Hendersonville dietary supplement company Basic Reset shut down by federal judge Brett Kelman, Nashville TennesseanPublished
Hendersonville dietary supplement company Basic Reset shut down by federal judge
Brett Kelman, Nashville TennesseanPublished
Researchers at Tufts University found no connection between vitamin and mineral supplements and a lower risk of death. USA TODAY
A federal judge ordered a Middle Tennessee distribution company to shut down on Tuesday after prosecutors accused the business of blurring the line between proven medicine and dietary supplements with no scientifically backed use.
Prosecutors also said the company was selling an $80 necklace based on false claims that it could ward off childhood cancer by protecting against electromagnetic waves.
Basic Reset, which also goes by the name Biogenyx, must halt all sales unless its products are reviewed and approved by the Food and Drug Administration and an independent auditor, according to a court order from U.S. District Judge William Campbell.
The shutdown is in response to Basic Reset and its owners failing four FDA inspections since 2012. Prosecutors petitioned the judge to take action last week, saying the owners were "repeatedly warned" about the company's violations of federal laws.
“The public has the right to expect that products perform according to claims included in their labeling and that the products are safe for use,” said U.S. Attorney Don Cochran in a news release. “FDA regulations exists to safeguard consumers and when those regulations are circumvented we will take whatever action is necessary to protect the public.”
Basic Reset, which is headquartered in a strip mall in Hendersonville, is owned by Fred and Kim Kaufman, both of whom are named as defendants in the federal case against the company. The company website sells a mix of pills, tinctures, body sprays and dietary supplements, none of which have been reviewed or approved by the FDA.
The federal case against Basic Reset hinges on the regulatory difference between drugs and dietary supplements.
Drugs are evaluated by the FDA with an extensive testing process designed to verify the drugs serve a medical purpose. Supplements, however, are barely regulated and not required to produce results.
Prosecutors say in court records that Basic Reset sells supplements but effectively markets these products as drugs by claiming they can cure, treat or prevent disease. For example, some products are advertised as treating allergies, chronic pain, burns, inflammation and depression.
Basic Reset sells pendant to ward off energy waves
Prosecutors made a similar argument about the "Energy FX" pendant, saying Basic Reset advertises the pendant as a de facto medical device that can protect customers from disease.
The website says the metal pendant shields wearers from an “electromagnetic smog of bad energies” projected from cell phones, Wi-Fi, florescent lights and other electrical devices. Basic Reset describes these energies as an “onslaught” with a “possible link” to childhood leukemia, but does not explicitly say the pendant will protect the wearer from cancer.
"Even if you don’t 'feel' any different wearing Energy FX, you can rest assured that you are being protected," the website states.
The theory that electromagnetic waves are a significant cause of cancer has been largely dismissed as fringe science by medical and public health experts, including the federal government's National Institute for Occupational Safety and Health.
Finally, prosecutors also allege Basic Reset does not properly disclose the ingredients in its products. For example, a bee pollen supplement lists ingredients that aren’t present, prosecutors claim, and an electrolyte supplement says it contains coral minerals but doesn’t disclose what those are.
The Kaufmans did not respond to requests for comment.
A Basic Reset employee hung up on a reporter who asked for the name of the company's attorney.
Brett Kelman is the health care reporter for The Tennessean. He can be reached at 615-259-8287 or at email@example.com. Follow him on Twitter at @brettkelman.