This blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.
Company Action Alert: Biennial Food Facility Registrations Due Dec 2016
This memorandum is paraphrased from a number of sources and is intended as a private communication to the regular clients of The Vitamin Consultancy.
The Food Safety Modernization Act was signed in 2011 (with some
protection for DSHEA products that I fought hard to have included) and
with it, notably tougher government and retailer food safety standards.
Demands on companies to demonstrate regulatory compliance and
due diligence will continue to escalate, yet just one failed performance
verification audit or one product recall can significantly damage your
business -- even if you have written Standard Operating Procedures in
In these litigious times, lawyers and consumers alike will seize on any
opportunity to take legal action against manufacturers in the event of
finding any issue with the product purchased. Food manufacturers
supplying retail organizations understand the need to ensure the highest
It is therefore in the best interests of manufacturers marketers to take
steps to ensure systems and procedures are in place to minimize the
risk of harm to the public and consequent litigation. In the event of
such an instance, the company must have the necessary documentary
evidence that the company has been duly diligent in the manufacturing
The FDA states that the Label Owner for the product is
ultimately responsible for assuring that the ingredient providers,
manufacturers, packers, shippers and all persons involved in the process
adhere to all food safety regulations.
[Practice Note: you must confirm the registration receipt email
by return email within 30 days or the registration is not valid.]
 Good Manufacturing Processes (GMPs) which vary
depending on whether the product is an OTC drug, a cosmetic, or a food
or dietary supplement (by the way, in DSHEA, the Dietary Supplement
Health and Education Act of 1994, Congress directed FDA to model the
Dietary Supplement GMPs after Food GMPs, not Drug GMPs.
 The 2011 Food Safety Law which gave enhanced powers to FDA, but, in section 1011 of the Act preserved our grandfathered DSHEA ingredients from those enhanced powers.
[Practice Note: this means the battle has shifted to exactly what ingredients are “grandfathered.”]
Additionally there are local (city, county) and state regulations that apply to the handling of foods.
Some of the overall concerns that arise are included in the following “Black Letter Law” overview:
Duty of Care
Under the common law we each have a Duty of Care which requires
that we conform to a standard of reasonable care regarding any acts or
omissions that could foreseeably harm others. The Standard of Care is
the standard degree of watchfulness, attentiveness, prudence and caution
of a reasonable individual who is under a Duty of Care.
In manufacturing the Standard of Care is determined by the cGMPs as
implemented by a reasonably prudent manufacturer of a product.
Failure to meet the Standard of Care will likely be regarded as
negligence, and any proximately caused, foreseeable damages may be
claimed by an injured party.
That the company engaged in Due Diligence to determine the Duty and
Standard of Care can be a defense for to manufacturers accused of
violating food safety regulations (but, of course, the regulations have
to be implemented going forward). This defense asserts that the accused
took all reasonable practicable steps to avoid the harm. It is a
sufficient defense for the person charged to prove that:
• All reasonable precautions were taken, with
• All due diligence to avoid the occurrence, whether personally or through any person under their control.
“Taking all reasonable precautions” includes setting up systems of
control which are appropriate to the risk. What is reasonable is
determined by the size and resources of the business. “Exercising all
due diligence” involves having procedures in place which review and
audit the system to ensure it is operating effectively.
Whether or not a defense will be successful depends on the circumstances surrounding each case.
Hazards Analysis Critical Control Points
In food production cGMPs call for a Hazards Analysis Critical Control
Points (HACCP) based system to support the procedures to identify where
hazards might occur. The HACCP structure is then used to put into place
procedures to mitigate the risk of the hazard from occurring in the
first place. The HACCP process strictly monitors and controls each
manufacturing step, to reduce the probability for hazards to occur. This is similar to the section in my standard SOPs on CAPA (Section 20).
HACCP is based on 7 core principles:
• Conduct a food safety hazard analysis
• Identify the Critical Control Points (CCPs) (point at which a hazard is optimally controlled)
• Establish critical limits for each CCP
• Establish CCP monitoring requirements
• Establish corrective actions when monitoring indicates that a particular CCP is not under control
• Establish record keeping procedures
• Establish procedures to verify system is working as intended
We have briefly looked at the Black Letter law concepts of Duty and
Standard of Care, and Due Diligence and have listed the three primary
areas of FDA food safety control.
Having Standard Operating Procedures (SOPs) that track the appropriate
GMPs for the type of regulated product manufacturing is an important first step in meeting regulatory requirements.
The second step is to fully implementing them.
However, even if “all your papers are in order” your ingredients or
claims may run afoul of FDA food safety regulatory actions. Only close
attention to changes in the enforcement climate will keep you ahead of
the pack of competitors.
The Vitamin Consultancy aims to keep you informed so you can
continue to develop and market your dietary supplement products in