Summer Reg Changes Coming and Branding Basics

The Vitamin Consultancy eLetter View this email in your browser

It's Summer Soon... Bureaucracy Getting Edgy! [1] Daily Values -- DVs -- for Dietary Supplements Changing [2] Branding Profiles and my new Systems Processing Integration Site [3] Proposition 65 Changes: Running Out of Time! -------------- [1] FDA Extends Compliance, But Now is the Time to Plan! It has been reported that the new regulations on dietary supplement and food label "Facts Boxes" have been delayed a bit, but the time to get ready is NOW! The good folks at RAPS.org [*] have made this detailed information available: "FDA made a significant number of changes to several Dietary Reference Values (DRV) and many Reference Daily Intakes (RDI) [for Nutrient Facts panel for regular foods -rf]. As previously mentioned, the DV for dietary fiber was increased to 28g and a new DV of 50 g for added sugars was established. Other DV's that changed include:     DRV for fat was increased to 78 g     DRV for carbohydrates was decreased to 275 g     DRV for sodium was decreased from 2,400 mg to 2,300 mg Most vitamins and minerals had their RDI for adults and children age four and older revised. The vitamins and minerals for which the RDI was reduced include:     Biotin has decreased from 300 mcg to 3 mcg.     Chloride has decreased from 3,400 mg to 2,30 mg.     Chromium has decreased from 120 mcg to 35 mcg.     Copper has decreased from 2 mg to 0.9 mg.     Molybdenum has decreased from 75 mcg to 45mcg.     Pantothenic acid has decreased from 10 mg to 5 mg.     Riboflavin has decreased from 1.7 mg to 1.3 mg.     Thiamin has decreased from 1.5 mg to 1.2 mg.     Niacin has decreased from 20 mg to 16 mg.     vitamin B-6 has decreased from 2 mg to 1.7 mg.     vitamin B-12 has decreased from 6 mcg to 2.4 mcg.     Selenium was decreased from 70 mcg to 5 mcg.     Zinc has decreased from 15 mg to 11 mg. The following vitamins and minerals had their RDI for adults and children age four and older increased:     Calcium has increased from 1,000 mg to 1,300 mg.     Magnesium has increased from 400 mg to 420 mg.     Manganese has increased from 2 mg to 2.3 mg.     Phosphorus has increased from 1,000 mg to 1,250 mg.     Potassium has increased from 3,500 mg to 4,700 mg.     Vitamin c has increased from 60 mg to 90 mg.     Vitamin k has increased from 80 mcg to 120 mcg. Further, several vitamins will now need to be declared using different units of measure. In the case of vitamins A, D and E, International Units (IU) will be replaced by metric units, such as micrograms of Retinol Activity Equivalents (mcg RAE) for vitamin A; micrograms for vitamin D and mg for vitamin E. For vitamin D, however, IU may continue to be used in addition to mcg. Also, folate must now be declared as micrograms of "Dietary Folate Equivalents" (mcg DFE) instead of simply mcg. The revised RDIs for these four vitamins are:     vitamin A 900 mcg RAE (from 5000 IU)     vitamin D 20 mcg (800 IU) (increased from 10mcg or 400 IU)     vitamin E 15 mg (from 30 IU)     folate 400 mcg DFE (from 400 mcg)" [Note: these changes will have to be integrated into your label Supplement Facts boxes over the next 18 months. This website can help you with those pesky Supplement Facts calculations: https://www.recipal.com/ - rf] [*] https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/10/preparing-for-dietary-supplement-label-changes-under-the-final-rule-for-nutrition-and-supplements-fa --------------------------- [2] BRANDING BASICS COMPANY BRANDING PROFILE www.SystemsProcessingIntegration.com http://www.SystemsProcessingIntegration.com What is a Company Branding Profile (CBP)? It is an organized document that is part of the Intellectual Property of the company. The Branding Profile adds value to the company by better defining the company brand.  It is a company IP asset. The CBP needs to have a prominent position in the Company Culture since it defines, for all the Company Team Members, the details of the Brand the Company promotes and defends.  It is posted as part of the Operating Process System (OPS) and is a key element in Systems Processing Integration. The Profile covers such core marketing issues as: Patents and Trademarks Slogans Trade Names and Logos Precisely what colors represent the company What typeface fonts What types of images The "look and feel" of the labeling and sales copy Trade Dress and Branding Indicia Substantiated advertising language should be cataloged. The Company Mission Statement should be included. One Branding Agency [http://duffy.agency/insight/what-is-a-brand-profile/] lists: "The brand codification process typically involves defining and aligning elements like: Target audience / segments Target beliefs & perceptions Target options / competitors Category Value proposition Position Speaking points Personality Selling points Tone & manner Visual profile Backstory Brand persona Brand architecture Vision, mission, goals" The Branding Profile is intended to offer guidance to the copywriters and customer service people in the company, as well as the planners and managers. That is why this essential part of the company culture rightfully belongs in the OPS, as one of the chief expressions of the company's Mission. More at: www.SystemsProcessingIntegration.com ------------- [3] Proposition 65 Changes Just 2 Months to Go! Is Your Company Ready? Proposition 65 Coming at YOU! www.ProfessionalSafetyDossier.com

Three New Vitamin Consultancy Videos

Three New Videos Updating Regulations View this email in your browser

3 Vitamin Consultancy Videos My summer blockbusters will help preserve your natural product business.  Three videos -- two of which are my gift to you for being on this email list -- are Continuing Education (CEs) for the natural products industry. The first features Robert Goodman PhD and me talking about our Cosmetic Safety Dossier service. In both the US and the EU third party safety certifications are an important part of successful cosmetics marketing. You can see the video on the CSD web site; click here:   The second is my explanation of the new OPS -- the Operating Procedures System -- which makes it simple to use your company's SOPs to actually run the business efficiently and in compliance with FDA requirements. This training video will be added to the Vitamin Consultancy Webinar system, but here it is for you now, gratis. Click here:   The third is my new Webinar on Quality Control The 26 slide presentation covers both FDA QC requirements and the qualifications needed for your QC Manager. Don't have a QCM? You need to watch this video. If you are the person who acts as QCM in your company, you need to watch it even moreso! Please email me for access: ralph.fucetola@usa.net with QC Webinar in the subject line. Have a great balance of the summer... winter holiday marketing starts soon! Regards, ralph ... Ralph Fucetola JD

OPS for SOPs

INDEX:
OPS 4 SOPs
Branding Basics

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This Article Also Posted Here:

http://vitaminconsultancycertification.weebly.com/ops-4-sops.html

 Standard Operating Procedures and OPS

This newsletter describes the Standard Operating Procedures (SOP) Operating Procedures System (OPS) which the Vitamin Consultancy maintains for our monthly retainer clients. 

A New Vitamin Consultancy Service
Operating Procedures System - OPS
SOP Maintenance
Branding Profile

Dietary Supplement purveyors face an ever-changing regulatory climate as various federal agencies, led by FDA, seek to control the market. After practicing law for 36 years, gaining a reputation as The Vitamin Lawyer, I focused my efforts on The Vitamin Consultancy which brings top-level regulatory services to medium and small vitamin companies.

Those services include not only FDA-vetted, GMP compliant Standard Operating Procedure (SOP) formats, but also a webinar training program that teaches how to use SOPs to meet regulatory requirements -- and more, with specialized webinars on topics such as The Forbidden Words, to keep your company ahead of the curve. I provide GMP audits and copy/label/claims reviews.

In addition to keeping an eye on FDA regulatory developments through the Agency web site and various industry newsletters, I also have people coming to me for my advice who have been recently inspected by FDA and received "Comment" letters. Often these letters are an "early warning" of FDA regulatory focus, giving me the opportunity to prepare you for the changing regulatory environment.

As a result of some language used in a recent FDA letter to a company selling homeopathic patches, I saw that FDA was recommending certain language, in effect, for the Quality Control (QC) parts of the SOPs, more clearly specifying the role of the Quality Control Manager (yes, in a small company the CEO/COO may also be the QCM), so I created certain amendments to the SOPs to cover this new FDA focus and clarify the role of the QCM.This is one way for Vitamin Consultancy clients to stay a head of the curve. [BTW, I am working on a new webinar about the role of the QCM.]

While there is a Change Procedure in the SOPs, how will such changes be communicated and implemented?

I've been thinking, therefore, about how to more effectively automate the process.  I suggest it may be time to "go digital" with the Operating Procedures System -- OPS.

Using the paper file hard-copy as a back up, the company could have a private [password protected] online OPS copy as the official copy.

Even, or especially, in an emergency managers would have access to necessary procedures from their smart phones that would give them always up-to-date copies of the procedures.  Properly indexed with hyperlinks, the necessary information would always be available, and, perhaps more importantly, FDA would see that there is a system in place to ensure that the most up-to-date procedures are being implemented.

In addition to the SOP format that I've prepared there are probably other formal or informal operating procedures that should be recorded, not necessarily for FDA compliance, but for brand and operations consistency.

The Operating Procedures System could become a repository for the company culture, for such essential factors as the Company Branding Profile (see article below).

Properly developed and maintained, the OPS can be a valuable company asset.

The Vitamin Consultancy's SOP Maintenance System provides your company with a powerful tool for the continued regulatory compliance of your operations. Here is how it works:

1. The Company and the Consultancy enter into a privacy contract for the maintenance of the OPS. The maintenance fee is included in the monthly retainer.

2. The SOP document, based on the Consultancy format, is finalized with the Company and posted on the protected site. Only the OPS Administrator, provided by the Consultancy, has authority to change the document (and with company COO approval).  Additional operations documents that may be useful can also be posted, under COO direction.

3. The Company specifies which managers are to have access. That access is granted to specific email addresses and can be password protected. At any time access can be terminated.

4. The Consultancy will keep the SOPs up-to-date and will notify the managers, through the master list, of changes.

5. These procedures will themselves be set down in a new SOP specifying the OPS Online Official SOPs.

Here is an outline of the Operating Procedures System:

[1] The SOP document details the operating procedures of the Company, in conformity with FDA and FTC regulations of dietary supplement and similar businesses. See SOP Index below.

[2] The OPS is the private online repository for the updated official copy of the SOP document, available to the managers of the Company.

[3] The OPS consists of a Google Documents file folder and subfolders with the following items:

1. The OPS Use Memorandum
2. The SOP indexed manual consisting, currently, of 24 specific SOPs
3. The SOP Appendix with standard forms
4. The Company Branding Profile
5. The CCDS (Company Core Data Sheet) for each current product.

 [4] The SOP Manual consists of the following procedures:

1.  Introduction / Index
2.  Refund, Delivery & Returns Policies
3.  Standard Disclaimers; Site Use Statement
4.  Standard Waivers: Model – Testimonial – Clinical Study
5.  Email Privacy Policy
6.  Document Retention Policy
7.  Quality Control / Claims Control / Complaints
8.  Contract Manufacturer Agreement GMP Enforcement Terms
9.  Password and Internet/Program Access Controls
10.  Order Processing Procedure
11.  Bookkeeping and Account Management
12.  Order Record Keeping and Retrieval; AER Reporting
13.  Emergency Planning and Crisis Management
14. Payment Card Industry Data Security System
15. Private Labeling / Labels
16. Receiving, Handling, Shipping & Storage of Inventory and Returns
17. Recalls
18. Complaint Form
19. Change Controls / New SOPs
20. CAPA
21. CCDS (Company Core Data Sheets)
22. New Employee Qualification and Training
23. Official Inspections: Procedures
24. New Product Development; Product Retirement & Archiving

[5] The SOP Appendix includes these forms:

Waivers
Complaint Form
CCDS Form
Contract Terms
Social Media Schedule / Program Access

[6] These are records are kept in the ordinary course of business and may be offered as evidence in court. The Branding Profile is an expression of the company’s Intellectual Property and claims to trademarks, trade dress and branding indicia.

[7] The following Positions in the Company are listed in the SOPs: the CEO, COO, Quality Control Manager (QCM), Emergency Manager (EM), SOP & CCDS Manager, Customer Service Manager and Warehouse Manager.

The COO or (where one is not designated) the CEO shall hold these Manager Positions unless the Positions are filled by appointment by the CEO

[8] All managers shall maintain online access to the current SOPs at all times; for example, on their smart phones.

[9] The private link to the OPS Google Docs folder which includes the SOPs can be provided to anyone in the company, or any consultant, who needs access to the OPS

Depending on company size, the Vitamin Consultancy can maintain your OPS and their contents for as little as an hour a month retainer. For that you receive our guidance on developing your SOPs, including FDA-compliant forms, your basic Company Branding Profile (more about that below) and our private client alerts regarding breaking FDA and FTC news impacting natural products. Of course, we set up and maintain your OPS online.

Interested? Call Ralph: 973.300.4594. We invoice monthly through PayPal. 

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BRANDING BASICS

COMPANY BRANDING PROFILE

What is a company Branding Profile? It is an organized document that is part of the Intellectual Property of the company. It adds value to the company by better defining the company brand.

The Profile covers such issues as patents and trademarks, slogans; trade names and logos; precisely what colors represent the company; what typeface fonts; what types of images, the "look and feel" of the labeling and sales copy (trade dress; branding indicia). Standard advertising language may be cataloged. The Company Mission should be included.

One Branding Agency lists:

"The brand codification process typically involves defining and aligning elements like:

• Target audience / segments
• Target beliefs & perceptions
• Target options / competitors
• Category
• Value proposition
• Position
• Speaking points
• Personality
• Selling points
• Tone & manner
• Visual profile
• Backstory
• Brand persona
• Brand architecture
• Vision, mission, goals"

http://duffy.agency/insight/what-is-a-brand-profile/

The Branding Profile is intended to offer guidance to the copywriters and customer service people in the company, as well as the planners and managers.

That is why this essential part of the company culture rightfully belongs in the OPS, as one of the chief expressions of the company's mission.