Our fully-comprehensive supplement and pharmaceutical fulfillment and packaging process


The Food Safety Modernization Act (FSMA)

The FSMA is a Federal law that was signed into law on January 4th, 2011 by the Obama administration. The act granted the FDA considerably more power to control the growing, harvesting and processing of consumables. This act was a broad stroke and was controversial. Conservatives were concerned with the overreach of power and the liberals were happy due to additional controls that they felt protected the public. What it meant to consumers was an increase in pricing (Cost of 2.2 Billion in 5 Years), a small limitation on certain goods but consumer protection if there were dangers in the market that somehow escaped the system. Claims of billions of dollars in costs due to contaminants affected the food industry.

This gave the FDA the power to perform forced recalls, it also granted the FDA the power to deny entry without approval. When any consumable comes into the US, the FDA needs proof that a product is safe and must pass the following criteria:

  1. Safety – that will not harm the person taking it.
  2. Identity – written proof that is what the company says it is.
  3. Strength – measured to have the function the company claims.
  4. Quality – provided in a way where the process is repeatable and consistent.
  5. Purity – free from microbial contamination.

The FDA felt that without the approval of US Congress, or any governing body; that practically any consumable could be dangerous or adulterated. An extensive list of products was generated and continues to grow today. It is depicted as the Import Alerts + (Sections). These products could virtually be anything the FDA felt was unsafe, harvested incorrectly or processed in a manner that the US did not agree with. Lasting arguments are posed if this is a solution or just another regulation that the FDA wanted for control over food.

What does this mean for resellers?

The Act was put forth far enough in the past that any impacts to cost have been recognized and absorbed but product costs remain high. Container sizes have been made smaller and food content weights have been greatly reduced to hide the cost increases. The main result for current operations is the inherent liability to costly recalls for non-compliant companies. The supplement industry has been impacted with salmonella and forced recalls have been enacted. When a forced recall is enacted, the FDA reviews all the records of the store who sold the contaminated product. The product chain is then traced to all the resellers and manufacturers that the product followed. An immediate seizure of all the related stock from suppliers is performed by the FDA. The product is quarantined until a qualified determination is made and then fines may be issued for non-compliance. The seized product, in most cases, is not reimbursed by the suppliers because they are not a viable company. They don’t have the funds and the collectability is simply not present. Resolution for this collection can only be enforced through the US courts.

Need an attorney?

On request, Atofil provides an attorney review to confirm compliance. We have to meet a GMP standard, upholding excellence in everything we do. Therefore, we are happy to audit your product through our legal team to ensure you are compliant. Compliance is a foundational principle of our Atofil operation.