News and Resources

x

 

NEWS & RESOURCES

NEWS & EVENTS:

2019

May 23rd, 2019 – Building trust in a contract manufacturer’s supply chain
April 29th, 2019 – FDA GMP compliance demands
April 24th, 2019 – Alkemist Labs, REJIMUS team up to offer full suite of analytical, consulting services
April 22nd, 2019 – Alkemist Labs, REJIMUS Partner to Offer Comprehensive GMP Compliance Solutions
April 3rd, 2019 – FDA’s thinking on dietary ingredient status could hinder biotechnology advancements
March 25th, 2019 – Botanical must be in food, not medicine, for ‘historical use’ safety justification
March 7th, 2019 – Don’t take it personally—Regulations are the same for everyone
February 7th, 2019 – A brand’s best face forward
January 30th, 2019 – CBD concentration matters
January 25th, 2019 – Choosing, reviewing and improving contract manufacturers
January 17th, 2019 – Ingredient Identity rebrands to honor founder, highlight expansion plans
January 4th, 2019 – Narrowing of heart health claims
January 4th, 2019 – Ingredient Identity Evolves and Rebrands to REJIMUS

2018

December 27th, 2018 – Healthy aging claims: Time is the ultimate regulator
December 17th, 2018 – Ingredient transparency beyond legal requirements
December 7th, 2018 – Adulteration and claims in curcumin
November 27th, 2018 – Regulatory hurdles for probiotics
November 19th, 2018 – US federal government stays steady despite administration
November 13th, 2018 – Claims for joint health—Structure first
November 1st, 2018 – Preventing class action lawsuits: regulatory compliance is key
October 26th, 2018 – Auditing a contract manufacturer: Essential for both parties
September 21st, 2018 – Claims considerations for adaptogens for sleep, stress
August 21st, 2018 – Compliance: is your new product a food or supplement?
August 17th, 2018 – Good Data vs. Bad Data: Know the Difference
July 11th, 2018 – Legal Healthy Aging Marketing Claims
June 28th, 2018 – Legally Marketing Immune Health Products
June 19th, 2018 – Meeting Contractual Obligations With Quality Agreements
May 14th, 2018 – Three Supplement Testing Requirements and Their Challenges
May 1st, 2018 – Regulatory Enforcement in Contract Manufacturing: An Emerging Normal
March 20th, 2018 – Industry and Regulatory Bodies Collaborate with Adversarial Respect
February 28th, 2018 – Modern-Day Laws for Traditional Ayurvedic Botanicals

2017

October 31st, 2017 – Who’s Afraid of GMO’s?
August 30th, 2017 – Bog Bilberry recognized as new dietary ingredient for US market
August 28th, 2017 – The First Bog Bilberry New Dietary Ingredient For The US Market
August 10th, 2017 – SupplySide West Podcast 35: Supplement Regs ‘Efficient if Applied and Enforced’
August 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
April 19th, 2017 – IM 2017: NDIs, FTC and More: Navigating the Changes Posed by a New Administration
March 20th, 2017 – Consumer Education Hindered by Claims Regulations
February 21st, 2017 – Joint Health Claims Substantiation
February 15th, 2017 – NDI Guidance and Sports Nutrition
February 10th, 2017 – The Science of Sports Nutrition
February 1st, 2017 – Ingredient Identity Delivers Project Insights to Clients with Intuit QuickBase
January 30th, 2017 – Certifiable: Sorting Through the Certification Marketplace
January 17th, 2017 – Tips for a Successful Contract Manufacturing Partnership
January 13th, 2017 – Ingredient Identity Selected as Strategic Regulatory Partner by Harmony Health Labs

2016

December 13th, 2016 – New Dietary Ingredient Notifications and Related Issues: Guidance for Industry
December 13th, 2016 – Ingredient Identity boosts training capabilities with expansion
December 13th, 2016 – Ingredient Identity Submits Comments on FDA’s New NDI Draft Guidance
December 9th, 2016 – New Corporate Headquarters for Ingredient Identity
November 10th, 2016 – GMP Booyeah!
October 4th, 2016 – New Dietary Ingredients (NDI)– A Better Solution
August 11th, 2016 – Ingredient Identity offers pay as you go QA plan for virtual organizations
June 1st, 2016 – ABC-AHP-NCNPR Botanical Adulterants Program

2015

September 4th, 2015 – Daane Labs Retains Ingredient Identity for Growth
September 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
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)

USDA (United States Department of Agriculture)

EPA (Environmental Protection Agency)

ICH (International Conference of Harmonization)

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

Search Engine – AddMe