The Criminalization of Dietary Supplement Enforcement

FDLI Update Magazine December 2018/January 2019

Jack Wenik, Member of the Firm in the Health Care & Life Sciences and Litigation practices, in the firm’s Newark office, authored an article in the Food and Drug Law Institute (FDLI) Update Magazine, titled “The Criminalization of Dietary Supplement Enforcement.”

Following is an excerpt (see below to download the full version in PDF format):

Is dietary supplement enforcement going the way of health care? Those practitioners who represent hospitals, physicians, and other providers have by now grown accustomed to aggressive government enforcement efforts, which have moved well beyond administrative actions or civil False Claims Act litigation. Health care companies, non-profit institutions, clinicians, and other health care providers are now routinely prosecuted by the Department of Justice (DOJ) and/or various United States Attorney’s Offices, many of whom now have units expressly dedicated to “health care fraud.” It has become almost an annual ritual in which DOJ bundles together a series of unrelated health care fraud cases and, with much fanfare, announces a “takedown” of defendants as if they were members of organized crime organizations.

More concerning still is that the line between civil and criminal enforcement has been blurred. Health care institutions routinely face parallel proceedings with civil, regulatory, and criminal exposure. While ethical rules in theory prevent the use of a criminal prosecution to gain advantage in a civil case, defense practitioners will relate that the reality is much different.

Finally, the government has brought criminal prosecutions in disputes involving clinical judgment alleging unnecessary stent or angioplasty procedures where there is and has been considerable scientific debate.

We are beginning to see seeds of this aggressive government approach taking root in the world of dietary supplements. The Consumer Protection Branch of DOJ (the unit responsible for dietary supplements) is increasingly bringing criminal prosecutions in matters where, in the past, a civil proceeding would have been commenced on behalf of the Food and Drug Administration (FDA). Borrowing from the health care playbook, DOJ has bundled together unrelated criminal cases involving dietary supplement companies and announced nation-wide “sweeps” with the attendant publicity accompanying its press release.

Two recent federal prosecutions, both of which are still pending, illustrate this new aggressive approach by the government, using extensive criminal charges against dietary supplement companies even in areas where the science is controversial. They raise a concern as to the increasing “criminalization” of dietary supplement enforcement by the government.