Wednesday, October 23, 2019

Vitamin Consultancy Services

Special October Newsletter

This Issue: Archive Link, STS Webinar and Discounted VC Services!

STS Webinar

My STS webinar focuses on three areas from Part IX of the DSHEA GMPs: Specifications, Testing and Samples.

Webinar video (27 minutes), ebook and the New Product checklist included.  The Vitamin Consultancy regular retainer clients have received access to this important webinar.  For all other clients, we have a special (May only) introductory price:

Now just $69 for full access, was $99.  Just email me at with STS in the subject line and I'll send you a PayPal money request to give you access.

The Vitamin Consultancy Archive Link


Vitamin Consultancy Services - 2019
Some of These Services are with Third Parties


A. New Product Development Checklist
B. DSHEA, Medical Food and Cosmetic Labels Review
C. Sales Copy Review
D. GMP (Good Manufacturing Procedures) Manufacturer Review
E. Standard Operating Procedures (SOPs) & Forms
   (1) - SOP Format (41 Pages)
   (2) - Specifications for Master Manufacturing Record Checklist
   (3) - Food Safety Plan Format
   (4) - Site Use Statement Format
   (5) - Waivers (Testimonial, Model, Clinical Trial)
   (6) - Complaint Form
   (7) - CCDS (Company Core Data Sheet) Form
   (8) - Manufacturer Contract Terms
   (9) - Standard Quality Control Contract, Manufacturer

2. [with Robert Goodman, PhD]

A. Safety Data Sheet (SDS) Dossier
B. Cosmetic Safety Dossier
C. California Prop 65 Safety Dossier


A. Operating Procedures Systems (OPS) -- SOP Documentation Private Website
B. Mission and Branding Dossier

Institute for Health Research [with Robert Goodman, PhD]

A. Institutional Review Board (IRB) Services for Clinical Trials
B. Protocol Development for Clinical and Research Studies, and Clinical Trials


A. SOP Certifications
B. GMP Certifications
C. PCQI (Preventive Controls Qualified Individual) Certifications


The Vitamin Consultancy Webinars

   -- CAM Cautions
   -- Cosmetic Safety Dossier Introduction
   -- DS & Medical Foods for Physicians
   -- Food Safety Plan - PCQI Training
   -- Health Claims
   -- Lawful Copy Writing
   -- Minister CAM Practices
   -- NGO Formation
   -- OPS 4 SOPs
   -- Quality Control
   -- Record Keeping for GMPs
   -- Second Opinion Wellness Coaching
   -- SOP1: Introduction
   -- SOP2: Section 1
   -- SOP3: Section 2
   -- SOP4: Conclusion
   -- SOPs Certification Test
   -- SOPs Certification Test for HCPs
   -- SOPs for Health Care Practitioners
   -- STS: Specifications, Tests, Samples
   -- Terms of Use
   -- Testimonials
   -- Therapy is Not Treatment

Tuesday, October 8, 2019

Safety Data Sheets

October 2019 Vitamin Consultancy Newsletter

 Informed Consent Podcast

I presented a paper on Informed Consent to the Libertarian Scholars Conference held at Kings College in Manhattan last weekend.  Sharry Edwards, MEd. interviewed me on the presentation for her podcast, so here is the hour-long discussion of the paper, your right of Informed Consent and the powerful forces that want to abrogate your Right.


29 CFR § 1910.1200 - Hazard Communication is the Federal version of California's Proposition 65.  Learn more about that here: 
"The purpose of this section is to ensure that the hazards of all chemicals produced or imported are classified, and that information concerning the classified hazards is transmitted to employers and employees. The requirements of this section are intended to be consistent with the provisions of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Revision 3. The transmittal of information is to be accomplished by means of comprehensive hazard communication programs, which are to include container labeling and other forms of warning, safety data sheets and employee training."

If you or your contract manufacturer import any chemicals (which includes natural sourced ingredients) you must be able to product an SDS for each during any FDA inspection.
Dr. Bob Goodman and I are available to consult with your Company regarding its SDS needs.

Just send me an email with SDS in the subject line: 
SDS Outline

29 CFR 1910.1200 (Appendix D) provides guidance on the contents of the SDS

Section 1—Identification:  Product identifier, manufacturer or distributor name, address, phone number, emergency phone number, recommended use, and restrictions on use.
Section 2—Hazard(s) identification:  All hazards regarding the chemical and required label elements.
Section 3—Composition/Information on ingredients:  Information on chemical ingredients and trade secret claims.
Section 4—First-aid measures:  Required first aid treatment for exposure to a chemical and the symptoms (immediate or delayed) of exposure.
Section 5—Fire-fighting measures:  The techniques and equipment recommended for extinguishing a fire involving the chemical and hazards that may be created during combustion.
Section 6—Accidental release measures:  Steps to take in the event of a spill or release involving the chemical.  Includes:  emergency procedures, protective equipment and proper methods of containment and cleanup.
Section 7—Handling and storage:  Precautions for safe handling and storage, including incompatibilities.
Section 8—Exposure controls/Personal protection:  OSHA’s permissible exposure limits (PELs), threshold limit values (TLVs), appropriate engineering controls, and personal protective equipment (PPE).
Section 9—Physical and chemical properties:  The chemical’s characteristics.
Section 10—Stability and reactivity:  Chemical stability and possible hazardous reactions.
Section 11—Toxicological information:  Routes of exposure (inhalation, ingestion, or absorption contact), symptoms, acute and chronic effects, and numerical measures of toxicity.
Section 12—Ecological information:  How the chemical might affect the environment and the duration of the effect.
Section 13—Disposal considerations—describes safe handling of wastes and methods of disposal, including the disposal of any contaminated packaging.
Section 14—Transportation information—includes packing, marking, and labeling requirements for hazardous chemical shipments.
Section 15—Regulatory information—indicates regulations that apply to chemical.
Section 16—Other information—includes date of preparation or last revision.

Sections 1-11 and 16 - required; sections 12-15 - not required.