Monday, April 8, 2013

Vitamin Lawyer SOP Certification Program


“Bureaucracy wants to devour your company!”

This web site, provides access to my Standard Operating Procedures certification program, specially designed for the industry, with special emphasis on small and start-up companies, but any company that has its own labels needs this program!

You need my 40 years’ experience as The Vitamin Lawyer! I can save your company hundreds of thousands of dollars in regulatory costs! Just embrace my three simple steps to regulatory compliance:

[1] PROCEDURE – I work with your CEO to tweak my Standard Operating Procedures and Good Manufacturing/Marketing Practices for your company

[2] CLAIMS – I work with your company for proper claims control, definition & substantiation... and the FDA required S&F Claims Notice.

[3] TRAINING - It's not enough to have procedures, says FDA: train your team and prove they are qualified - through my Three Step Program: Presenting, Training, Certifying. That third step is what this Certification program is designed to accomplish: meeting FDA training requirements.

Says FDA - "...documentation of employee training is necessary to track which employees have been trained in which operations. Therefore, final Sec. 111.14(b)(2) requires you to keep documentation of training, including the date of the training, the type of training, and the person(s) trained." Federal Register, page 34811

The Vitamin Lawyer SOP Certification program consists of the SOP document, four training webinars, an extensive lecture eBook with additional features and the Third Party Certification.

FDA 3.27.13: "FDA on the hunt..."

"Dietary supplement makers: The party’s over. The grace period on inspections has expired and the FDA is on the hunt. More warning letters were issued in 2012 than in the previous two years combined. GMP compliance is the FDA’s focus..."

"Dietary supplement manufacturers are facing a high level of regulatory scrutiny from the government as a result of the study released last week by the U.S. Dept. of Health & Human Services Office of the Inspector General. This study raises new concerns that structure/function claims are not accurate and misleading to consumers. A sample of 127 dietary supplements were reviewed and concluded 'Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence.'..." – Natural Products Association

Further from NPA: "FDA is concerned with the current lack of GMP compliance and is preparing to take a closer look during inspections. FDA has also said they are circling back to companies who have already been inspected. Dr. Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs recently stated, “'the majority of inspections [the FDA] have done have resulted in a non-compliance atmosphere, whether resulting in a warning letter or just observations on the 483s.'..." - NPA

Said one FDA Compliance Officer to me: “Your company must be in a state of control with its training, labels, claims, manufacturer, shipping & customer service…”

And this from a Vitamin Lawyer client: [Name Redacted] Wellness Company CEO “Alice” - “The FDA showed up unannounced. Said they’d be here for at least 6 days. e showed them the SOPs Counsel Ralph prepared for us. It was comforting to know we could call Ralph Any time during this, and he was there for us.”

More information:


Here is an outline of my SOP format:

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 Procedures / Claims Controls, Standards, Complaints and Policy Coordination
8. Contract Manufacturer Agreement GMP Enforcement Terms
9. Order Processing Procedure
10. Bookkeeping and Account Management
11. Order Record Keeping and Retrieval; AER Reporting
12. Emergency Planning and Crisis Management
13. Payment Card Industry Data Security System
14. Private Labeling
15. Receiving & Storage of Inventory and Returns
16. Returns and Recalls
17. Complaint Form
18. Change Controls / New SOPs
20. CCDS (Company Core Data Sheets) SOP
21. New Employee Qualification and Training © 2013