An unusual step? FDA files criminal case against supplement marketer who ignored civil contempt ruling

By Hank Schultz contact

- Last updated on GMT

Image: (c) iStockPhoto
Image: (c) iStockPhoto

Related tags: Contempt of court

The Department of Justice at FDA’s behest has launched a criminal contempt action against a Montana dietary supplement marketer who continued selling misbranded supplements and unapproved drugs even after a civil contempt ruling.  It’s an unusual step, said one expert.

“The agency will usually go to great lengths to avoid bringing an action for criminal contempt,”​ Jason Sapsin, an attorney with the firm Faegre, Baker & Daniels told NutraIngredients-USA.

FDA filed the action against Toby McAdam​ of Livingston, which comes as the last step in a play that has had many acts. According to documents filed yesterday, McAdam violated the order of civil contempt by failing to shutter Internet businesses on Amazon.com, websites and a promotional Facebook page McAdam uses to promote his products.

“Court orders must be taken seriously,”​ said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Civil Division’s Consumer Protection Branch will aggressively pursue those who violate court orders imposed to protect public health and prevent false product claims.”

McAdam has operated his dietary supplement business under many guises and in fact continues to do so at the website www.bloodrootproducts.com​, which was still active as of this morning (July 30, 2015). The criminal contempt action arises out of a prior civil action the department filed in 2010 against McAdam, who was the owner and operator of Risingsun Health, based in Livingston.

According to court documents, McAdam sold misbranded and adulterated dietary supplements and drugs that made unsupported claims to cure cancer, ADD/ADHD, epilepsy and intestinal parasites, among other things. McAdam agreed to close his business until the FDA authorized him to return to business. No such authorization was given and McAdam was later held in civil contempt for violation of the consent decree. The Ninth Circuit Court of Appeals later upheld the order of civil contempt against McAdam. A find of $85,000 was levied against McAdam in 2013.

Unusual persistence

Sapsin said the case is unusual in several ways, most prominently of which is McAdam’s apparent zeal for taking on the federal government.

“It’s pretty unusual when you have a situation where any defendant is willing to persist in conduct after already having been in court about that conduct (as McAdam has in his civil contempt proceeding). I don’t think it is something that the agency encounters very much,”​ he said.

“One of the interesting features of this case is that a fair amount of time went by before the agency decided to pursue it vigorously. That could lull someone into the sense that they could continue to conduct business as usual,”​ Sapsin said.

Sapsin said the stately progress of the case is an indicator that in the agency’s view that while McAdam was violating the law in the way he was branding and marketing his products, his actions did not constitute an immediate public health risk.

“We are really talking about one more step in the process. The idea of a contempt charge is to coerce obedience. It’s not really to punish. What has happened here is the agency is saying to the court and to the defendant, apparently you are not going to come along voluntarily so some additional pressure needs to be applied.  And now the court has its own interests in play, too, to make sure that its orders are being enforced,”​ Sapsin said.

The action asks the court to impose a fine and a jail sentence on McAdam.

Related topics: Regulation, GMPs, QA & QC, Product claims

Related news

Show more

Follow us

Products

View more

Webinars