For industries regulated by the US Food and Drug Administration (FDA) and similar agencies in this era of increasing governmental scrutiny, the pace of change creates both opportunities and challenges. We offer a group of nationally recognized FDA lawyers and science professionals who know this field inside and out and offer creative, compelling solutions for our clients.
This week we are hosting our first Food Industry Roundtable, a forum for food company executives to discuss relevant topics related to the food and dietary supplement industry and to share practical advice on the latest legal trends. While the roundtable will cover a lot of ground, there will be a special focus on allergen cross-contamination and labeling issues; these are the largest source of recalls in the food industry, and the plaintiff’s bar is taking notice.
We spoke to FDA partners Robert Hibbert (DC) and Anthony Pavel (DC), as they were preparing for the event:
Who is speaking to the allergen cross-contamination topic?
Our guest is Dr. Steve Gendel, FDA’s allergen coordinator from 2010 to 2014, who will provide insight into FDA’s and FSIS’s current policies and offer some best practices to attendees such as testing and mitigation strategies. This is a major issue in our industry. Within the last several months, more than 700 different products have been recalled by more than 40 manufacturers because of spices contaminated with peanuts and almonds.
What other legal issues do you see trending in this space?
The big shift that the food industry has been dealing with is consumer class action litigation involving a broad range of claims – from natural, to whole grain, to caloric content. There are a number of regulatory changes that could further increase exposure such as partially hydrogenated oils and added sugars. Companies need to be very vigilant with claims development and review practices.
Another big shift is the new food safety rules that FDA is finalizing – which are similar to the regulations USDA FSIS implemented a decade and a half ago. Part and parcel with all of these new rules are whistleblower claims, which were authorized in the Food Safety Modernization Act. We have already seen a number of food-safety-related whistleblower suits, and we expect these types of claims to increase when the food safety rules are finalized.
What are some best practices for clients regularly dealing with the FDA and other regulators?
In most specific product categories, a given manufacturer can work his way to any number of highly specific regulations, guidelines, and recommendations that will address his particular situation. But the general principles that apply across the board include the following: identify potential risk areas and specific strategies for dealing with them. Back that up with proper scientific support and ongoing documentation. Don’t let production concerns and other business realities overwhelm the focus upon food safety. Put together the right team of people with resources inside and outside the company as needed. Any company that can project these attributes to the FDA and other regulators is going to avoid most regulatory problems in the first place and survive the ones that do inevitably occur in good shape.
Since we’re on the subject of food, what is your go-to lunch?
The Morgan Lewis Cafeteria of course!
Interested in more?
Check out our team’s Well Done blog, a new source for food litigation and regulation.