FDA Law Blog: For FSMA Consulting, It’s Buyer Beware

FDA Law Blog: For FSMA Consulting, It’s Buyer Beware

For FSMA Consulting, It’s Buyer Beware Posted: 24 Jan 2016 07:09 PM PST By Ricardo Carvajal – It’s getting hard to turn around without bumping into a Food Safety Modernization Act (FSMA) consultant.  Perhaps it was inevitable, given the compliance dates that suddenly don’t seem so far away, the law’s many moving parts, and the mantra that FSMA is the most sweeping reform of the nation’s food safety laws in the last 70 years.  The temptation to turn the reins over to someone claiming to have all the answers is understandable, but here are some reasons to question that strategy. No one has all the answers.  Yes, four of the major regulations have already published, but they are accompanied by hundreds of pages of preambles that need to be digested, and there are guidance documents under development at FDA that will help flesh out the regulations. The law is here to stay.  As a long term strategy, query whether it might be more beneficial to start investing in developing your internal expertise up front. No one is likely to understand your facility, products, and processes as well as you.  Someone who doesn’t appreciate that could try to saddle you with answers that are appropriate in a different context, but aren’t in yours. Self-proclaimed experts are under significant pressure to give substantive answers, and will find it uncomfortable to answer a question with the phrase “I don’t know.”  This can lead to answers that, upon further investigation, turn out to be wrong.  Wrong answers can lead to wasted resources, or worse. There is no training or certification system for FSMA consultants.  This means that there is little to stop an individual or entity from claiming expertise that they might or might not have – but would be happy to acquire at your expense.  This is not to say that seeking external help to ensure readiness with the law or even ongoing compliance with its requirements is a bad idea.  Indeed, the regulation on preventive controls for human food recognizes that a “qualified individual” or a “preventive controls qualified individual” can be a third party, and there might be perfectly good reasons to outsource those or other functions.  Just beware how loosely you hold the reins, or you could find yourself meandering the long – and potentially expensive – way home.