Stormy Times and Fake News Washington D.C. Update Daniel Fabricant, Ph.D NIA West Spring Conference May 23, 2018
Who We Are Largest and oldest natural products trade group in U.S. established in 1936 Represent almost 1,200 retailers and suppliers of natural products including: Dietary supplements & ingredients Natural and organic foods Cosmetics, health and beauty aids Approx 10000 storefronts
What We Do Our Mission As the leading voice of the natural products industry, the Natural Products Association's mission is to advocate for the rights of consumers to have access to products that will maintain and improve their health and well being, and for the rights of retailers and suppliers to sell these products. NPA helps consumers maximize their health and wellbeing by working with the natural product industry at large to set industry standards, certify products to those standards, and ultimately promote and make it easy to identify truly natural products.
Who We Are NPA keeping natural product industry in business since 1936 National office in Washington, D.C.. *If you are in business, you are in politics *If you are not at the table in Congress, you are on the menu 4
Vision
NPA Positions 2018 Congressional Solution for Patent Reform U.S. Food and Drug Administration (FDA) Protein Content Food Labeling Fix Ensuring no added costs or registration requirements for Dietary Supplements in Puerto Rico Health Savings Act of 2017 Regulatory Reform (FDA, EPA, USDA) Women, Infants, and Children (WIC) Supplemental Food Program FDA New Dietary Ingredients (NDI) Draft Guidance and NDI Enforcement Personal Care Products Safety Act Congressional Dietary Supplement Caucus (DSC) Oppose Food Labeling Modernization Act 2018
NPA Positions 2018 Vinpocetine Natural Color/Excipient allowances NDI enforcement
Natural Products Day 2018 21 st Annual Lobby Day
Natural Products Day 2018 Rep. Mimi Walters (R-CA 45 th District)
Natural Products Day 2018 Senator Orrin Hatch (R-UT)
Natural Products Day 2018 Rep. Jamie Raskin (D-MD 8 th District)
Natural Products Day 2018 Rep. Brian Mast (R-FL 18 th District)
2018 MIDTERM ELECTIONS OVERVIEW A look ahead to the 2018 congressional and gubernatorial elections
CONTROL OF CONGRESS Democrats will need to pick up 23 seats in the House and two seats in the Senate to control both chambers of Congress House of Representatives Senate Total Republicans 240* Total Democrats 195* Total Republicans 51 Total Democrats/Independents 49 *There are currently four vacancies in the House but they are not expected to change parties in upcoming special elections April 23, 2018 Daniel Stublen
Republicans Have Key Retirements Incumbent John Barrasso(Wyo.) Bob Corker (Tenn.) Ted Cruz (Texas) Deb Fischer (Neb.) Jeff Flake (Ariz.) Orrin Hatch (Utah) Dean Heller (Nev.) RogerWicker (Miss.) Note Seeking re-election Retiring; likely Rep. Marsha Blackburn (R) vs. former Gov. Phil Bredesen(D) Seeking re-election; Rep. BetoO Rourke (D) running Seekingre-election Retiring; candidates include Rep. Kyrsten Sinema (D), Rep. Martha McSally (R), ex-state Sen. Kelli Ward (R) and former sheriff Joe Arpaio (R) Retiring;former Mass. Gov. Mitt Romney (R) running Running; only Republican incumbent running in state won by Clinton; Rep. Jacky Rosen is the likely Democratic nominee Running; opposed in the June 5 primary by ex-state Sen. Chris McDaniel, who almost unseated Sen. Thad Cochran (R) in 2014 primary
10 Democrats Running in States Trump Won Incumbent Trump margin 2012 margin Notes Joe Manchin (W. Va.) 42% 24% Rep. Evan Jenkins, state AG Patrick Morrisey, coal executive Don Blankenship in May 8 primary Heidi Heitkamp (N.D.) 36% 1% Rep. Kevin Cramer (R) entered race in February Jon Tester (Mont.) 20% 4% June 5 GOP primary includes state auditor Matt Rosendale, businessman Troy Downing, retired judge Russ Fagg Joe Donnelly (Ind.) 19% 6% Reps. Todd Rokita and Luke Messer and former state Rep. Mike Braun in May 8 primary Claire McCaskill (Mo.) 19% 16% State AG Josh Hawley (R) won statewide in 2016 Sherrod Brown (Ohio) 8% 6% Rep. Jim Renacci (R) shifted from governor's race Bill Nelson (Fla.) 1% 13% Gov. Rick Scott (R) expected to run and could self-finance bid Tammy Baldwin (Wis.) <1% 6% State Sen. Leah Vukmir, businessman Kevin Nicholson each have GOP megadonor ally* Bob Casey (Pa.) <1% 9% Rep. Lou Barletta likely Republican nominee Debbie Stabenow (Mich.) <1% 21% Businessmen John James and Sandy Pensler seek to deny Stabenow fourth term Note: Vukmir is backed by billionaire Diane Hendricks, while Nicholson is backed by Richard Uihlein, the founder of the packaging company Uline Corp. Source: Official state election results
Democrats Defending 16 Seats in Clinton States Incumbents listed in ascending order of Hillary Clinton s margin Amy Klobuchar (Minn.) 2% Tina Smith (Minn.) 2% Angus King (I-Maine) 3% Tim Kaine (Va.) 5% Martin Heinrich (N.M.) 8% Tom Carper (Del.) 11% Chris Murphy (Conn.) 14% Robert Menendez (N.J.) 14% Sheldon Whitehouse (R.I.) 16% Maria Cantwell (Wash.) 16% Kirsten Gillibrand (N.Y.) 22% Bernie Sanders (I-Vt.) 26% Ben Cardin (Md.) 26% Elizabeth Warren (Mass.) 27% Dianne Feinstein (Calif.) 30% Mazie Hirono (Hawaii) 32% Notes: Smith running in special election after replacing Al Franken (D) King and Sanders caucus with Dems, who won t field top-tier candidates Kaine aided by state trending Democratic and a subpar GOP field Murphy is a leading Senate advocate for gun-control legislation Justice Department dropped bribery case against Menendez Feinstein opposed by more-liberal state legislator Kevin DeLeon; state uses "Top Two" primary system Source: Official state election results
HISTORICAL MIDTERM ELECTIONS The president s party has lost an average of 25 seats in midterm elections since World War II President s party gain/loss of seats in House VITAL STATISTICS ON CONGRESS Democrats Republicans -63-30 -13 2014 2010 2006 +8 2002 2010: Democratslose control of the House after passing the ACA -52-48 -47-48 -45-26 -29-15 -12-18 -8-5 -4 +5 1998 1994 1990 1986 1982 1978 1974 1970 1966 1962 1958 1954 1950 1946 1994: Democratslose their House majority due to health reform plans and Gingrich s Contract with America Sources: UC Santa Barbara, The American Presidency Project April 23, 2018 Daniel Stublen
2018 MIDTERM ELECTIONS The president s party has lost Senate seats in 19 of the last 26 midterm elections President s party gain/loss of seats in Senate VITAL STATISTICS ON CONGRESS Democrats Republicans 2014 1 1 1 2 Surge and decline theory When presidents are elected or reelected, their party picks up House and Senate seats, causing them to be overexposed in the following midterm election, or six years later in the Senate 10 1914 Sources: Charlie Cook, Will History Hold in 2018 Midterms? The Cook Political Report,January9,2017. 5 April 23, 2018 Daniel Stublen
2018 MIDTERM ELECTIONS Historic polling of generic ballots suggests Democrats will gain seats in 2018, but will it be enough to flip the House? Comparison between generic ballot polling and House outcomes NBC/WSJ POLL Democrats Republicans 70 60 50 40 R+1 Not sure D+1 D+15 D+13 R+2 63 D+2 D+4 Current generic ballot: D+4 NBC/WSJ Poll: April 8-11, 2018 D+2 D+4 30 20 10 3 Net number of seats gained 8 3 30 23 8 13 6 0 Sources: Federal Election Commission, 2017. April 23, 2018 Daniel Stublen
2018 MIDTERM ELECTIONS Presidents with a sub-50% approval rating lose an average of 40 seats in the midterms Presidential job approval vs. midterm results since 1966 57% 52% 63% 58% 66% 63% 49% 47% 43% 46% 5 8 39% 45% 42% -12-15 -26-5 -8-30 -13-47 -48-52 -63 1966 1970 1974 1978 1982 1986 1990 1994 1998 2002 2006 2010 2014 Trump JobApproval 41.6% RCP Average: April 22,2018 Job Approval Over60% 50%-60% Under 50% Average Change +3 Seats -12 Seats -40Seats Sources: Gallup, The Cook Political Report, National Journal
NATIONAL PARTY FUNDRAISING The national GOP party committees ended Q1 with $20 million more cash on hand than Democratic committees
NATIONAL PARTY FUNDRAISING The national Republican Party committees raised $47 million more than their Democratic counterparts in the 2018 cycle
NATIONAL PARTY FUNDRAISING Democratic candidates for Congress have raised more than Republican candidates Total cash on hand by federal candidates AS OF MARCH 31, 2018 Incumbent Open/Challenger House D $175,356,922 $99,695,580 House R $217,196,382 $38,250,152 Senate D $169,962,409 $24,542,813 Senate R $31,842,097 $69,632,854 Total Dem $345,319,331 $124,238,393 Total GOP $249,038,479 $107,883,006 Sources: Federal Election Commission, 2018.
How big of a swing? Control of the House will depend on whether Democrats can win most toss-up races HOUSE 2018 RACES
2018 MIDTERM ELECTIONS House members with the largest war chests for the 2018 midterm elections Top 10 House candidates with the most cash onhand AS OF MARCH 31, 2018
2018 ELECTIONS Why are Republicans worried about the midterms? House of Representatives Current stats (3 vacancies): 238 Republicans 194 Democrats Democrats need to gain 23 seats to control the House Republicans who won by a smaller margin than the swing in PA-18 (R -8.5%) Republican districts where Trump won by 20% or less Republican districts thathave a lower PVI than PA-18 (R+11) Sources: National JournalResearch.
HOUSE RETIREMENT TRACKER Many more Republicans are retiring from vulnerable seats than Democrats
HOUSE RETIREMENT TRACKER COMMITTEE CHAIRS Regardless of the 2018 outcome, many House chairmanships will change hands due to 11 retirements Republican committee and subcommittee chairs retiring after2018 REPUBLICAN CONFERENCE RULES LIMIT CHAIRMANSHIPS TO 6 YEARS Term-limited and retiring Retiring but not term-limited Term-limited but still running Space, Science & Technology Lamar Smith (R-TX21) Transportation & Infrastructure Bill Shuster (R-PA9) Budget Diane Black (R-TN6) Oversight Trey Gowdy (R-SC4) Rules Pete Sessions (R-TX32) Judiciary Bob Goodlatte (R-VA6) Foreign Affairs Ed Royce (R-CA39) Financial Services Jeb Hensarling (R-TX5) Administration Gregg Harper (R-MS3) Homeland Security Michael McCaul(R-TX10) VA AppropriationsSub.* Charlie Dent (R-PA15) Aviation Sub. Frank LoBiondo(R-NJ2) Appropriations Rodney Frelinghuysen (R-NJ11) *Dent is a lso the cha ir of the House Ethics Committee but is not term-limited from that position Sources: National Journal Research, 2017.
RACE FOR SPEAKER The 2018 midterms will also determine who will replace Paul Ryan as speaker in the 116 th Congress Frontrunners in the race for Speaker of thehouse Nancy Pelosi (D-CA) Minority Leader No. 1 House Democrat Previous experience as speaker Largest Dem. fundraiser Has led House Dems since 2003 78 years old Kevin McCarthy (R-CA) Majority Leader No. 2 House Republican Has ties to President Trump Major fundraiser for House Republicans Lacked support in 2015 from Freedom Caucus Steny Hoyer (D-MD) Minority Whip No. 2 House Democrat Has been deputy to Pelosi for 15 years 78 years old Steve Scalise (R-LA) Majority Whip No. 3 House Republican Former Republican Study Committee chair First elected in 2008 Has some support from conservatives Joe Crowley(D-NY) Chair of the House Democratic Caucus No. 4 House Democrat New generation of Dem. leadership 56 years old Mark Meadows (R-NC) Chair of the House Freedom Caucus First elected in 2012 Campaigned with Pres. Trump in NC Sources: Deirdre Shesgreen and Deborah Barfield Berry, Who's who in the race to become the next Housespeaker?, April 12, 2018, USAToday
2018 COOK SENATE RANKINGS Senate Dems are defending 26 seats in 2018, five toss-ups Breakdown of 2018 Senate races THE COOK POLITICAL REPORT 14 8 5 2 3 3 0 Solid Democrat Feinstein (CA) Murphy (CT) Carper (DE) Hirono (HI) Warren (MA) Cardin (MD) King (ME)(I) Klobuchar (MN) Heinrich (NM) Gillibrand (NY) Whitehouse (RI) Kaine (VA) Sanders (VT)(I) Cantwell (WA) Likely Democrat Stabenow (MI) Tester (MT) Menendez (NJ) Casey (PA) Baldwin (WI) Lean Democrat Smith (MN) Brown (OH) Toss Up Nelson (FL) Donnelly (IN) McCaskill (MO) Heitkamp (ND) Manchin (WV) Flake (AZ)* Heller (NV) Corker (TN)* Lean Republican Likely Republican Hyde-Smith (MS) Fischer (NE) Cruz (TX) Solid Republican Wicker (MS) Hatch (UT)* Barrasso (WY) * Not seeking re-election Source: The Cook Political Report, April 5, 2018.
Senate members with the largest war chests for the 2018 midterm elections 2018 MIDTERM ELECTIONS
2018 MIDTERM SENATE ELECTION Of the 26 Democratic senators up for re-election, Trump won 10 of their states and five by double digits Senators up for re-election in states won by the opposing party s 2016 presidential candidate PERCENTS INSIDE THE STATE REPRESENT BY HOW MUCH THE OTHER PARTY S PRESIDENTIAL CANDIDATE WON IN2016 Clinton victory Trump victory Democratic senator up for re-election Republican senator up for re-election Dean Heller (R) won in 2012 by 1.2% Jon Tester (D) won in 2012 by 4% CA AK OR WA NV 2.4% ID AZ UT HI Heidi Heitkamp (D) won in 2012 by 0.9% MT 20% WY CO NM ND 36% SD NE TX KS OK Tammy Baldwin (D) won in 2012 by 5.6% MN IA MO 19% AR LA WI 0.7% IL MS MI 0.3% IN 19% TN AL KY OH 8.1% GA Debbie Stabenow(D) won in 2012 by 21% WV 42% SC PA 0.7% VA NC FL 1.2% NY Joe Donnelly (D) won M E in 2012 by 5.7% Claire McCaskill (D) won in 2012 by 16% Sherrod Brown (D) won in 2012 by 6.0% Bob Casey, Jr. (D) won in 2012 by 9.1% Joe Manchin (D) won in 2012 by 14% Bill Nelson (D) won in 2012 by 13% Sources: National Journal Research, 2017.
CONGRESSION AL RETIREMENT TRACKER: SENATE Retirements from the Senate open seats to costly primaries and potentially contentious general elections Senators retiring and not seeking reelection in2018 Bob Corker (R-TN) Jeff Flake (R-AZ) Orrin Hatch (R-UT) Corker has been an outspoken critic of Trump Rep. Marsha Blackburn (R-TN) is the Republican frontrunner Former Democratic TN governor Phil Bredesen (2003-2011) also announced his candidacy Flake decided not to run in light of low polling numbers a strong challenge by Kelli Ward Competitive Republican primary between Rep. Martha McSally (R-AZ02), State Rep. Kelli Ward and former sheriff JoeArpaio Rep. Kyrsten Sinema (D-AZ09) is considered the Democratic frontrunner Hatch announced his retirement after initially deciding to run Former MA governor and presidential candidate Mitt Romney announced he was running for the open seat in mid-february and is expected to win nomination and the seat Thad Cochran (R-MS) Al Franken (D-MN) Cochran announced his resignation due to health concerns Gov. Phil Bryant (R) appointed Ag Commissioner Cindy Hyde-Smith, a former Democrat, to fill the seat until a Nov. 2018 special election She will be challenged by hard-right state senator Chris McDaniel (R) Mike Espy (D), a former US Secretary of Agriculture intends to run Sen. Roger Wicker (R) is also upfor re-election in 2018 Franken resigned on January 2 nd amid a sexual harassment scandal He was replaced by Tina Smith (D) to fill his seat until a special election in November 2018 Both Minnesota Senate seats will be on the ballot in November Sources: NationalJournalResearch 2017. *Includes Sen. Al Franken (D-MN) who resigned in Januaryand was replaced by thetina Smith (D)
GUBERNATORI AL EL ECTIONS 2018 At least one Republican-held governorship is likely to flip although five are considered toss-ups Cook Political Report ratings 2018 GUBERNATORIAL RACES Republican held gov er norships (26) Democrat/Independent held governorships (10) Solid Republican 10 Likely Republican 7 Lean Republican 3 Toss Up 5 3* Lean Democrat 1 2 Likely Democrat 2 Solid Democrat 3 *One toss-up seat is held by Ala ska n g overnor Bill Walker, an independent Sources: Cook Political Report, 2018.
GUBERNATORI AL EL ECTIONS 2018 In 2018, Republicans must defend 14 governorships without an incumbent running, as opposed to only 4 for Dems 2018 gubernatorial races by incumbent and status Dem. incumbent (5) GOP incumbent (12) Dem. open* (4) GOP open* (14) Ind. incumbent (1) No election (14) WA CA OR NV ID UT MT WY CO ND SD NE KS MN WI IA IL MO MI OH IN KY WV VT NY PA VA ME NH MA RI CT NJ AZ NM OK AR TN NC SC DE MD MS AL GA AK TX LA HI FL * Open sea ts are governorships where incumbent governors are term-limited or they have announced that they are not running for re-election Sources: Cook Political Report, 2017.
CONGRESSION AL FILING DEADL INES Most states have primary filing deadlines in March or April 2018 congressional filing deadlines by state Filing deadline for primary candidates January February 1 2 3 4 5 6 1 2 3 7 8 9 10 11 12 13 4 5 6 7 8 9 10 14 15 16 17 18 19 20 11 12 13 14 15 16 17 21 22 23 24 25 26 27 18 19 20 21 22 23 24 28 29 30 31 25 26 27 28 March 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 April 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 May June July August 1 2 3 4 5 1 2 1 2 3 4 5 6 7 1 2 3 4 6 7 8 9 10 11 12 3 4 5 6 7 8 9 8 9 10 11 12 13 14 5 6 7 8 9 10 11 13 14 15 16 17 18 19 10 11 12 13 14 15 16 15 16 17 18 19 20 21 12 13 14 15 16 17 18 20 21 22 23 24 25 26 17 18 19 20 21 22 23 22 23 24 25 26 27 28 19 20 21 22 23 24 25 27 28 29 30 31 24 25 26 27 28 29 30 29 30 31 26 27 28 29 30 31 Jan 30: KS andky May 4:FL Feb 9: AL and IN Feb 27: MD Feb 28:NC Jun 1: AK and WY Jul 20:LA Jun 5: MN Jun 25:RI Mar 1: AR and MS Mar 6:OR Mar 9: CA, GA, and ID Mar 12:MT Mar 13:NM Mar 15:Utah Mar 16: IA and NV Mar 20:CO Mar 27: MO andsd Mar 30:SC Apr 5:TN Apr 9:ND Apr 13:OK Apr 23:VT Apr 24:MI No data as of October 6, 2017 for the following states: AR, CT, DE, ME, MA, 38 NE, NH, NJ, NY, PA, VA, WV, WI Sources: B allotpedia, 2017
CONGRESSION AL PRIMARY CALENDAR Most states will hold their primaries in June or August of 2018 2018 congressional primary calendar Primary election March 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 May 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 June 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 August September November 1 2 3 4 1 1 2 3 5 6 7 8 9 10 11 2 3 4 5 6 7 8 4 5 6 7 8 9 10 12 13 14 15 16 17 18 9 10 11 12 13 14 15 11 12 13 14 15 16 17 19 20 21 22 23 24 25 16 17 18 19 20 21 22 18 19 20 21 22 23 24 26 27 28 29 30 31 23 24 25 26 27 28 29 25 26 27 28 29 30 31 30 Mar 6:TX Mar 20:IL Aug 2:TN Aug 21: AK,WY Aug 7: KS, MI, MO, Aug 28: AZ,FL WA Aug 11:HI Aug 14: CT, MN, VTWI May 8: IN, NC, OH May 15: ID, NE, OR, PA May 22: AR, GA, KY Sept 11: DE, NH,RI Sept 18:MA Jun 5: AL, CA, IA, MS, MT, NJ, NM, SD Jun 12: ME, NV, ND, SC, VA Jun 26: CO, MD, NY, OK, UT Nov 6:LA *No primary elections in April, July or October Source: Ballotpedia, 2017.
NUTRITION & SUPPLEMENT FACTS LABELING COMPLIANCE DATE EXTENSION
Nutrition & Supplement Facts Labeling Compliance Date Extension
Nutrition & Supplement Facts Labeling Compliance Date Extension FDA final rule to extend compliance date for about 1.5 years, for two rules: Nutrition Facts Label Final Rule Serving Size Final Rule Manufacturers with $10 million or more in annual food sales July 26, 2018 à January 1, 2020 Manufacturers with less than $10 million in annual food sales July 26, 2019 à January 1, 2021
SSCI UPDATE
SSCI Update: Pilot Audit Program Completion Objective: To ensure consistency in the interpretation, auditing, certification and therefore manufacturing of dietary supplements Consistent with CFR 111 and demonstrating continuous GMP standards in order to improve efficiency Manage cost and provide a platform for stakeholders to collaborate and exchange knowledge and information. Purpose: Help benchmark the audit tool from being used for the facility assessment and auditor assessment for consistency using the standard audit and inspection practices that will be applied during audits
SSCI Update: Building Confidence in Certification Once certified, accepted everywhere UL/ USP Joint Certification Scheme Determine the role, tasks, and expectations of auditors Define competencies (skills, knowledge, and attributes) for each task Recommend options by which they can be assessed and verified
SSCI Update: Next Steps Develop Benchmarking Committee Review UL/USP Joint Benchmarking Scheme Create ILG Identify and Staff Technical Workgroups Define criteria for each workgroup Technical Competencies Finalize SSCI Board Review Final Version of Governance Document Articulate SSCI Charter Develop Bench-Marking Document and Harmonization Standard
NPA Comments to FDA Comments Submitted in 2017 Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling: Draft Guidance for Industry FDA Citizen Petition for Exemption from One Hundred Percent Identity Testing FDA Citizen Petition to Stay and for Reconsideration (the Food Labeling Rule of July 26, 2016) from Porzio, Bromberg & Newman Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Proposed Extension of Compliance Dates Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration FDA Citizen Petition RE: 100 Percent Identity Testing Requirement for Dietary Ingredients
NPA Comments to FDA Comments Submitted in 2018 Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration Review of Existing Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease; Extension of Comment Period. Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry; Availability
USDA on Bio-Engineered Foods Disclosure Standard Proposed Rule Require food manufacturers and other entities that label foods for retail sale to disclose information about BE food and BE food ingredient content Intends to provide mandatory uniform national standard for disclosure of information to consumers about the BE status of foods. Requesting comments on whether to consider intellectual property law as one potential method of determining whether a genetic modification could be found in nature.
USDA on Bio-Engineered Foods Disclosure Standard Proposed Rule Using intellectual property protection under 35 U.S.C. 101 to inform its decision about whether a modification could not otherwise be found in nature Based on a U.S. Supreme Court decision & U.S. Patent and Trademark Office guidance, products of nature are not patentable subject matter under 35 U.S.C. 101. Similarities in how a product of nature is interpreted for purposes of patent eligibility and how a modification could be found in nature for purposes of determining whether a modification is bioengineered. AMS would limit its consideration to patents under 35 U.S.C. 101 Excludes the intellectual property protections obtained by plant patents and plant variety protection certificates
NEW DIETARY INGREDIENTS UPDATE
New Dietary Ingredient (NDI) Update NDI Notifications and Related Issues Draft Guidance was released August 2016 New proposals in Draft Guidance Development of Pre-DSHEA List of Old Dietary Ingredients (ODI) Master File Total NDI Notifications (1994-Present) 977 NDINs that received a substantive response letter from FDA
New Dietary Ingredient (NDI) Update Development of Pre-DSHEA ODI List Public meeting (Oct. 3 rd, 2017) to discuss the development of a list of Pre-DSHEA Dietary Ingredients FDA not required to put together list of ODI NPA s Pre-DSHEA List of Old Dietary Ingredients Book First pre-dshea ODI list to be published and available to the public. Created with independent & verifiable sources These ingredients would be exempt from filing notification with FDA as New Dietary Ingredients (NDIs) Book also includes ingredients submitted as GRAS notices to FDA with no further comment by the Agency. Met with and notified the Agency of NPA s ODI book.
New Dietary Ingredient (NDI) Update Master File Currently FDA is trying to set up Masterfile System There were three meetings with FDA on dietary ingredient Masterfile and as to how this will work. Any further discussion on NDI Masterfile is a useless endeavor unless FDA supports enforcement on NDI piggybacking We are waiting on what agency will do as they have a list of issues.
NATURAL PRODUCTS FOUNDATION
Natural Products Foundation Truth in Advertising Warning Letters Warning letters are sent to firms with supplements that have dietary ingredients that FDA has rendered as unapproved drugs. TruLabel Testing Program NPF purchased 75 of the top selling dietary supplement Amazon products Products chosen base upon: Popular claims Target population Implied claims through green seals placed on product packaging Supplements declaring botanical roots Components Form of supplement
Natural Products Foundation Truth in Advertising Warning Letters Selective Androgen Receptor Modulators (SARMs) Hot Issue Ingredients Met with FDA & USADA to discuss: Increasing presence of SARMS as undeclared hidden ingredients and declared dietary ingredients in sports supplement products sold over the internet and what can be done. SARMs as unapproved drugs if used in dietary supplements In November 2017, warning letters were sent to two firms selling anabolic steroids and SARM designer drugs. These letters were forwarded to FDA (CDER, CFSAN, and Health Fraud Group) and FTC.
Natural Products Foundation TruLabel Testing Program Testing of Products ICP (heavy metals: arsenic, lead, cadmium, mercury) Micro testing (bacteria, yeast, and mold) Screening (70 pesticides) Quantitative levels (Calcium & Vitamin D) C14 (natural vs. synthetic bases) Most Recent Test: C14 test on 5 different multivitamins with the USDA Organic Seal to determine the percentage of natural vs. synthetic materials in products. Results showed traces of non-plant based carbons (synthetic bases)
States Mass, NY, CA Kratom/CBD EPA reclassifying DS for wastewater purposes Imports/Exports India CoFS NAFTA
Thanks Daniel.Fabricant@npanational.org