WELCOME to the - ingredientsonline.com · Vice President Sales/Marketing. INTRODUCTION FACTORY-DIRECT ... (Amway Corp), Robinson Pharma, ... Implement a Plan Recognize Progress

WELCOME to theFACTORY-DIRECT GLOBAL SOURCING EVENT

SO CAL ROADSHOWFEATURED FACTORY SPONSOR: BBFY

https://www.ingredientsonline.com/

A B2B E-COMMERCE PLATFORMCONNECTING BUYERS AND SELLERS WITH NUTRITIONAL INGREDIENTS

I N T RO D U C T I O N


I N T R O D U C T I O N

DAVID JIExecutive Vice PresidentBusiness Development

EXECUTIVE TEAM

SHERRY WANGFounder and President

PEGGY JACKSONVice President Sales/Marketing


FACTORY-DIRECT

FACTORY-DIRECT ONLINEB2B E-COMMERCE MARKETPLACE

FACTORY CUSTOMER


SERVING FIVE INDUSTRIES

• DIETARY SUPPLEMENT

• FOOD & BEVERAGE

• COSMETIC

• ANIMAL NUTRITION

• PHARMACEUTICAL


CURRENT DATA

• 5,000+ Registered Members• 74% Reorder Rate• 1,000+ Ingredients• 200+ Factories• 180+ New Registrations Per Month• 145,000+ Page Views Per Month


TOP INGREDIENT SALES BY VOLUME

• ASCORBIC ACID

• BCAA

• CITRIC ACID

• CoQ10

• CREATINE MONOHYDRATE


TOP INGREDIENT SALES (CONTINUED)

• L-CITRULLINE

• L-GLUTAMINE

• STEVIA

• SUCRALOSE

• TAURINE


FACTORY PARTNERS IN THESE COUNTRIES

• CANADA

• CHINA

• FRANCE

• GERMANY

• INDIA

• INDONESIA

• ITALY

PAKISTAN •

ROMANIA •

SOUTH KOREA •

THAILAND •

UNITED STATES •


FACTORY TRANSPARENCY

We encourage everyone to meet our factory partners

• Executive level meetings at customer facility offering technical support and exchange

• Arrange customer visits to audit our factory partners

• Arrange for meetings at various events throughout the year


ASSOCIATIONS

Please view our video presentation here:https://www.youtube.com/watch?v=G60KScOaYiQ

https://www.youtube.com/watch?v=G60KScOaYiQ


TRANSPARENCY


WHY INGREDIENTSONLINE.COM?

Size of U.S. Supplement Market• $41 billion U.S. supplement industry by product category

(vitamins, minerals, herbs, etc.)

• $196 billion U.S. nutrition industry by channel (natural & specialty, mass market, multi-level, etc.)

Source – Nutrition Business Journal – Supplement Industry Report, 2017


RESOURCE SAVINGS WITH INGREDIENTSONLINE.COM

Save Time, Save Money with Radical Transparency- Eliminate Broker/Distributor Added Costs

• 798+ ingredient brokers/distributors

• According to Datamyne, less than 10% of those directly import

• $40B in U.S. supplement sales at a estimated rate of 25% in raw material costs or $10 billion



• With brokers/distributors taking 10% to 15% margins, that is conservatively $1 billion to $1.5 billion in added costs

• These savings are calculated for the U.S. supplement industry only



• The savings for all those categories is billions and billions of dollars.

• No waiting on middlemen for documents or products. Order factory-direct online instantly, 24/7!

SPEAKERS


S P E A K E R S

FEATURED SPEAKER

Jim Lassiter oversees all consulting divisions at Ingredient Identity, leveraging over 40 years of experience in quality control and regulatory & government affairs in the

pharmaceutical, food, dietary supplement and cosmetic industries for companies and organizations such as Nutrilite (Amway Corp), Robinson Pharma, Irwin Naturals,

Chromadex, AHPA and CRN. He served on numerous industry and trade boards and is a contributing author to several online and print media forums.

His work has received notable recognition in trade publications and journals including

the Food and Drug Law Institute Update, Natural Products Insider, The Tan Sheet and FDA Weekly. A recognized and respected voice of the industry, Jim frequently offers his

insight at various discussion forums, webinars, conferences and panels of industry renowned experts. Jim holds a M.Sc. in Biochemistry from Berkeley and an M.B.A. from

Pepperdine.

Jim Lassiter

Chief Operating OfficerIngredient Identity

Founder/COO - Jim Lassiter, M.Sc. MBA©2018 INGREDIENT IDENTITY

GUIDANCE � DEVELOPMENT � COMPLIANCE©

Founder - Jim Lassiter, M.Sc. MBA©2018 INGREDIENT IDENTITY

GUIDANCE � DEVELOPMENT � COMPLIANCE©

Do You Suffer from RD*?

*Regulatory Dysfunction

Objectives

Understand the Law and Regulatory Structure

Understand the Roles of FDA and FTC

Understand the Challenges RD Creates

Labeling and Claims

Manufacture, Packaging and Distribution

Know the Basics to identify the Need

Learn where the current regulatory ”squeaky wheels” are

Identify upcoming regulatory challenge

Determine what you can do

Identify what to emphasize going forward

©2018 INGREDIENT IDENTITY

The Basics

Congress Passes LawsFFDCA: 1938Rogers/Proxmire Amendment: 1976NLEA: 1990DSHEA: 1994FALCPA: 2004FSMA: 2011

Regulatory Agencies Interpret the LawRegulationsGuidance DocumentsAdditional Pronouncements

Regulations and Actions Carry the Force of The Law


21CFR §101.93 – Structure/Function Claims Requirements

FTC Guidance Regarding Promotion of Dietary Supplement Products

Discussions and Notations from FDA on various topicsInflammation

Social Media

Regulatory actions against companies

Critical Regulatory Items

©2017 INGREDIENT IDENTITY©2018 INGREDIENT IDENTITY

There are NO regulations telling you specifically what NOT to say

There are classes of claims other than structure/function and therein lies the challenge

Interpretation is the key and the cause

The audience is IMMATERIAL

Additional Regulatory Items


Avoid Drug ClaimsThe five Magic Words

Avoid Specific AreasCholesterolBlood SugarInflammationChelation

Watch Out for Every Changing Hot Button ItemsWeight LossSexual EnhancementInflammationCardiovascular Claims (delicately handled)

Know the Difference in ModifiersPromotesSupportsHelps Maintain

Some Critical Elements


Regulatory Caveat: It DependsQuality of the ScienceApplicability of the ScienceAdequacy of the Science

Key Words that May be UsedImproves [rarely]Promotes . . . . Benefits from . . . .Helps with . . .Supports . . . .

What Can YOU Say


Regulatory Caveat: It DependsLabelLiteratureElectronic LiteratureTraining SessionsSocial Media

Each has its own pitfalls and opportunities

Where Can You Say It


FDA Discovers FacebookKey Elements:

Is it YOUR page?Is the Testimonial “liked”?Is the Testimonial from and Expert?Is the Testimonial “over the line”?

Clean Up the Act RoutinelyBlogs, Private Pages, Password Only Access

No safe harborIntent is NOT sufficientWatch the link-outs as well

The Social Media Challenge


Everything PrintedPaper or Electronic

Everything SaidTraining SessionsHandoutsSponsored Presenters

Expert TestimonialsGenerally FTC governanceBased on Clinical ExperienceWatch the Corporate Relationships

Say Again?


Just because it’s truthful doesn’t mean you can say itFree Speech vs. Controlled Speech

Science Can Pose ChallengesSubstantiation using HEALTHY populationsDeclaratives out of one studyDifference between an ingredient and a productKnow the Quality of the studies

TestimonialsDocumented Mechanism of Action

Science and Controlled Speech


GMPs are 11 Years OldFDA is Probing More In DepthExpectations are higher

Requirements for ManufacturersDocumentationTesting

These are NOT the Only Folks with RDOwn Label DistributorsAnyone who does anything with the product

The Production


Simple ThingsMMRs and BPRs

Requirements and detailsComponent Specifications

Details in dysfunctional statesFinished Goods Specifications

Details in What is TestedDysfunctional Approaches

Greater DetailMethodsReferencesDysfunctional application of technology

Fundamentals


The expectations are more detailedYield CalculationsExemption from TestingSignatures in placeDates AND times of activitiesDetails of the steps performed

The expectations are NOT newDiscretion to dateDysfunctional to date?

Details


Seems SimpleSimple dysfunctionRequired to know the performane of their contractors

Audit of contractorsBatch RecordsShared Responsibility

Quality OperationsDo you distribute?What do you need to be functional?

Own Label Distributors


ScienceSubstantiation of claimsTesting of the componentsTesting of the finished goodsSupport for the testing chosen

Instructional DetailsThe “how to” portion of your functions and activities

What is Functioning Next?


HistoryThe way we’ve always done it

Uneven enforcementNot even noticed within the operationThere is no Little Blue Pill

Causes of Dysfunction


What We’ve Always DoneCertificates of AnalysisSkip Lot TestingTesting Only a Little

What We Don’t DoGather SubstantiationDocument our Functional CuresTest Appropriately

There are some allowancesSTOP relying on FTIR or NIR

Historic Challenge


They Said it – Why Can’t We?Wait your turn – and theirsHow much do you want to risk?How much do you want to spend?

If THEY said it What Can You Do?NADFTCFDA

Know the ramifications of the attackKnow that turn-about is fair playKnow that “justice” is slow

The Dysfunction of Uneven Enforcement


Production RecordsMMRs and BPRsAll Elements and Requirements

Testing MethodsAppropriate

Current USP Is 41Suitability to Purpose

Contract Lab EvaluationANY OOS activities

Material ReviewInvestigationsDocumentation

The Documentation of Function


Determine to FunctionRisk aversion – How Much Do You Want?Learn to know where the trip wires areEvaluate Each documentLeave History behindKeep an attorney on speed dial – not necessarily on retainer

The Company Determination


The Current AdministrationNOT an acceptance of dysfunctionDoes NOT control the enforcersDetailed evaluation of existing regulationsYes, delay has occurred but . . .Administrations ChangeThere is NO effort to roll back regulations

Administrative Relief


RD is a Serious IssueAcceptable:

Details in the processMeeting All of the Obligations

DocumentationSubstantiationMethod Performance

Unacceptable:Coming Up Short on DocumentationComing Up Short on ImplementationComing Up Short on Compliance

What Is Your Dysfunction?


Initial StepsAdmit you have the problem

It’s nothing to be embarrassed aboutIt’s totally fixable

Commit to ComplianceBe RationalBe Efficient

Identify the Gaps

Treatment of RD


ActionsBe reasonableBe circumspectImplement a Plan

RecognizeProgressTraining NeedsProcess not a Project

Dealing with RD


RD is not uncommonHistoric causes“Nature of the Industry” causes

RD can lead to more serious challengeFDA is digging deeperExpectations are higher and actions more severe

RD is very treatablePlan, Commit, Implement, RepeatSeek professional help – but not reliance

Summary


THANK YOUJim Lassiter

Ingredient IdentityChief Operating Officer

[email protected] x403

mailto:[email protected]

FEATURED FACTORY


2018.06.06

Who We Are - BBFY Industrial USA

• Subsidiary coporation of BBCA Group in China

• Started business in America in 2010

• Specialized in the ingredient of food/feed industry

• 20,000 square feet warehouse both in CA and NJ

• Biggest player in U.S market of Citric Acid and D-aspartic acid

• Total revenue in 2017 is 40 million USD

��

��

What We Can DoProducts:

• Citric Acid• D-Aspartic Acid• L-Alanine• DL-Malic Acid• Biotin Pure• L-Ascorbate-2-Phsophate

Service:• Prompt shipping, standard documents, quick response to the clients.

��

BBCA/BBFY and ingredientsonline.com™

• Partnership in the very beginning of the online platform was built

• BBFY became one of ingredientsonline.com’s™ golden members

• Strong support for each other

• Both of us are optimistic about the development of this online platform

in the raw materials industry in the United States

��

BBCA Group is a Major Bio-chemical Technology and Innovative Multinational Enterprise.

Revenue in 2017: 1.5 Billion USDTotal Employee: 11,000

1958

Bengbu Chemical

Plant

Bengbu Citric Acid

Plant

(3000MTs/year)

New patent of citric acid fermentation

technology (6000MTs/year, the third

largest in China)

1. BBCA Group founded

2. BBCA Biochemical founded

and listed (60,000MTs/year

of citric acid ,the largest in

China )

BBCA Pharmaceutical founded and listed

APIs:

1. Analgesics-antipyretic drugs

2. Anti-inflammatory

3. Cardiovascular

4. Anti-biotics

5. Anticancer drug

1. 220,000MTs/year of citric acid the

largest in the World

2. 100,000MTs/year of lysine

3. 300000MTs/year of fuel ethanol

4. 100,000MTs/year of MSG

Total corn consumption: 3million tons per

year

BBCA History

19951995

1977

2000

2003

2006

1999

2006BBCA Biochemical was sold to COFCO

2009

2015

Second business design completed.Plants were relocated to BBCA Industrial Park which is 50KMs from the center of Bengbu City. 17 projects will be started in the Industrial Park.

2018

BBCA Group was reformed(state-owned shares were reduced from100% to 30%)

Thailand Citric Acid Plant (80,000MTs/year)

�� BBCA History

First Stage:• Plan to implement a total of 17

projects and 5 billion RMB investment

Progress:• By the end of 2017, 10

projects and about 3.38 billion RMB investment has been completed

• The rest of the projects will be done by the end of 2018

• Total Revenue: 4.5 Billion USD

Second Stage: • The local government has

stimulation plan and provides strong support in line with BBCA PLA product development

• Total revenue: 5 Billion USD

Industrial Develop plan

��

BBCA Industrial Park

Five Core Boards

BBCA biological• Lysine • Threonine• Alanine

BBCA biological• L- lactic acid• Malic acid

Tiger Biotech• VC derivatives• B vitamins

BBCA Biomaterial• Injection grade PLA• Fiber grade PLA• Film blowing PLA

BBCA Pharmaceutical• Pharmaceutical• Antipyretic-analgesia• Cardiovascular• Anticancer• Antibiotics• Antivirus

Industrial chain amino acid, organic acid company

ProfessionalVitaminManufacturer

Bio-based new material leader

Top 50 listed Chinese pharmaceutical companies

��

��

The Whole World Nets

Organization ��

► Citric acid and citrates► Lactic acid► DL-Malic acid► L-Malic acid► Fumaric acid

Organic Acid► Lysine► Threonine► L-Alanine► D-aspartic acid► L-aspartic acid

Amino Acid

► VC and its derivatives► Biotin► Folic acid► VB5► VB6

Vitamins

Products

► Corn starch► Crystal glucose► Crystal Fructose► Malt dextrin► Sorbitol

Starch and Starch Sugar

► Gelatin► Acetaminophen► Aspirin-dl-lysine► Triethyl citrate► Cilnidipine► Naftopidil► Lysine hydrochloride► Fructose► Glucosamine

APIs and Intermediates

��

NORTH AMERICA BBFY Indutrial USA Inc.

BBCA AMERICA

►BBFY in CaliforniaStarted in 2010, 50 miles from the Los Angeles-Long Beach harbor.

►BBFY in New Jersey.Registered in 2013, 30 miles from the port.

��

Corn Glucose Lactic acid PLA

The Process of new bio-material — PLA

Green fiber - the main alternative to chemical fibers in the future (PET, PBT, PTT, etc.) - Cloth

Green plastics - the main alternative to petrochemical plastics in the future (PeEEEEEEEEEEEE, PP, PVC, etc.).- Cups and plates.

Bio-fermentationtechnology Extraction, purification and polymerization

PLA

Saccharity

��

CORN Lac Acid PLA

Green fiber

Green Plastics

AdvantageEnvironmental protection Anti-flaming Skin-friendly Anti-miteBreathability AntibacterialNon-moisture regain

Application of Poly Lactic Acid PLA��

THANK YOU

TRANSPARENCYIN QUALITY CONTROL PROCESS

Q A / Q C

S P E A K E R S

FEATURED SPEAKER

Felicia Ly is the QA/QC Manager at ingredientsonline.com™ and one of the most integral parts of the team. With her wealth of product and regulatory knowledge, Felicia is responsible for all aspects of quality, manufacturer/product qualification, and internal and external regulatory compliance. Previously, Felicia has worked at Paragon Laboratories as their QC Microbiologist in addition to establishing their vendor qualification program. Felicia has also held a position at Organic by Nature, Inc. as their QA/QC Manager.

With her Bachelor of Science degree in Microbiology, Immunology and Molecular Genetics from UCLA, Felicia puts her skills to work ensuring products and their manufacturers meet and uphold the proper standards for quality and safety. Felicia can regularly be found at our major trade show booths to answer any and all of your questions regarding QA/QC at ingredientsonline.com™.

Felicia Ly

QA/QC

Q A / Q C

1. FACTORY QUALIFICATION

Factories must pass our Qualification Program before we bring them onto our platform.

PURPOSE: Ensure factory operations are compliant with GMP regulations and that the factory has the means to produce quality ingredients. HOW: Factories must complete self-questionnaires and provide detailed descriptions of their procedures.

THERE ARE THREE STEPS FOR FACTORY QUALIFICATION:

Q A / Q C


STEP 1: DOCUMENTATION

QUESTIONNAIRE #1: GENERAL BUSINESS QUESTIONNAIRE• Provides basic information about the manufacturer/company as a

whole. • Allows us to get to know the company and gives us basic background

information about the factory.

Q A / Q C


STEP 1: DOCUMENTATION (continued)

QUESTIONNAIRE #2: GMP QUESTIONNAIRE• Requires the factory to provide a detailed explanation of their

procedures related to cGMP topics. • Questions the factory about procedures related to manufacturing,

packaging, labeling, holding, distribution and quality.• Allows us to get insight on how the factory runs and if they have the

proper procedures in place to maintain the integrity of their products.

Q A / Q C


STEP 1: DOCUMENTATION (continued)

ADDITIONAL DOCUMENTS• Factory Certifications – as an indicator of standard compliance

• Examples: GMP certification, ISO 9001 (Quality Management Systems), ISO 14001 (Environmental Management), ISO 22000 (Food Safety Management), BRC, FSSC 22000, etc.

• Factory SOPs and related documents – as an indicator of how procedures are implemented & followed through on

• Food Safety Plans – as an indicator of how product safety is taken into account

Q A / Q C


STEP 2: ON-SITE AUDIT

• Decisions to perform an on-site audit are based on the information gathered during documentation review. On-site audits are performed by either IO’s Quality Control Manager or in-house SGS-trained QA auditor.

• On-site audit includes an intensive 20+ page audit inspection checklist.

• Covers topics ranging from site security to product testing.

Q A / Q C


STEP 3: FACTORY GRADING

• Factories are initially graded based on how they perform during this qualification process. Factories must exhibit sufficient ability to produce and maintain production in a cGMP compliant manner in order to be qualified.

• Factories are given a score from 0 -100. They must earn at least 70 points to be a qualified factory.

Q A / Q C


STEP 3: FACTORY GRADING (continued)

As we continue to work with the factory, additional factories are taken into account to determine their grade. This includes:

• Product conformance to specifications• Factory responses to inquiries and complaints• Quantity of quality-related returns• Competitive pricing• On-time shipments and delivery, inventory availability

Q A / Q C

2. INGREDIENT QUALIFICATION

Ingredients are pre-approved before they are added onto the platform.

THERE ARE THREE STEPS FOR INGREDIENT QUALIFICATION:

Q A / Q C


STEP 1: ABILITY

When factories request to introduce a new ingredient onto the platform that isn’t currently existing, we research it first to make sure it’s appropriate for use. This includes searching for:• FDA warnings listed about the product• Known/proven health hazards about the product• Inclusions on the WADA Prohibited List

Q A / Q C


STEP 2: DOCUMENTATION

If there are no issues with the product in general, factories must provide ingredient-specific documentation for review. This includes documents such as:• Specification Sheets• Safety Data Sheets• Sample Certificates of Analyses• Allergen Statements• Composition Statements

Q A / Q C


STEP 3: PACKAGING INFORMATION

• If all supporting documents about the ingredient appear in order, understandable and useful, we will request packaging configuration information. This way, we know what to expect when we receive new products.

• This also allows us to determine if the packaging configuration chosen by the factory is suitable for the product. For example, light sensitive ingredients shouldn’t be packaged in transparent poly bags.

Q A / Q C

3. PRE-SHIPMENT TESTING AND INSPECTION

STEP 1: FIRST DOCUMENTATION REVIEW

• Our China-based QA/QC department reviews and approves product batches before releasing shipments to our U.S. warehouses.

• Certificates of Analyses are reviewed and compared against Specification Sheets.

Q A / Q C


STEP 2: MATERIAL REVIEW

• For new products or products that have not been qualified, the QC personnel perform a physical inspection on the material.

• Basic physical tests and microbial contamination tests are performed on the product to ensure compliance to basic specifications.

• The product is physically examined for organoleptics, homogeny and foreign matters.

Q A / Q C


STEP 3: SHIPPING CONDITIONS

• Pallet conditions are checked and verified to make sure the product is secured. Pallets must be in good condition and placement of the product onto the pallets must be organized to minimize possible damage during transit.

• Once shipments are received at our U.S. warehouses, our local teams inspect the shipments again to make sure everything is intact and untampered with.

Q A / Q C

4. MATERIAL QUALITY AND CONSISTENCY

RANDOMIZED, PERIODIC TESTING

• We know that adherence to specifications is imperative, so for our own internal peace of mind, we do randomized periodic testing on batches we have in stock to verify manufacturer-provided data.

Q A / Q C


WE TEST THE PRODUCTS AGAINST THE MANUFACTURER’S SPECIFICATIONS FOR:

• IDENTITY• PURITY• STRENGTH• COMPOSITION• LIMITS ON CONTAMINANTS

Q A / Q C


• We only use U.S. laboratories with ISO 17025 accreditation.

• We already have confidence in our factory partners; this just helps strengthen that.

Q A / Q C

5. WAREHOUSING AND CUSTOMIZED SHIPPING

WAREHOUSE SET UP

• Warehousing plans and procedures are established with the goal of efficient order processing and protection against adulteration in mind.

• Products remain properly sealed and stored in good condition to minimize cross-contamination.

Q A / Q C

5. WAREHOUSING AND CUSTOMIZED SHIPPING

ORDER FULFILLMENT

• Any customized shipping requirements you have get recorded into your customer file. This information is reviewed with each one of your orders to ensure that you receive your order the way you want it.

• Before an order is shipped or picked up from our docks, we perform a three-inspection check to make sure the order is fulfilled correctly.