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Dietary Supplement Recall


January 17, 2020 — Dietary Supplement Recall announced for 1,200 products from 850 supplement distributors made between January 2013 and November 2019.

FDA Supplement Recall
FDA Supplement Recall on 1200 product from 850 companies made from 2013-2019

ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. (the “COMPANIES”) is conducting a nationwide recall of ALL lots of its dietary supplement products pursuant to a Consent Decree entered by the U.S. District Court for the Eastern District of New York. This recall applies to all dietary supplement products manufactured and sold between January 2013 – November 2019 and all lots of products are included in this recall.

These products are being recalled after an FDA inspection found significant violations of current good manufacturing practice regulations. Manufacturing practices that are not in adequate control represent the possibility of risk being introduced into the manufacturing process resulting in finished supplement products with decreased identity, purity, strength and composition.

To date, there have been no reported illnesses or injuries as a result of this situation.

The COMPANIES contract manufactured dietary supplements for other firms and did not sell products directly to consumers. Link to Press Release


Contract Manufacturing Advocacy and Recall Prevention

It’s important to recognize the differences between GMP certification and GMP verification.

If you own a supplement brand, and are not 100% sure whether your supplement contract manufacturer is meeting FDA requirements, contact us.


Here is the list of supplement brands and own-label distributors affected by the recall:

9Round LLC
A-Game
A & E Medical Supply
A Ham
A Twin
Abacus Pills
Abigon-Wilde Research LLC
Absonutrix
Abulon Ltd
Accelerated Intelligence
Active Beauty
Active Remedy
Acuintegra
Adapt Sport Supplements
ADK
Adnanbadnan Industries DBA Love Mom
Advanced Blend Inc.
Advantage Wellness
AFS INC
AFUW LLC
Akta Innovations
Alcyon Health LLC
Alhambra Group Inc
All By Usa LLC
All Star Health
Allied Bait, Beverage, and Yarn
Aloha Turmeric
Alpha Formula Labs
Alpha Wolf Nutrition LLC
AlphaBolix
Alternative Laboratories
Altius Nutraceuticals
Always Plug LLC
AMAZING COMMERCE
AMAZING PRIME LLC
America Medic & Science LLC
American  Health Formulations
Ames United Pte Ltd
AMP NUTRA INC
AMZ DIRECT
Amz Sales
ANNE BEAUTY LTD
ANS NUTRITION
Antiaging Institute of California Inc.
APLOS NUTRITION
APOTHEOS LLC
Apothoes LLC
Apricot Power
Arem Nutritionals
ARIGEN NUTRITION LLC
ARROW VITAMINS
Art is Hearted
ASQUARED BRANDS
Athlete Elite
Athletic Elite 10
Atronarch Media Solutions Inc.
AV LABORATORIES
AVADOR BUSINESS GROUP
AWAKEN HEALTH AND WELLNESS
Awakened Alchemy
Axis Labs
AYURVEDIX HERBAL HEALTH PRODUCTS
AZOE Enterptises
Azoth LLC
B2 Industries
BACIAMI
BALLISTA GROUP
BARANSU
BARATS AND BURKE PRODUCTS
BARRE BOOST LLC
Barrientos Inc
BarSpout, LLC
Basic Organics, Inc
Basis
Bauman Medical Group
BE AND BE HAPPY
BE HERBAL
Beautiful Once Again
Beauty Group LLC
Bee Nutritional & Packaging LLC
Bee Xtreme LLC
BeLive
BELLA ALL NATURAL
BelloHoldings LLC
Bergen Bulldog Supplements
Best  Vite
Best Nutritionals LLC
Binh Nghia MST. CO.LTD
Binto
Bio-Energy System
BIO-REBALANCE
BIO-TECH PHARMACAL
BioFinest
BioHackMD
Bionatures
BioPhysiko
BIOS LLC
BIOSCHWARTZ LLC
Biotech Factory
Bishalnagar
BJKB Inc. Pain & Stress Center
Black Doctor LLC
Black Edged LLC
BLACK SHEEP SUPPLEMENTS
Bluvos Energy LTD
BMO Nutrition
Bobby Buka MD Dermatology
BODIKORE
BODY EARTH
Body Nutriceuticals LLC
Bona Dea Boric
BonCalme LLC
BONE BROTH BROTHERS
Boost Beauty LLC
Borlan Industries
Boston Functional Nutrition
BOSTON SANTE INC
Botanycl Ltd
BOTTOM LINE LIVING LLC
Boyett LLC
BPI SPORTS
BR International
Brain Mind Body L.L.C.
Brainvincible GmbH
Brandable
Break Ventures
Brilliant Ways
BROKER NUTRITION
Buddah Brain
BUNCH BROTHERS
Busy Life Brands Inc.
BUY AMERICA GROUP, LLC
Cambridge Institute for Better Vision
Campanella Holdings LLC
CANADA ENTERPRISES LLC
Caraway Vitamins
Carecam International
CARRIAGE TOWN USA
Catalyst Nutraceuticals
Catalytic Edge Lifestyle
CAYS LLC
CB SUPPLEMENTS LLC
CELINE WANG
Cellreon Corporation
Centurion Sellers LLC 
Century IQ
Certified Nutraceuticals
CERTIFIED ORGANIC ESSENTIAL
Charcohol LLC
Chengdu Nutri-Packs Health Technology Co.
Chews-4-Health, Inc.
Chic Shakes
CHILAN MERA LLC
Chiral Balance LLC
Chiropractor Future, inc.
Chosen Pro Fit LLC
CLASSWARE LLC
Claudia Berciotti
CLC Nutracuticals
CLEAN AND HAPPY LIVING
Clean Tribe Co. LLC
Clean Victory LLC
CloudX
Coaches Nutrtion LTD
COGNITUNE
Cognitune LLC
Coinfort LLC
COLIN COONS LIMITED
COLLAGEN FOR HER
COMPREHENSIVE MEDICAL WELLNESS
CONVALESCENCE
COOPER COMPLETE
CoreIngredients Vietnam Company
CORNER CHAIR
COURAGE NUTRITION
Creating Health Nutrition
CTE JONES LLC
Cyber Group USA
Cynergy
Cyrene LLC
D&L INVESTMENTS LTD
DAILY NEURO
Damage Control
DAN LANDMANN MD
DANCE2FIT
David Agudelo
David Parker Ventures
DC Stewart Nutrition Labs
De Lune Inc
DECENT HEALTHCARE
Dee Cee Lab
DEMD 860
Derivative Nutrition
Destine
Deswill integrated services INC
DIAMOND ARMOR
Diet Standards LLC
DIETITIAN’S BEST
DIP TRADE INC
Dishes for Dogs LLC
DISRUPT MN
DIVINE HEALTH
DN Global Trading
DNS NUTRITION
DOC VITAL HEALTH
Doctor Jess MD LLC
DOCTORLIFE SP Z.O.O.
Dom Medical
Download Apps Services, Inc
Dr. Boz LLC
Dr. Ernesto Herger
Dr. Moritz Inc
DR. NORMAN’S MYRTLE BEACH DIET
Dr. Olivia Naturals Inc
Dr. Owusu Skincare & Wellness, LLC
dr. russell imboden pc
Dr. Scott’s
DR.KETO
Du Soleil Noir
DUVOLLE BRANDS INC
EARTHLING NATURALS
East Coast Group NY LTD
Eastward Brands LLC
Edible Health Ltd
Elements First
Elmira Imports LLC
Elysium Health
Emperor International Network FZ LLC
Empire Koz LLC
EMS ORGANICS
Energy By Science
Eniva USA, Inc.
ENZO Nutrition LLC
Enzymotec Ltd
EQUINOX NUTRACEUTICAL
ETS.OT VENTURES LTD
Eurark LLC
Everlife LLC
EVERSCO
EVL Nutrition
EVOLVING HEALTH
EZ-BUGZ
EZ Commence In
EZYABSORB PTE LTD
Faris Bros, LLC
Fayza Rhaimi AB
Feed Me More Nutrition
FEEL GREAT 365
Femelabs LLC
Fight Brands LLC
FINEST VITAMINS
FINEVINE
First Opps
Fit and Focused Supplements
Fitness Innovative Technologies LLC
Fitness One Formulas LLC
Flex Fit Lives
Flora Optima
FLORIDA SUPPLEMENT
FLYBY VENTURES
FMDK Consulting Ltd
FROMM Carolina
FTM Brand LLC
FUNCTION NUTRITION
Furst Place Nutrition
G & L Medical Company Limited
G.O.A.T. NUTRITION LLC
Gainzville Athletics
GameChanger Nutrition
GCSB, Inc
GearBox Rx, Inc
GemPak
GENERAL WELLNESS COMPANY (PVT) LTD
GENIE DEPOT LLC
Gentech Nutrition
Ghayal Global
Ghost Nutrition
Gives Health
Global Health and Wellness Group
GLOBAL NATURALS
GLOBE TRADER SOURCE
Gloryfeel Global GmbH
GN TRADING LLC
GnuPharma Corp
Go Pure Labs
Golden Life Blends
Golden Protein
Golgotha pharma  LLC
Goliath Marketing Services LLC
Good Brands
Grateful Health
Graystone LLC
Green Bracket LLC
green fettle
GREEN WEALTH PHARMACY
Green Wood Biotech LLC
GREENHEALTH PHARMACEUTICALS
Greenpoint Nutrition Labs LLC
Gro Hair Vitamin
GTOGBRANDS LLC
Gussy Proteins LLC
GYM GEM GUMMIES
HA COMPANY D.O.O
Habit Hair Hearts
HAIR BLAST
Hair369 LLC
HairBurst
HARMONY LIFE USA
Harvest Trading Group
Hatfield Holdings Company
HCitySite.com, Inc.
Health Management Group
HEALTH SOLUTION
Health Support
Healthy and Beauty Group Inc
Healthy Belly Company LLC
Healthy Healing Enterprises, LLC
Healthy Life Creations
Healthy Living Proteins
HEAVEN’S ENERGY LLC
Helios Healthcare Consultants
her fit club
HERBAL CARE USA LLC
Herbalists Best
Herbalore
HERBAN HEALTH
HERBTONICS
Hercules Laboratory Group
HeyMate Health
Highland Laboratories
Highmark Nutrition
Hillside Naturals
Holiday Cove LLC
Holistic Health Center
HOLISTIC LABS LIMITED
Holistic Media Inc
HolyLand Botanicals
HONGKONG SHARED DREAM
HormoneSynergy Inc
HP Ingredients, Inc
HYBRID NUTRACEUTICALS LLC
I&Z INTERNATIONAL CORP
IcySpicy.com LLC
IDEA MAN LLC
Ievgen Barskyi
Ignite Media LLC
IGNITE OKAMI LTD
iHeart Nature
INDALO LLC
Infinities Life 101 LLC
Infinity Maximus
Ingredient Evolution
Ingredient Evolution Customer
Inner Armour Sports Nutrition
INNOVATIVE MARKETING LLC
INNOVATIVE REMEDIES
Intelligent Holdings, Inc
Intellivite, Inc.
INTRACELL NUTRITION
iNutrition
IRON BROTHERS
IRON PUSHERS
Isolator Fitness
ITTT
IXANDA
Jackson Raider Consulting, LLC
JILL CHRISTENSEN INC
JISBC Trading INC
JL HALE LLC
JMH Capital, LLC.
JOHNSON INVESTMENT GROUP
Joie Organics
JPK Nutri
JUMPING CARROT INNOVATIONS
Juniper Mountain LLC
Kamire Nutrition LLC
Kaori Rodman
Kapsulations LLC
KARL IMPORTS
Karmin Professional
KB MIDWEST DISTRIBUTORS
Kelker Pharma
Kelsey Park Limited
Kennedy Wellness Labs
KEPREA, LLC
KERRI DEVINE
Kessep Dermaceuticals
KETO 22
KETO BOOM
KETO5.COM
KEVIN J JONES
Key to Youth LLC
Kilburn Industries
Kings Best Nutrition
KIRKLAND SCIENCE LABS
KISS MY KETO
KITCHEN KARMA
KO NUTRITION
Komodo Pharmaceuticals Inc.
KOVOH NUTRITION
KS LA UG
KYZIA
Labrada Nutriton
Lacehold Limited
LASVEGASDIET
Lazarus Enterprises Inc
LDL81.LLC
Leaf Biome, LLC
Leaner Living
Lemon Box
LET’S LOSE
LEVERAGE ENTREPRENEURS LLC
Lexington International LLC
LFI Labs, Inc
LIDCA LLC
Life Botanica
LIFE CARE PRODUCTS
Life Pharmacy
Life Pulse Inc
Lifebrook, LLC
LIFTED PRODUCTS
LIGHT WITHIN LLC
Limitless venture Group, Inc.
Lingroup Global LLC
Liquid Assets
Lisanne Wellness Center, LLC
LITE NUTRACEUTICALS
Liv Body LLC
LIV GLOBAL LLC
LIVE INFINITELY LLC
LIVE LIFE INNOVATIVE
Living Essentials Inc
Living Health Care
LNRBIZ LLC
Loan from -jahirul
Local Rewards
LOFTWELL LIMITED
Loocid Labs
Lubbock Sports Medicine
Lucky Nature Inc.
LUMINOWAY CORP
Luna Pharmaceuticals Inc.
LuxGanix
Lycol Pharma
Made Nutrients LLC
Mademoiselle Hair Vitamins
Mahima For Life
MAI MIND & BODY
Maine Natural Health
Maju Superfoods LLC
Makers Nutrition
Maks Ventures LLC
Mammoth Fuel
Manikinn Group Pty Ltd.
MARC FIT NUTRITION
Marina Naturals
Mashay Inc
Masta Corporation
Mat Rat Supplements
MAV Nutrition
MaxFire LLC
MAXIMUS PHARMACEUTICALS LLC
McPherson Labs, Inc.
MDR Fitness Corp
Me By Kiki
Me Power LLC
Me Professional BV
Medza llc
MELCHEL CS INC
MENSAH ALLIANCE GROUP
METABOLIC MELTDOWN
MetaFormula International
METONE LIFE
Metrosel Inc.
MHNY Global
Michigan Cherry LLC
Mighty Ant Nutrition
Millenium Natural Health Products
Mind Body & Coal
MINDX
MMTUM Inc.
MO4T, LLC
Modexus LLC
MOJDEHRx LLC
Monarca Marketing LLC
Moon Oral Care
MORE NATURAL HEALING
MORHAIR
Moringa Source LLC
MOSS NUTRITION
MTC Industries Inc.
Muhammad Qureshi
Muriello Muscle Products, LLC
Muscle Feast
MYOPRYNT NUTRITION
N & S Supply INC
N.A.T.E
NASSENTIAL HEALTH
NATIVE WISDOM LLC
NATRILLIUM INC
Natura Lifestyle Produce Inc
NATURAL EDGE HAWAII INC
Natural Health Corner
Natural Health Corp
Natural Products Corp
NATURALISTIX
naturals food 360 LLC
Naturamone
Nature’s Beneficials Inc.
Nature’s Boost
Nature’s Love
NATURE’S ONLY CHOICE
NATURE’S PROPERTY
NATURE FITS YOU
NATURE MAMA LLC
Nature Smart
NatureALL Inc.
NatureLab Corp.
Natures Cures
Natures MD
Naturiste
NaturMents
Naxos Nutrition LLC
Necessity Nutrition
Neff’s Naturals
Neoblends LLC
New Beginnings Nutritionals
New Pharma Inc.
next generation supplement
NEXT LEVEL ATHLETICS LLC
nextPHARM sp. z o.o. Sp.k
NHS Gold Corp
NIKETO
No Jitter Caffeine
Nolies Naturals
NomNom Now Inc.
Nootrous Supplements LLC
North East Development Commision Billing
Nova Medical Health Care Trade LLC
NOVUSERA
Nuevo Nutrition
NUGEMA RESEARCH
Nugru Inc.
NUOPTIMAL
NURA NUTRITION
NUTRACHAMPS INC
NutraCode
Nutraglow
Nutrakey
NUTRALIVE
Nutrapak
NUTRELIXER
Nutrend Products, LLC.
NUTREX RESEARCH INC
NUTRI SOLUTIONS
Nutri trade llc
Nutrimark
NutriMarket S.A.
NutriMedika Corp.
NUTRITION BOD LLC
Nutrition For Healing
Nutrition Mode
NUTRITION WORLD
Nutritional Resources,Inc
O POSITIVE
OAT Organization
Ocean Blue Life
OcuServe
Omega Health Products LLC
Omnite LLC
Oneword, Inc
ONN INVEST OU
Optimal Health Systems
Optimal Lifestyle LLC
Organax Ltd
Organic Benefit
ORGANIQUE SCIENCE
Organs Life Sciences
ORIGIN LABS LLC
OSL Labs
Osyris Nutrition Lab
Over Powered Energy
Oz Detox LLC
PALEO LIFE LLC
PALEOVALLEY
Palm Beach Nutra, LLC
Pangea Biomedical Ltd
Paradise Supplement
Paragon Fruits
PASTOR-VILLAREAL INC
Paul’s Family Store LLC
PAVILION COMPOUNDING PHARMACY LLC
PCOS NUTRITION
PEACE&CO
Peachy Lazuli
PEAK FIT LABS
PEAK PERFORMANCE
PEAK VITALS
PEMBERTON OUTFITTERS
PEPPERWOOD INTL LLC
PERFECT ORIGINS
Perfect Supplements LLC
Persimmon Health, LLC
Personal Care Healthy Living
Pharma Cap Labs
PHARMATECH
Pharmatech USA LLC
Pharmethicals
PHENIX XXI
Pinnacle of Wellness
Pivot Labs LLC
Positive Naturals LLC
Potent Supplements LLC
Power Co. Nutrition LLC
Powerful LLC
PR SOL TRADING CORP
PRETTY FIT
Primal Life Organics LLC
Prime Business Group, Inc
Prime Vitamina
Primerose Hill Inc
Primeval Labs
Private Label Supplements
Proactive Sciences LLC
PROBIORA
Products Development LLC
Progene Healthcare Inc
PROGRESSIVE HEALTH NUTRACEUTICALS
PROMETHEUS WELLNESS LLC
Prospera Supplements LLC
PROTEITH SOLUTIONS
ProX Formulas
PURA NUTRIENTS
PURBODI LLC
PURE AFFINITY
Pure Health Naturals
Pure Life Keto Inc
Pure Life LLC
Pure Naturals LLC
PURE PRESCRIPTIONS
Pure science supplements
PURE STAR ENTERPRISE LIMITED
PURITY PRODUCTS
PUT ME ON BHS INC
Python Holdings
Quick Weight Loss Centers, LLC
RADIANT MEDICAL
RAMSLING
Rask Health LLC
Raw 1 Nutrition
Raw Complexions
Raw Purities
Real Health Products
Real Herbs Limited
RED FOX USA LLC
Reda Saad Medical
REDFIELD GLOBAL LLC
Rediston LTD
RegenaLife, LLC
REGENTEC PTE LTD
Regora Pharmaceuticals Inc.
Rejuvenation Technologies Inc.
Relay Peak Research LLC
RELEVIUM
REMPA PHARMACEUTICAL LLC
Restore Hair Restoration
Revita
Revive Naturals
Ricolife, LLC
Rizie De La Nawa
RKC
RM BIOSCIENCE
RM Discounts Direct, LLC
RMM Trading CO LLC
RNC Limited
Rokeda LLC
ROOD CONSULTING
RooFormance
RR NUTRITION
RSP Nutrition
RTG Commerce
SalesVenue Inc
Salt Supplement Co.
SAPIEN PRODUCTS LLC
Saving Dinner
Schizandu Organics
Science Backed Naturals
Script Essentials
SDC NUTRITION
Secucom, LLC.
SENSHI NUTRITION LLC
SFK Discount Properties
SHADOW SUPPLEMENTS
Shanab Pharma E.U
Shedavi
SHEER STRENGTH
Shefinity Inc
SHWANY SERVICE CORP
SIARHEI MAKRYTSKI
SilverOnyx LLC
SIMPLISTIC CANDLE SHOPPE
Sirin Sports LLC
Skyview Naturals LLC
Smart Fitness Products
Smash Bid LLC
SMASHTECH
Smoky Mountain Naturals LLC
SoCal Herbal Remedies LLC
Soflete LLC
Source Omega
SOURCE VITAL, LLC.
Spark Punch LLC
Sportika
Squad Tour Pty
STAGES OF LIFE MEDICAL INSTITUTE
STAYWELL NUTRITION
SUGAR LUSH HAIR
Summit Rx, Inc.
Sunup Nutritionals LLC
Sunvita Health
Superior Supplement Manufacturing
Supernatural Man LLC
Supernova PTE
SuperNutrient Corp.
SUPPLEMENT HUNT
Swan Trading Corp, Inc.
SYBA CORP
SYLVIA CHIMHINA GROUP
Synaptent
TANGOR
TAO AD-VENTURES LLC
Targe LLC
TCS
Tea of Life Health Inc.
Teami LLC
Teaveli Inc
TechWorld Corporation Inc.
TEK NATURALS
TEKBOARD INNOVATIONS
Tennessee Scientific, Inc.
Teraputics
TET METABOLIC RESEARCH
The Coveterie Showroom Inc.
The Creative Hub LLC
THE DOC LAB
The International Eye Wellness Institute
The Prostate King
THE S3 XINNOVATIONS
Three Peaks Direct LLC
Thrival Nutrition
ThrivePlus LLC
Thrivr LLC
TILDEN COOPER LLC
Time Pioneer Limited
TNP
TOP KNOT HAIR CARE PRODUCTS
Total Tonic
Transparent Supplements Co LLC
Treadcorp, LTD
Treasure Holdings
Tres Chique
TRIBAL X FITNESS
TRINITY PERFORMANCE LLC
TrovRx
True Compare LLC
TruePeak Supplements
TRUTH NUTRITION
TURBOCHARGED NUTRITION LLC
Turmeripure, LLC
Typhoon Sales
U.S. 2015, INC.
UFAM LLC
UGH LLC
Uhlmann Packaging Systems L.P.
Ultimate Life LTD
Ultra Life
Ultra Life Inc.
ULTRA VULGAR MEDIA LLC
Union Springs
University of Nevada, Las Vegas
Unkown Customer
UNL TD
Untamed
Unwindly LLC
urohealth
USA Supplements LLC
USQD
VALHALLA MEDIA
Valyrian
VAPOR JEDI INDUSTRIES
Various customers
Vergence Naturals
Vianutra
Vibrant Health
Vida Essentials, LLC
Vida Glow Pty Ltd
Vigorocity/ Anti Aging Central
Vinkem Pharma LLC
ViSalus, Inc.
VISION BODIES
Vita-Gen Labs
VITA G
Vita Health Essentials
VitaCoat
VITACORENATURALS
Vitadocs, Inc
VitaGen Laboratories
Vitalchemy, LLC
Vitalitus LLC
Vitality Max Labs
VITALITY VITAMINS
VITALIX FITNESS
Vitamin Makers USA
VITAMINIQS
Vitamonk
VitaRave
Vitarim, Inc.
Viva Deo, LLC
WABTECH MEDIA
WARRIOR STRONG
Water Divine
Wealth Nutrition
Wellness and Vitality
WELLNESS CREATIONS
WELLNESS PLEASE
White Label Cosmetics LLC
WILD FOODS BRAND
Wildflower Nutrients
Willhaven Group
WINFREE LLC
Wisnewski Enterprise
WMF LLC
WOMEN’S ESSENTIALS
Wonder Active LLC
WONDER WORKS AMERICA, INC
WORLD RANGE S.R.O
WPN Supplements
XANFREE CORPORATION
XANTHIC COLORADO LLC
Xeco Limited
Young Life Research, Inc.
Younger Tomorrow
yours2u Limited
Z&Z IMPORTS
Zach Attack Supplements LLC
Zammex Nutrition
Zanimo Inc
ZEN NATURE LLC
Zenarco LLC
Zenith Herbal
ZENWISE
Zint LLC
ZION
ZOLO HEALTH
Zongle Therapeutics
Zulu Heritage Corporation
ZYANA

NaturPro Verified Supply™

by NaturPro in Uncategorized Comments: 0

As consultants for a diversity of supplement and food firms, NaturPro Scientific has qualified numerous ingredients, suppliers and products.

So, we decided to share some of the products and ingredients that we have verified, within a curated supply catalog: NaturPro Verified Supply™

What’s different about NaturPro Verified Supply compared to other suppliers and manufacturers?

  1. Suppliers cannot pay to be listed. Unlike most suppliers, NaturPro does not accept fees or commissions to represent or promote any specific ingredients or products. Our core business is in vetting the best ingredients and products — not selling them.
  2. We are not tied or committed to any one ingredient or supplier, so we can keep our standards high.
  3. Our vetting process goes beyond FDA regulatory requirements. NaturPro standards include our intimate understanding of supplier practices, supply chain quality, sustainability, GMP’s, best practices, traceability to source, a track record of integrity, and a demonstrated commitment to quality and research.

Connect to NaturPro Verified Supply™ Portal

Contact us with questions or comments!

Ethical Sourcing Assessments for Ingredients, Supplements and Foods

by NaturPro in Uncategorized Comments: 0

NaturPro has served an essential role in helping our clients source and evaluate ethically sourced ingredients. 

Our Ethical Sourcing Assessments include elements from many recognized programs such as Fairtrade(R), and uses one of the most comprehensive set of standards guiding the evaluation of the social and environmental impact of natural products and foods.

Ethical Sourcing Assessments are Key to Understanding Social, Environmental and Product Sustainability

Ethical Sourcing of Ingredients for Supplements and Foods
Ethical Sourcing of Ingredients for Supplements and Food is used to benchmark sustainability and identify ways to improve supply chains.

The following outline covers subject matter covered in our evaluation protocol, which is derived from multiple sources, including the International Labour Organization Labour Principles of the United Nations Global Compact, the UN Forum on Sustainability Standards, Fairtrade,, WHO GAP, Global G.A.P., and NOP Organic.

General Guidelines for Ethical Sourcing: The Human Element

Product:

  1. Contact information
  2. Product name
  3. Specifications, nomenclature
  4. Sourcing origin
  5. Land use and inputs
  6. Harvest practices
  7. Plant population care
  8. Raw material processing and labeling

Relationships

  1. Type and controls
  2. Prices and wages
  3. Non-discrimination
  4. Reciprocity
  5. Communications

Employment

  1. Labor practices
  2. Fair wages and prices
  3. Child labor
  4. Harrassment
  5. Working conditions
  6. Worker safety

Environment

  1. Legal requirements
  2. Policies and communications
  3. Management responsibilities
  4. Waste management
  5. Emissions
  6. Energy usage

Management and Supply Chain

  1. Written policies
  2. Training
  3. Supplier management
  4. Dealing with non-compliances
  5. Audit program
  6. Geographic risk
  7. Community improvements

NaturPro fits our review protocol and minimum standards according to your practices currently in place, and we also evaluate according to the ‘stretch goal’ standards our clients are working to achieve, and set a clear path towards improved social and environmental impact.

Global Herb Producer Cooperative
Reviewing your ‘people practices’ helps our clients to better understand and support their supply chain.

Here are a couple examples of case studies we have performed for clients:

1. “Seed-to-Shelf Independent Audit” — A comprehensive, umbrella independent review of all quality and ethical procedures, relating to both farm-level and manufacturing practices.

We review all documentation, audit reports and other information, provide a list of opportunities to improve quality, identify gaps that minimize business, regulatory and product quality risk, help our clients meet the minimum level of regulatory compliance, and identify ‘best practices’ that are either already in place, or can be implemented. 


2. “Human Impact Audit” – A third-party independent review of the “human element” of an agricultural or wild-collected product, focusing in particular on staff training, farming practices and GAP, worker health and safety, and cultural preservation.   This includes a review of personnel SOP, safety, fair trade, farm practices, environmental impact estimates, ethical sourcing & organic practices.

The above 2 programs could be done separately or combined, and are typically performed in 2 phases: 

Phase 1: Document Audit
Phase 2: In-person/field Audits

3. Program marketing and communications – A comprehensive review paper that describes in detail all the elements of the program, references to the standards applied, and images or video footage. This comprehensive review can then be broken down into separate stories, that can become webpages, Youtube videos and social media posts that educate your audience.

Contact us for more information on NaturPro Scientific’s ingredient traceability and ethical sourcing programs. 

Product Strategy Consultants for Dietary Supplements

by NaturPro in Uncategorized Comments: 0

Product strategy for health products like supplements requires extensive knowledge of consumer trends, marketing, consumer behavior, food science, regulatory requirements and technical and scientific affairs.

NaturPro Scientific combines expertise in a wide array of product types and disciplines, offering clients a way to maximize chances for consumer product success in the market.

Product Strategy – Cores of Discipline 

A product may be determined as safe and effective, and also legal and kosher — but still not be positioned for success.  For example, it may be undifferentiated in a crowded market, or not provide a meaningful benefit that is valued by the consumer. A great product may find itself swimming in infested waters filled with competitors.

Supplement capsules prototype pilot samples
NaturPro offers seed-to-shelf strategy and execution for supplement product development

 Our in-depth analysis and advisory process helps to guide our clients in the right direction.

Some main considerations for any supplement product design consultants includes the following:

  1. Target Health Category(s) and subcategories, including potential niche markets
  2. Market Opportunity Analysis
  3. Market Size & Market Leaders
  4. Key Competitor Analysis
  5. Pricing Sensitivity
  6. Consumer Preference Analysis, including consumner surveys and focus groups
  7. Key Product Benefit
  8. Regulatory Review
  9. Customer Demographics
  10. Differentiation, Positioning and Competitive Analysis
  11. Innovation Strategy
  12. SWOT Analaysis
  13. Marketing and Distribution Channel Analysis

FSVP: FDA’s Requirements under FSMA for Imported Ingredients

by NaturPro in Quality Comments: 0

Importing any food or supplement products? Do you have training, procedures and records according to FDA’s FSVP guidance? 

Many firms in the food and dietary supplement industry are quietly putting significant investment into meeting the Food Safety Modernization Act (FSMA). FSMA was signed by President Obama in 2011 as the first major legislation to update food safety regulations in more than 50 years. FSMA and FSVP represent the best approach to ensuring a safe global food chain.

supplement food verification

For supplements and health foods, its more reliable to verify than it is to trust.

FDA Requires You To Do these Things:

  1. Your FSVP includes all written procedures and records that demonstrate compliance with FSMA, especially the requirements for Supply Chain Preventive Controls (PC). If you purchase any ingredients directly from foreign sources outside the U.S., then you must have a written FSVP. And if your U.S. based supplier imports ingredients, you are responsible for verifying their FSVP is effective.
  2. Warehouses, marketers and distributors, and supplement manufacturers are subject to “modified” FSVP requirements. Even if you don’t receive product, or open any containers, you must still verify those you designate to handle, order, process or store your product.  If your name is on the  label of any product or package, then you must be able to show (with written documentation) that your supplier, warehouse, processor, and customer ensures the safety of the product within 24 hours of the FDA visiting you or requesting this information by phone.
  3. If you import, own and/or have a financial stake in the imported goods, then you are probably responsible for the goods as the designated “FSVP Importer”. For imports involving multiple U.S. parties, there must be a written agreement specifying who is responsible for what. Foreign firms who send goods to the U.S. without a designated buyer must have a U.S.-based agent to act as importer, and take responsibility for the shipment once it arrives to the U.S.
  4. You need to have a Qualified Individual or QI to write your FSVP. No standard training is required to be a QI, but it will greatly help your QI to be trained on PCQI and/or FSVP. Because the final FSVP rule includes more than 300 mentions of the word ‘flexibility’, you still gotta know what you’re doing.
  5. With few exceptions, importers must perform a hazard analysis on all imported products. This requires you to know how your ingredients are grown and made, where they came from, and what biological, chemical or physical hazards may be present that could make them unsafe. A hazard requiring a preventive control is defined as one that is “known or reasonably foreseeable to cause significant injury or illness”. It’s up to your QI to determine these hazards.  You can agree in writing with your supplier or customer to ensure that they are responsible for a preventive control – otherwise, the responsibility probably falls on you.
  6. The most common hazards are:
    1. Undeclared allergens
    2. Salmonella
    3. Listeria
    4. These three are the source of 88% of all product recalls! 
  7. Economically Motivated Adulteration (EMA) and radiological contamination are often overlooked as hazards, and often require PC in the FSVP guidance.
  8. Much of the available information on hazards is provided by FDA for free. Some examples:
    1. FDA Import Alerts
    2. FDA Warning Letters
    3. FDA Product Recalls
    4. FDA Guidance on Potential Hazards for Foods and Processes
    5. FDA Bad Bug Book
    6. FDA Guidance on Chemical Hazards
    7. FDA Reportable Food Registry
    8. Product specifications that control for hazards like salmonella and allergens. These are often not publicly available, but many are found on industry databases like UL Prospector.
  9. The easiest and most impactful thing you can do to start evaluating your foreign supplier is to request their hazard analysis!
  10. Third party experts are the most popular way to develop FSVP programs. A couple days of staff training is not the same as experience and expertise, especially with today’s global supply. Remember that suppliers are not allowed to verify themselves – this duty is left to customers, third party auditors, or other qualified individuals sent on behalf of the customer.

If you don’t have the time or expertise on staff to handle your supplier verification according to FSMA, make sure you talk to someone trained in FSVP with experience in qualifying your type of products and suppliers.

For more information on FSVP, visit the FDA page “FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

NaturPro Scientific LLC is a leading natural products consultancy specializing in evaluating and maximizing the value of foods and dietary supplements. Contact us for more information at http://naturproscientific.com/contact-us

7 Steps to Dietary Supplement Product Development


We often get asked what we think of a product concept. The thought process to develop an answer is generally similar, regardless of the type of product, and whether its a consumer packaged good (CPG) or finished product, or an ingredient or raw material.

A number of considerations go into developing and producing successful, effective, safe and compliant dietary supplements, foods, and food and dietary ingredients.  These include:

  • What does the product do?
  • What can be claimed about the product?
  • Is the evidence supporting the claims sufficient?
  • How safe is the product?
  • Who will benefit from the product?
  • How is the dosage determined?
  • Are the ingredients available at an acceptable quality, cost and volume?

 

The 7 Steps to Dietary Supplement Product Development

There are seven basic elements to developing a groundbreaking product:

  1. Begin with the finished product in mind. Determine in full detail how the product will be marketed, what the desired product claims will be, and how the product will address an unmet market need.
  2. Intimately understand the product value and market positioning compared to the competition. How will the product address an unmet need, or be different than what is already found on the market?  How will the product be priced compared to the competition? A full competitive analysis is important to determine positioning.
  3. What language will be used to describe the product? (This language, found on product labels and on webpages, is considered to be part of product claims.)
  4. In what country(s) will the product be marketed?  Regulations in different countries vary, and it is important to understand the unique requirements of each location.
  5. How will it be sold? Online, Amazon, Whole Foods, health food stores, clubs, MLM and practitioner channels have distinct customer needs, pricing and positioning requirements
  6. Evaluate the regulatory landscape. What steps need to be taken to access the market? What gaps need to be filled in order to be compliant with the regulations?
  7. Evaluate ingredients and suppliers. An ingredient that is processed in a way that makes it different than material used in studies will negate the supporting evidence. And, an ingredient that does not meet GMP and quality requirements under FDA is illegal to sell. Don’t go far down the path of product development without a rigorous evaluation of supply and ingredients.

 

Product Development Planning

Working backwards from the product claim may sound simple, but it is an analytical process that benefits greatly from industry experience and forethought.  A solid plan is what separates a rocket from a dud.


Sufficient time spent in the planning phase is the difference between success and failure.


Product development plans often coordinate the knowledge of supplement consultants and experts, review regulatory status of the product and evaluate the available scientific evidence.  A good development plan will identify not only opportunities, but also gaps and risks that may prevent success.

Contact us for more information on Natural Product Development

 

Additional Reading:

Food and Supplement Claims with Confidence

Dietary Supplement Formula Development

Dietary Supplement Ingredient Regulatory Status

Supplement Manufacturing Consulting

Creating Natural Product Intellectual Property

 

 

Dietary Supplement Facts and Label Review


There’s a lot of detail required for dietary supplement labels. Between supplement facts, structure-function health claims, content claims, and required formatting, it’s easy to overlook some of the FDA requirements for labeling.

Supplement Label Review Nutrition Facts

Supplement Label Review for Supplement Facts, Nutrition Labeling and Claims

Dietary Supplement Facts and Label Review

As part of our Label Review services, NaturPro helps clients develop, review and suggest improvements to dietary supplement labels, to ensure compliance with FDA regulatory requirements

Our clients enjoy the following benefits:

  1. Reliability: 100% accuracy and FDA compliance
  2. Experience: 15+ years of experience reviewing supplement labels
  3. Science-driven: Our reviews are based on the most current, reliable information, techniques and evidence
  4. Perspective: We have experience on the business side of the industry, so we know what the law is, whether it’s followed, and what is likely to happen if you don’t.

Updated Pricing:

Label Review (Basic): $350-550  — review only label — for “red flags” and suggested improvements

Label Review (Complete): $550-850 – review of label for red flags and suggested improvements, and matching finished product specifications

Label and Marketing Review: $800-1500 per label – web page / sales sheet

 (Volume discounts may apply for similarly labeled products — Contact for Pricing


FDA Dietary Supplement Labeling Guidelines

See our Dietary Supplement Label Review Checklist.

The following outlines some of the most frequently asked questions (FAQ) for dietary supplement labels:

  1. How are dietary supplements defined?Dietary supplements are defined, in part, as products (other than tobacco) intended to supplement the diet that bear or contain one or more of the following dietary ingredients:
    1. A vitamin;
    2. A mineral;
    3. An herb or other botanical;
    4. An amino acid;
    5. A dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
    6. A concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above.Further, dietary supplements are products intended for ingestion, are not represented for use as a conventional food or as a sole item of a meal or the diet, and are labeled as dietary supplements.
  2.  What label statements are required on the containers and packages of dietary supplements?Five statements are required: 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.
  3.  Where do I place the required label statements?You must place all required label statements either on the front label panel (the principal display panel) or on the information panel (usually the label panel immediately to the right of the principal display panel, as seen by the consumer when facing the product), unless otherwise specified by regulation (i.e., exemptions).
  4.  What label statements must I place on the principal display panel?You must place the statement of identity and the net quantity of contents statement on the principal display panel. Where packages bear alternate principal display panels, you must place this information on each alternate principal display panel.
  5.  How do I locate the principal display panel?The principal display panel of the label is the portion of the package that is most likely to be seen by the consumer at the time of display for retail purchase. Many containers are designed with two or more different surfaces that are suitable for use as the principal display panel. These are alternate principal display panels.
  6.  What label statements must I place on the information panel?You must place the “Supplement Facts” panel, the ingredient list, and the name and place of business of the manufacturer, packer, or distributor on the information panel if such information does not appear on the principal display panel, except that if space is insufficient, you may use the special provisions on the “Supplement Facts” panel in 21 CFR 101.36(i)(2)(iii) and (i)(5). See questions 46 and 56 in Chapter IV for more details.
  7.  Where is the information panel?The information panel is located immediately to the right of the principal display panel as the product is displayed to the consumer. If this panel is not usable, due to package design and construction (e.g. folded flaps), the panel immediately contiguous and to the right of this part may be used for the information panel. The information panel may be any adjacent panel when the top of a container is the principal display panel.
  8.  What name and address must I list on the label of my product?You must list the street address if it is not listed in a current city directory or telephone book, the city or town, the state, and zip code. You may list the address of the principal place of business in lieu of the actual address.
  9.  May I place intervening material on the information panel?No. You may not place intervening material, which is defined as label information that is not required (e.g., UPC bar code), between label information that is required on the information panel.
  10.  What type size, prominence and conspicuousness am I required to use on the principal display panel and the information panel?You are required to use a print or type size that is prominent, conspicuous and easy to read. The letters must be at least one-sixteenth (1/16) inch in height based on the lower case letter “o,” and not be more than three times as high as they are wide, unless you petition for an exemption in accordance with 21 CFR 101.2(f). The lettering must contrast sufficiently (it does not need to be black and white) with the background so as to be easy to read. See Chapter IV for the type size requirements for the nutrition label.
  11.  Do I need to specify the country of origin if my product, or the ingredients in my product, is not from the United States?Yes. Unless excepted by law, the Tariff Act requires that every article of foreign origin (or its container) imported into the United States conspicuously indicate the English name of the country of origin of the article.
  12. What is the nutrition label for a dietary supplement called?The nutrition label for a dietary supplement is called a “Supplement Facts” panel.
    1. You must list dietary ingredients without RDIs or DRVs in the “Supplement Facts” panel for dietary supplements. You are not permitted to list these ingredients in the “Nutrition Facts” panel for foods.
    2. You may list the source of a dietary ingredient in the “Supplement Facts” panel for dietary supplements. You cannot list the source of a dietary ingredient in the “Nutrition Facts” panel for foods.
    3. You are not required to list the source of a dietary ingredient in the ingredient statement for dietary supplements if it is listed in the “Supplement Facts” panel.
    4. You must include the part of the plant from which a dietary ingredient is derived in the “Supplement Facts” panel for dietary supplements. You are not permitted to list the part of a plant in the “Nutrition Facts” panel for foods.
    5. You are not permitted to list “zero” amounts of nutrients in the “Supplement Facts” panel for dietary supplements. You are required to list “zero” amounts of nutrients in the “Nutrition Facts” panel for food.How does “Supplement Facts” differ from “nutrition facts?”The major differences between “Supplement Facts” panel and “Nutrition Facts” panel are as follows:
  13. What information must I list in the “Supplement Facts” panel?You must list the names and quantities of dietary ingredients present in your product, the “Serving Size” and the “Servings Per Container.” However, the listing of “Servings Per Container” is not required when it is the same information as in the net quantity of contents statement. For example, when the net quantity of contents statement is 100 tablets and the “Serving Size” is one tablet, the “Serving Per Container” also would be 100 tablets and would not need to be listed.
  14. How must I display the “Supplement Facts” panel?The “Supplement Facts” nutrition information (referred to as a panel) must be enclosed in a box by using hairlines. The title, “Supplement Facts,” must be larger than all other print in the panel and, unless impractical, must be set full width of the panel. The title and all headings must be bolded to distinguish them from other information.
  15. How must I present the information in the “Supplement Facts” panel?You must present all information using the following:
    1. A single easy-to-read type style;
    2. All black or one color type, printed on a white or neutral contrasting background, whenever practical;
    3. Upper- and lowercase letters, except that you may use all uppercase lettering on small packages (i.e., packages having a total surface area available to bear labeling of less than 12 square inches);
    4. At least one point leading (i.e., space between lines of text); and
    5. Letters that do not touch.

  16. What are the type size requirements for the “Supplement Facts” panel?Except as provided for small and intermediate-sized packages, you must set information other than the title, headings, and footnotes in uniform type size no smaller than 8 point. You also must use a type size larger than all other print size in the nutrition label for the title “Supplement Facts.” You may set the column headings and footnotes in type no smaller than 6 point type. See the section on “Special Labeling Provisions” for the exceptions for small and intermediate-sized packages.
    For more information, visit FDA Dietary Supplement Labeling Guide

Cannabis, Hemp & CBD | SOP and Procedures



Standard Operating Procedures (SOP) for Cannabis, CBD and Hemp operations are required for every type of business — even if you are only a distributor or marketer. 

Our experts have decades of experience with all types of document requirements, for all types of firms — especially SOP supporting the following:

  1. Good Manufacturing Practices (GMP’s)
  2. Good Agricultural and Collection Practices (GACP)
  3. Good Distribution and Storage Practices

     


Need help with your SOP’s and GMP’s?  Contact us!

 

Our goal is to help you meet Cannabis, CBD and Hemp regulatory requirements as efficiently as possible.

 

Cannabis & Hemp Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging, marketing, distribution, or testing business.

Cannabis SOP are required by each state where cannabis, marijuana or hemp are regulated.

Cannabis SOP and procedures

Cannabis SOP and procedures are required in every state or jurisdiction.

All cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of regulations and standards from seed to shelf. 

NaturPro Scientific has supported a number of clients in the aim of providing safe, effective cannabis and hemp products to support human health.

Startups who invest in solid standard operating procedures (SOP) accelerate their growth from the start.

 

The worst thing a start-up can do is go in blind to what their processes and procedures — their Good Manufacturing Practices — should be.

But within a patchwork of regulations, processes and procedures depend on the type of product you are making. 

So what GMP guidelines should you follow?

Here’s some free advice, that’s common sense: Follow the most applicable regulatory guidelines, that are closest to your type of product.

The following types of products are generally considered dietary supplements, which are products intended to supplement the diet, but not replace food. Supplements in the U.S. are governed by 21 CFR 111, Good Manufacturing Practices (GMP) for Dietary Supplements:

  • Tinctures
  • Oils
  • Capsules and Softgels
  • Tablets
  • Powders
  • Food products with structure-function claims nutrients without recommended daily values

 

The following types of products are generally considered foods, governed under 21 CFR 117, that are FDA GMP’s for Food:

  • Protein powders
  • Ready to drink beverages
  • Snacks
  • Infused coffee and tea

Need help with your SOP’s and GMP’s?  Contact us!

 

When it comes to other types of products, standards or test methods, we generally recommend to pick the most relevant standards for your type of product.

Here is a basic set of quality management SOP’s for a Food facility: 

  1. Quality Management Systems
    1. Product Quality Policy/Manual
    2. Recordkeeping
      1. Document Control
      2. Formula Records
      3. Batch Records
      4. Certificates of Analysis
    3. Traceability & Recall
    4. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
      3. Supplier Qualification
      4. Intentional Adulteration
      5. Preventive Controls
    5. Product Approval & Rejection, Material Inspection
    6. Complaints & CAPA (Corrective Actions)

       

We recommend to follow the standards and requirements set by FDA and other standards-setting organizations:

Need help with your SOP’s and GMP’s?  Contact us anytime!

 


Farmers are at the root of high quality product, so here’s some free SOP’s for farmers, followed by a sample guidance proposed for cannabis, hemp and CBD agricultural materials (i.e. “Farm SOP’s”)

CANNABIS, HEMP AND CBD FARM SOP LIST

  1. Cultivation or Processing
    1. Management
    2. Applicable Regulations
    3. Operations
    4. Training & Safety
    5. Hygiene
    6. Sanitation & Cleaning
    7. Farm or Facility
    8. Equipment
    9. Seeds and Propagation Materials
    10. Agricultural Inputs
    11. Pre-harvest practices
    12. Harvesting
    13. Post-harvest practices
    14. Drying & Milling
    15. Sampling
    16. Testing (Potency, purity, cannabinoids, microbiology, heavy metals, pesticides)
    17. Waste Management

———————

A BASIC EXAMPLE for FARM OPERATIONS

The following information is a partial excerpt from draft from U.S. Hemp Roundtable guidance for CBD products, which NaturPro was fortunate to contribute to.

CBD SOP’s and Cannabis Procedures

U.S. Hemp Guidance Program PHASE 2

1 GROWER
1.1 GENERAL TERMS & DEFINITIONS

The following Definitions and Interpretations apply to such terms when used in this U.S. Hemp Guidance Program.

Adulteration refers to a food that may be considered adulterated if it contains “any poisonous or deleterious substance which may render it injurious to health…..or if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is”.

Batch means a specific quantity of industrial hemp that is uniform, that is intended to meet specifications for identity, purity, strength, and composition, and that is produced during a specified period of time according to a single manufacturing record.

Batch number, or lot number means any distinctive group of letters, or numbers, or any combination of them, from which the complete history of the processing, packaging, labeling, and/or storage of a batch or lot of industrial hemp product can be determined.

Biomass means the amount of living matter in a given habitat, expressed either as the weight of organisms per unit area or as the volume of organisms per unit volume of habitat.

Component means any substance intended for use in the manufacture of industrial hemp, including those that may not appear in the finished batch of the industrial hemp.

Growth Medium means the solid, liquid or semi-solid substance used to support the growth of the plant.

Hemp refers to cannabis varieties and any part of the plant, whether growing or not, containing a delta-9 tetrahydrocannabinol (THC) concentration of no more than three-tenths of one percent (0.3%) on a dry weight basis.

Industrial Hemp is Hemp
Ingredient means any substance that is used in the manufacture of hemp and that is intended to

be present in the finished batch of the hemp product.

In-process material means any material that is compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any way for use in the manufacture of the hemp product.

Lot means a batch, or a specific identified portion of a batch, or, in the case of a hemp product produced by continuous process, a specific identified amount produced in a specified unit of time or

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1

U.S. Hemp Guidance Program PHASE 2

quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.

Microorganisms means yeasts, molds, bacteria, viruses, toxins, and other similar microscopic organisms which may or may not have a health or sanitary concern.

Pest means any objectionable insect or other animal including but not limited to birds, rodents, flies, mites, and larvae.

Physical plant or facility means all or any part of a building or facility used for or in connection with manufacturing, processing packaging, labeling, or storage of industrial hemp products or ingredients.

Processor means making a transformative change to the hemp plant or product following harvest.

Product complaint means any communication that contains any allegation, written, electronic, or oral, expressing concern, which may or may not have be related to the quality of an industrial hemp product.

Quality means that the hemp product meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration.

Quality Management Systems means a planned and systematic operation or procedure for ensuring the quality of a hemp product.

Quality Management Systems personnel means any person, persons, or group, within or outside the organization, designated to be responsible for quality control operations.

Representative sample means a sample with an adequate number of units that are intended to ensure that the sample accurately portrays the material being sampled.

Reserve sample means a representative sample of product that is held for a designated period of time.

Sanitize means to adequately treat cleaned equipment, containers, utensils, etc.by a process that is effective in destroying of microorganisms of public health concerns.

2

U.S. Hemp Guidance Program PHASE 2

1.2 REGISTRATION/APPLICATION/NOTIFICATION

Prior to the Industrial Hemp Grower planting any seed, a license or agreement with the State must be obtained. The following information is required to make the application before a license will be issued: (Each State may have different regulations – refer to application – See Kentucky Hemp Policy Guide as an example)

1.2.1 Registration/Application Guidance

  • Name of the person or corporation to whom the license or authorization is to be issued
  • Address of the farm or place including county and township or legal description
  • The number of acres
  • Global Positioning System coordinates
  • Intended purpos of industrial hemp
  • In the case of a plant breeder, the variety of industrial hemp that may be cultivated; and

o Any conditions that are necessary to minimize security, public health or safety hazards related to the licensed or authorized activities.

o Specify if the hemp is for food or non-food purposes

1.2.2 Notification of Changes to the licensor by the licensee

Every licensee shall notify the State of any changes to the information provided on the application, within 15 days after the change, including:

  • Corporate name or ownership, or officers, and the replacement of an officer, or director
  • Any change to the address of the licensee
  • The replacement of an individual referred to a licensee
  • Any change in the mailing address of the licensee
  • Any change in the ownership of the land used to cultivate industrial hemp
  • Any change to the approved cultivar being sown or, in the case of a plant breeder, to thevariety of industrial hemp being sown;
  • Any genetic modification.

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Signature: _____________________________ Date: ________________________ Printed Name: __________________________ Company/Location: ________________________

3

U.S. Hemp Guidance Program PHASE 2

1.3 PERSONNEL

Qualified employees who grow, manufacture, package, or label industrial hemp shall be qualified to do so, and those responsible for quality control or performing any quality control operations, must have the education, training, or experience to perform the assigned functions.

Supervisors shall be qualified by education, training, or experience to supervise.
Contamination Prevention and Hygienic measures shall be taken to exclude from any operations

any person who might be a source of microbial contamination.

Such measures shall include the following:

  • Exclude personnel from working in any operations that may have an illness, infection, open lesion, or any other abnormal source of contamination.
  • Instructing employees to notify their supervisor if there is a possibility that they have a health condition described above.
  • Wearing outer garments in a manner that protects against the contamination.
  • Maintaining adequate personal cleanliness.
  • Washing hands thoroughly, and sanitizing if necessary, in a hand-washing facility.
  • Removing or covering all unsecured jewelry and other objects that might fall into components, industrial hemp, equipment, or packaging.
  • Using gloves when appropriate.
  • Wearing, where appropriate, hair nets, caps, beard covers, shoes, PPE etc.Personnel and employee safety measures shall include the following:
  • Appropriate and Adequate First Aid Equipment
  • Adequate bathrooms and changing rooms
  • Appropriate OSHA warnings, labels, and training
  • Appropriate training and personal protective equipment for pesticide application

4

U.S. Hemp Guidance Program PHASE 2

1.3.1 U.S. HEMP GUIDANCE – GROWER – PERSONNEL CHECKLIST

√ ifApplicable

 

YES

NO

NOTES

 

Are the supervisors qualified for their responsibilities by training, education or experience?

     
 

Do the employees performing the growing, processing, packaging and labeling tasks, have the proper training necessary to perform the tasks?

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Are contamination and hygienic measures in place to exclude personnel who might be a source of contamination?

     
 

Are personnel excluded from operations if they have, an illness, infection, open lesion, or any other abnormal source of contamination?

     
 

Do employees notify their supervisor if there is a possible health condition as described above?

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Do personnel wear outer garments in a manner that protects against the contamination?

     
 

Do operating personnel maintain adequate personal cleanliness?

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Are hand washing facilities available and used?

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Do operating personnel remove or cover unsecured jewelry etc. to prevent them from falling into hemp products or causing harm?

     
 

Are gloves used when appropriate?

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Are caps, shoes and head covering used when appropriate?

     
 

Is the appropriate Personal Protective Equipment (PPE) used as needed?

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Are there adequate and appropriate first aid equipment available?

     
 

Is there adequate bathrooms and changing rooms?

     
 

Are the OSHA warnings and signs visible?

     
 

Has there been adequate training?

     
 

If applicable is the PPE and trains available for the pesticide applicators?

     

Signature: _____________________________ Date: ________________________ Printed Name: __________________________ Company/Location: ________________________

5

U.S. Hemp Guidance Program PHASE 2

1.3.2 U.S. HEMP GUIDANCE – GROWER – BEST MANAGEMENT PRACTICES CHECKLIST

NOTES

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YES

NO

Are you using the best soil available?

   

Have you Soil tested for macro and micro nutrients?

   

Have you used the appropriate Growth Medium for intended purposes?

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Has the licensee determined the concentration of THC in the hemp?

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Is seed planted listed on the license?

   

Is the entire hemp plant used as licensed?

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Do you properly use pre- plant weed control?

   

Do you have a Germination Certificate from the seed supplier

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Did you use the proper Certified Seed suitable for location?

   

Did you use the proper seed treatment?

   

Do you have a site history?

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Do you have a water quality report or history?

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Did you use fertilizer to target desired yield per acre according to soil test?

   

Did you use animal manure for fertilizer or biomass purposes?

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Did you plant by optimum seeding date?

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Did you plant at the optimum rate of seeds per acre?

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Have samples of the industrial hemp been collected in accordance with the Guidance Procedures?

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Has the equipment used to sow, harvest and transport the hemp been thoroughly cleaned to prevent contamination?

   

Are you prepared to harvest when the plant is ready?

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Have you complied with the drying procedures

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Do you have sufficient and proper storage facilities or adequate transportation equipment available?

   

Is the biomass sold to a licensed person or entity according the Guidance Procedures?

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Is the biomass packaged, labeled, and transported according to the Transportation Guidance Procedures?

   

Has any loss or theft been reported according to the license requirements?

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Are the records being kept according to the Guidance Procedures for Record Retention?

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Grower Signature___________________________ Date _________________ Printed Name___________________ Farm location or identifier__________________

6

U.S. Hemp Guidance Program PHASE 2

1.3.3 U.S. HEMP GUIDANCE – GROWER – FACILITY & BIOSECURITY AWARENESS CHECKLISTA.

√ ifApplicable

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Facility Security (physical security of buildings and grounds)

Is the facility using:

YES

NO

NOTES

Security lighting

     

Perimeter fencing

     

Controlled gate access

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Off-hours security guard

     

Electronic motion detectors

     

Door alarms

     

Video cameras

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Adequate indoor lighting

     

Alarms linked to an off-site security system

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Door hardware is of industrial design

     

Guards are installed on exterior ladders

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Exit doors and gate are electronically/mechanically secured

     

Entry and discharge points of exterior tanks are padlocked when not in use

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All vehicles parked outside are locked

     

Empty/loaded containers are parked inside

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Law enforcement patrol over company premises on regular but unpredictable basis

     

Employees reporting any suspicious behaviors

     

Restricted access to computer process control and data systems

     

Safeguard of data systems using data security program

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Backup of all data and processes at an off-site place

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B.

√ ifApplicable

Visitor Policy

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Is the facility using:

YES

NO

NOTES

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Company representative for visitor to check in with

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Signs informing visitors where to report

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Specific area for visitor parking

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Records of visitors (include name, company, arrival and departure, and purpose of visit)

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Visitor badges/identification cards

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Company representative to escort visitor all the time

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Restricted access to key manufacturing areas

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C.

√ ifApplicable

Distribution

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Is the facility implementing the following:

YES

NO

NOTES

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Bulk containers are inspected prior to loading for foreign and/or suspicious material

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7

U.S. Hemp Guidance Program PHASE 2

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Verify that all customer pick-up drivers are representatives of the customer

     

The product stream is inspected visually

     

Container access points are secured after loading

     

Seal numbers are documented on the shipping papers

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Shipping documents are used to identify the contents of each compartment

     

Shipping log is maintained

     

Bio-sanitation program is implemented

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Procedures exist to disinfect vehicles and drivers

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D.

√ if Applicable

E.

√ ifApplicable

Housekeeping

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Is the facility implementing the following:

YES

NO

NOTES

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Written housekeeping program for all areas of the facility

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Written pesticide and rodenticide program

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Emergency Response

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Is the facility implementing the following:

YES

NO

NOTES

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Employees are adequately trained to respond to a crisis as calmly and safely as possible

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Current inventory of all hazardous and flammable products

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A plan to provided MSDS to emergency response teams etc.

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A list of emergency contacts is posted

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An action plan to deal with suspicious devices or substances

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Evacuation plan in case of fire and explosions is published

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Establish and maintain an up-to-date employee roster and visitor log to facilitate personnel head count at any time

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Disaster Preparedness Plan

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A weapons security program

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Conduct evacuation and respond drill periodically

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Post a site plan depicting escape routes, fire-fighting and rescue equipment

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Signature: _____________________________
Printed Name: __________________________ Company: ________________________________

Date: ________________________________ Facility Location: ________________________________8

U.S. Hemp Guidance Program PHASE 2

1.4 SAMPLING AND HANDLING HEMP FOR THC & CBD1.4.1 Definitions

delta-9-THC means delta-9-tetrahydrocannabinol concentration.
Authority having jurisdiction usually means the state, but it could be FDA, USDA,

county or city.

Certified seed means seed for which a certificate or any other instrument has been issued, by an agency authorized under the laws of a state, territory, or possession to certify seed and which has standards and procedures approved by the United States Secretary of Agriculture to ensure the genetic purity and identity of the seed certified.

Plot means a contiguous area in a field, greenhouse, or indoor growing structure containing the same variety or strain of hemp throughout the area.

ppm means parts per million.ppb means parts per billion.

Post-Harvest Sample means a sample taken from the harvested hemp materialfrom a particular plot’s harvest. The entire plot’s harvest must be in the same form(e.g., intact-plant, flowers, ground materials, etc.), homogenous, and not mixed with non-hemp materials or hemp materials from another plot.

Pre-Harvest Sample means a composite, representative portion from plants in a hemp plot collected in accordance with the procedures as defined by the state providing authority.

Processing means converting an agricultural commodity into a marketable form.Prohibited Variety means a variety or strain of cannabis excluded from the state

providing authority.

Sample means a sufficient amount of material that is representative of the population from which it is taken. A sample may be a particular plant part, including inflorescence (flower), leaf, stalk or seed, or it may be a processed product (oil, extract, powder. Samples must be dried to a sufficiently low moisture content so as not to harbor growth of microorganisms.

Seed source means the origin of the seed or propagules as determined by the state providing authority.

9

U.S. Hemp Guidance Program PHASE 2

  1. 1.4.2  Sampling Timeline and Grower Responsibilities
    1. The grower shall refer to the jurisdiction having authority to determine a timeline.
    2. During the sampling, the grower or an authorized representative shall be present at the growing site.
    3. Floral materials harvested for phytocannabinoid extraction shall not be moved beyond the processor, nor commingled, nor extracted, until test results are complete
  2. 1.4.3  Pre-Harvest Sampling Procedure
    1. Adequate personal protective equipment shall be used.
    2. Proper equipment shall be used to prevent cross contamination.
    3. The material selected for Pre-Harvest Sampling will be determined by the grower. Cuttings will be collected to make one representative sample.
    4. Refer to the authority having jurisdiction to determine adequate number of samples and proper locations. In the absence of jurisdictional requirements, the following guidance is given.
      1. Clip the top 12 inches of hemp plant’s primary stem, including female floralmaterial.
      2. Take cuttings from at least five (5) hemp plants within the plot.
      3. Place the complete sample in a paper bag.
      4. Seal the bag by folding over the top once and staple the bag shut.
      5. A separate sample must be taken from each non-contiguous plot of a given variety.
      6. A separate sample must be taken for each variety.
      7. Samples shall be secured in a paper bag (to allow for air-drying during transport).
      8. Label the sample container with a sample ID.
  3. 1.4.4  Handling Procedures of Pre-Harvest Samples
    1. Samples will be taken for drying and storage.
    2. Samples should be arranged in a single layer for drying.
    3. Drying oven will be used when possible.
    4. Samples in the oven will be left in the labeled sample bag.
    5. If selected for testing, the entire sample will be sent to a testing lab for analysis.
  4. 1.4.5  Post-Harvest Sampling Procedures for Floral Material
    1. Refer to the authority having jurisdiction to determine adequate number of samples and proper locations. In the absence of jurisdictional requirements, the following guidance is given.
    2. Adequate personal protective equipment shall be used.
    3. Proper equipment shall be used to prevent cross contamination
    4. The plot selected for sampling shall be designated by the Pre-Harvest Sampleresults. The material selected for Post-Harvest Sampling from this plot will be

10

U.S. Hemp Guidance Program PHASE 2

determined by the grower. All Post-Harvest Samples of floral material shall be taken from the designated harvested plot materials in the form (intact-plant, flowers, ground materials, etc.) in which the material will be sent to the processor

e. Grower must inventory the entire harvest to determine the form in which it exists and follow the protocol as appropriate in part a), b), or c) below.

  1. If, upon inventory, the grower determines that the entire harvest is not in a homogenous form (intact-plant, flowers, ground materials, etc.), it must be determined to take additional samples or other course of action or take the pre-harvest results.
  2. For intact-plant post-harvest samples:
    1. Ensure that the entire harvest is accounted for and in the sameform (i.e., intact-plants).
    2. Clip the top 12 inches) of hemp plant, primary stem, includingfemale floral material.
    3. Take cuttings from at least five (5) non-adjacent hemp plantswithin the harvest’s storage/drying area.
    4. Place the complete sample in a paper bag.
    5. Seal the paper bag by folding over top once and stapling to keep closed.
    6. Complete sampling procedures in part (d) –(f).
  3. For ground plant or ground floral material Post-Harvest Samples:
    1. Ensure that the entire harvest is accounted for and in the sameform (i.e., all harvested material whether whole plant or floral material only must be ground with no intact plants or whole flowers remaining from that harvest).
    2. Sample material from bag or container.
    3. Sample from a minimum of four locations within the containers from a given harvest.
    4. Place the complete sample in a plastic sample container.
    5. Seal the plastic sample container.
    6. Complete sampling procedures in part (d) –(f).
  4. For Post-Harvest Samples in other forms (e.g., trimmed floral material, or floral material and stems, etc.):
    1. Ensure that the entire harvest is accounted for and in the same form (i.e., all harvested material must be uniform).
    2. Randomly collect at least one cup of material by volume.
    3. Place the complete sample in a paper bag or plastic containerand seal the container, as appropriate.
    4. Complete sampling procedures in part (d) –(f).
  5. A separate sample must be taken for each plot designated for Post-Harvest Sampling.
  6. Samples shall be labeled and prepared for transport to the lab.
  7. Label the sample container with a sample ID.

11

U.S. Hemp Guidance Program PHASE 2

1.4.6 Handling Procedures of Post-Harvest Samples

  1. The entire sample will be sent to the testing lab for analysis.
  2. Industrial hemp crops generated from Certified seed will incur pre-harvest testing of at least five percent (5%) of growing plots per variety, per seed source.
  3. Industrial hemp crops from planting materials other than Certified seed will incur pre- harvest testing of at least fifty percent (50%) of growing plots per variety, per seed source.
  4. 100% of post-harvest samples will be tested.

Historical Food and Supplement Adulterant List


Adulteration of food and agricultural materials has a long history. NaturPro has generated a list of references citing adulteration of food and dietary ingredients in recent times (publications in the past ~30 years).

Historical Food and Supplement Adulterant List

The intent of this list to promote awareness for historical adulterants in natural products. This list is for comprehensive and historical reference only.

Free Download:

 

Workshop on Product Testing at Supplyside

by NaturPro in Quality Comments: 0

2018 SUPPLYSIDE WORKSHOP — Effectively Partnering with a Contract Laboratory

Location: Lower Level, North Convention Center

Wednesday, November 7 | 1:30-4:30pm

  • NaturPro Scientific will be discussing common pain points (and reliable cures) to forging long-lasting client-lab partnerships. For example, many companies responsible for testing their product pay little attention to how the material is being tested, and whether the lab is using a scientifically valid method.
  • Miscommunication, lack of transparency, and insufficient lab QC practices can hamper the reliability and consistency of lab test results. Ultimately, product quality suffers.
  • Open communication, verification, and investment in testing of ingredients and finished products are critical factors of successful partnerships in many ways — the main being to prove the validity of test methods required by GMP, and ensure accurate and reliable results.
  • The business benefits of positive client-lab relationships are often reflected in key performance metrics such as fewer production delays and product recalls, and reduced testing expenses.

——————

About the Workshop:

The extensive range of requirements for testing—of ingredients and finished products—places a great burden on manufacturers to invest in their own laboratory facilities, or to select an appropriate contracted partner. Many companies do both, using internal resources for day-to-day operations and outsourcing higher cost tests or seeking independent validation of results. Understanding the steps involved in selecting the right laboratory partner to meet your needs, and managing that partnership over the long term, can lead to greater peace of mind and, ultimately, ensure you’re delivering the highest quality products to consumers.

  • Top considerations and questions for a contract laboratory partner
  • Ensuring your laboratory is compliant with all regulations—and that you’re covered
  • Determining the type of testing that can be accommodated in-house and what is best served by an outside partner.

Speakers:

  • Tara Couch, EAS Consulting
  • Blake Ebersole, NaturPro Scientific
  • Michael Hoard, Arizona Nutritional Supplements
  • Holly Johnson, AHPA
  • Aaron Secrist, NOW Foods

Underwritten By:

American Testing Lab

Eurofins

Micro Quality Labs