSHEA -- essentially to provide some reasonable assurance of safety of ingredients for which that history didn’t exist. UNPA © 2016
• So, let’s go through this guidance with that lens and see what is necessary to promote the public health and protect consumer safety and what is not. • And then discuss how the guidance can be structured to get that protection in the most cost effective manner possible so as to not reduce consumer access. • That cost is the cost that responsible industry must bear. UNPA © 2016
• But, if it is regulation for regulation sake that adds costs for no advancement of public health and safety, or does so in a cost excessive manner, then it should not be there, or it should be moderated. • This is not different from how we are looking at it today, but more of a starting point and guiding post for discussion. I am concerned if we focus on cost as a test in and of itself, regardless of public safety, we add to our consumer trust / stakeholder trust issues. UNPA © 2016
And yet, if you file your NDIs, we are still left with uncertainty.
UNPA © 2016
“Please note that acceptance of this notification for filing is a procedural matter, and thus, does not constitute a finding by FDA that the new dietary ingredients or supplement that contains the new dietary ingredients are safe or are not adulterated under 21 U.S.C.342. FDA is not precluded from taking action in the future against any dietary supplement containing your new dietary ingredients if they are found to be unsafe, adulterated or misbranded.” -- Dan D. Levy, Ph.D. NDI Review Team Div. of Dietary Supplement Programs UNPA © 2016
Steve McNamara – The Thomas Jefferson of DSHEA
UNPA © 2016
We are now leaving Power Point land. Eyes down. Workbooks open.
UNPA © 2016
NDI Price Tag
UNPA © 2016
FDA Assumptions • You already have safety substantiation as part of your DSHEA compliance. • An NDI is the organization and filing of this existing data. • Estimated assembly time: 20 hrs
UNPA © 2016
• Prior safety research investments are amortized and not new capital costs. • Hence, no need for an economic impact assessment. • No asset value is assigned to the 75-day waiting period.
UNPA © 2016
Industry Assumptions • Many DIs are ODIs with no associated costs. • DS are not NDIs – not relevant to safety assessments. • Manufacturing changes and chemical alteration as defined in the 2016 NDIG are new FDA interpretations. Where does that leave us? UNPA © 2016
• An expectations gap exists. • FDA has an expectation of NDI compliance. • Industry has an expectation that the mission of NDIs is to assess safety of new ingredients as defined by DSHEA and confirmed by DSHEA’s authors. • A growing recognition that a select list of ingredients of interest should be the NDI focus for both sides. • Can both sides be persuaded in this direction? UNPA © 2016
Tox Studies: How Much? Three data points for a tox battery as laid out in the 2016 NDI Guidance: • Data Point 1: $350,000 - 500,000 • Data Point 2: $1-1.5 million • Data Point 3: $950,000 • Average: $790,000 • Consulting fees range from: $20,000 - 100,000 UNPA © 2016
Now back to the workbook to run some numbers together.
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
