Wednesday, July 5, 2006

07/05/06 - FDA inspections & SoPs - Operations Manua


This Vitamin Lawyer Update is addressed primarily to the Dietary Supplement formulators and marketers on my eList.


1. FDA Inspection - What to expect from an FDA site inspection
2. Codex Meeting in Geneva - Latest internationalist regulations
3. SoP- Operations Manual - Why a good SoP Manual helps with QC requirements.



1. FDA inspections

According to the respected vitamin industry publication FDA News, "The FDA conducted more than 19,000 inspections, issued more than 6,000 Form 483s and sent out 535 warning letters in fiscal 2005 alone. With an estimated $22 million in new user fees in 2007, the FDA plans to fund increased reinspections and follow-up work."

While most of these inspections are in the other areas FDA regulates: drugs, cosmetics, OTCs and devices, the number of inspections are increasing in the Vitamin industry as well.

So, how do you prepare for a possible inspection?

Primarily by having your physical location clean and orderly while making sure your paper work is in order.

This is what FDA will look for:

1. Quality Control to assure that every product is tested upon receipt from manufacturer
2. Complaint procedures to ensure that all adverse reactions are identified
3. Training programs for customer service and sales people
4. Disclaimers must be located at the site of the claim
5. New dietary ingredient, structure and function and health claim filings
6. Copies of labels and ads will be required to be provided.


Of the above, the most important are probably:

1. Copies of your Structure and Function Notices to the FDA (this notice is required within 30 days of whenever you make or change a claim made about a dietary ingredient). Up 'til now, FDA has not had the resources to police the S&F Notice requirement so few marketers file them; I recommend that marketers do prepare and file these notices for at least their most important products. Of course, The Vitamin Lawyer has proper formats for the notice; estimate: about 1 hour legal time to do a notice properly.

2. Copies of your labels and ads.

3. Operations Manual – including QC, complaint (adverse reaction) and staff training information; a standard Employee Manual and the Rules for your online affiliation program could be part of this too. The Vitamin Lawyer has the proper formats available for much of this.

2. Codex Meeting in Geneva

The Codex Commission is meeting this week in Geneva. The international organization appears to be increasingly chaotic as various nations try to assert their interests against the globalizing interests of the US and EU.

From the standpoint of the US Dietary Supplement industry, the most important development thus far at the meeting was an admission by the Codex Secretary that, in the proposals before the Commission, “No sentence provides that Codex standards and related guidelines are mandatory…” This admission, in keeping with the provision in the Codex Statute that its guidelines are “advisory” means the US supplement industry can continue to develop regardless of international regulations – so long as Congress does not adopt those restrictive international norms, or permit the FDA to “backdoor” those restrictions under the guise of “harmonization.”

For an up-to-date report on one observer’s view of what is happening in Geneva, see:


3. SoPs Manual - Standard Operating Procedures

The summer time tends to be a little less hectic than other times of the years, so this might be the best time for you to engage the Vitamin Lawyer in preparing your Operation Manual so you can be ready in the event of a surprise FDA visit. Good Quality Control (QC) procedures necessitate the existence of an Operations Manual. My simple format for small supplement purveyors includes the following sections.

A. Refund, Delivery & Returns Policies
B. Standard Disclaimers; Site Use Statement
C. Standard Testimonial Waiver
D. Email Privacy Policy
E. Document Retention Policy
F. Quality Control Procedures - Standards, Complaints and Policy Coordination
G. Order Processing Procedure
H. Bookkeeping and Account Management
I. Order Record Keeping and Retrieval; AER Reporting
J. Emergency Planning and Crisis Management [added 11/16/06]

Contact me at if you want a customized OPs Manual; please put "Op Manual" in the subject line.

[03/16/07 update: For an outline of the VL standard SoP and Employee Manual, see:]

Well, that’s all for now.

Ralph Fucetola JD