The Food Safety Modernization Act (FSMA), signed into law in January of 2011, places the responsibility for food safety squarely on food producers, with requirements that will come into force as all portions of the Act are finalized and implemented. From the beginning, dietary supplements were considered to be foods, and supplement makers were required to register with the U.S. Food and Drug Administration (FDA). However, Supplement makers were not then required to create and implement specific food safety control plans, as were general food manufacturing and processing companies.
Nevertheless, many supplement manufacturers have since been “waiting for the other shoe to drop” and for FSMA’s full regulations to apply to them. Few doubted that, inevitably, that day would come.
FSMA will have enormous impact on the dietary supplement industry. The law gives FDA additional authority on recalls, which it has already used to recall some pre-workout supplements that were associated with cases of liver damage. FSMA also gives FDA enforcement tools to regulate the import of ingredients.
The law will revolutionize how the supplements industry operates, as it has revolutionized the food industry, and each company should be educating itself now and preparing to meet those requirements, rather than waiting for them to come into full force.
What is involved?
That preparation is not as awful as companies may imagine; In fact, it includes planning and preparations that most prudent managers are already considering.
Under FSMA, registered companies will have to develop and maintain a written food safety plan. The FDA’s Rule for Preventive Controls for Human Food requires risk-based preventive controls based on hazard analysis described as being “similar” to the HACCP system, and including controls that may be required at points other than traditional Critical Control Points.
This broader approach means that, while the preventive controls are science- and risk-based, and required to prevent hazards to public health, they are also flexible enough so that firms can develop preventive controls that fit their specific operations––as long as they can significantly minimize or prevent all food safety hazards.
Next, each company must maintain records of how these controls have worked in its operations, and produce those records on request from the FDA.
Fortunately for supplements makers, they are following in the steps of food companies that have spent three years meeting FSMA requirements. Metal detection inspection of products and vision inspection of labels that form an essential part of every Food Safety program will work as well for supplement makers as for meat packagers, and electronic data collection systems like the Mettler Toledo ProdX System that store and retrieve data instantly will keep that essential data ready for any inspection.
The proven tools for meeting FSMA’s requirements are already in place, but the time to implement them is now, not when the FDA is knocking on your door.
Written by: Robert Rogers
Senior Advisor for Food Safety and Regulations
METTLER TOLEDO Product Inspection
