In recent years, the food industry has learned that an investigation by the DOJ can have a profound effect on the business. It is costly, time-consuming and depending if the investigation leads to a prosecution, very impactful on a company’s reputation, so any changes with the DOJ that may impact the food industry are important to know about. Thus, when a late September Department of Justice (DOJ) announcement of a realignment was made, we wanted to take a deeper look. However, it appears that changes to the judicial oversight of Health and Human Services (HHS) are unlikely to have much impact on the food industry.
As detailed in the DOJ release, a new office within the Civil Division consisting of two branches, the Enforcement Section and the Affirmative Litigation Section, is “dedicated to safeguarding public health and safety through proactive enforcement and high-impact affirmative litigation.” While the office is intended to focus in on these areas, it does not gain any legal or legislative powers that it did not already hold; it is largely a change in priorities.
That is, the release makes it clear that the priorities of the new office will be primarily focused on those of the Administration: the drug side of FDA, transgender practices, and immigration, stating “the Branch will strengthen the Civil Division’s ability to advance the Department’s enforcement priorities, including protecting women and children from pharmaceutical companies, health care providers, and medical associations profiting off of false and misleading claims related to so-called gender transition, and ending sanctuary jurisdiction laws, policies, and practices that impede federal immigration enforcement.”
This is not to say that the food industry will never see any impact from the realignment. The new office is heavily focused on “proactive enforcement and affirmative litigation” to enforce federal law and prosecute actions harmful to the public, such as unfair and deceptive trade practices, false and misleading claims, and defective consumer goods. But even given these direct citations from the release, the full wording shows that there is little focus on US food businesses at this time, as the goal is protecting consumers “whether it be from unfair and deceptive trade practices of the largest technology companies in the world, defective consumer goods, or false and misleading claims about drugs and dietary supplements manufactured by pharmaceutical companies.”
Additionally, the only direct mentions of the food industry are in the DOJ’s two-paragraph “About the Branch” webpage which includes agricultural standards as an area “affecting Americans’ safety and well-being” on which the Affirmative Litigation Section touches; and a mention of the FD&C Act (of which food is just one part) as an area of enforcement in the four-paragraph media release. Whether there is more intention to focus on food at some point is unknown given that these two publications are the only ones publicly released on the change.
Reading into the documents, one area where the food industry could eventually see some impact is the crackdown on deceptive advertising. Once again, the current focus is on drugs, as depicted in the FDA September announcement of its “sweeping reform” on misleading direct-to-consumer pharmaceutical advertisements. Based on the concern that patients are not seeing a fair balance of information about drug products, the focus includes social media and paid influencer promotion which have “blurred the lines among editorial content, user-generated media and pharmaceutical advertising,” making it difficult for consumers to distinguish between evidence-based information and promotional material. While the resulting 100 cease-and-desist letters sent by FDA went only to pharmaceutical companies, it is an action of which food companies should be aware, should review their own promotional practices, such as around health claims (including digital web, social media, and influencer practices) and ensure none are misleading, particularly if any blur the supplement/medicinal lines or could impact public health.
Another area of emphasis that could have some impact on parts of the food industry, which the DOJ publications emphasize, is on state laws that interfere with or obstruct federal policies, based on the Supremacy Clause of the U.S. Constitution. By calling out this clause, DOJ is stressing that federal law supersedes state laws; that is, if a state law conflicts with a valid federal law, as the “supreme Law of the Land,” the federal law prevails and the state law is considered void. And the DOJ will litigate to uphold the federal law.
The DOJ had, in fact, already invoked the clause in July, filing a lawsuit challenging California’s Prop 12 farm-animal confinement laws. Arguing that the state’s egg rules conflict with the federal Egg Products Inspection Act (EPIA) and are “overly burdensome and unnecessary,” the suit seeks to invalidate those provisions of the California law. California is requesting a dismissal, arguing the EPIA governs the quality of eggs not the hen confinement conditions. Where this will land is yet to be seen, but it is showing that the current Administration is heavily focused on federal law reigning supreme.
Given all this, while there has been some media hype that the DOJ realignment will lead to increased litigation against food safety “scofflaws,” TAG does not see it as having a dramatic change to the risk of DOJ action on food companies. This does not, of course, mean that food safety should be taken any less seriously, but we also don’t see that invoking fear of a federal lawsuit as the best way to relay the realignment or promote food safety. For companies seeking to be their best (and, yes, stay out of court), the development of a positive, company-wide food safety culture, from the executive team to those on the floor, will not only involve everyone in keeping the public safe but will have a positive impact on your business overall.
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