One of the most interesting items that made its way into the FDA Food Safety Modernization Act (“FSMA,” enacted in January 2011) is the whistleblower protection provision. FSMA amended the Federal Food, Drug, and Cosmetic Act (“FDCA”) to add new section 1012, which affords certain whistleblower protections to employees of firms “engaged in the manufacture, processing, packing, transporting, distribution, reception, holding or importation of food” – a very broad group of companies.
These new personnel rules prohibit the covered firms from discharging or otherwise discriminating (in terms of compensation or other privileges of employment) against a whistleblower employee. “Whistleblower” is our term, it does not appear in the statute. Rather, the statute protects workers from retaliation for engaging in so-called whistleblower activities. An employee engages in a protected activity if he–
- “provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of …” the FDCA or FDA regulations or orders;
- “testified or is about to testify in a proceeding concerning such violation;” or
- “objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee … reasonably believes to be in violation of …” the FDCA or FDA regulations or orders.
The law charges the U.S. Department of Labor with investigating and adjudicating discrimination complaints.
These are very interesting provisions because the protections that they establish are based on the employee’s reasonable belief about a legal or regulatory violation. Thus, even if no violation has in fact occurred, the employee could be protected because his or her mistaken belief was reasonable.
In our experience, some food law enforcement actions have in the past resulted from whistleblower reports – but these have not been as common as in the pharmaceutical industry. Similarly, in the past, there have been a number of qui tam actions (e.g., lawsuits by private individuals against federal contractors claiming fraud against the government) based on whistleblower reports against the pharmaceutical industry – but these have not been as common in the food industry.
Now, as FSMA encourages whistleblowing in the food industry, these types of cases are likely to become more prevalent with respect to the activities of this industry.
All food companies that are covered by these rules should review their personnel procedures and training programs to ensure that they do not take adverse personnel actions in a way that is prohibited by FSMA. Companies should clearly document the factual and legal basis for any disciplinary action, including any prior reviews and/warnings that culminated in the action. It would also be prudent to ensure that documentation of adverse personnel actions clearly conveys that such actions were not taken in a manner prohibited by FSMA.
