UP TO SPEED
2019

ASEAN + THAILANDASEAN
Harmonisation
HealthSupplements
SectorUpdateDaniel Quek
Chairman
ASEAN Alliance of Health Supplement Associations
Sydney 10 April 2019

Outline•

ASEAN HS Harmonisation Overview•

Current stage of TMHS PWG progress•

Implementation Challenges Crucial
Action 2019-2020 & Beyond

3 PILLARS Targeted for 2020

ASEAN
SECURITYCOMMUNITY

ASEAN SOCIALCOMMUNITY

AEC : Accelerate to 2015

ASEAN
ECONOMICCOMMUNITY
ASEAN HS industry
representation

AEC: 11 priority sectors including health supplements

ACCSQ

ASEAN Consultative
Committee for Standards
and Quality

Traditional Medicines /Health Supplements
Product Working GroupWhat are the standards and technical requirements for healthsupplements that will be harmonised in ASEAN?

GMP Requirements
Stability & Shelf-life

Labelling Requirements
Claims & Substantiation

Q
u
a
l
I
T
y
L
a
b
e
l

Not Included in the Regulatory
Framework
Product Dossier Requirements

Safety Substantiation
Negative List of Actives
Additives & Excipients  
      

S
a
f
e
t
y

Maximum Levels of Vitamins &Minerals

Limits of Contaminants:• Heavy Metals Limits• Microbial Limits• Pesticides Limits

Product Interface Classification
Lists of Restricted Active Ingredients &Additives

Minimising Risk of TSEKey Phases of Harmonisation•
Finalisationof
Agreement&
Guidelines
Phase 1
Phase 2• Final Endorsement by TMHS PWG•
Signing
By
AEM
Phase 3Phase 4• Ratification & Implementation
5

Close to Competing Phase 2i.

The TMHSPWG has agreed on the instruments: “ASEAN
Agreement on Regulatory Framework for Traditional
Medicines” and “ASEAN Agreement on Regulatory
Framework for Health Supplements”.

ii. In order to clarify the term “Regulatory Framework” as usedin the titles that the Agreements do not include theharmonisation of the regulatory regimes of TM and HS, a“Question and Answer (Q&A)” has been developed by
TMHSPWG.

6HS Harmonisation Schedule• April/May 2019 = 31st TMHS PWG (Lao PDR)
• June 2019 = Finalisation/Endorsement of theAgreement by TMHS PWG• July 2019 – Jan 2020 = National approval procedures• February 2020 = Endorsement by ACCSQ• April 2020 = Signing of the Agreement by AEMs
• June 2020 – June 2025 = Ratification & Notification
to ASEAN Secretariat• June 2025 = Full Implementation by all ASEAN
7

Crucial Action to address
Implementation Challenges

9

Framework Transposed in Respective Country By?
Country2017

2018/19

2020…

2025

Malaysia
Indonesia
Philippines
Vietnam
MyanmarCambodia
Laos

TrainingofRegulatorsandIndustry

Transposition
into
Local
Law
May
Adopt
Early?

Harmonised

Thailand

BruneiSingapore10

Crucial Actions in Preparation for Implementation= AAHSA must push in TMHS PWG & separately
TRAINING•Training Regulators & Industry

LEGAL•Transposition into local law

TECHNICAL•Capacity Building esp SMEs

SPECIFIC•Reduce Country Specific Aspects
11

Support For Implementation 2019-20• Training for Regulators and Industry - major training programmeis ongoing---Stability study requirements training 4-6 October 2016
Safety Substantiation training 25-28 April 2017
GMP training 3-4 May 2017

• 2019 Key Activities- Claims Substantiation training for regulators & industry (IADSA / AAHSA )- SMEs training and capacity building (AAHSA / ASEAN Regulators)• 2020 & Beyond : Continued support for ASEAN harmonisation- IADSA/AAHSA strategic and scientific guidance/support for ASEAN TMHS Committee(ATMHSC) ie after the Agreement has been signed- IADSA/AAHSA to drive Increased participation from National HS Associations andmember companieso Target on minimising country specific requirements
o Focus on consistency in guidelines applicationso Tracking transposition to local law
o Initiate training as required- AAHSA/IADSA advocacy with respective Min of Trade and Min of Health toadvocate for quick adoption & transposition into local law

12

Next 3 Key TMHS PWG Meetings• 31st TMHS PWG Meeting is scheduled to be held in the Lao
PDR on 29 April - 3 May 2019.
• 32nd TMHS PWG Meeting, tentatively scheduled in the
October of 2019 in Kuala Lumpur/Penang.
• 33rd TMHS PWG meeting, tentatively scheduled in the 1st halfof 2020 in Myanmar. * Signing of the Agreement by AEMs.

13

Action & Timeline• TMHS PWG = Need to maintain current office bearers until 2020 /signing– No changes ie no rocking the boat
– National HS Associations to push for national implementation
preparation• ASEAN Secretariat = IADSA/AAHSA visibility and push for HS
Agreement signing– Clearly understand ASEC processes /procedures– Enlist ASEAN Secretary General & Team to push for implementation
preparation in member countries– Continued involvement in ATMHSC especially on implementation
challenges

14End of Presentation
Thank You forYour Attention

Thank You for Your Attention

Daniel Quek
Chairman
ASEAN Alliance of Health Supplement Associations
Sydney 10 April 2019

Thai FDA and
ASEAN Harmonization
Janjira Intra
Health Food Supplement Association(HFSA)

Thai FDA StanceFrom the 30th meeting of ASEAN TMHS:
I. Thailand reported their response on the comments of the
proposed modified text on the Annexes V (Stability and Shelflife) and VIII (GMP) received from the AMS.
II. Thailand conducted internal consultation on Annex V and
Annex VIII
Ø Ministry of Public Health (Thai FDA, Department of Thai
Traditional Medicines and Alternative Medicines)
Ø Ministry of Foreign Affairs (Department of Treaty andLegal Affairs, Department of ASEAN Affairs),
Ø Ministry of Commerce (Department of Trade Negotiation)
Ø Ministry of Industry (Bureau of the Industry Standards).

BackgroundA). Legal issues to enforce different GMP standards (PIC/S
GMP vs ASEAN GMP) for TM manufacturers (TM is apharmaceutical in Thailand)

The consultation
meeting
concluded that
Annexes V and
VIII are “grave”
constraints forboth TM and HS
industries inThailand.

b) Impractical enforcement of ASEAN GMP in HS
manufacturers co-producing other types of food products
under Thai GMPc) Technical capacities and unbearable economic burdens
for both TM and HS industriesd) The proposal to modify the texts in the Annexes V and
VIII in order to accommodate the “grave” concerns are not
the right approach in that there is high risk to various
interpretations that may potentially cause trade disputes
among AMS in the future upon implementation, and it does
not solve the problems but a temporary measure to address
the problems that will most likely re-surface in the future.

Thailand Proposal:
Thailand withdraw the proposed modified texts inAnnexes V and VIII from future consideration andrequested the omission of Annexes V and VIII from thedraft ASEAN Agreements for both TM and HS.

AMS Point of View (9 AMS except Thailand)• Annexes V and VIII are important Guidelines andagreed to be retained in the Agreements.

• The guidelines provide flexibility to accommodate thedifferences in AMS.

• The proposed additional texts on Annexes V and VIII
could be further discussed to accommodate Thailand ‘ssituation, without excluding Annexes V and VIII fromthe Agreements.

AAHSA and AATMI Points of View
• AAHSA shared that the HS industry is supportive of
the flexibility on the implementation of the
Guidelines, and for the AMS and industry to havecommon interpretations and understanding on theimplementation of the Guidelines.

• AATMI, coming from a legal view, shared that when
making a rule, not define in detail so it will not limit
the future. The existing flexibility provided in theexisting Guidelines is sufficient for AATMI.

HOD Meeting:
Option 1: Annexes V and VIII to be removed form the

HOD:

Agreements on TM and HS.
Option 2: To insert a language in Article 4 of theAgreements on TM and HS.
Option 3: To insert a language in Annexes V and VIII of theAgreements on TM and HS.

Meeting agreed to exclude Option 3 and focused on
Thailand’s proposal to remove Annexes V and VIII fromthe Agreements on TM and HS, and the 9 AMS tokeep Annexes V and VIII, taking into consideration the
proposed language from the ASEAN Secretariat to beinserted in Article 4 of the Agreements on TM and HS.

Thai FDA Organization
Secretary General
Dr. Tares K.

Food Bureau

Drug Bureau

HealthSupplement (HS)

Traditional
Medicine (TM)HS contains herbal with claims

Department of
Herbal Product

HFSA action plans to support HS Agreement tobe signed and implementation

SUBMIT LETTER TO THAI FDA ON
THE POSITIONING OF HFSA AND
INDUSTRY TO SEE THE
HARMONIZATION OF ASEAN. HFSAREQUESTED THAI FDA TO AGREE ON
BOTH ANNEXES.

MET WITH DIRECTOR OF HERBALPRODUCT (NEW DEPARTMENT OF
THAI FDA WHICH TM WILL MOVE
INTO THIS DEPARTMENT).

FROM MEETING WITH DIRECTOR
OF HERBAL PRODUCT, THE
DIRECTOR AGREED THATTHAILAND SHOULD ADOPT ON
BOTH ANNEXES.

What next?
HS: Thailand will agree with both Annexes.
TM: For the next meeting, TM might not be able to
finalize the agreement.
If TM moves to new department, high chance for
Thailand to agree on both annexes for TM.

AUSTRALIA

Australia: Leaders in Progressive
Legislation

Adjunct Prof John Skerritt
Deputy Secretary, Australian Department of HealthInternational Alliance of Dietary /FoodSupplement Associations
Sydney 10 April 2019

In Australia, dietary supplements are regulated
either as medicines or foods in Australia
Medicines (therapeutic good) if• they are “represented …..or in the way in which the goods arepresented…..likely to be taken to be for therapeutic use”
Foods if
• there is an Australian NZ Food Standard relating to the product(e.g. standard 2.9.4 for Sports supplements), or• they have a tradition of use as foods for humans in the form in which
they are presented
HOWEVER:
If a food standard applies, making therapeutic claims or presenting
the product as a medicine does not make it a medicine in law
1Why does it matter ?
Whether a product is regulated as afood or medicine will determine:• Who regulates it– The national medicines regulator (TGA), or– State and Territory food regulators (agencies
and/or parts of health departments)• What information the company sponsor
is required to hold• What product claims can be made,including in advertising
An online Food-Medicine Interface tool
helps in classifying dietary supplements
2

Food Medicine Interface: just because something is ina capsule or tablet form does not make it a medicine!
– Honey products– Vitamin gummies– Herbal teas
– Androgen modulators– Pre-workout stimulants– Weight loss products– Adulteration of ‘food’ products• Need to know who regulates if there areadverse reactions, packaging, tampering
or illegal ingredients, or advertising
issues• Has become more complex over recent
years as health claims are made in for awider range of products

Foods referred to
FSANZ andregulated at a state
and territory level

Therapeutic Goods
regulated by TGA at
a federal level3

But the rest of my presentation will consider
complementary medicines
Dietary supplements that are therapeutic goods usually
are categorised as “listed” complementary medicines
The over 11,000 Complementary medicine products on the ARTG contain one ormore designated active ingredients, each of which has an established identity:– Plant or herbal materials– Vitamins and minerals, Amino acids, Essential oils
– Homoeopathic preparations– Other substances such as: carbohydrates. Lipids, animal substances (e.g.
cartilage), microorganisms ( e.g. Acidophilus sp)
A major review of Australia’s regulatory system including
complementary medicines was carried out between 2014 and 2016
Reforms are being implemented between 2017 and 2020

4

A tiered system: Unless exempt, complementary
medicines supplied in Australia must be in the Australian
Register of Therapeutic Goods (ARTG)
LISTED MEDICINESREGISTERED

Complementary medicines

Over-the-counter

Prescription medicines
Low risk

High risk
5Complementary medicines are classified on theiringredients and indications (health benefits) they claim
AUST L

AUST L(A)AUST R

Listed medicines

Assessed Listed medicines

Registered complementary
medicines

No premarket
evaluation
•
•
•

GMP
Permitted ingredients
Permitted indications

Lower riskPremarket evaluation for
Efficacy only
(Intermediate level &permitted indications)••

GMP
Permitted ingredients

Can use a claimer

Full premarket
evaluation for:• Quality• Safety• Efficacy
Can use a claimer

Higher risk
6

Indications (health claims or benefits) andproduct classification
AUST L listed
medicines

AUST L(A) assessed
listed medicines

AUST R registeredcomp medicines

A low level indication

Intermediate indications

High-level indications

may refer to:that are not appropriate for thelist of permitted indications

that refer to theprevention, alleviation orcure of a more serious
form of a disease,ailment or injury•

health enhancement•

health maintenance•prevention of dietary
deficiency•

a disease, ailment,
defect or injury otherthan a serious form of
those diseases

Lower risk

Intermediate level indications
may refer to:•

the prevention,
alleviation, or cure of anon-serious disease/ailment•

restricted representations(i.e. a serious form of adisease)Higher risk

Evidence for AUST L listed medicines• Sponsor must hold evidence for all indications andclaims at the time of listing• Guidelines on the evidence required provide
information on: types of evidence and evidence sources
 quality and credibility of evidence how to present evidence• For a low-level scientific specific indication
 need an RCT OR an observational study plus a
review/ reference text/ monograph• For a low-level scientific non-specific indication

 two observational studies OR Two reviews,
reference text, monograph/regulatory review

8Indications can be based on a traditional
or a scientific paradigm
Traditional indications• present factual statements of a health benefit relating to a historical
record of use within a traditional paradigm• cannot make a scientific claim of efficacy e.g. lowers HB1Ac indiabetes• must be based on evidence of a history of medicinal use of theingredients or medicine– that exceeds three generations (75 years) and– is extensively recorded in recognised evidence sources for traditional
medicine

9

AUST L listed medicines
Only Permitted
ingredientsGood
manufacturing
practice (GMP)

Medicine listed
in the ARTG with
AUSTL number

Post-market
compliance

Only
Permitted
indications
10

Listed medicines - permitted ingredients
Permitted
ingredientsGood
manufacturing
practice(GMP)

Permitted
indications• Low risk ingredients that havebeen specifically approved by
the TGA, and present in asearchable database• Must not contain a scheduled
substance• Some ingredients may haverestrictions, such as:
 concentration limits
 route of administration
 plant parts
 type of preparation
 container type warning statements

Included in a
legislative
instrument

11Market exclusivity for new ingredients• A successful applicant for a new
permitted ingredient may ‘opt in’ tohave 2 years exclusive use of that
ingredient• The applicant can assign rights of useof that ingredient to others• At the end of the exclusivity period,
any company can include theingredient in their listed medicine
product
12

Good manufacturing practice
Permitted
ingredientsGood
manufacturing
practice (GMP)

Permitted
indications• Good manufacturing practice(GMP)− all listed medicines MUST be
manufactured under the
principles of GMP− ensures the products are of highquality• Medicines standard (PIC/S) GMP
but recognising the lower risks of
non-prescription oral and topical
products• Australian manufacturers must
hold a GMP licence• Overseas manufacturers must
hold GMP clearance certificate

13Permitted indications - AUST L
Included in a legislative instrument
Permitted

ingredientsGood
manufacturing
practice (GMP)

Must Relate to:– health maintenance - normal physiologicalconsequences for good health associated with aproduct, or provision of nutritional support– health enhancement - for normal healthypeople, such as improving, promoting, enhancing
or optimising body organs or systems.
– prevention of a dietary deficiency;

Permitted

indications– or for certain non-serious, self-limiting
diseases, ailments, defects or injuries - claim
can relate to the temporary relief of a particularsymptom
14Permitted indications• Transparency for industry on what indications are
accepted for listed complementary medicines• May also require a warning statement / specify
population for which the indication is not suitable• Avoids consumers from being misled byinappropriate indications to increase consumer
confidence in listed medicines• From 6 March 2018, all new listed medicines mustselect permitted indications …. and existing listed
medicines must transition by 6 March 2021
• Can alter wording on the product label (pack) if
the intent and meaning does not change
15

Using permitted indications
1. Select
tradition ofuse(mandatory fortraditional
indications)

Tradition of use‘Traditionallyused in Western
herbal medicine
to’….

2. Select corepermitted
indication(Mandatory)

Core permitted
indication‘Relieve
symptoms ofindigestion’4. Select specifying
qualifiers(Optional)

3. Select linked
indication(Optional)

Linkedindications‘Relieve abdominal
bloating’‘Relieve cramping’

Healthytargetpopulation

Time of use

Indication qualifiersTime of use: ‘after eating’Target population: ‘in
adults’Final permitted indication on product label‘Traditionally used in Western herbal medicine to relieve symptoms of indigestion (such as
abdominal bloating and cramping) after eating in adults’16

AUST L(A) assessed listed medicines• Ingredient must meet
Permitted
ingredientsGood
manufacturing
practice (GMP)

Intermediatelevel indications– safety (permitted ingredients) list
– quality (pre-approved GMP) of their medicine• TGA pre-market assessment of scientificevidence supporting efficacy of the indications infinished product• Must have at least one intermediate indicationthat is not included on the permitted indications list
– prevents cold sores– reduces symptoms of tinnitus– relieves rheumatoid arthritis symptoms• Can also include low level permitted indications• Have the option to use an efficacy ‘claimer’17

Claimer of efficacy• Sponsors of assessed listed medicinesand registered complementary medicines
have the option to indicate that theefficacy of the product has been assessedby the TGA• The claimer can be used on all
promotional materials and on the medicine
label• The claimer can be the approved symbol
and/or the approved label statement
Evidence for the approved indications has been assessed by the TGA
18

Registered complementary medicines• Full pre-market evaluation of quality, safety, efficacy of the product• Can refer to prevention or alleviation of a serious form of a disease• But must not refer to a prohibited representation
IngredientsGood
manufacturing
practice(GMP)

If evidence issuitable,
medicine isregistered in
the ARTG withan AUSTR
numberPost-market
monitoring

Higher levelindications
19

Use of comparable international regulators
evaluations for complementary medicines• Where possible, the TGA makes use of evaluations from certain
other regulators– for evaluation of a substance or a full product– for use in listed or registered complementary medicines• Complicated by the lack of alignment of different regulatory
systems internationally• Can use part or all of an evaluation e.g. just safety or efficacy
assessment• Will require applicant to submit the information to us

20

Post market (on - market) compliance for listedcomplementary medicines
Products may be randomly selected or targeted for review
Risk based regulatory approach includes:– desk-based audits of listed medicines – ‘compliance reviews’– laboratory testing of products and ingredients– monitoring of adverse reactions– recalls– audit of manufacturing sites– controls over advertising21

Where do our signals come from to monitor
for compliance and safety?
Internal
screening

TGA referrals

Other
Government
departments

Consumers

Industry

Signals

Outcomes ofrandomreviews
22

Compliance review outcomes
Where we identify a compliance problem TGA can:• Issue a proposal to cancel notice– sponsor has opportunity to correct the issue,
and product can continue to be marketed, OR– product can be cancelled if the concerns are
not addressed• Cancel product immediately – major safety issue• Suspend the product from the ARTG

• Recall the product from the marketplace
Cancelled/suspended medicines cannot be
supplied23

Overall, compliance is not very good
Random plus targeted
compliance reviews

2016-172017-18

July to June
Actions following a Request for Information
Medicines found to be compliant
Proposal to cancel notice/ warning sent by TGA

87
330

42
129

Total

417

171

Medicines cancelled by the TGA

17

10

Medicines cancelled by sponsors

84

45

Compliance breaches addressed

229

74

Total

330

129

Actions following Proposal to Cancel notice24Complianceproblems• Indications and/or ingredients
don’t comply with listing
requirements• Manufacturing, quality,
formulation• Labelling• Advertising• Unacceptable presentation• Evidence provided does notsupport claims made• Safety
TGA reviews do bring many
products back into compliance

Compliant
12%

Compliantafter
Proposalto Cancel
63%

Cancelled
by TGAafter
Proposalto Cancel
5%

Cancelledbysponsorafter
Proposalto Cancel
20%
25

TGA is implementing enhancements to thecompliance monitoring program
As consulted upon withstakeholders, these include:• More information on review
outcomes through publication on our
website• Greater targeting of sponsors foundto have non-compliant products• New online training modules forsponsors

26

Advertising of complementary medicines to thegeneral public• Regulated by TGA through a legally binding
Code, to support appropriate use of products
and advertising does not mislead or deceive• Mandatory pre-approvals of certain types ofadvertising will be abolished by 1 July 2020
• TGA now the single body responsible forhandling advertising complaints• Investigation and enforcement powers havebeen broadened• Sponsor education programs to assist incompliance also enhanced27

Aspects of the Advertising Code
• Requirements for ‘prominently displayed or communicated’ in adverts• New mandatory statements apply for internet sales (where purchaser
cant see physical product)• Comparisons in adverts cannot claim others are harmful or ineffective• Adverts cannot offer free samples (except sunscreens and condoms)• Scientific representations (cited research and scientific claims),
endorsements and testimonials carry particular disclosure
requirements• Requirements for advertising directed primarily to children• Requirements to have “health warnings” such as allergens
28Some complementary medicine products
have specific requirements• If based on traditional use, the paradigm must be prominently
displayed or communicated• Vitamins and mineral supplements must not claim they are a
substitute for good nutrition or a balanced diet
• Weight management product advertisements– Must balance claims with need for healthy energy controlled diet– cannot claim that supplement will reverse effects of over-eating– individuals featured in advertisements must represent average / expected
results

29

Classification of advertising complaints

30

Despite the most stringent regulatory schemes
globally, some consumer groups are not happy
Some groups have proposed:• Premarket evaluation of all products• Limitation of scientific claims• Abolition of traditional use claims• Sales of homoeopathic products not permitted• Larger number of complementary medicine on-market reviews• More immediate cancellations of products• More consumer education on products and their regulation31And even the average consumer says they
are unsure…despite widespread use ofcomplementary medicines

Responses from a July 2018 survey of random consumers(panel) commissioned by TGATGA also continues to receive over 100 new advertisingcomplaints each month, many relating to the advertising ofcomplementary medicines
32

BREXITImplications of Brexit

THE

BROKENBREXIT1th March 20

29
Leave onth June
0
3
o
t
n
io
Extens9
Leave on 12 thApril 2019 w
ith no deal?

2019?

Agreed with EU
last night: ‘Flexib
le extension’ to
31st October 201
9Implications?
Distribution

Product labelling
Health ID marks

LabourTariffs

Import system
Intellectual property
Export system

Free Trade
Agreements

Where will future UK regulation go?
Health claims“Little or no change for 2 years”

Novel foods‘Safety’ legislation

Devolved
Administrations

EU Exit Roundtable•Various government agencies•Monthly physical meetings•Weekly conference calls

What are
we doing?
Supporting our members!

Maintaining formal andinformal contact withdifferent government
agencies

Maintaining inter-industry
communication

Meanwhile…

…and normal life
carries on!
The Week, 29/3/19

Thank you for listening!
spj@berryottaway.co.uk
www.crnuk.org

CHINAUP TO SPEED…CHINA BRIEF
IADSA ⚬ SYDNEY ⚬ APRIL 2019

Social stability

TIMELINE …. 2018

Government Announced Reorganization
New
Government
AgencyCFDAFood Safety
Supervision

NFSC

AQSIQ
•
•

Imp./Exp. Food Safety
Local CIQs

SAIC

GAC

NHFPC

Responsibilities

SAMR• Market Order and Food
Safety Regulation• Registration of Health Food
• Food Safety Supervision,
Risk Assessment

GAC• Customs clearance & tariffs• Quality Inspection andQuarantine Regulation• Entry & Exit Enforcement

NHC• Health & Nutrition Planning• Food Safety & Nutrition
Related Standards

State Administration forMarket Regulation (SAMR)

Food Safety
CFDA
National Food Safety Committeeof the State Council

Market Order andCompetition

IPR Protection

SAIC: Direct selling, anti-unfair
competition, Consumer Protection;
Advertising;

SIPO: Pattern

MOFCOM: M&A Approval

CNCA

State Council's Anti-Monopoly
Committee

SAC

NDRC: Anti-price monopoly

SAIC: Trademark

AQSIQ: Geographical Indications

Acronyms for Government Entities:AQSIQ: the General Administration of Quality Supervision, Inspection and Quarantine
CDC: Centers for Disease Control
CFDA: China Food and Drug Administration
CIQs: China Entry-Exit Inspection and Quarantine Bureaus
CNCA: Certification and Accreditation Administration
GAC: General Administration of Customs
MOFCOM: Ministry of Commerce
NDRC: State Development and Reform Commission
NFSC: National Food Safety Committee of the State Council
NHC: National Health Commission
NHFPC: National Health & Family Planning Commission
SAC: Standardization Administration of China
SAIC: State Administration for Industry and Commerce
SAMR: State Administration for Market Regulation
SIPO: State Intellectual Property OfficeTIMELINE …. MARCH-APRIL 2019

AGENDA• SAMR structuralchanges• Impact on
functional foodpolicy, landscapeand operations

What happened?
The State Council
r
ge
n
o
l
s
No xisteState
Administrationof Industry andCommerce(SAIC)§ All responsibilities

r
ge
n
o
l
s
State
No xiste
Administration

r
ge
on s
l
No xiste
China Food &of Quality
Supervision,
Inspection andQuarantine(AQSIQ)

Drug
Administration(CFDA)§ All responsibilities§ All responsibilities

National
Development &ReformCommission(NDRC)

Ministry ofCommerce(MOFCOM)

The Office ofAnti-Monopoly
Committee of theState Council§ Pricingsupervision§ Anti-monopoly of
pricing sector§ Anti-monopoly
for concentrationof undertakings§ All responsibilities(originally basedin MOFCOM)

March 2018
March 2019

State Administration for Market Regulation (SAMR)* Local regulatory agencies have also been restructured accordingly……

28 + 2China’s unified market regulatory body§ 28 internal departments

Key oversight§ Supervises 2 state bureaus:§ Function food (dietary

National Medical Products
Administration (NMPA) andsupplements)

National Intellectual Property

registration/notification§ Food safety

Administration (CNIPA)§ Consumer protection

800+§ Advertising§ Over 800 officials in total§ Licenses & permits (business18§ Lawful portfolios cover 18 areas,

ZHANG, Maoe.g. business registration, market

Minister, SAMR

supervision & law enforcement,anti-monopoly, IPR protection,
domestic food safety, etc.

registration, food operation
permits, etc.)§ Direct Selling/anti-pyramid
schemeFOOD CLASSIFICATION IN CHINA

Food

General Food
Functional Food(= Health Food)Special Food
Requires pre-market authorisation)

Infant Formula
Milk Powder

Food for Special
Medical Purpose

Functional
Food
Registration

Two Track
Authorisation

Single Track
Authorisation

FUNCTIONAL (HEALTH) FOOD AUTHORISATION SYSTEM

July 1, 2016

1.Functional Food
Registration
2.Functional Food
Notification

27 FUNCTIONAL FOOD CLAIMSFOR ‘BLUE HAT’ REGISTERED PRODUCTS
1 Enhance Immune
2 Assist Blood Lipids Reduction
3 Assist Blood Sugar Reduction
4 Anti-oxidant
5 Assist Memory Improvement
6 Alleviate Eye Fatigue
7 Alleviate Lead Excretion
8 Clear the Throat
9 Assist Blood Pressure Reduction
10 Sleep Improvement
11 Facilitate Milk Secretion
12 Alleviate Physical Fatigue
13 Enhance Anoxia Endurance
14 Assist Irradiation Hazard Protection

15 Weight Control
16 Improve Child Growth
17 Increase Bone Density
18 Improve Nutritional Anemia
Assist the Protection Against Chemical
19 Injury of Liver
20 Eliminate Acne
21 Eliminate Skin Chlorasma
22 Improve Skin Water Content
23 Improving Skin Oil Content
24 Regulate Gastrointestinal Tract Flora
25 Facilitate Digestion
26 Facilitate Feces Excretion
27 Assist the Protection of Gastric Mucosa

SUPPLEMENT NUTRIENTS PERMITTEDIN NOTIFIED FUNCTIONAL FOOD

22 Vitamin and Minerals
Calcium, Magnesium, Potassium, Manganese, Iron, Zinc,
Selenium, Copper, Vitamins A, B1, B2, B6, B12, C, D, E,
K, Nicotinic acid, Pantothenic acid, Folic acid, Biotin,
Choline27 Claims forregistered functional
foods

Blue Hat

Vitamin/Mineral
Supplements
by notification

Approved ‘Blue Hat’ Registered Functional Foods
1800
1562

1600

1351

1400
1200

996

1000
800

705 682600

700 665

579
437

828

932
729
473

0

10

19
96
19
97
19
98
19
99
20
00
20
01
20
02
20
03
20
04
20
05
20
06
20
07
20
08
20
09
20
10
20
11
20
12
20
13
20
14
20
15
20
16
20
17
20
18

0

59

1097

834

832

824

806
492

400
200

1048

Only 10 new Functional Food registrations approved since July 2016

Meanwhile, approved functional food
notifications are booming, with domestic
notifications exceeding 2000 from July 2017
to March 2019

RECENT REGULATORY POLICY CHANGES FROM SAMR
Registrations and Notifications• strict control of functional food registrations with less new
registrations likely to be approved• more ingredients will be added into the functional food ingredient
list to allow more notified functional foodLabeling• an increase in functional food warning statements on productlabelsClaims• adjustments to the 27 functional food claims

PROPOSED FUNCTIONAL FOOD LABELING REGULATION

Current

Proposed  ; 
.
This product cannot replace a drug; Functional
Food has no disease prevention and disease
treatment function.
1. SAMR agreed to delete sentence of“functional food has no disease prevention”
2. Finalized and effective wording TBDPROPOSED CHANGES TO 27 FUNCTIONAL FOOD CLAIMSOn March 28, SAMR issued the drafting proposal for one month public comment to adjust
nomenclature and control of functional food claims. Effective timing is still TBD.
1. Pre-2005 grandfathered functional food claims approved by the Ministry of Healthq 18 functional claims will be canceled.
2. Current 27 functional food claims
q 18 functional claims will be renamed (requiring labeling modification):q 3 functional claims will be canceledq 6 functional claims will be suspended for further study, e.g., assist blood lipids
reduction
q Most changes add “help XXX”;
e.g. “weight control” will be renamed as “help adjust body fat”.

18 FUNCTIONAL CLAIMS TO BE RENAMED
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18

Current Function Claim

New Proposed Claim

Enhance Immune

Help Enhance Immune

Sleep Improvement
Alleviate Physical Fatigue
Enhance Anoxia Endurance
Increase Bone Density
Alleviate Eye Fatigue
Eliminate Acne
Eliminating chlorasma
Improve Skin Water Content
Anti-oxidant
Assist Memory Improvement

Help Sleep Improvement
Help to alleviate Physical Fatigue
Help to enhance Anoxia Endurance
Help Increase Bone Density
Help to alleviate Eye Fatigue
Help Eliminate Acne
Help Eliminating chlorasma
Help Improve Skin Water Content
Help Anti-oxidant
Help to assist Memory Improvement

Clear the Throat
Weight Control
Improve Nutritional Anemia
Regulate Gastrointestinal Tract Flora

Help to clear the Throat
Help Adjust Body Fat
Help to improve Nutritional Anemia
Help Regulate Gastrointestinal Tract Flora

Facilitate Digestion
Facilitate Feces Excretion
Assist the Protection of Gastric Mucosa

Help Facilitate Digestion
Help Facilitate Feces Excretion
Help to assist the Protection of Gastric Mucosa

6 FUNCTIONAL CLAIMS TBD AND 3 FUNCTIONAL CLAIMS TO BE CANCELED

Assist Blood Lipids Reduction
Assist Blood Sugar Reduction
Assist Blood Presure Reduction
Alleviate Lead Excretion
Assist the Protection Against Chemical Injury of Livercancel or keep, TBD
cancel or keep, TBD
cancel or keep, TBD
cancel or keep, TBD
cancel or keep, TBD

24Assist Irradiation Hazard Protection

cancel or keep, TBD

25
26

Improving Skin Oil Content
Facilitate Milk Secretion
Improve Child Growthcancelcancelcancel

19
20
21
22
23

27

A FEW CLOSING THOUGHTS ON FUNCTIONAL FOOD
REGULATORY AND COMMERCIAL STRATEGIESMAINTAIN EXISTINGFUNCTIONAL FOOD
REGISTRATIONSCROSS BORDER ECOMMERCE 2017-2019
WILL LIKELY EXTENDCONSIDER PRODUCTFORMULATIONS BASEDON PERMISSABLE
NOTIFICATIONNUTRIENTS

INTER-GOVERNMENTNEGOTIATEDRELATIONSHIPS

Thank you
RicHobby@Herbalife.com

iadsa.org

INDIAINDIA

COMPLIANCE DOCUMENTGMP: INTEGRATION WITH FSSAI- FOSTAC INITIATIVE

Training Package prepared by ReCHaN included
under FoSTaC training program•

ReCHaN in collaboration with FSSAI initiated a
Consumer Awareness program at Eat Right Mela
held on 14-16 December 2018, IGNCA, New Delhi.

•

A Guidance Kit intended to create a sensitizationon the myths and facts about Health Supplements& Nutraceuticals and their impact on overall healthwas developed and distributed•

To support this initiative, an Animated Video wasdeveloped, educating consumers on the basic
aspects in both Hindi and English language.

KNOW YOUR SUPPLEMENTS

7https://twitter.com/IADSA_Global?lang=en

CLAIMS TRAINING

Dr David Richardson
Dr Andrew Shao

TRAINING ON VITAMINS &MINERALS, MAX LEVELS

Mr. Basil Mathioudakis
Dr B.H. Lim

VALUE OF SUPPLEMENTATIONRESULTS

1. FSSAI confidence in the sector
2. Joint communication to consumers
3. Opportunity to talk directly to the scientific panel
4. Training the regulators
5. Open the door to review the 1X RDA limit for VMs
6. Institutionalize relationship with government

HOW SECURE IS THIS?
1. Keep delivering value
2. ReCHaN is not a trade association
3. Create bridges with other influencers

iadsa.org

LATIN AMERICAUp to speed:

What is going on
inLatin America?
Juan Pablo Waimann- Executive Manager

Who are we?
The Latin American Alliance for Responsible Nutrition (ALANUR)
is the main regional association of food supplements andingredients in Latin America
Headquartered in São Paulo, Brazil

Founded in November 2011 with the purpose ofcontributing to the development of a regulatory
framework that ensures the responsible access of foodsupplements and ingredients in Latin America

Overview• Latin America at a glance• Opportunities for our sector• Challenges for our sector• Key takeaways

Latin America at a glance
20 sovereign states
Population: +612 million

Languages: Spanish, Portuguese, French
GDP (nominal): USD$ 5.2 T
GDP per capita (nominal): USD$ 9,274
GDP growth 2019: 1.7%
2 countries with GDP over 1T: BR and MX

Latin America at a glance
Argentina Others
Chile

VDS largest markets
in LATAM
2018

1.79%

8.06%

2.84%

Ecuador
4%

Colombia

Brazil5.03%

41.58%

Peru
8.21%

Brazil & Mexico represent 70% of the total
MexicoSource: Euromonitor International

28.49%

Latin America at a glance
VDS market growth 2014-2018 (%)
40,00%

Argentina (28,4%)
Chile (11,4%)
Brazil (9,9%)
have been the fastest
growing markets
in the 2014-2018 period

35,00%
30,00%
25,00%
20,00%
15,00%
10,00%
5,00%
0,00%-5,00%

2014

Argentina

Source: Euromonitor International

2015

Brazil

Chile

2016

Colombia

2017

Ecuador2018

MexicoPeru

Opportunities for our sector
Latin America

Steady growth continues
VDS market growth vs. LATAM GDP
growth (%)
10
8

8,6
7,2
6,2

6

6,4

7,2

4
2

-0,434

1,01
0
-2

2014

0,084
2015
REGIONAL GDP GROWTH

Source: Euromonitor International

2016

1,676
2017
VDS MARKET GROWTH

1,2
2018

• Our market has performed
with a healthy rate of growtheven if the regional GDP has
stagnated• The regional sector
experiences the second
highest growth rate globally
after APAC
• Interest on healthy lifestyles
and nutrition are strong
driversCementing a long-term trend

Source: IADSA, The Evolution of the Health Supplements Sector. From the 1990s to the current dayFormidable evolution of the regulatory landscape✔Regulatory frameworks improved drastically vs. a decade ago✖Normative divergence is vast, evenbetween members of the same trade bloc
Regulatory
landscape2011

Specific regulation for FS
No specific regulation for FS

Formidable evolution of the regulatory landscape✔Regulatory frameworks improved drastically vs. a decade ago✖Normative divergence is vast, evenbetween members of the same trade bloc
Regulatory
landscape2019

Specific regulation for FS
No specific regulation for FS
Specific regulation for FS being developed

Formidable evolution of the regulatory landscape

Ecuador (2017)

Bolivia (2018)✔ Highlights of our regulatory impact in recent years

Brazil (2018)

Uruguay (on going)
Argentina (on going)Renewed levels of normative certainty for
LATAM’s largest market
BrazilNew Brazilian bloc of regulations for food supplements (2018)✔ A sound definition for the category✔ Notification procedure for most products✔ Maximum levels for micronutrients not based on RDA✔ 189 authorized claims in a positive list
✔ A positive list of +350 ingredients

Pop.: 200 million
USD 1.8 B market+40% of the LATAM market
9.9% CARG (2013-2018)✖ Probiotics✖ Botanicals and other ingredients not included in the positive list
✖ Levels for specific micronutrients

Renewed impulse for regulatory harmonization
Pop.: ~225 million
Mexico40% of regional GDP

Colombia
Peru

Growth will surpass regional average up to 2021

Chile
2nd, 3th, 4th and 6th largest FS markets in LATAM
USD$ 1.9 B in 2018
7% CARG for the sector (2013-2018)

Pacific AlliancePacific Alliance harmonization initiative
May 2017
Harmonization
annex

2013
Industry
agenda isintroduced

2014

2015

2016

2017

2018

2019

Industry proposal isalignedGovernments agreement
Reglamentary work on the proposal

Increased knowledge on our consumers
Mexico (Planned)

Colombia (2019)
Peru (2018)✔ Consumer surveys have beendeveloped for LATAM largest FS
markets✔ Questionnaires are mutuallycomparable for most data
✔ Results to be used as a tool for
raising governments awarenessBrazil (2015)
Chile (2018)
Projects developed by ALANUR
Projects developed by ALANUR partners
and third parties

Challenges for our sector
Latin America

Main regulatory challenges
Key stakeholders still hold misperceptions of the category
A vast diversity of regulatory definitions & categories
Prolonged registration processes

Restrictions in the use of health claims and in advertising
Restrictions in the use of some ingredients in specific countries
Probiotics
Enzymes
Botanicals
Bioactive compounds

Specific sub-regions and countries require
extensive regulatory reformCentral America has the most underdeveloped
regulatory frameworks in our region✔ ~47 million people✔ CAM is evidencing the highest rate of growth of LATAM✔ PA & CR are projected to enjoy some of the highest GDP
per capita rates in LATAM✖ Regulatory reform is required for market growth tomove along GDP growth
FS regulated as foodFS regulated as drugs✖ Incentives for sub-regional harmonization are very
lowCentral America has the most underdeveloped
regulatory frameworks in our region
How are we responding?

GuatemalaHonduras

El Salvador

Costa Rica

✔ From harmonization to convergence✔ Focusing our effors on the national level✔ Achieving national improvements to be
spread to the rest of the countries

Nicaragua

PanamaHarmonization is inherently complex & requires time
Prominent pending proposals:
MexicoColombia
Peru
Chile

• Negative list of botanicals• Harmonization of maximum levels for
micronutrients• Health claims
Increasing the expertise of public decision-makers
is deemed vital✖ Ideological collision with the sector in Chile✖ The new administration in Mexico increased
the levels of uncertainty

Pacific AllianceHarmonization is inherently complex & requires time

MexicoHow are we responding?

Colombia
Peru
Chile

Pacific Alliance✔ Aligning the industry position✔ Streghtening the technical resources ofnational associations✔ Working along public authorities in theirown countries

Key takeaways• In the last 10 years the regional regulatory landscape has
improved substantially, but not harmoniously: normative
divergence is still an issue.
• We are better equipped to fight misperceptions thanks to thedevelopment and use of consumer surveys.
• Harmonization is still considered vital to make LATAM market
more attractive and lower costs. However, the process is longand complex.
• Taking into account the experience from the EU and ASEAN canshed light on our own harmonization processes.

• General macroeconomic stability has made LATAM more
attractive to FDI and the growth of the sector is showing
resiliency

Thank you !
info@alanurla.org
juanwaimann@alanurla.org

www.alanurla.org/ALANURNEW ZEALAND

Natural Health Products
New Zealand
Regulatory Update
IADSA

10 April 2019

Samantha Gray

WHO WE ARE
NEW ZEALAND INDUSTRY SECTORREGULATOR ENVIRONMENT AND
PROGRESSMISSION STATEMENT
The collective voice of thenatural health products industry of New Zealand
VISION STATEMENTNatural Health Products New Zealand represents
an innovative and collaborative industry that istrusted worldwide as a leading provider ofnatural health products

Strategic Imperatives
To be regarded as the authoritative and public voice of theindustry in
NZ and internationally
To build trust in the industry collaboration and innovation
Support members through regulatory and legislativechanges and improvements

Who is Natural Health Products NZ• The industry association in New Zealand for natural
products, including dietary supplements, plus more
140 MEMBERS
Industry Partners
11%
Retailers2%
Branded Goods
33%

Manufacturing
6%

Ingredients
16%

Services
32%

Voice of the industry•

Representing over 85% of the industry

For a full list of members go to: www.naturalhealthproducts.nz/members

SECTOR AND SALES TRENDS

NZ’S NATURAL HEALTH
PRODUCTS SECTOR
70% of NZ export earnings are from biologically
based industries
Natural health products have made a significant
and growing contribution to NZ’s GDP over past
decade.
Natural health products exports are a significant
and growing contributor
NZ’s clean green image, ethics and high quality
manufacturing standards mean that natural healthproducts are trusted in export markets

Last Sector Survey• NZ$1.4bn contribution to economy (+40%)• 85% of respondents export, over $285 million
per annum• Strong growth projected• Primary export markets are Australia, China –UK, USA and Europe

2014 Sector Survey

Sector Survey• Quality rather than cost driven• Strongly positive perceptions of NZ as amanufacturing provider• Strongly positive perceptions for– unique and innovative products,– product integrity, safety, quality, cost
– and clean and green image

STANDARDS AND REGULATIONNZ Manufacturers- High Standards, safety assured• NZ's natural health products industry is quality-driven rather thancost-driven, so has high product quality, safety and efficacy
standards.
•

NZ law requires products to be true-to-label.

•

Most natural health products manufacturers belong to Natural
Health Products NZ, which helps to ensure high quality standards
are maintained.

• Many of NZ's natural health products manufacturers export theirproducts and therefore already have to comply with a range ofinternationally recognised requirements (e.g. TGA (Australia),
Organic (Biogro and AsureQuality), Halal, Kosher, NSF (USA),
Medical Devices by Medsafe, ISO for Medical Devices (USA), meet
PIC/S GMP standards, etc.)

Natural Health Products Bill
• NHPNZ has long been advocating for an update to ourregulatory system, and continues to positively engage with
the new coalition Government.
– An appropriate regulatory system that reflects our unique culture,
identity and place in the world– Safety and efficacy are paramount– Consumer information, to make informed comparative choices about
efficacy and quality is fundamental– Our regulatory system must meet these needs and allow NZ to engage into global market place to capitalise on opportunities for export growth– We are demographically a small country/industry so aligning all our
industry is paramount to success – NHPNZ represents over 80% of ouyr
sector– Our MMP political system both reflects these values and provides
challenges to achieving these goals.

Natural Health Products
Bill-19 years……

NZs Current Regulatory
Structure
Food

Dietary Supplements

General Foods

Food Type

Therapeutic TypeMPI
Food Act

Medicines
Medicines

MOH
Food Act

Food Act

Medicines Act

Food Standards Code Supplemented Food Dietary Supplements
Standard
Regulations

Medicines
Regulations

Sports or
InfantNutrition

ManukaWounddressing

ManukaHoney in a Jar

Nutraceuticals
Vitamins etc

FAIR TRADING ACTMPI = Ministry for Primary Industries MoH = Ministry of HealthWe were nearly there –what happened ……
Condition of the coalition agreement at the time of the last electionthat the Bill was removed from the parliamentary order paper
Subsequently a private members bill introduced – not fit for purpose
and was withdrawn
In mean time Dietary Supplements 1985 extended to March 2021
NHPNZ lobbying has resulted in a new plan now being worked on by
the Ministry
Ready late 2020
May not meet next General Election deadline
Group of dissenters active
NHPNZ are hopeful
Ministries plan is:
To provide advice to Ministers
Starting with a survey of industry!

16Thank youUSAFour Issues for the U.S.
Supplement Market(and how the industry is responding)
Steve Mister
President & CEO
Council for Responsible NutritionCouncil for Responsible Nutrition

Four Issues for Discussion:• Legalization of CBD• Supplement Facts Changes• FDA Modernization of Regs

• Retailer, Third-Party Certification

Council for Responsible Nutrition

1. A Legal Pathway to Market CBDin Food and Dietary Supplements• Prior to December 2018, all cannabis sativa, including both hemp andmarijuana, was considered a Schedule 1 controlled substance in the
U.S.
• The 2018 Farm Bill, a comprehensive package of legislation affecting
agriculture, removed hemp and its non-THC constituents from theControlled Substances Act. Article must contain <.3% THC.
• Many falsely viewed that new law as removing ALL legal barriers to thesale of hemp and CBD. It did not.
Council for Responsible Nutrition

CBD: Is it Legal in the US?
• FDA maintains CBD and “whole spectrum hemp extract” containing
CBD, are prohibited from use in food or supplements for reasons
unrelated to the CSA, its THC content, or its relationship to marijuana.
• FD&CA defines a “dietary ingredient” and expressly excludes any“article” that was first subject to substantial clinical investigations as adrug prior to being sold as a food or supplement. 21 USC §321(ff)(3)(B)• But the provision also allows FDA to use its discretion through noticeand comment rulemaking to alloinw use of the article a food or
supplement—even if the drug was subject to substantial clinicalinvestigations first.
Council for Responsible Nutrition

So Is It Legal, Or Not?
• FDA has issued numerous warning letters (but no further
enforcement) against CBD products making illegal drug (disease)claims.
• The agency continues to insist CBD is illegal in food and supplements,
but asserts it is open to exploring “a legal pathway to market.”• Then FDA proposes that a regulatory pathway could take 3-5 years; alegislative approach from Congress may be faster.
• Meanwhile, FDA concedes it is exercising enforcement discretion andonly prosecuting those cases where the product is making unlawful
disease claims.
Council for Responsible Nutrition

How Does the Industry Respond?
• FDA Public Meeting scheduled for May 31.
• Most major retailers have resisted the temptation to sell food andsupplements containing CBD; a couple are selling topical products
without making claims.
• Small retailers and online platforms are selling CBD or whole hemp
extract in all forms.
• CRN has announced it will consider CBD marketers for membership.
• Industry continues to pressure FDA and Congress to act, and to impose
other supplement requirements on products marketed as
supplements.
Council for Responsible Nutrition

2. Supplement Facts Label Changes• A 2017 FDA regulation mandates changes to the
Nutrition Facts and Supplement Facts labels,
effective January 2020.
• The Percent Daily Values have changed for many
nutrients to reflect updated science.
• Added sugar must be disclosed prominently.
• Fiber has been defined to eliminate somecarbohydrates• International units (iu) have been replaced withmilligrams (mg) or micrograms (mcg)• Folic acid listed as folate
Council for Responsible Nutrition

How Industry Responds• CRN launches an education campaign to address consumer andretailer questions and concerns about the impending changes to
the Supplement Facts Label.
• The campaign will fill the knowledge gap and assure the labelchanges are expected, viewed positively and perceived as helpful.
• Messaging underscore that the dietary supplement industry is
regulated.
• The label has not been updated in over 20 years. In that time,science has developed and the American diet has changed.
• Supplement Facts labels are changing to better provide
information consumers need to make informed choices.
Council for Responsible Nutrition

Campaign Toolkit• www.BeLabelWise.org• Fact Sheet

Produced by CRN to guide discussions• Infographic

Produced by CRN/optimized for social sharing• Microsite: BeLabelWise.org
Produced by CRN to curate materials• Explainer Video

Created with outside vendor• Social Media Content

Produced by CRN for sharing by members/partners• Bylines/Blog Posts

Produced by CRN for partners to share

Council for Responsible Nutrition

3. FDA Recommendations to Modernize
Dietary Supplement Regulation“ a routine part of the American lifestyle”“I’ve personally benefitted from the use of
dietary supplements”“as a physician, [I] recognize thebenefits of certain supplements ”“It’s clear to me that dietary
supplements play an important role in
our lives as we strive to stay healthy.”“DSHEA imposes a number of requirements around the
manufacture and labeling of dietary supplements.”“we achieve the right balance between preserving consumer
access…while…protect[ing] the public from unsafe and unlawful products.”
Council for Responsible Nutrition

FDA Recommendations• Gottlieb’s statement promised a public meeting this spring on“responsible innovation” to be held May 16th
• New rapid-response tool to alert consumers to unsafe products• Updated compliance policy for NDIs
• Botanical Safety Consortium• New enforcement strategies• Additional steps “to modernize DSHEA”:• Dietary supplement exclusivity• A product listing requirement
Council for Responsible Nutrition

How Industry Responds• Industry preparing to raise issues around definition of dietary
ingredients (e.g., “nutritive value,” synthetic botanical constituents,
items that increase daily intake)• Clarity around New Dietary Ingredients• Grandfather date that separates “old” and “new” ingredients• Alternatives to NDIs: in the food supply, GRAS self-affirmation• When is an ingredient chemically altered?

• How can FDA incentivize innovation?
• Master files for NDIs and piggy-backing on supplier safety data
• Actual enforcement of IP from a “public safety” agency
Council for Responsible Nutrition

FDA Proposes a Mandatory Registry“A mandatory listing requirement could provide significant benefits by improving
transparency in the marketplace and promoting risk-based regulation. It could also
help facilitate efficient enforcement of the law and establish new mechanisms toidentify bad actors who put the public at risk and undermine consumer confidence
in the entire industry.”
Statement of FDA Commissioner Scott Gottlieb, Feb. 11, 2019
“This proposal would require all products marketed as “dietary supplements” to belisted with FDA and give FDA authority to act against non-compliant products andthe manufacturers and/or distributors of such products. This would allow FDA toknow when new products are introduced, quickly identify and act against
dangerous or otherwise illegal products, and improve transparency and promoterisk-based regulation.”
FDA Justification for Budget Estimates, Statement to Congress, March 18, 2019

Council for Responsible Nutrition

FDA asks:“[I]s it possible to design a product listing regime that helps us protect
consumers and level the playing field for responsible industry
participants by making it easier for us to take swift action against
illegitimate and dangerous products, such as products that are tainted
with drug ingredients? And is it possible to do this without disrupting
the balance struck by DSHEA, and without imposing any significant new
burdens on responsible firms? The answer to these questions may very
well be yes.”Statement of FDA Commissioner Scott Gottlieb, Feb. 11, 2019

Council for Responsible Nutrition

A Mandatory Product Listing:
How Industry Responds• The U.S. voluntary industry registry, the Supplement OWL, launchedin 2017, continues to grow.
• Industry evaluating the concept of an FDA-administered database anddeveloping a position.
• Consideration given to “must-haves” from FDA and possible trade offs
and concessions. Stay tuned….

Council for Responsible Nutrition

4. Retailer Demands for Quality
Assurance / Third-Party Certification• Retailers increasing imposing their own requirements for quality andcertification of GMPs, in addition to federal regulations.
• Increasing need for harmonized standards for third party audits for
GMP certification and supply chains to create uniformity of audit
standards and create efficiencies for both manufacturers andretailers.

Council for Responsible Nutrition

How Industry Responds• Industry-led initiatives to develop harmonized standards for bothsupply chain quality/integrity and for GMP inspections• Benchmarking of third party standards and certification of theauditors.
• Encouraging major retailers to forestall their own requirements for
widely agreed upon standards to promote efficiency as well.

Council for Responsible Nutrition• New ANSI-accredited standards toevaluate a dietary supplement firm’s
adherence to cGMPs.
• Coming soon: Auditing scheme using
these standards and trained auditors
accepted by retailers as satisfying
their cGMP requirements.

Council for Responsible Nutrition

Thanks for listening!
For more information, see our website at www.crnusa.org
or contact me at smister@crnusa.org

Council for Responsible Nutrition