The Food and Drug Administration (FDA) is requesting comment on several issues with respect to withdrawal periods for animal drugs when those animals are raised for human consumption. The withdrawal period is the intervals between the time of the last administration of a new animal drug and the time when the animal can be slaughtered and safe for human consumption.  Similarly, the milk discard time is the interval between drug administration and the point at which humans can safely consume the animal’s milk.

Specifically, the agency requests public input on: (1) industry practices regarding how long it takes to transport certain food producing animals from production facilities to slaughter facilities; (2) how frequently dairy animals are milked; and (3) how end users, such as animal producers or veterinarians, interpret animal drug labeling that states the drug has a “zero-day withdrawal period” or “zero-day milk discard time,” terms that indicate that an animal’s products may enter the food chain regardless of how much time has passed since the animal was last given the drug.

In the livestock industry, the FDA approves drugs for food-producing animals and then assigns certain withdrawal periods and milk discard times for such drugs. To allow drug levels to meet safety criteria, it is essential to provide enough time between the animal’s last dosage and the time of human consumption. Without these lead times, consumers could potentially ingest toxins from the drugs that remain in the animal’s system or milk.

Given the importance of these issues, it is surprising that the FDA has not updated its standards since the 1980s. The technological advances in science and medicine over the past forty years have been vast, and drugs, including those administered to animals, have also progressed. In addition, the animal agriculture industry has significantly changed including current practices applicable to milking frequency and transit time to slaughter. Supply chain improvements and technological advances can limit transit times to almost nil. In addition, milking frequency has only increased in the past two decades with the introduction of automatic milking systems in the 1990s. These efficiencies arguably date the FDA’s imposed withdrawal times, making them inapplicable or obsolete.

Even with these advancements, the FDA has given no indication of any new safety concerns, and the number of drug residue violations detected by USDA at slaughter and reported to the FDA has been trending downward since 2013. Instead, the FDA’s request for comment appears to be focused on consumer awareness and ensuring best practices; two issues that are encouraged in the animal agriculture world. Given the agency’s focus on the “end user’s interpretation of labeling statements”, and its goal to clarify these interpretations, it appears to be prioritizing transparency, consumer awareness, and accuracy in food labeling

Should the FDA make any ruling, it will likely have a legal impact given the rise in misleading packaging litigation in the food industry. Misleading advertising lawsuits in the food industry continue to rise with an annual uptick in suits filed between 2017, 2018, and 2019. Should consumers have viable claims for deceptive practices with respect to the drugs given to livestock, there may be potential for new class action cases in this regard.

Comments may be submitted to the FDA until October 8, 2019.

For more information on food labeling regulation and litigation, please contact Sarah Firnschild at (313) 223-3025, sfirnschild@dickinsonwright.com or Samantha Pattwell at (517) 927-4776,  spattwell@dickinsonwright.com.