FSMA, or the Food Safety Modernization Act, has been called the most sweeping change in food industry regulation since the creation of the Food, Drug and Cosmetic Act itself in 1937. When the law first came onto the books, the story within the dietary supplement industry seemed to be that most companies would be exempt from the law’s new provisions, with the exception of ingredient suppliers, who, in a cost adjustment move, were given a pass on some of DSHEA’s GMP provisions.
FSMA has broad implications for supplement industry
But as the picture has become clearer, it has become obvious that many of FSMA’s provisions have implications for a number of operations within the dietary supplement industry. So understanding the regulation will be as fundamental to doing business in this industry as understanding DSHEA has been.
One of FSMA’s provisions that will affect supplement companies is the requirement to have a plan to protect against intentional adulteration. The issue was the subject of a draft guidance issued by the US Food and Drug Administration in March. FDA will accept comments on the guidance until July 5, and the initial date for complying with the guidance’s provisions is in July as well.
“It’s vitally important for companies in the dietary supplement industry to understand how FSMA affects their businesses,” said Larisa Pavlick, vice president of regulatory and compliance for UNPA.
“The Intentional Adulteration Rule is one of the seven foundational rules under FSMA,” she said.
“Initially, it looked like this rule was primarily focused on bioterrorism events. However, in the recent draft guidance FDA identified three Key Activity Types (KAT) that will impact the supplement industry directly. These KATs, which are part of a Food Defense Plan, include raw material dispensing, blending and bulk liquid storage,” Pavlick added.
Detailed look at development of mitigation plan
The webinar will go into detail on teh following topics:
- Bulk liquid receiving and loading
- Liquid storage and handling
- Secondary ingredient handling: “…any point step, or procedure where dry or liquid secondary ingredients are manipulated by human contact prior to addition into the product stream” such as raw material dispensing, blending operations including adding materials to the blender or mixer, and the process of creating preblends.
The webinar, which is schedule for June 12 at noon Eastern time, will also delve into what are the responsibilities for a so-called Food Defense Qualified individual, how a company can conduct a vulnerability assessment, and options for developing a mitigation strategy.
The webinar is free for GOED and UNPA members in the upper membership categories. Other interested individuals may participate for a cost of $199. For more information or to register, click here.