This is the third blog in a series of articles on civil and criminal enforcement actions that have been taken against dietary supplement firms in recent years.
For several years, FDA accused Truman J. Berst of peddling herbal supplements as remedies for treating diseases such as arthritis, cancer and Crohn’s disease. Now, Berst whose company was shut down in 2012 is entangled in a New York Attorney General’s investigation, and his family also captured the attention of federal regulators last year.
Berst's entanglements with FDA date back a decade. FDA issued a warning letter to him in 2005, then another one in January 2007 in which the agency claimed a number of products were being promoted for conditions that caused the products to be drugs.
Berst, a self-professed “master herbalist" and minister who had been doing business as Alternative Health & Herbs Remedies, fought back. In late October 2011, without the assistance of counsel, he sued FDA and the U.S. Department of Justice (DOJ). Berst described himself as the victim “of an ongoing campaign by the U.S. Food & Drug Administration to put him out of business in order to benefit pharmaceutical companies."
The Justice Department reportedly threatened to sue Berst if he didn’t sign a consent decree. Berst said in the lawsuit that the proposed consent decree reflected the government’s plan to burden him “with so many rules, regulations, and costs that said consent decree is impossible to comply with and will, in a very short time, simply destroy" his business.
The government sued Berst just weeks later and eventually won, shutting down the business through a permanent injunction that was entered against him in 2012. Berst challenged the decision, but it was dismissed by the U.S. Court of Appeals for the Ninth Circuit because he failed to file an opening brief.
Devil’s claw probe targets Minister
Berst later advised a different federal judge that the herbal business had been sold to his daughter, and he said he was no longer involved in the operation.
But he now finds himself subject to an unrelated supplement investigation that was launched by New York Attorney General Eric Schneiderman. In letters addressed Sept. 9, 2015 to Bishop Dr. Truman Berst of Alternative Remedies Health & Herbs and 12 other supplement businesses, Schneiderman’s office demanded that the companies cease and desist from sales of “devil’s claw" supplements, the commercial name for the Kalahari Desert plant Harpagophytum procumbens. A New York Botanical Garden (NYBG) study that used an advanced DNA barcoding technique, upon which the cease-and-desist letters relied, concluded the products contained a cheaper related species that is deemed less desirable: Harpagophytum zeyheri.
But the American Botanical Council (ABC) described the two plant species that were found in the devil’s claw supplements as “very closely related species" that “are like two siblings."
“While both species differ marginally in shape and chemical composition, both are considered equally effective," noted Thomas Brendler, a medicinal plant expert and editor of the African Herbal Pharmacopeia, a compilation of technical information of various African medicinal plants, in a press release issued by ABC.
Citing subpoenaed documents, the attorney general’s office said the tested supplements included a product sold by Berst’s company named “Devil’s Claw Root."
“Your product’s label did not disclose the presence of the Substitute Plant," Simon G. Brandler, senior advisor and special counsel to the attorney general’s office, wrote in the letter to Berst. “The NYBG study concluded, however, that your company’s product contained the Substitute Plant, not Devil’s Claw."
Berst did not respond to multiple emailed requests to comment on the FDA injunction and Schneiderman’s recent letter.
Brandler addressed the letter to Berst, even though his company had been shut down in 2012 and, according to him, previously sold to his daughter. Alternative Health & Herbs Remedies, through which Berst was doing business, still hasn’t been authorized by FDA to resume operations, Natural Products INSIDER confirmed last month through a Freedom of Information Act (FOIA) request.
Schneiderman’s office said in an emailed statement that it was aware of the FDA enforcement action against Berst. “By all appearances, Bishop Berst is still running an herbal business in Albany, Oregon," Schneiderman’s office said. It had no further comment.
Dennis Stevenson, Ph.D., vice president for botanical research at The New York Botanical Garden (NYBG), said the devil’s claw study was conducted over the last 18 months, and the supplements were obtained through retail stores and online purchases. However, he declined to specify where the Health & Herbs supplements were purchased.
“The New York Attorney General obtained the information about the identity of the devil’s claw manufacturers as a result of a subpoena, but we are not commenting on any specific companies," Stevenson said in an emailed statement.
FDA warns family member of disease claims, manufacturing violations
Berst is not the only one in his family who has attracted the government’s interest.
In October 2014, FDA issued a warning letter to Brittney M. Haywood, who was listed in the letter as the owner of Evangelical Christian Ministries. Albany, Oregon-based Health & Herbs, which is described as a church outreach of Evangelical Christian Ministries, says on its website that the herbs have been produced by three generations of herbalists: Berst, his daughter Crystal Sublette-Maceira, and her daughter Brittney Haywood.
Sublette is listed with the Oregon Secretary of State as the authorized representative of Health & Herbs, a sole proprietorship, but the company failed to renew its status with the secretary of state in 2014, according to online records. But Haywood is listed as the authorized representative of Evangelical Christian Ministry, which is described in a public record as a “ministry/herbal supplements" business.
FDA’s 2014 letter to Haywood—Sublette’s daughter—advised her that Health & Herbs had been making disease claims, rendering the products including a “Parasite Cleanse Kit" unapproved new drugs. The letter also claimed the company failed to meet a number of cGMPs (current good manufacturing practices)—the regulations governing dietary supplements that FDA adopted in 2007—including failing to verify the identity of any component that is a dietary ingredient through a test or examination.
“This is kind of the typical warning letter that goes out to companies that make these wild claims who then have the products manufactured for them by a third party," said Anthony Young, a food and drug lawyer in Washington, D.C. and partner with the law firm Kleinfeld, Kaplan & Becker LLP, who reviewed FDA’s letter in order to comment for this article.
Marianna Naum, an FDA spokesman, said the agency “is still looking into the firm." Haywood did not respond to multiple emails and phone messages.
Marc Sanchez, an attorney who specializes in FDA law and regulations, reviewed the permanent injunction against Berst, a transcript from a 2013 court hearing where Berst appeared and the warning letter to Haywood.
“It may be only a matter of time before the DOJ files a new permanent injunction action claiming [Haywood] is both a successor—something casually breezed through in the hearing—and/or a new company with prior notice and continued violations," Sanchez of the law firm Contract In-House Counsel and Counselors LLC said in an email.
Berst himself isn’t likely to be the subject of another FDA civil enforcement action, unless the government produces evidence that he is still involved in the herbal business.
Court hearing: ‘FDA should be going after potato chips’
On Sept. 24, 2013, almost exactly one year after the permanent injunction had been entered against Berst, he appeared in a federal courtroom in Eugene, Oregon. Josh Burke—a trial attorney with the Justice Department’s Consumer Protection Branch and one of three named defendants in Berst’s lawsuit—sought to convince a federal judge to hold Berst in civil contempt for violating the 2012 injunction.
FDA claimed Berst was continuing to sell herbal supplements and make unlawful claims, even though he wasn’t authorized to resume business under the permanent injunction.
Berst, then 72 years old, described himself as an ordained minister and bishop who worked under a “vow of poverty" and had created herbal remedies for more than half a century. The herbal business had been sold to Berst’s daughter, Sublette, in February 2011, well before the injunction had been entered against him, he explained.
“If I were to pray with you and hand you a cup of herbal tea, then that cup of herbal tea becomes a drug, and that’s what they are talking about," Berst said in open court, according to a transcript of the hearing. “And that’s all it is is harmless herbal teas, herbal products … And I have never harmed, and they have no evidence of any harm. I have tried to comply."
Berst told the judge he was living off Social Security.
“And I again in all these years," he continued in his testimony, “I have prayed with people and handed them herbs, and these—most of these people are the poor, and I operate on donations."
Burke, the government lawyer, countered that the intended uses of Berst’s herbs were broader than Berst had discussed, and included claims to help dissolve tumors and fight diseases that may cause cancer. He also noted the court order binds successors of Berst’s business.
Under the permanent injunction that still remains in effect today, the company could not resume business until it retained an outside labeling expert, removed all unauthorized claims and obtained confirmation from FDA that it was in compliance with the court order. Berst had not done all those things.
But in noting the “absurdity of being here today," Chief District Judge Ann Aiken in Eugene, Oregon referenced what appeared to be a letter to Rep. Mike Conaway and Sen. John Cornyn, two Republicans from Texas. The statement highlighted the judiciary’s limited resources and burdensome case load. It also noted the judicial branch uses just $1.89 of every $1,000 in federal spending.
“I am sorry, but the FDA should be going after potato chips, frankly, and I am going to suggest that I want you to … direct a letter to the purchaser of your company, your daughter, just saying she is to comply," the judge said in open court.
Aiken made it clear that any future problem that arises in the case would first be handled through a phone conference; she said, “[We] will make sure the order is complied with, or if the order needs something else, I will address it."
“And I am really serious. Let’s go after those potato chip people," the judge added later in the hearing. “If they have trans fats, that’s a bigger problem than some herbal remedies … from what I read in the science literature."
A website run by Berst’s daughter hailed the ruling as “a victory for Christians and everyone who uses natural remedies."
Lawyer weighs in on ruling
The Justice Department’s decision to name Berst, rather than his actual company, as a defendant in the lawsuit seeking an injunction may have been problematic for the government in its 2013 hearing, according to Steven Shapiro, a New York lawyer whose expertise includes counseling dietary supplement firms.
Shapiro, a partner with the law firm Ullman, Shapiro & Ullman LLP, also pointed out the owner of the company—Berst’s daughter—wasn’t before the judge during the hearing.
Berst’s daughter Sublette did not respond to emailed requests for comment.
“If the correct parties were before her, would she have ruled differently?" asked Shapiro, who wasn’t involved in the case. “Would she have entered an injunction against the company? That’s difficult to say."
“This case really turns on a procedural question, not a substantive question," he continued, “because the judge never reached the substance issues."
The government’s investigation into Berst and Haywood may symbolize the challenges facing small regulated companies—including dietary supplement firms—that have limited resources to retain lawyers and other experts who can effectively counsel them in navigating FDA’s Byzantine maze of regulations.
“In many cases, formal FDA enforcement can be avoided by early involvement of effective counsel," said Sanchez, who advised companies to seek legal advice early.