The U.S. Food and Drug Administration has gone to court to stop an Atoka company from allegedly selling products containing colloidal silver as a remedy for COVID-19.
The FDA, in a civil lawsuit filed Wednesday, claims Xephyr LLC, doing business as N-Ergetics, asserts on its company website and on product literature that colloidal silver “cures, mitigates or treats coronavirus and other diseases,” according to a complaint filed in Muskogee federal court.
The lawsuit names company owners Brad Brand, Derill J. Fussell and Linda Fussell as defendants along with the company.
The lawsuit alleges N-Ergetics offers on its website colloidal silver products for sale in the U.S. that it claims are intended to cure, mitigate, treat, or prevent coronaviruses, including COVID-19 and other diseases, including urinary tract infections, yeast infections and pink eye.
The lawsuit describes a web page with the heading “Human Coronavirus” on the N-Ergetics website as evidence of the alleged unlawful claims.
Colloidal silver, according to the U.S. Department of Health and Human Services, “consists of tiny silver particles in a liquid that is sometimes promoted on the Internet as a dietary supplement. However, evidence supporting health-related claims is lacking. In fact, colloidal silver can be dangerous to your health.”
The company website page lists various afflictions including various flu types, cholera and smallpox, calling them “non-pharmaceutical intervention viruses,” saying that they can only be controlled by “running their course,” according to the lawsuit.
A vaccine eradicated smallpox in the U.S. in the 1970s.
The web page claims there is an over-the-counter supplement used to treat pathogens for 123 years and follows with a question mark that acts as a link that takes the reader to the company’s colloidal silver page if clicked, according to the complaint.
The company sometime Wednesday afternoon replaced the text on its colloidal silver website page with the following: “Due to the FDA and the DOJ’s requests, this site has been removed. Anyone who has ordered in the last 90 days, and would like a refund, please email admin5@n-ergetics.com within the next 20 days.”
The FDA claims it conducted comprehensive searches of publicly-available medical and scientific literature for colloidal silver and determined that there was no published, adequate and well-controlled studies demonstrating that N-Ergetics’ colloidal silver products are safe and effective for use under the conditions prescribed, recommended or suggested in their labeling.
“Because there are no published adequate and well-controlled studies for the intended uses of defendants’ colloidal silver products to cure, mitigate, treat or prevent coronavirus or any other disease, qualified experts have not come to the consensus of opinion that the products are effective for such uses,” according to the complaint.
The FDA claims it issued a warning letter to the company and its owners on March 6, advising them that they were violating federal law by distributing unapproved new drugs and misbranded drugs in interstate commerce.
The lawsuit claims the company responded by posting the warning letter on its website with a news release that stated “we sell several products including colloidal silver, an ex-prescription since 1938. This now, over-the-counter supplement has been laboratory, university and doctor tested to kill 650 pathogens in vitro.”
The website also includes a disclaimer that N-Ergetics products do not mitigate, prevent, treat, diagnose or cure any virus or disease in people.
The lawsuit seeks a preliminary and permanent injunction restraining and enjoining Xephyr LLC/N-Ergetics from introducing or delivering new drugs into interstate commerce or taking part in activities related to misbranding drugs.
The lawsuit asks a judge to authorize the FDA to inspect the business and its records related to its allegations and to make restitution to all purchasers of its colloidal silver products and recall their unapproved new drugs and misbranded drugs.
YouTube has terminated N-Ergetics’ account due to what it describes as multiple or severe violations of YouTube’s policy against spam, deceptive practices, and misleading content or other violations of its terms of service.
Xephyr LLC/N-Ergetics responded to a request for comment with an email noting the take down of the colloidal silver page.
“To the best of our knowledge, we are in compliance,” the email stated.
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Gallery: Oklahoma Watch: Details on violations being reported as virus restrictions lifted in cities across the state
Oklahoma Watch: Details on violations being reported as virus restrictions lifted in cities across the state
Tulsa
Each of the police departments that responded said they either are not tracking the number of COVID-19 related calls and violations or have issued a relatively small number of violations.
“We are not doing any proactive enforcement on this,” said Tulsa Police Department Lt. Richard Meulenberg. “If anything, we are just responding to calls from citizens who want us to let us know what is going on.”
Meulenberg said the department doesn’t track the number of calls it has received from the public. But he said it hasn’t been a lot of calls “by any stretch of imagination.” And he said the number of complaints that constitute a misdemeanor violation has been less than two dozen since the pandemic began.
Event May 9 in Tulsa
A crowd is pictured at Tulsa Raceway Park on Saturday, May 9. Many residents across Oklahoma have complained on social media about a lax attitude toward wearing masks and social distancing – actions that they say endanger the wider population and increase the risk of another wave of coronavirus infections and deaths. In addition to public events, there have been reports of crowded restaurants and food service workers not wearing masks or gloves, inside or at drive-thru windows.
Oklahoma City
On May 1, Cattlemen's Steakhouse and other restaurants begin their gradual reopening. Oklahoma City Police Department spokesman Capt. Larry Withrow said punishing businesses is not one of its top priorities; the protocol for most officers is to first inform a business of the current restriction and give a warning before the business is cited. The city also isn’t tracking reopening complaints or citations.
“Our goal is voluntary compliance,” Withrow said. “Taking enforcement action would be a last resort.”
In one highly publicized incident in Oklahoma City last week, several people called the police to complain about large crowds gathering in the outside area at Kong’s Tavern, a bar and restaurant in the city’s Midtown district, during a Cinco de Mayo celebration.
Upon arriving, Oklahoma City police found that the “outside patio was full of people,” according to a police report. But no citations were issued after officers found the restaurant was following proper practices inside.
Broken Arrow
Ben Summers draws attention to Elephant in the Room barber shop in Broken Arrow on April 24, after select businesses were told they could reopen. Police in Moore and Broken Arrow said the agencies there aren’t tracking reopening complaints or citations. But the two cities, whose restrictions have largely mirrored those of Stitt’s executive order, haven’t seen an explosion of conflict. Broken Arrow spokesman Chris Walker said police received some calls shortly after the state initially required that most businesses close. But aside from a select number of calls related to people not social distancing and businesses that were supposed to close but hadn’t, they haven’t seen an influx. “We didn’t get that many,” he said. “I don’t think we gave out any citations.”
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Stillwater Mayor Will Joyce declared state of emergency for his city, as its hospital has run out of bed space and several upcoming events, including Oklahoma State University football games, are on the horizon.
Norman
In addition to the restrictions in Stitt’s executive order, localities are allowed to impose more restrictive rules.
Norman Mayor Breea Clark issued one of the most cautious reopening plans of any city.
Originally, places of worship were not allowed to reopen at the beginning of the month. At the urging of state and federal officials, Clark amended the order to allow places of worship to open but strongly discouraged them from holding in-person services.
Clark had been sued earlier by salon owners who wanted to open in the first phase. A county judge sided with salon owners and they were allowed to open, although the case is now headed for federal court.
Norman’s rules will again clash with the state’s reopening plan this Friday, when bars are allowed to operate. Under Norman’s order, bars can reopen starting May 29.
Norman
Among the cities contacted, Norman was only large city keeping a count of its reopening complaints and violations. Sarah Jensen, a spokeswoman for the Norman Police Department, said police officers had responded to 208 calls regarding compliance violations between March 25 and last Friday. Only 21 came during the first week after restrictions were relaxed on May 1. Of the 208 calls, officers determined no violations existed for nearly half the complaints; 24 led to a verbal warning and five led to a citation. A violation can be a misdemeanor punishable by a fine up to $750 and 60 days in jail. For the five violations, all given before May 1, two went to a Mitsubishi car dealership and two were given to a pair of vape shops when they remained open despite being labeled nonessential businesses. The home improvement store Lowe’s, pictured here May 8, was cited for being over capacity and not following social distancing practices.
Curtis Killman
Staff Writer
I'm a member of the Projects Team with an emphasis on database analysis. I also cover federal court news, maintain the Tulsa World database page and develop online interactive graphics. Phone: 918-581-8471
