Stakeholders in the supplement and other industries subject to FDA oversight could expect the branch to be more circumspect about alleged violations executive agencies bring to the DoJ division for litigation.

Morrell said CBD is adhering to an executive order President Trump made earlier in 2019 instructing federal agencies to file charges of regulatory violations based on noncompliance with actual rules and laws.

"The executive order is designed to prevent unfair surprises and to ensure that agency guidance does not become a back door means of regulation," he said, adding that "violations of law should be based on statutes and regulations enacted in proper notice and comment."

Morrell pointed out that the president noted when he issued the order on 9 October, "many federal agencies have issued thousands of guidance documents and instead of serving their purported and intended purpose, namely guidance, the documents often morph into requirements used to assign liability."

He added that the executive order reinforces the approach the DoJ always has followed when litigating regulatory complaints brought by other federal agencies. "Nothing here has changed and the department may still take enforcement action consistent with agency policy statements including FDA's compliance policy guidelines so long as those statements are not the sole basis for enforcement and are firmly based in statute or regulation," Morrell said.

The DoJ's emphasis on enforcing against actual regulatory noncompliance opposed to running afoul of agency guidance should be important to the supplement industry, which occasionally has accused the FDA of "regulation by guidance" for compliance with the new dietary ingredient notification requirement. The two draft guidances the agency has published on the requirement don't align with the NDI notification language in DSHEA, some stakeholders say. (Also see "FDA Could Stick With Current Advice On NDI Notifications, Old Ingredient Evidence" - HBW Insight, 26 June, 2018.)

US DoJ Has 'Key Focus' On Supplement Industry, Adds 6 Attorneys To Sector

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