Source: https://www.fdli.org/2018/11/the-criminalization-of-dietary-supplement-enforcement/
Timestamp: 2019-04-26 15:43:44+00:00

Document:
United States v. USPlabs, LLC, et al.
In United States v. USPlabs, LLC, et al.,6 the government alleges a host of adulteration, misbranding, fraud, and conspiracy charges arising out of the defendants’ sale of certain workout and weight-loss products. Among other things, the superseding indictment alleges that in late 2013 the USPLabs’ product, OxyElite Pro, caused liver toxicity and liver injuries, including liver transplants.7 These allegations appear to be the impetus for many of the criminal charges that follow.
Indeed, such was the case with OxyElite Pro. A series of illnesses in Hawaii prompted FDA to send a warning letter about OxyElite Pro in late 2013. However, subsequent to the issuance of the warning letter, considerable debate arose within the scientific community as to whether OxyElite Pro, or any other dietary supplement, was associated with the liver issues reported in 2013. For example, in an article published in the journal Annals of Hepatology, the authors concluded that “[T]he Hawaii liver disease cluster is now best explained by various liver diseases rather than any [dietary supplement] or [OxyElite Pro].”9 Nevertheless, the government is pursuing criminal charges related to these circumstances.
As a civil matter, it might be appropriate for the government to take action against a dietary supplement company’s marketing of a product that has had questions raised as to its safety. However, it is a different matter entirely, to bring a criminal prosecution. Pursuant to the United States Attorney’s Manual, a prosecution should only be brought when the “government believes that the admissible evidence is sufficient to obtain and sustain a guilty verdict by an unbiased trier of fact…”10 When an issue is subject to legitimate scientific debate, the initiation of a criminal prosecution is questionable, at best.
United States v. Hi-Tech Pharmaceuticals, et al.
In United States v. Hi-Tech Pharmaceuticals, et al.,11 the government alleges, among other things, misbranding, conspiracy and fraud charges against the defendants arising out of the sale of several products. Of particular interest is the government’s allegation that the defendants’ sale of the dietary supplement Choledrene was illegal because it did not list Lovastatin, an FDA-approved drug, as an ingredient on its label.
While there may be legitimate reasons why FDA would want to regulate red yeast rice products, and there are certainly a wide array of administrative tools to insure the quality and safety of such products, and how they should be labeled and marketed, a criminal prosecution regarding the labeling of them is simply unprecedented. There is no reason to believe that Choledrene has any unique attribute making it less safe or suitable for sale to the public than the dozens of other brands of red yeast products with which it competed, many of which had vastly higher levels of monacolin K. The aggressive use of a criminal charge for this conduct is concerning.
It would be a mistake to dismiss the government’s aggressive use of criminal charges against dietary supplement makers as limited to a small array of outlier companies. Again drawing a parallel to what occurred in health care, what began as targeted efforts against select providers, has expanded to the point where some of the nation’s most prestigious teaching hospitals operate under corporate integrity or non-prosecution agreements, and publicly traded health care companies and their executives are routinely targeted in criminal investigations.
ultimately pay dividends. The government is raising the stakes for dietary supplement companies and the industry needs to respond in kind.
See, for example, U.S. Department of Justice, Criminal Division, Fraud Section’s Health Care Fraud Unit, which is composed of 55 prosecutors focused on health care fraud-related cases, https://www.justice.gov/criminal-fraud/health-care-fraud-unit.
In a June 28, 2018 Press Release, the Department of Justice announced its “Takedown” with charges against 601 defendants, including 76 doctors. See https://www.justice.gov/opa/pr/national-health-care-fraud-takedown-results-charges-against-601-individuals-responsible-over.
See, e.g., New Jersey Rule of Professional Conduct 3.4(g).
States v. Patel, 485 F. App’x 702 (5th Cir. 2012).
See, for example, the Department of Justice’s November 17, 2015 Press Release trumpeting the round-up of 100 dietary supplement companies in both criminal and civil actions. See https://www.justice.gov/opa/pr/justice-department-and-federal-partners-announce-enforcement-actions-dietary-supplement-cases.
United States v. USPlabs, LLC, et al., 3:15-cr-00496-L (N.D. Tx.), Doc. 95, January 5, 2016.
The initial USPLabs indictment was filed on November 4, 2015, two years or more after many of the underlying events.
Teschke, et. al, The mystery of the Hawaii liver disease cluster in summer 2013: A pragmatic and clinical approach to solve the problem, 15 Annals of Hepatology 2016:91-118.
United States Attorney’s Manual, Section 9-27.220.
United States v. Hi-Tech Pharmaceuticals, et al., 1:17-cr-00229-AT-CMS (N.D. Ga.), Doc. 7 September 28, 2017.
Defendants Motion to Dismiss, 1:17-cr-00229-AT-CMS, Doc. 193, September 28, 2018.
P. Cohen, et. al, Variability in strength of red yeast rice supplements purchased from mainstream retailers, 24 European Journal of Preventive Cardiology at 1431-1434 (2017).
See, Pharmanex v. Shalala, 221 F.3d 1151 (10th Cir. 2000).

References: v. 
 v. 
 v. 
 v. 
 v. 
 v. 
 v. 
 v.