News and Resources

                                    NEWS & RESOURCES

NEWS & EVENTS:

2017

Aug 30th, 2017 – Bog Bilberry recognized as new dietary ingredient for US market
Aug 28th, 2017 – The First Bog Bilberry New Dietary Ingredient For The US Market
Aug 4th, 2017 – SK Laboratories Selects Ingredient Identity as Strategic Management Partner
May 10th, 2017 – Heathy INSIDER Podcast 62: Unified Industry Can Benefit in New Political Climate
May 9th, 2017 – Bio-gen Extracts Selects Ingredient Identity as Regulatory Strategy Partner
May 2nd, 2017 – Ingredient Identity joins Organic & Natural Health Association
Apr 26th, 2017 – It’s For Sale, But Is It Legal? Sports Nutrition Products
Apr 19th, 2017 – IM 2017: NDIs, FTC and More: Navigating the Changes Posed by a New Administration
Mar 20th, 2017 – Consumer Education Hindered by Claims Regulations
Feb 21st, 2017 – Joint Health Claims Substantiation
Feb 15th, 2017 – NDI Guidance and Sports Nutrition
Feb 10th, 2017 – The Science of Sports Nutrition
Feb 1st, 2017 – Ingredient Identity Delivers Project Insights to Clients with Intuit QuickBase
Jan 30th, 2017 – Certifiable: Sorting Through the Certification Marketplace
Jan 17th, 2017 – Tips for a Successful Contract Manufacturing Partnership
Jan 16th, 2017 – Ingredient Identity Launches Outsourced PTE Quality Assurance Solution
Jan 13th, 2017 – Ingredient Identity Selected as Strategic Regulatory Partner by Harmony Health Labs

2016

Dec 13th, 2016 – Ingredient Identity boosts training capabilities with expansion
Dec 13th, 2016 – Ingredient Identity Submits Comments on FDA’s New NDI Draft Guidance
Dec 9th, 2016 – New Corporate Headquarters for Ingredient Identity
Nov 10th, 2016 – GMP Booyeah!
Oct 4th, 2016 – New Dietary Ingredients (NDI)– A Better Solution
Aug 11th, 2016 – Ingredient Identity offers pay as you go QA plan for virtual organizations
Aug 11th, 2016 – Ingredient Identity launches outsourced PTE quality assurance solution
Jun 1st, 2016 – ABC-AHP-NCNPR Botanical Adulterants Program
Apr 12th, 2016 – Abattis receives NPN from Health Canada for Phyto[NOS]™

2015

Oct 6th, 2015 – Jim Lassiter – “Industry Rockstar” at SSW 2015 Reception
Sept 4th, 2015 – Daane Labs Retains Ingredient Identity for Growth
Sept 1st, 2015 – FSMA Scrutiny – Part I
July 15th, 2015 – GRAS & NDIN Strategies Webinar Recording with TraceGains
July 15th, 2015 – GRAS & NDIN Strategies Webinar with TraceGains
May 5th, 2015 – Abattis Selects Ingredient Identity
April 10th, 2015 – New II Corporate One Sheet Published

2014

October 25th, 2014 – DSHEA – 20 Year Anniversary
October 15th, 2014 – Regulatory 101 for Sales & Marketing Professionals
October 9th, 2014 – SupplySide Rockstar Talk
July 22nd, 2014 – Announcement at NBJ Summit 2014
June 10th, 2014 – Our Social Media Monitoring Services Reduce Your Risks
April 1st, 2014 – Consulting Firm Ingredient Identity expands capabilities with new divisions
March 26th, 2014 – A Regulatory Management Consulting Breakthrough

2013

December 18th, 2013 – Why this Consulting Firm Chose Intuit QuickBase for Project Management
September 20th, 2013 – Grappling with a “Great Mountain of Paperwork” (Part 2)
April 11th, 2013 – Vestiage Announces Key Partners for Launch of Monterey Bay Nutraceuticals Anti-Aging Wellness Products
April 4th, 2013 – CRN & Virgo Premium Series: Complex Structure Function Claims
January 7th, 2013 – Is Your Label a Liability?

REGULATORY TERMINOLOGY:

Quality Agreement – A Quality Agreement is a binding document, in addition to any standard service contract or agreement, that identifies all the quality control, quality assurance, and related regulatory responsibilities and obligations of a vendor and customer to one another in order to conduct business in full compliance with the applicable Good Manufacturing Practices (GMP’s).

Formulation Data Sheet – A Formulation Data Sheet or FDS is a controlled document that identifies all of the parameters and acceptance criteria for a given formulation, as defined by the owner of a given formulation such that the product can be produced reliably and be upheld to the standards of production. This document is not the same as a Specification Sheet for the given formulation.

Ingredient Data Sheet – An Ingredient Data Sheet or IDS is a controlled document that identifies all the parameters and acceptance criteria for a given ingredient, including all ingredient sources, as defined by the owner of a given formulation to which the ingredient may be included, such that the end product can be produced reliably and be upheld to the standards of production. This document is not the same as Certificate of Analysis or Specification Sheet for the given ingredient.

Specification Sheet – The Specification Sheet or “Spec Sheet” is a controlled document that identifies the parameters, testing methodology and other criteria for a given formulation or ingredient, as defined by the vendor accepting the raw material(s), manufacturing the raw material(s), manufacturing the finished product(s) inclusive of co-packing, or conducting the release testing of the ingredient(s) or finished product(s).

Quality Manual – A Quality Manual is the governing set of Standard Operating Procedures, inclusive of the Master SOP, that all companies operating in compliance with the applicable GMP’s based on their business type, must maintain current at all times, whether electronically or a in paper-based format.

Standard Operating Procedure – The Standard Operating Procedure (SOP) is the fundamental document required to define each daily activity, role and responsibility of key personnel and operational function involved in the production, testing, storage, transportation and/or distribution of raw materials and/or finished products.

Quality System – The Quality System or “Quality Program” is the general term to addresses all aspects of given company’s quality control, quality assurance and regulatory affairs activities, including the Quality Manual, SOP’s and all applicable controlled documents. Quality System’s are unique to a company’s business model, target market(s) and geographical location(s).
Other Industry Resources:

Professional Organizations

   AHPA (American Herbal Products Association)

    AOAC (Association Of Analytical Chemists)

    USP (United States Pharmacopoeia)

•    UNPA (United Natural Products Association)

    NBJ (Nutrition Business Journal)

    NASC (National Animal Supplement Council)

Industry News and Information

    NPI Center

•    Consumer Labs

    NutriSupLaw

Regulatory Resources

    NDI Filings (Regulations.gov or Docket 95S-0316)

    GRAS Notifications (FDA.gov)

    FDA/CDER (Food & Drug Administration)

    CCN (Chemical Consultants Network)

    USDA (United States Department of Agriculture)

    EPA (Environmental Protection Agency)

    ICH (International Conference of Harmonization)

    CRN (Council for Responsible Nutrition)

Internet News Sources & References

    2017 Warning Letters

    2016 Warning Letters

    2015 Warning Letters

    2014 Warning Letters

    FDA Docket Submission

    HerbalGram Article (Quality Control of Herbals)

•    Manufacturing Guidelines for Nutritional Supplements

    Dietary Supplement GMPs (Book)

    Dietary Supplement Information Bureau (Commentary)

•    Search Engine – AddMe