Monday, November 21, 2016

Food Safety Summary for DSHEA Products

Food Safety Summary for DSHEA Products

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 place.

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 product quality.

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 process.

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.

The Primary Food Safety Regulations include:

[1] The Food Facility RegistrationBiennial renewals are due Oct – Dec 2016 (and 2018, 2020, etc) --

[Practice Note: you must confirm the registration receipt email by return email within 30 days or the registration is not valid.]

[2] 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.

[3] 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.

Due Diligence

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 relative freedom.