The Red Rocker, Sammy Hagar, sang in 1984, “I Can’t Drive 55.” When counseling clients at our Firm about the potential of enforcement risk by the Food and Drug Administration (or any other regulatory authority for that matter), we often use the speed limit analogy. Most companies will want to comply with applicable laws because “it is the law,” or non-compliance will cost them more money and time to fix the inevitable problems that will arise, or both. However, there are company executives who will, understandably for business reasons, ask about the potential for “risk” or the consequences if they choose not to follow the letter of the law. (This is typically followed by, “Of course, I want to do the right thing” and “I don’t want to go to jail.”)
Sometimes, the law is clear. The statute or regulations describe what is or is not allowed and provide a precise definition of a term of art, or there are well-written guidance documents that clearly articulate the regulatory agency’s ‘current thinking’ concerning the topic at hand. In these situations, the speed limit sign is clearly visible and it says 55 mph.
However, there are other times when the law or the agency’s thinking on how to enforce it is not so black and white. This may be intentional; perhaps, Congress or FDA, did not want to limit itself to a narrow interpretation. It may also be that the particular fact pattern had yet to emerge or be considered, what the agency calls a ‘question of first impression’, and the agency has not previously had an opportunity, or reason, to make a formal determination on the issue (for example, a new technology has evolved since the statute, regulation, or guidance was first effective or available). To use our speed limit analogy, the sign telling us how fast we are allowed to go is simply nowhere to be found. In this situation, FDA might contend, if it were to take an enforcement action, that it was basing its decision on existing law (the sign was present a few miles back for one to see), but the company could counter that it did not know that there was law on point, it was vague, or interpretation was sketchy (a speed limit sign was present many miles back, everyone was driving the same speed, and the police had not pulled over anyone previously). These cases are the harder ones for companies. We recommend that companies evaluate not only the legal and regulatory considerations, but also the potential business and liability consequences.
One point should not be forgotten. There is no requirement that a safety issue might occur or have occurred for FDA to take action. Violations of the law, such as adulteration or misbranding, are not dependent on an actual illness or injury having occurred. Mislabeling of a product is unlawful. Making an unsanitary product is unlawful. A statutorily prohibited act is a prohibited act. Of course, if an illness or injury occurs, all bets are off for FDA scrutiny (as well as product liability exposure). The “but, we didn’t hurt anyone” defense will simply not be available. In our speeding analogy, going 70 mph in a 55 mph zone is not allowed. One may be wearing a seatbelt, be sober, and driving with a valid license but can still receive a speeding ticket, even if no one is injured.
As Gregg Allman sang, “I’m no angel.” No one is perfect, and the authors here have not been immune from a friendly police stop over the course of their driving careers (although, thankfully, nothing major). However, remember, lack of illness or injury is no defense. Furthermore, when the law is clear, being “close to compliance” will rarely win the day with a regulatory body when it comes to enforcement (although it might mitigate the type of enforcement). And, when the law may not be so clear, one must carefully consider a number of factors and the potential risks and consequences if the government chooses to take enforcement action.
Alan G. Minsk is a partner and leader of Arnall Golden Gregory’s Food & Drug practice team.
Robert Durkin is an of-counsel at Arnall Golden Gregory and the former Deputy Director of FDA’s Office of Dietary Supplement Programs.