Some food manufacturers may be inclined to say, “Compliance with FSMA rule is costly; what if we just don’t invest in compliance?” Let’s, for a moment, think about this question and evaluate the cost of not implementing preventive controls, as mandated by the Food and Drug Administration (FDA). Below are possible repercussions:
- Adverse Events: If you don’t have a risk-based hazard analysis and preventive control program in place, the occurrence of adverse events will potentially increase. You may find contamination in your processes and products. It takes time, effort and money to overcome the contamination, rework the product, or discard it.
- Illness: Microbial contamination or presence of allergens may threat consumers’ health. In addition to causing harm to consumers, a chain of troublesome effects on the business starts here.
- Administrative Detention: Prior to the Food Safety Modernization Act (FSMA) rule, the FDA could only ask for voluntarily recall of food products. Under the new rule, the FDA is authorized to order an administrative detention if the agency has credible evidence or information to believe that the food presents a threat of serious adverse health consequences or death.
- Seizure and Injunction: If the risk of health hazards is high, the administration detention may lead to seizure of the food article.
- Recall: Food product recalls have significantly increased after implementation of FSMA. The FDA has now the authority to assess and collect fees for activities associated with a food recall order.
- Warning Letters: The FDA issues a warning letter if it finds violations to the Food Safety rules during a facility inspection. Warning letters are public records and are published on the FDA’s website.
- Re-inspection: Companies are normally given 15 days to respond to the warning letter. The FDA may re-inspect the plant to assure the non-compliant issues are resolved. The agency is authorized to collect fees to cover the FDA’s costs related to re-inspection.
- FDA Extended Audit & Scrutiny: After a major non-compliance event or recall, the FDA watches the company’s practices more closely for some time.
- Suspension of Registration: The FDA has new powers to suspend the registration of food facilities when there is a reasonable probability of causing serious adverse health consequences or death. This may lead to temporary or permanent shut down of the facility. Do you remember the bankruptcy of Peanut Corporation of America after salmonella illnesses in 2009?
- Damage to the Brand Reputation: Brand reputation diminishes fast and can take years to build back.
- Loss of Market Share: Even if the company continues to operate after a serious adverse event, it loses market share due to the loss of consumer trust. Blue Bell ice cream lost sales even when it restarted operation after the listeria contamination in 2015.
- Loss of Competitive Advantage in Business-to-Business (B2B) Sales: If you are a supplier to other food businesses and you are not complying with FSMA rule, you’d pose a high risk to your business partners considering FSMA enhanced requirement for supplier verification.
- Law Suits: The cost of implementation of FSMA preventive controls is nowhere close to the cost of fighting law suits due to wrongful death or illness resulting from consuming contaminated food. The first lawsuit was just filed against Vulto Creamery after listeria-contaminated cheese caused the death of a Vermont man.
Do you still think it is too expensive to comply with FSMA preventive control rules?
About the Author
Nikoo Arasteh is a quality and compliance consultant to food industry as well as biotech and pharmaceutical industries. She has more than 20 years of experience in quality management, project management, validation and R & D.