For three straight years, the operator of a dietary supplement manufacturer stonewalled FDA investigators attempting to inspect his facility, prosecutors alleged in criminal charges filed in March against the operator and another member of the business.
In a 2012 inspection of Ohio-based Genesis Herb Co. LLC, FDA identified failures to follow cGMPs (current good manufacturing practices) related to testing, quality control (QC) and recordkeeping, then sent the company a warning letter the following year.
Despite FDA’s admonishments, the manufacturer did not come into compliance with cGMPs, according to FDA data. Based on an inspection in 2014, FDA identified 19 “observations”—or violations of the cGMPs—at Genesis Herb Co.’s facility, including many repeat infractions from previous years, an FDA Data Dashboard shows.
FDA returned to the manufacturing facility in Monroeville, Ohio, to conduct additional follow-up inspections, but a member of the dietary supplement company allegedly refused to grant the agency access to the plant for three consecutive years.
In 2016, 2017 and 2018, Shaun Cotterill denied FDA access to his facility, even though FDA had obtained a warrant in each of those years from a federal magistrate judge for an administrative inspection, according to the U.S. Department of Justice (DOJ). Cotterill, 54, of Monroeville, was a member, trustee and operator of Genesis Herb Co., which DOJ also described in a news release as Genesis Herb LLC.
DOJ’s case against the operators of the dietary supplement manufacturer is “a cautionary tale in that FDA gave not one, not two, but three bites at the apple before actually doing something,” said Todd Harrison, an attorney in Washington, D.C., who co-chairs Venable LLP’s FDA group, in an email. “It generally shows that FDA is willing to give companies the benefit of the doubt as long as you’re willing to work with the agency.”
Cotterill and another member, trustee and operator of Genesis Herb, Michael Sanor, 61, of North Canton, Ohio, intend to plead guilty to failure to register a food manufacturing facility and refusal of an FDA inspection, DOJ announced in a March 15 news release.
Eric Long, an attorney who represents Cotterill, and Maxwell Hiltner, a lawyer who represents Sanor, confirmed their clients intend to plead guilty to misdemeanor charges filed March 15 by the government.
“Mr. Cotterill and Mr. Sanor have waived presentation to the grand jury and have agreed to plead guilty to the charges,” the lawyers said in a joint emailed statement. “Mr. Cotterill and Mr. Sanor recognize that navigating such a complex, highly regulated and ever-changing industry presents unique challenges and pitfalls.”
The lawyers’ statement added, “To their credit, they [Cotterill and Sanor] intend on accepting responsibility for these misdemeanor charges. They are committed to learning from this matter and to serve as a cautionary tale to those seeking to bring supplements to market. Mr. Cotterill and Mr. Sanor are well respected and look forward to continuing their efforts to make positive contributions to their communities.”
The next court date for the criminal case is scheduled for May 6 in U.S. District Court in Toledo, Ohio.
DOJ charged Cotterill with three counts of failure to allow an FDA inspection, one count of introduction of adulterated food, and one count of failure to register a food manufacturing facility. Sanor was charged with one count of introduction of adulterated food and one count of failure to register a food manufacturing facility.
Each of the charges carry maximum criminal penalties of up to one year in prison and a statutory fine of $1,000, said Daniel Ball, a spokesman for the U.S. Attorney’s Office for the Northern District of Ohio. Ball did not comment on whether the defendants intend to plead guilty to all the counts filed against them.
“As alleged in the charges, those who purposely subvert the regulatory functions of the FDA by obstructing inspections are potentially endangering the lives of their customers and the general public,” Acting U.S. Attorney Bridget M. Brennan said in DOJ’s news release. “The Department of Justice and our partner agencies will continue to protect the health of the public by ensuring critical regulatory functions, such as this, continue unabated.”
Food facility registration
Attorneys and regulatory experts interviewed for this article found remarkable certain aspects of DOJ’s case, including prosecutors’ filing of criminal charges for failure to register a food manufacturing facility.
The Bioterrorism Act—also known as the Public Health Security and Bioterrorism Preparedness and Response Act of 2002—required domestic and foreign facilities that produce food to register with FDA. In 2011, FDA’s Food Safety Modernization Act (FSMA) amended the registration requirements.
According to DOJ, Cotterill and Sanor neglected to renew a registration for Genesis Herb Co. as a food manufacturing facility and never registered a private membership organization (Genesis Herb Private Membership Association) that distributed dietary supplements to its members.
Typically, neglect to register a food facility is noted as an “add-on” to other alleged violations of law identified in a warning letter, suggested Anne Walsh, a Washington, D.C.-based lawyer, in an interview.
“Because the [Federal] Food, Drug & Cosmetic Act is both a civil and criminal statute, the charges here evidence that FDA and DOJ were fed up with the company and really wanted to send a message,” said Walsh, who prior to joining her current law firm—Hyman, Phelps & McNamara P.C.—served as associate chief counsel with FDA’s Office of Chief Counsel.
Dan Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), said in an interview he believed the criminal charges related to food facility registration reflected an “add-on” to the other charges in the case.
“The tip of the spear wasn’t the food facility registration, but I don’t see why it can’t be,” said Fabricant, who before leading NPA oversaw FDA’s Division of Dietary Supplement Programs. “I don’t see why that’s not important [for FDA] to say, ‘Hey, you guys haven’t registered? What’s going on here?’”
The government has charged other individuals with failure to register their food facilities, Lindsay Haake, an FDA spokeswoman, suggested, but she said the agency cannot comment further since the investigations are ongoing.
FDA inspection attempts
According to the criminal charges filed in U.S. District Court in Toledo, FDA investigators on Sept. 23, 2016, “attempted to conduct a for-cause inspection of Genesis Herb at the Monroeville facility.”
Cotterill initially allowed FDA to inspect a storage shed that contained empty boxes and packaging materials, prosecutors said in the charging documents. Yet he allegedly declined to provide access to the area where the dietary supplements were produced and stored, and he purportedly failed to provide access to cGMP records—even after being presented with a warrant for an administrative inspection from a U.S. magistrate judge and two notices of inspection on an FDA Form 482.
Prosecutors further claimed Cotterill refused inspections in 2017 and 2018 after being served with warrants and notices of inspection.
FDA issues a Form 482 to a firm before conducting an inspection of its facilities. This form includes language showing FDA’s legal authority to conduct the inspection, explained former FDA investigator Larisa Pavlick, vice president of global regulatory and compliance with the United Natural Products Alliance (UNPA).
She conceded it’s unusual for a firm to not honor FDA’s notice to inspect its facilities.
“I only had one refusal my entire career, and they in the end decided to go ahead and let me in,” Pavlick shared in an interview.
That FDA obtained a warrant from a judge for an administrative inspection for three straight years shows the agency likely encountered earlier resistance from the manufacturer.
Based in part on her reading of FDA’s Regulatory Procedures Manual for FDA personnel, Walsh said an “administrative warrant is a tool used only after a company has refused an inspection in the first place.
“The 482 notice would operate just fine in the normal course, and that’s how most regulated entities respond to an FDA inquiry,” the attorney said, “but the administrative warrant is one step more powerful upon refusal.”
Refusal to follow such a warrant, she added, constitutes contempt of a court order.
Walsh has been practicing law for more than 20 years in the FDA space, and she’s only seen the use of an administrative inspection warrant a handful of times.
FDA may seek an administrative inspection warrant when, for example, a firm has refused an inspection or limited one, such as refusing photography or sample collection, according to its Regulatory Procedures Manual.
Fabricant said he was aware of cases in which a firm haggled with FDA over certain documents or photos to be collected, but he’s never seen a case like the one involving Genesis Herb.
“While the FDA cannot comment on the specifics of the case at this time, due to the ongoing investigation, the agency typically does not seek administrative warrants to carry out inspections authorized under section 704 of the Federal Food, Drug and Cosmetic … Act unless there is a refusal by the regulated entity, either to access the facility or to inspect relevant records or materials,” Haake, the FDA spokesperson, said.
Timing of criminal charges
Although criminal charges were filed in March 2021 against Cotterill and Sanor, the allegations suggest the government could have brought action a number of years ago—after FDA was first denied access to the manufacturing facility. Walsh, however, pointed out the government made a “conscious effort” to try to inspect the firm’s facility for a number of years, and she suspects “there was additional behind-the-scenes activity [from FDA] trying to get the company to cease activity.”
Ball, the spokesman for the U.S. Attorney’s Office, declined to comment on the government’s timing for bringing criminal charges.
“In essence, FDA’s inability to move quickly allows this inertia,” said Harrison, who has worked comprehensively in the areas of food and dietary supplement safety, labeling and advertising claims. “It emboldens bad characters to take the risk, knowing that the agency does not have a quick fuse. It also allows the development of markets and regulatory theories that could be considered questionable, which handcuffs the FDA and simply does not allow it to put the rabbit back in the hat.”
Harrison, nonetheless, concluded “working with the agency—instead of stonewalling—is always in the company’s best interest because at some point you will light that fuse.”